consultation on guidance for preparing safety data sheets ... · pdf fileguidance for...

Consultation on Guidance for Preparing Safety Data Sheets

According to the Globally Harmonized System of

Classification and Labelling of Chemicals for Pest Control

Products in Canada

(publié aussi en français) 16 December 2016

This document is published by the Health Canada Pest Management Regulatory Agency. For further information, please contact:

Publications Internet: [email protected] Pest Management Regulatory Agency healthcanada.gc.ca/pmra Health Canada Facsimile: 613-736-3758 2720 Riverside Drive Information Service: A.L. 6607D 1-800-267-6315 or 613-736-3799 Ottawa, Ontario K1A 0K9 [email protected]

http://www.healthcanada.gc.ca/pmra

© Her Majesty the Queen in Right of Canada, represented by the Minister of Health Canada, 2016 All rights reserved. No part of this information (publication or product) may be reproduced or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, or stored in a retrieval system, without prior written permission of the Minister of Public Works and Government Services Canada, Ottawa, Ontario K1A 0S5. .

Guidance for Preparing Safety Data Sheets (SDS)

Table of Contents

1.0 Introduction ....................................................................................................................... 1 2.0 Background ........................................................................................................................ 1

2.1 Safety Data Sheets and Pest Control Products ............................................................. 1 2.2 SDSs and Labels ........................................................................................................... 2 2.3 Basic Obligations .......................................................................................................... 2 2.4 SDS Information and GHS Hazard Classification ....................................................... 2

3.0 SDS Guidance to Registrants ............................................................................................ 3 3.1 Making SDSs Available to Workplaces ....................................................................... 3 3.2 International SDSs ........................................................................................................ 3 3.3 WHMIS 2015 Consistent SDSs .................................................................................... 4 3.4 Basic Contents of an SDS ............................................................................................. 4

3.4.1 16-Section SDS ......................................................................................................... 4 3.4.2 Label Reference ........................................................................................................ 4 3.4.3 Consistency with the Label ....................................................................................... 4 3.4.4 Length ....................................................................................................................... 5 3.4.5 Page Numbering........................................................................................................ 5 3.4.6 Language ................................................................................................................... 5 3.4.7 Missing Information.................................................................................................. 5 3.4.8 Numbers and Quantities ............................................................................................ 5

3.5 Updating an Existing SDS and Date of Issue ............................................................... 5 3.6 No Pre-Market Review of SDSs ................................................................................... 6 3.7 Use of Software to Create SDSs ................................................................................... 6 3.8 Implementation of the Guidance .................................................................................. 6

4.0 Next Steps .......................................................................................................................... 6 Appendix I SDS Format Requirements ....................................................................................... 9 Appendix II Further Information on Required Content for GHS-consistent SDSs ................. 13

Section 1 Identification ........................................................................................................... 13 Section 2 Hazard identification ............................................................................................... 14 Section 3 Composition/information on ingredients ................................................................ 15 Section 4 First-aid measures ................................................................................................... 17 Section 5 Fire-fighting measures ............................................................................................ 18 Section 6 Accidental release measures ................................................................................... 18 Section 7 Handling and storage .............................................................................................. 19 Section 8 Exposure controls/personal protection .................................................................... 20 Section 9 Physical and chemical properties ............................................................................ 22 Section 10 Stability and reactivity ........................................................................................ 27 Section 11 Toxicological information ................................................................................... 28 Section 12 Ecological information ........................................................................................ 31 Section 13 Disposal considerations ....................................................................................... 32 Section 14 Transport information ......................................................................................... 33 Section 15 Regulatory information ....................................................................................... 35 Section 16 Other information ................................................................................................ 36

Appendix III PMRA Hazard Class and the Comparable GHS Hazard Class (or classes) ........ 37

Guidance for Preparing Safety Data Sheets (SDS)

Guidance for Preparing Safety Data Sheets (SDS) Page 1

1.0 Introduction

This consultation document, produced by Health Canada’s Pest Management Regulatory Agency (PMRA), invites comments on the following guidance for registrants of pest control products on the expected format and content of GHS-consistent1 Safety Data Sheets (SDSs) for registered pest control products in Canada.

This guideline is intended for the voluntary adoption and use by all registrants with a pest control product registered in Canada. SDSs are primarily for use by workers (for example, handlers, warehouse workers, agricultural workers, pre- and post- application workers, and vendors) in workplaces involved in pest control product application and handling. Registrants should keep this audience in mind when writing an SDS. However, registrants should also take into account that SDSs are commonly used by emergency responders (including health professionals), consumers, and those involved in the transportation of dangerous goods.

The PMRA invites the public to submit written comments up to 45 days from the publication of this consultation document. Please forward all comments to PMRA Publications. (See Section 4.0, Next Steps, for more information.)

2.0 Background

2.1 Safety Data Sheets and Pest Control Products

SDSs (previously called “material safety data sheets” or MSDSs) are an important part of communicating the hazards associated with pest control products and other chemicals. The SDS format found in Table 1.5.2 of the Globally Harmonized System (GHS) of classifying and labelling of chemicals2 has become the international standard format for SDSs used in workplaces, with some modifications for each regulatory jurisdiction.

This document aims to help registrants prepare SDSs according to the GHS format and classification system. This will in turn support compliance with any eventual regulatory requirements for SDSs under the Pest Control Products Act to be established in the future.

1 GHS-consistent SDS means an SDS produced using an accepted version of the GHS (version 5 is the

version this guidance is largely adapted from but using versions 3, 4, or 6 would also be acceptable as long as the Canadian specific pesticide information is included), or a GHS based system that has been adopted by a recognized jurisdiction, see Sections 3.2 and 3.3.

2 Globally Harmonized System of Classification and Labelling of Chemicals (GHS), 5th ed. 2013. New York: United Nations. At: http://www.unece.org/trans/danger/publi/ghs/ghs_rev05/05files_e.html.


2.2 SDSs and Labels

The approved pest control product label (the label), under the Pest Control Products Act, needs to be followed at all times and in cases where there are any discrepancies between the approved label and an SDS for that product it is the label information that prevails. Note that labels approved under the Pest Control Products Act are not in the GHS.

2.3 Basic Obligations

To conform with this guideline, it is expected that:

• Registrants prepare bilingual (French and English) GHS-consistent SDSs for registered Commercial, Restricted, and Manufacturing class pest control products;3

• Registrants who develop SDSs make them available to workers and workplaces, wherever pest control products are used, sold, stored, transported and handled in Canada; and to the Minister of Health on request;

• Generally, SDSs be made available through websites and by email, however some workplaces may require paper copies be provided to them; and

• SDSs indicate all hazards of the product using GHS-consistent classification.

At a minimum, registrants are expected to disclose ingredients on SDSs in the same manner as is required for labels.4 Registrants may further choose to list or group ingredients (see Section 3 of Appendix II for more information).

This guidance does not call for the creation of GHS-consistent SDSs for Domestic Class pest control products or to pest control products scheduled under the Pest Control Products Act and Regulations. However, there may be situations where registrants or suppliers may want to make an SDS available for Domestic Class or scheduled pest control products (for example, warehouse storage, consumer requests); in which case, they may wish to use this guidance.

2.4 SDS Information and GHS Hazard Classification

The GHS is an international standard for communicating chemical hazard information through labels and SDSs using a standardized 16-Section SDS format (see Appendix I for the list of sections). The GHS label elements include signal words, symbols and hazard and precautionary statements. The GHS provides classification criteria for physical, health and environmental hazards associated with chemicals.

3 Pesticide classes are described in the Pest Control Products Regulations, see: http://laws-

lois.justice.gc.ca/eng/regulations/SOR-2006-124/page-1.html#s-1. 4 See section 43 of the Pest Control Products Act for more information on what ingredient information is

protected as confidential business information (CBI).


To be GHS consistent, pest control products are to be classified by hazard class in accordance with an accepted version of the GHS.5 Implementing the GHS classification system for SDSs should not require registrants to generate new data in order to derive a GHS classification. The current data needed to register a pest control product should be sufficient to populate the 16-section template.

3.0 SDS Guidance to Registrants

3.1 Making SDSs Available to Workplaces

Registrants are expected to make SDSs available to workers and workplaces wherever pest control products are manufactured, possessed, handled, stored, transported, imported, distributed or used in Canada. For the purposes of this document, “make available” includes distributing SDSs electronically and publishing them online. However, it is also expected that registrants provide paper copies to workplaces upon request. Consistent with the Pest Control Products Act definition, a “workplace” is a place where a person works for remuneration (that is, for pay/salary).

The SDS can be made available as an integrated bilingual document (for example, side by side), or as a document with two unilingual parts that constitute one bilingual SDS.

3.2 International SDSs

As GHS is an international standard and in use by other jurisdictions, an SDS produced for another country should only require minimal adaptation for use in Canada as a pest control product SDS. Jurisdictions where this minimal adaption should be possible for registered pest control product SDSs include the United States Occupational Safety and Health Administration (US OSHA) Hazard Communication Standard 2012 (HCS 2012) and the European Union Legislation on Classification, Labelling and Packaging of Chemicals in the GHS. For these cases, the adaptation would be adding the relevant information to Section 1: Identification, and Section 15: Regulatory Information as described in Appendix II.

Although sections 12 to 14 (ecological information, disposal considerations, and transport information) are not mandatory under the United States’ HCS 2012, registrants of pest control products may choose to include this information, if it is available.

5 The 5th revised edition of 2013 can be found at:

ttp://www.unece.org/trans/danger/publi/ghs/ghs_rev05/05files_e.html.


3.3 WHMIS 2015 Consistent SDSs

An SDS that is consistent with the Workplace Hazardous Materials Information System (WHMIS 2015), that meets the requirements of the Hazardous Products Regulations, which were published in the Canada Gazette, Part II, on February 11, 2015, would be consistent with this guideline with minimal adaptation. To be consistent with this guideline, these SDSs only need to have the relevant information added to Section 1: Identification, and Section 15: Regulatory Information as described in Appendix II.

Although sections 12 to 14 (ecological information, disposal considerations, and transport information) are not mandatory under WHMIS 2015, registrants of pest control products may choose to include this information, if it is available.

Note that pest control products, as defined in subsection 2(1) of the Pest Control Products Act, are excluded from the application of the Hazardous Products Act (that is, pest control products are exempt from the supplier labelling and SDS requirements of the Hazardous Products Act and Regulations).

3.4 Basic Contents of an SDS6

3.4.1 16-Section SDS

The information in the SDS is to be presented using the 16 sections outlined in Appendix I. Information on the required content for each of the 16 sections of the GHS-consistent SDSs is included in Appendix II.

3.4.2 Label Reference

All pest control product SDSs are to include a reference to the approved label as the label is the main document to be followed for safety, use, and handling. Section 15: Regulatory Information would be an appropriate section to indicate this information.

3.4.3 Consistency with the Label

As noted above, the existing hazard classification criteria for pest control products used on labels is a different system than the GHS. Appendix III to this document outlines the PMRA hazard class and the comparable GHS hazard class (or classes).

Differences between the approved label and the SDS hazard communications elements are to be described in Section 15: Regulatory Information. For example, a GHS label element in section 2 of the SDS could indicate the signal word and hazard statement “Warning, Harmful if swallowed” with the exclamation mark symbol inside a red square set at a point border shape; whereas the approved label may indicate “Caution” and “Poison” with the skull and crossbones symbol inside a black inverted triangle-shaped border. 6 GHS, Annex 4, at:

http://www.unece.org/fileadmin/DAM/trans/danger/publi/ghs/ghs_rev05/English/08e_annex4.pdf


If the label contains environmental hazard statements these should also be included in Section 15: Regulatory Information. For example, if the statement “Toxic to aquatic organisms” is used on the label, this should also be indicated on the SDS.

Other label differences in regulatory information (for example, disposal considerations) should also be included in Section 15: Regulatory Information.

However, to avoid duplication, if the relevant label information is included in one section of the SDS (for example, environmental label statements included in Section 12: Ecological Information) it does not also have to be included in Section 15: Regulatory Information.

3.4.4 Length

An SDS is not a fixed length document. The length of the SDS will be commensurate with the amount of information needed to clearly communicate the hazards and provide information on the safe storage, handling, first aid, precautionary and emergency response measures, and disposal of the product.

3.4.5 Page Numbering

All pages of an SDS are to be numbered and some indication of the end of the SDS should be given (for example: “page 1 of 3”).

3.4.6 Language

The language used in the SDS should be simple, clear and precise, avoiding jargon, acronyms and abbreviations as well as vague or misleading language such as “may be dangerous”, “no health effects”, “safe under most conditions of use”, or “harmless”.

3.4.7 Missing Information

If the information to be provided under sections 1 to 16 of the SDS is not applicable or is technically impossible to provide, the reasons for the absence of this information is to be clearly stated under the relevant section.

Additionally, the SDS is to clearly differentiate between cases where negative test results are available, cases where no information is available and cases where the information is not applicable. For example: under Section 10: Stability and Reactivity, item 5 (incompatible materials), if the pest control product is not reactive with any material, then it would be appropriate to indicate that this item is “not applicable”.

3.4.8 Numbers and Quantities

Numbers and quantities on an SDS are to be expressed in units appropriate to Canada. In general, the International System of Units (SI) is to be used.

3.5 Updating an Existing SDS and Date of Issue


Registrants are to revise their SDSs whenever new scientific, technical, health or safety information becomes available that will affect content, as well as when there are any changes in product registration and registrant information.

The date of issue of the SDS is to be indicated prominently (for example, on the cover page). The date of issue is the date the SDS version was made public. This generally occurs shortly after the SDS authoring and publishing process is completed. Revised SDSs are to indicate the date of latest revision of the SDS.

3.6 No Pre-Market Review of SDSs

SDSs are not part of the approved pest control product label and are not subject to pre-market approval by PMRA.

3.7 Use of Software to Create SDSs

In developing GHS-consistent SDSs, registrants may wish to use software such as the Canadian Centre for Occupational Health and Safety’s (CCOHS) CANWrite program (see http://www.ccohs.ca/products/canwrite/). CANWrite has been designed to produce SDSs compliant with WHMIS 2015 and/or the United States Occupational Safety and Health Administration Hazard Communication Standard 2012, and can be adapted to accommodate pest control products. An example of a SDS in the GHS format can be found on the CCOHS website at: http://www.ccohs.ca/products/canwrite/sample_canwrite_msds.pdf.

3.8 Implementation of the Guidance

Registrants with pest control products registered in Canada are encouraged to adopt and follow this guidance document from the date it is published.

4.0 Next Steps

The PMRA invites the public to submit written comments on this proposal up to 45 days from publication. Please forward your comments to PMRA Publications, and include:

• Your full name and organization;

• Your phone number; and,

• Your complete mailing address or email address.

The PMRA will consider all comments received before publishing the final guidance document on the Pesticides and Pest Management portion of the Health Canada website.

Comments or questions on this consultation or the proposed guidelines can also be directed to the Pest Management Information Service, by subject, at:

Pest Management Information Service Pest Management Regulatory Agency


Health Canada 2720 Riverside Drive Ottawa, Ontario Address Locator: 6606D2 K1A 0K9

E-mail: [email protected] Telephone: 613-736-3799 Toll-free: 1-800-267-6315 Facsimile: 613-736-3798 Teletypewriter: 1-800-465-7735 (Service Canada)

Appendix I


Appendix I SDS Format Requirements

The below format or a similar format that follows the same order and information requirements is to be used for pest control product SDSs. For further information on SDS content, see Appendix II, Further Information on Required Content for Safety Data Sheets. Items that are pest control product SDS specific to Canada are in bold.

Section Information 1 Identification 1) Product name as on the label

2) Pest Control Product Registration Number as on the label 3) Company contact information (for example, Registrant, Canadian Representative) 4) Product use (for example insecticide, herbicide, fungicide) 5) Emergency phone number (for example, 1-800 number, CANUTEC)

2 Hazard identification

1) GHS Classification of the active ingredient(s)/end use product(s) (EPs), manufacturing concentrate(s) (MAs), or Integrated System Product(s) (ISPs) 2) GHS Label elements including symbol(s) (or description), signal word, hazard and precautionary statements 3) Any other hazards which do not result in classification or are not covered by the GHS

3 Composition/ information on ingredients

1) Chemical identity for each active ingredient and any formulant or contaminant that is shown on the label: a) Chemical Abstracts Service (CAS) number and other unique identifiers b) name and concentration, as shown on the label

4 First-aid measures 1) Description of necessary measures, subdivided according to the different routes of exposure, in other words, inhalation, skin and eye contact and ingestion 2) Most important symptoms/effects, acute and delayed 3) Indication of immediate medical attention and special treatment needed, if necessary

5 Fire-fighting measures

1) Suitable (and unsuitable) extinguishing media 2) Specific hazards arising from the product (for example, nature of any hazardous combustion products) 3) Special protective equipment and precautions for fire-fighters

6 Accidental release measures

1) Personal precautions, protective equipment and emergency procedures 2) Environmental precautions 3) Methods and materials for containment and cleaning up

7 Handling and storage

1) Precautions for safe handling 2) Conditions for safe storage, including any incompatibilities

Appendix I


Section Information 8 Exposure controls/

personal protection 1) Control parameters: occupational exposure limit values or biological limit values and the source of that value 2) Appropriate engineering controls 3) Individual protection measures, such as personal protective equipment

9 Physical and chemical properties

1) Appearance (physical state, colour etc.) 2) Odour 3) Odour threshold 4) pH 5) Melting point/freezing point 6) Initial boiling point and boiling range 7) Flash point 8) Evaporation rate 9) Flammability (solid, gas) 10) Upper/lower flammability or explosive limits 11) Vapour pressure 12) Vapour density 13) Relative density 14) Solubility(ies) 15) Partition coefficient: n-octanol/water (Kow ) 16) Auto-ignition temperature 17) Decomposition temperature 18) Viscosity

10 Stability and reactivity

1) Reactivity 2) Chemical stability 3) Possibility of hazardous reactions 4) Conditions to avoid (for example, static discharge, shock or vibration) 5) Incompatible materials 6) Hazardous decomposition products

11 Toxicological information

1) Concise but complete and comprehensible description of the various toxicological (health) effects and the available data used to identify those effects, including: a) Information on the likely routes of exposure (inhalation, ingestion, skin and eye contact) b) Symptoms related to the physical, chemical and toxicological characteristics c) Delayed and immediate effects and also chronic effects from short and long term exposure d) Numerical measures of toxicity (such as acute toxicity estimates)

12 Ecological information

a) Ecotoxicity (aquatic and terrestrial, where available) b) Persistence and degradability c) Bioaccumulative potential d) Mobility in soil e) Other adverse effects

Appendix I


Section Information 13 Disposal

considerations Description of waste residues and information on their safe handling and methods of disposal, including the disposal of any contaminated packaging

14 Transport information

1) UN number 2) UN proper shipping name 3) Transport hazard class(es) 4) Packing group, if applicable 5) Environmental hazards (for example, Marine pollutant (Yes/No)) 6) Transport in bulk (according to Annex II of MARPOL 73/78 and the IBC Code) 7) Special precautions which a user needs to be aware of or comply with in connection with transport or conveyance either within or outside their premises

15 Regulatory information

1) Safety, health and environmental regulations specific for the product in question

2) Label reference 3) Label hazard elements 4) Description of differences between label and SDS

16 Other information The date of the latest revision of the SDS

Appendix I


Appendix II


Appendix II Further Information on Required Content for GHS-consistent SDSs

The following descriptions of the SDS’s 16 Sections provide further information on the required content to be included when completing an SDS for a pest control product in Canada. This information is adapted from the GHS 5th revised edition, Annex 4, “Guidance on the Preparation of Safety Data Sheets (SDS)”.7

Section 1 Identification 1 Identification 1) Product name as indicated on label

2) Pest Control Product Registration Number as indicated on the label 3) Company contact information (for example, registrant, Canadian representative) 4) Product use (for example, insecticide, herbicide, fungicide) 5) Emergency phone number (for example, 1-800 number, CANUTEC)

In this section the Canadian product name, Pest Control Products Act registration number, contact information is to be included.

In this section, identify the pest control product (active ingredient(s) / end use product(s) (EPs), manufacturing concentrate(s) (MAs), or Integrated System Product(s) (ISPs)) and provide the name of the registrant, recommended uses and the registrant’s contact information, including an emergency contact.

Product identifier

The identity (for example, name) of the pest control product (product identifier) is to be exactly as found on the label (that is, the registered pest control product name) and registration number of the pest control product. If one generic SDS is used to cover several minor variants of an active ingredient or EP, MA, or ISP, all names and variants are to be listed on the SDS or the SDS is to clearly delineate the range of substances included.

Other means of identification

In addition, or as an alternative, to the product identifier, the active ingredient or EP, MA, or ISP may be identified by alternative names, numbers, company product codes, or other unique identifiers. Provide other names or synonyms by which the active ingredient or EP, MA, or ISP is labelled or commonly known, if applicable.

7 GHS, Annex 4 at: http://www.unece.org/fileadmin/DAM/trans/danger/publi/ghs/ghs_rev05/English/ST-

SG-AC10-30-Rev5e.pdf

Appendix II


Recommended use of the chemical and restrictions on use

Provide the recommended or intended use of the active ingredient or EP, MA, or ISP, including a brief description of what it actually does, for example, insecticide, herbicide, adjuvant, etc. Restrictions on use are to, as much as possible, be stated including non-statutory recommendations for use only as directed on the registered product label.

Supplier identifier

The name, full address, and Canadian specific phone number(s) of the supplier of the pest control product is to be included on the SDS, if different than the registrant.

Emergency phone number

References to emergency information services are to be included in all SDSs. If any restrictions apply, such as hours of operation (for example, Monday-Friday, 8:00 a.m.-6:00 p.m., or 24 hours) or limits on specific types of information (for example, medical emergencies, or transportation emergencies), this is to be clearly stated. This can be a 1-800 number and/or CANUTEC.

Section 2 Hazard identification 2 Hazard

identification 1) GHS Classification of the active ingredient(s)/end use product(s) (EPs), manufacturing concentrate(s) (MAs), or Integrated System Product(s) (ISPs) 2) GHS Label elements including symbol(s) (or description), signal word, hazard and precautionary statements 3) Any other hazards which do not result in classification or are not covered by the GHS

This section describes the hazards of the active ingredient, EP, MA, or ISP and the appropriate warning information (symbol, signal word, hazard statement(s) and precautionary statement(s)) associated with those hazards.

Classification of the active ingredient or EP, MA, ISP

This sub-section indicates the hazard classification of the active ingredient, EP, MA, or ISP.

If the active ingredient, EP, MA, or ISP is classified in accordance with Parts 2, 3 and/or 4 (physical, health, and environmental hazards) of the GHS, generally the classification is communicated by providing the appropriate hazard class and category/subcategory to indicate the hazard (for example, Flammable liquid - Category 1 and Skin corrosion- Category 1A).

What GHS-classification system the pest control product has been classified in should be indicated, for example: “Classification in accordance with US OSHA regulation HCS2012:”, or “Classification in accordance with Canada WHMIS 2015 regulation:”, or “Classification in accordance with the UN GHS Version 5:”.

Appendix II


However, when classification is differentiated within a hazard class and results in unique hazard statements, then the classification also reflects that differentiation. For example, the route of exposure differentiates the acute toxicity classification as follows: Acute toxicity (Oral) - Category 1, Acute toxicity (Dermal) - Category 1 and Acute toxicity (Inhalation) - Category 1. If an active ingredient, EP, MA, or ISP is classified into more than one category in a hazard class that is differentiated, then all classifications are to be communicated.

Label elements

Based on the classification, provide the appropriate label elements: symbol(s) signal word, hazard statement(s), and precautionary statement(s).

A pictogram (or hazard symbol) may be provided in a black-and-white picture form. Alternatively, the name of the symbol, for example, “flame” or “skull and crossbones”, may be used.

Other hazards which do not result in classification or are not covered by the GHS

Provide information on other hazards that do not result in classification, but may contribute to the overall hazards of the material; for example, formation of air contaminants during hardening or processing, dust explosion hazards, suffocation, freezing or environmental effects such as hazards to soil-dwelling organisms.

The statements “May form explosible dust-air mixture if dispersed” or “May form combustible dust concentrations in air.” are appropriate in the case of a dust explosion hazard.

Section 3 Composition/information on ingredients 3 Composition/

information on ingredients

1) Chemical identity for each active ingredient and any formulant or contaminant that is shown on the label: a) Chemical Abstracts Service (CAS) number and other unique identifiers b) name and concentration, as shown on the label

The pest control product ingredient(s) are to be identified in this section. This section may also be used to provide information on complex active ingredients, EPs, MAs or ISPs.

At a minimum, registrants are expected to disclose the chemical identity of the active ingredient(s) on SDSs in the same manner as is required for labels (see section 43 of the Pest Control Products Act).

Formulants and contaminants are typically considered confidential business information (CBI) and the concentration and identity of these ingredients do not have to be disclosed unless there is a health concern (for example, allergens, petroleum distillates). These ingredients that are health concerns are already included on the label and the label statement is to be included in Section 15.

However, registrants may choose to voluntarily list or group ingredients by active ingredients, formulants (called inerts in the US) and impurities (contaminants) by common or chemical name, CAS number, and concentration. The intent of ingredient disclosure is to provide as much safety

Appendix II


data information as possible to workers and workplaces, especially for those ingredients that contribute to the GHS hazard classification of the product, without disclosing trade secrets (that is, CBI).

When applicable, indicate that confidential information about the composition was omitted. In such cases, the words “trade secret” may replace the CAS number or concentration of an ingredient. The actual concentration could be replaced by the corresponding cut-off/concentration limits specified in the GHS. For example, “Acute Toxicity (Oral) Category 3: LD50 > 50 and ≤ 300 mg/kg bw” can replace an acute oral toxicity LD50 falling within that range. Ingredients that do not contribute to the hazard classification can be grouped together and identified as ‘other ingredients’. Product composition should add up to 100 percent.

Active Ingredients

The chemical identity of the active ingredients is to be provided. The identity of an active ingredient can be provided by its common chemical name. The chemical name can be identical to the product identifier. The “common chemical name” may, for example, be the CAS name or International Union of Pure and Applied Chemistry (IUPAC) name, or the International Organization for Standardization (ISO) name, as applicable. The chemical name can also be identical to that given on the Health Canada PMRA Statement of Product Specification Form (SPSF).

Common name(s), synonym(s) of the active ingredients

ISO Common name or accepted name and synonyms are to be provided where appropriate.

CAS number and other unique identifiers for the active ingredients

The CAS registry number provides a unique chemical identification and is to be provided when available. Other unique identifiers specific to a country or region, such as the European Community (EC) number can be added.

Identify any impurities and/or stabilizing additives, which are themselves classified and which contribute to the classification of the substance.

EPs, MAs, and ISPs

For EPs, MAs or ISPs, provide the chemical identity and identification number (for example, CAS number, or EC number) unless they are trade secrets or CBI. However, EPs, MAs or ISPs, which are hazardous to health or the environment, within the meaning of the GHS, and are present above their GHS cut-off levels are to have the hazards indicated on the SDS. Hazards associated with EPs, MAs, or ISPs, as the GHS classification determines, have to be presented on the SDS even if the identity and/or concentration of certain ingredients are protected as CBI.

Registrants may choose to list all ingredients, including non-hazardous ingredients.

Appendix II


The concentrations of the ingredients for EPs, MAs, or ISPs are to be described as: (a) exact percentages in descending order by mass or volume; or (b) range of percentages in descending order by mass or volume.

When using a proportion range, the health and environmental hazard effects are to describe the effects of the most hazardous concentration (usually the highest concentration) of each ingredient, provided that the effects of the EPs, MAs, or ISPs as a whole are not available. For example, component A is present at 10-20% of the total composition of a product. The acute toxicity (oral) classification of component A at <15% is Category 4 and at 15-50% is Category 3. Therefore, since component A could be present at 20% of the total composition, the classification of component A would be acute toxicity (oral) Category 3.

The “proportion range” refers to the concentration or percentage range of the ingredient in the EPs, MAs, or ISPs.

Section 4 First-aid measures 4 First-aid

measures 1) Description of necessary measures, subdivided according to the different routes of exposure, in other words, inhalation, skin and eye contact and ingestion 2) Most important symptoms/effects, acute and delayed 3) Indication of immediate medical attention and special treatment needed, if necessary

This section describes the initial care that should be given to an individual who has been exposed to the product. This initial care is expected to be without the use of sophisticated equipment and without a wide selection of medications available. If medical attention is required, the instructions are to state this, including its urgency. It may be useful to provide information on the immediate effects, by route of exposure, and indicate the immediate treatment, followed by possible delayed effects with specific medical surveillance required.

Description of necessary first-aid measures

Provide first-aid instructions by relevant routes of exposure. Use sub-headings to indicate the procedure for each route (for example, inhalation, skin, eye and ingestion). Describe expected immediate and delayed symptoms.

Provide advice whether: (a) immediate medical attention is required and if delayed effects can be expected after exposure; (b) movement of the exposed individual from the area to fresh air is recommended; (c) removal and handling of clothing and shoes from the individual is recommended; and (d) PPE for first-aid responders is recommended.

Most important symptoms/effects, acute and delayed

Provide information on the most important symptoms/effects, acute and delayed, from exposure.

Appendix II


Indication of immediate medical attention and special treatment needed, if necessary.

Where appropriate, provide information on clinical testing and medical monitoring for delayed effects, specific details on antidotes (where they are known) and contraindications.

Section 5 Fire-fighting measures 5 Fire-fighting

measures 1) Suitable (and unsuitable) extinguishing media 2) Specific hazards arising from the product (e.g. nature of any hazardous combustion products) 3) Special protective equipment and precautions for fire-fighters

This section covers the requirements for fighting a fire caused by the active ingredient or EP, MA, or ISP or arising in its vicinity.

Suitable extinguishing media

Provide information on the appropriate extinguishing media. In addition, indicate whether any extinguishing media are inappropriate for a particular situation involving the active ingredient or EP, MA, or ISP (for example, avoid high pressure media that could cause the formation of a potentially explosible dust-air mixture).

Specific hazards arising from the product

Provide advice on specific hazards that may arise from the product, such as hazardous combustion products that form when the active ingredient or EP, MA, or ISP burns. For example: (a) “may produce toxic fumes of carbon monoxide if burning”; or (b) “produces oxides of sulphur and nitrogen on combustion”.

Special protective actions for fire-fighters

Provide advice on any protective actions to be taken during fire-fighting. For example, “keep containers cool with water spray”.

Section 6 Accidental release measures 6 Accidental

release measures

1) Personal precautions, protective equipment and emergency procedures 2) Environmental precautions 3) Methods and materials for containment and cleaning up

This section recommends the appropriate response to spills, leaks, or releases in order to prevent or minimize the adverse effects on persons, property, and the environment. The section should distinguish between responses for large and small spills where the spill volume has a significant impact on the hazard. The procedures for containment and recovery may indicate that different practices are required for large and small spills.

Appendix II


Personal precautions, protective equipment and emergency procedures

For non-emergency personnel

Provide advice related to accidental spills and release of the active ingredient or EP, MA, or ISP such as: (a) the wearing of suitable protective equipment (including personal protective equipment, see Section 8 of the SDS) to prevent any contamination of skin, eyes and personal clothing; (b) removal of ignition sources and provision of sufficient ventilation; and (c) emergency procedures such as the necessity to evacuate the danger area or to consult an expert.

For emergency responders

Provide advice related to suitable fabric for personal protective clothing (for example: “appropriate: butylene; not appropriate: polyvinyl chloride (PVC)”).

Environmental precautions

Provide advice on any environmental precautions related to accidental spills and release of the active ingredient or EP, MA, or ISP, such as keeping it away from drains, surface and ground water.

Methods and materials for containment and cleaning up

Provide appropriate advice on how to contain and clean up a spill. Appropriate containment techniques may include: (a) bunding, covering of drains; and (b) capping procedures (that is, providing a cover or protection (to prevent damage or spillage)). Note that bunding is a system to contain liquids in the event of a leak or spillage from tanks or pipe work that can capture well in excess of the volume of liquids held, for example, an embankment. Bunded areas are to drain to a capture tank with facilities for water/oil separation.

Appropriate clean-up procedures may make use of: (a) neutralization techniques; (b) decontamination techniques; (c) adsorbent materials; (d) cleaning techniques; (e) vacuuming techniques; and (f) equipment required for containment/clean up (include the use of non-sparking tools and equipment where applicable).

Provide any other issues relating to spills and releases. For example, include advice on any inappropriate containment or clean-up techniques.

Section 7 Handling and storage 7 Handling and

storage 1) Precautions for safe handling 2) Conditions for safe storage, including any incompatibilities

This section provides guidance on safe handling practices that minimize the potential hazards to people, property, and the environment from the active ingredient, EP, MA, or ISP. The section should emphasize precautions that are appropriate to the intended use and to the unique properties of the active ingredient, EP, MA, or ISP.

Appendix II


Precautions for safe handling

Provide advice that: (a) allows safe handling of the active ingredient, EP, MA, or ISP; (b) prevents handling of incompatible active ingredient, EP, MA, or ISP; (c) draws attention to operations and conditions that create new risks by altering the properties of the active ingredient, EP, MA, or ISP, and to appropriate countermeasures; and (d) minimizes the release of the active ingredient, EP, MA, or ISP to the environment.

It is good practice to provide advice on general hygiene. For example: (a) “eating, drinking and smoking in work areas is prohibited”; (b) “wash hands after use”; and (c) “remove contaminated clothing and protective equipment before entering eating areas”.

Conditions for safe storage, including any incompatibilities

Ensure to provide advice consistent with the physical and chemical properties detailed in Section 9 (Physical and chemical properties) of the SDS. Where relevant, specify storage requirements as related to:

(a) avoiding (i) explosive atmospheres, (ii) corrosive conditions, (iii) flammability hazards, (iv) incompatible active ingredient, EP, MA, or ISP, (v) evaporative conditions, and (vi) potential ignition sources (including electrical equipment);

(b) controlling the effects of (i) weather conditions, (ii) ambient pressure, (iii) temperature, (iv) sunlight, (v) humidity, and (vi) vibration.

(c) maintaining the integrity of the active ingredient, EP, MA, or ISP by the use of (i) stabilizers, (ii) anti-oxidants, or (iii) preservatives.

(d) other issues, including: (i) ventilation requirements, (ii) specific designs for storage rooms/vessels, (iii) quantity limits under storage conditions (if relevant), and (iv) packaging compatibilities.

Section 8 Exposure controls/personal protection 8 Exposure

controls/ personal protection

1) Control parameters: occupational exposure limit values or biological limit values and the source of that value 2) Appropriate engineering controls 3) Individual protection measures, such as personal protective equipment

In this document, the term “occupational exposure limit(s)” refers to limits in workplace air or biological limit values; and “exposure control” refers to the specific protection and prevention measures available during pest control product use to minimize worker and environmental exposure. The term “control banding” is a system used to assess and manage workplace risks. It refers to a process that matches an exposure control measure (ventilation, engineering controls, containment, etc.) to a range or “band” of hazards and exposures (skin/eye irritant, very toxic, carcinogenic, high potential of exposure, etc.). Engineering control measures needed to minimize exposure to, and risks associated with the hazards of, the active ingredient, EP, MA, or ISP are to be included in this section.

Appendix II


Control parameters

Where these are available, list the occupational exposure limits (limits in workplace air or biological limit values), including notations, for an active ingredient and for each of the ingredients of an EP, MA, or ISP. If air contaminants are formed when using the active ingredient, EP, MA, or ISP as intended, available occupational exposure limits for these are to also be listed. If an occupational exposure limit exists for the province or region in which the SDS is being supplied, this is to be listed. The source of the occupational exposure limit is to be stated on the SDS. When listing occupational exposure limits, the chemical identity as specified in Section 3 (Composition/Information on ingredients) of the SDS is to be used.

Where these are available, list the biological limit values, including notations, for an active ingredient and for each of the ingredients of an EP, MA, or ISP. The source of the biological limit value is to be stated on the SDS; wherever possible, the biological limit value is to be related to the provinces or regions in which the SDS is being supplied. When listing biological limit values, use the chemical identity as specified in Section 3 of the SDS.

Where a control banding approach is recommended for providing protection in relation to specific uses, sufficient detail is to be given to enable effective risk management. The context and limitations of the specific control banding recommendation is to be made clear.

Appropriate engineering controls

Exposure control measures are to relate to the intended modes of use of the active ingredient, EP, MA, or ISP. Sufficient information is to be provided to enable appropriate risk assessment. Indicate when special engineering controls are necessary and specify which type. Examples include: “applicators must be in fully enclosed cabs or if not in fully enclosed cabs, applicators must wear additional personal protective equipment and clothing.”; “observe a restricted-entry interval of 12 hours after application for all post application activities”; “calibration tubes and instructions are available from your supplier”; “if application of the fumigant is performed from within the structure to be fumigated, approved respiratory protection is required to be worn by all personnel inside the structure”; and “a product must be used in a closed transfer system only”.

The information provided here is to complement that provided under Section 7 (Handling and storage) of the SDS.

Individual protection measures, such as personal protective equipment

Consistent with good occupational hygiene practices, PPE is to be used in conjunction with other control measures, including engineering controls, ventilation and isolation. (See also Section 5 of the SDS on fire-fighting measures for specific fire/chemical PPE advice.)

Identify the PPE needed to minimize the potential for illness or injury due to exposure from the active ingredient, EP, MA, or ISP, including:

(a) Eye/face protection: specify the type of eye protection and/or face shield required, based on the hazard of the active ingredient, EP, MA, or ISP and potential for contact;

Appendix II


(b) Skin protection: specify the protective equipment to be worn (for example, type of gloves, boots, footwear, bodysuit, coveralls, or clothing) based on the hazards associated with the active ingredient, EP, MA, or ISP and the potential for contact;

(c) Respiratory protection: specify appropriate types of respiratory protection based on the hazard and potential for exposure, including air-purifying respirators and the proper purifying element (cartridge or canister) or breathing apparatus; and

(d) Thermal hazards: when specifying protective equipment to be worn for materials that represent a thermal hazard, special consideration is to be given to the construction of the PPE.

Special requirements may exist for gloves or other protective clothing to prevent skin, eye or lung exposure. Where relevant, this type of PPE is to be clearly stated. For example, “polyvinyl chloride (PVC) gloves” or “nitrile rubber gloves”, and thickness and breakthrough time of the glove material.

Section 9 Physical and chemical properties8 9 Physical

and chemical properties

1) Appearance (physical state, colour etc.) 2) Odour 3) Odour threshold 4) pH 5) Melting point/freezing point 6) Initial boiling point and boiling range 7) Flash point 8) Evaporation rate 9) Flammability (solid, gas)

10) Upper/lower flammability or explosive limits 11) Vapour pressure 12) Vapour density 13) Relative density 14) Solubility(ies) 15) Partition coefficient: n-octanol/water (log Kow) 16) Auto-ignition temperature 17) Decomposition temperature 18) Viscosity

Describe the empirical data of the active ingredient, EP, MA, or ISP (if possible) in this section. In the case of an EP, MA, or ISP, the entries should clearly indicate to which ingredient the data apply, unless it is valid for the whole EP, MA, or ISP. The data included in this sub-section should apply to the active ingredient, EP, MA, or ISP.

Clearly identify the following properties and specify appropriate units of measure and/or reference conditions where appropriate. If relevant for the interpretation of the numeric value, the method of determination is to also be provided (for flash point, open-cup/closed-cup, etc.): appearance (physical state, colour, etc.); odour; odour threshold; pH; melting point/freezing point; initial boiling point and boiling range; flash point; evaporation rate; flammability (solid, gas); upper/lower flammability or explosive limits; vapour pressure; vapour density; relative density; solubility(ies); partition coefficient: n-octanol/water; auto-ignition temperature; decomposition temperature; and viscosity.

8 The GHS 6th revised edition provides further information on physical and chemical properties and can be

found at: http://www.unece.org/trans/danger/publi/ghs/ghs_rev06/06files_e.html#c38156.

Appendix II


If specific characteristics do not apply or are not available, they are to still be listed on the SDS with a statement that information for the property is not applicable or not available. Other physical or chemical parameters in addition to those included above, may also be included in this section of the SDS.

Property Remarks / Guidance Physical state Standard conditions are generally used for gas, liquid, and solid states. Colour Indicate the colour of the active ingredient, EP, MA or ISP. Odour Give a qualitative description of the odour if it is well-known or described

in literature.

If available indicate the odour threshold. pH Not applicable to gases.

Applicable to aqueous liquids and solutions (the pH is linked to aqueous media by definition; measurements carried out in other media do not give the pH).

Indicate the concentration of the test substance in water.

Where the pH is ≤ 2 or ≥ 11.5, see Table A4.3.9.3 of the GHS 6th revised edition for information on acid/alkaline reserve

Melting point / Freezing Point

Not applicable to gases.

At standard pressure.

Indicate up to which temperature no melting point was observed in the case the melting point is above the measuring range of the method.

Indicate if decomposition or sublimation occurs prior to or during melting.

For waxes and pastes the softening point / range may be indicated instead.

Indicate if it is technically not possible to determine the melting point / freezing point.

Boiling point or initial boiling point and boiling range

Generally at standard pressure (a boiling point at lower pressure might be indicated in case initial boiling point the boiling point is very high or decomposition occurs before boiling). Indicate up to which temperature no boiling point was observed in case the boiling point is above the measuring range of the method. Indicate if decomposition occurs prior to or during boiling. For mixtures indicate if it is technically not possible to determine the

Appendix II


Property Remarks / Guidance boiling point or range; in that case indicate also the boiling point of the lowest boiling ingredient.

Flash point Not applicable to gases, aerosols and solids. For information on test methods etc., see Chapter 2.6, paragraph 2.6.4.2 of the GHS 6th Revised Edition. For EP, MA, ISPs: Indicate a value for the mixture itself if available, otherwise indicate the flash point(s) of those substances with the lowest flash point(s) as these are generally the main contributing ones.

Evaporation rate Applicable to liquids and solids.

Can be given in comparison to other chemicals, such as butyl acetate, which evaporate fairly quickly. For example, the rate might be given as "0.5 (butyl acetate=1), or given as greater or less than 1.

Flammability (solid, gas)

Applicable to gases, liquids and solids.

Indicate whether the substance or mixture is ignitable (capable of catching on fire or being set on fire, even if not classified for flammability).

If available and appropriate, further information may be indicated in addition, for example, whether the effect of ignition is other than a normal combustion (for example, an explosion), or ignitability under non-standard conditions.

More specific information on the flammability may be indicated based on the respective hazard classification in accordance with Table A4.3.9.2 of the GHS 6th Revised Edition.

Upper and lower flammability / explosive limits

Not applicable to solids.

For flammable liquids indicate at least the lower explosion limit:

• if the flash point is approximately > -25 °C, it might be not possible to determine the upper explosion limit at standard temperature; in that case it is recommended to indicate the upper explosion limit at elevated temperature,

• if the flash point is > +20 °C the same holds for both the lower and upper explosion limit.

Note: Depending on the region of the world the term "explosion limit " or ''flammability limit" is used, but is supposed to mean the same.

Appendix II


Property Remarks / Guidance Vapour pressure Generally at standard temperature.

Indicate the vapour pressure at 50 °C for volatile fluids in addition (in order to enable distinction between gases and liquids based on the definitions in Chapter 1.2).

In cases where one SDS is used to cover variants of a liquid mixture or liquefied gas mixture indicate a range for the vapour pressure.

For liquid mixtures or liquefied gas mixtures, indicate a range for the vapour pressure or at least the vapour pressure of the most volatile ingredient(s) where the vapour pressure of the mixture is predominantly determined by this/these ingredient(s).

For liquid mixtures or liquefied gas mixtures, the vapour pressure may be calculated using the activity coefficients of the ingredients.

The saturated vapour concentration (SVC) may be indicated in addition. Vapour density Applicable to gases and liquids only.

For gases, indicate the relative density of the gas based on air at 20°C as reference (=MW/29).

For liquids, indicate the relative vapour density based on air at 20°C as reference (=MW/29).

For liquids, the relative density of the vapour/air-mixture at 20°C (air = 1) may be indicated in addition.

Where MW is the molecular weight. Relative density or specific gravity

Applicable to liquids and solids only.

Generally at standard conditions.

Indicate as appropriate:

• the absolute density; and/or

• the relative density based on water at 4 °C as reference (sometimes also called the specific gravity).

A range may be indicated in cases where variations in density are possible, for example, due to batch manufacture, or where one SDS is used to cover several variants of an active ingredient or EP, MA, ISP.

Appendix II


Property Remarks / Guidance NOTE: For clarity, the SDS should indicate if absolute density (indicate units) and/or relative density (no units) is being reported.

Solubility Generally at standard temperature.

Indicate the solubility in water.

The solubility in other (non-polar) solvents may also be included.

For mixtures, indicate if it is fully or only partially soluble in or miscible with water or other solvent.

Partition coefficient: n-octanol/water (Kow)

Not applicable to inorganic and ionic liquids.

Generally not applicable to EPs, MAs, and ISPs.

May be calculated (using QSAR - Quantitative structure-activity relationship).

Indicate whether the value is based on testing or on calculation. Auto-ignition temperature

Applicable to gases and liquids only.

For EPs, MAs, and ISPs:

Indicate a value for the mixture itself if available, otherwise indicate the auto-ignition temperature(s) of those ingredients with the lowest auto-ignition temperature(s).

Decomposition temperature

Applicable to self-reactive substance and mixtures and organic peroxides and other substances and mixtures which may decompose.

Indicate:

• the SADT (self-accelerating decomposition temperature), together with the volume to which it applies; or

• the decomposition onset temperature (see also section 20.3.3.3 of the Manual of Tests and Criteria9).

Indicate whether the temperature given is the SADT or the decomposition onset temperature.

If no decomposition was observed, indicate up to which temperature no

9 See the UN Manual of Tests and Criteria, Sixth revised edition at: http://www.unece.org/trans/areas-of-

work/dangerous-goods/legal-instruments-and-recommendations/un-manual-of-tests-and-criteria/rev6-files.html

Appendix II


Property Remarks / Guidance decomposition was observed, for example, as "no decomposition observed up to x °C/°F''.

Viscosity Kinematic viscosity:

Applicable to liquids only.

Use preferably mm2/s as unit (as the classification criteria for the hazard class aspiration hazard are based on this unit).

The dynamic viscosity may be indicated in addition. The kinematic viscosity is linked to the dynamic viscosity by the density:

Kinematic viscosity (mm2/s) = Dynamic viscosity (mPa·s) / Density (g / cm3).

For non-Newtonian liquids, indicate thixotropic or rheopexic behaviour.

Section 10 Stability and reactivity 10 Stability and

reactivity 1) Reactivity 2) Chemical stability 3) Possibility of hazardous reactions 4) Conditions to avoid (for example, static discharge, shock or vibration) 5) Incompatible materials 6) Hazardous decomposition products

Reactivity

Describe the reactivity hazards of the active ingredient, EP, MA, or ISP in this section. Provide specific test data for the active ingredient, EP, MA, or ISP as a whole, where available. However, the information may also be based on general data for the class or family of chemical if such data adequately represents the anticipated hazard of the active ingredient or EPs, MAs, and ISPs.

If data for EP, MA, or ISP are not available, ingredient data is to be provided. In determining incompatibility, consider the substances, containers and contaminants that the active ingredient, EP, MA, or ISP might be exposed to during transportation, storage and use.

Chemical stability

Indicate if the active ingredient, EP, MA, or ISP is stable or unstable under normal ambient and anticipated storage and handling conditions of temperature and pressure. Describe any stabilizers or preservatives that are, or may need to be, used to maintain the product. Indicate the safety significance of any change in the physical appearance of the product.

Appendix II


Possibility of hazardous reactions

If relevant, state if the active ingredient, EP, MA, or ISP will react or polymerize, releasing excess pressure or heat, creating other hazardous conditions. Describe under what conditions the hazardous reactions may occur.

Conditions to avoid

A list of conditions to avoid such as heat, pressure, shock, static discharge, vibrations, and other physical stresses that might result in a hazardous situation is to be included.

Incompatible materials

A list of the classes of chemicals, or specific substances, with which the active ingredient, EP, MA, or ISP could react to produce a hazardous situation (for example, explosion, release of toxic or flammable materials, liberation of excessive heat) is to be included.

Hazardous decomposition products

List known and reasonably anticipated hazardous decomposition products produced as a result of use, storage and heating. Hazardous combustion products are to be included in section 5 (Fire-fighting measures) of the SDS.

Section 11 Toxicological information 11 Toxicological

information 1) Concise but complete and comprehensible description of the various toxicological (health) effects and the available data used to identify those effects, including: a) Information on the likely routes of exposure (inhalation, ingestion, skin and eye contact) b) Symptoms related to the physical, chemical and toxicological characteristics c) Delayed and immediate effects and also chronic effects from short and long term exposure d) Numerical measures of toxicity (such as acute toxicity estimates)

This section is used primarily by medical professionals, occupational health and safety professionals and toxicologists. A concise but complete and comprehensible description of the various toxicological (health) effects, and the available data used to identify those effects, is to be provided. Under GHS classification, the relevant hazards, for which data are to be provided, are: acute toxicity; skin corrosion/irritation; serious eye damage/irritation; respiratory or skin sensitization; germ cell mutagenicity; carcinogenicity; reproductive toxicity; specific target organ toxicity (STOT) -single exposure; STOT-repeated exposure; and aspiration hazard.

Provide information on these hazards when applicable and available. Also provide information on any other hazards which do not result in classification or are not covered by the GHS. The health effects included in the SDS are to be consistent with those described in the studies used for the classification of the active ingredient, EP, MA, or ISP.

Appendix II


Where there is a substantial amount of test data on the active ingredient, EP, MA, or ISP, it may be desirable to summarize results (for example, by route of exposure).

The data included in this sub-section are to apply to the active ingredients or EP, MA, or ISP as used. The toxicological data are to describe the EP, MA, or ISP. If that information is not available, the classification under GHS and the toxicological properties of the hazardous ingredients are to be provided and clearly identify the ingredient to which the information relates. General statements such as “Toxic” with no supporting data or “Safe if properly used” are not acceptable, as they may be misleading and do not provide a description of health effects. Phrases such as “not applicable”, “not relevant”, or leaving blank spaces in the health effects section can lead to confusion and misunderstanding and are to not be used unless the explanation is provided (for example, “not applicable (gas)”. For health effects where information is not available, this is to be clearly stated. Health effects are to be described accurately and relevant distinctions made. For example, allergic contact dermatitis and irritant contact dermatitis are to be distinguished from each other. If data for any of these hazards are not available, they are to still be listed on the SDS with a statement that data are not available.

Also provide information on the relevant negative data. If data are available showing that the active ingredient, EP, MA, or ISP does not meet the criteria for classification, it is to be stated on the SDS that the active ingredient, EP, MA, or ISP has been evaluated and based on available data, does not meet the classification criteria. Additionally, if an active ingredient, EP, MA, or ISP is found to be not classified for other reasons, for example, due to technical impossibility to obtain data, or inconclusive data, this is to be clearly stated on the SDS.

Information on the likely routes of exposure

Provide information on the likely routes of exposure of the active ingredient, EP, MA, or ISP, that is, through ingestion (swallowing), inhalation or skin/eye contact.

Symptoms related to the physical, chemical and toxicological characteristics

Describe the potential adverse health effects and symptoms associated with exposure to the active ingredients, EP, MA, or ISP and its ingredients or known by-products. Provide information on the symptoms related to the physical, chemical and toxicological characteristics of the active ingredients, EP, MA, or ISP following exposure related to the intended uses. Describe the first symptoms at the lowest exposures through to the consequences of severe exposure; for example, “headaches and dizziness may occur, proceeding to fainting or unconsciousness; large doses may result in coma and death”.

Delayed and immediate effects and also chronic effects from short and long term exposure

Provide information on whether delayed or immediate effects can be expected after short or long term exposure. Also provide information on acute and chronic health effects relating to human exposure to the active ingredients, EP, MA, or ISP. Where human data are not available, animal data is to be summarised and the species clearly identified. It is to be indicated in the SDS whether toxicological data is based on human or animal data.

Appendix II


Numerical measures of toxicity (such as acute toxicity estimates)

Provide information on the dose, concentration or conditions of exposure that may cause adverse health effects. Where appropriate, doses are to be linked to symptoms and effects, including the period of exposure likely to cause harm. For example, the acute oral LD50 (lethal dose at 50%) for product “X” is “1250” mg/kg bw (milligrams/kilogram of body weight).

Where specific chemical data are not available

It may not always be possible to obtain information on the hazards of an active ingredient, EP, MA, or ISP. In cases where data on the specific active ingredients, EP, MA, or ISP are not available, data on the chemical class, if appropriate, may be used. Where generic data are used or where data are not available, this is to be stated clearly in the SDS.

EP, MA, or ISP

If an EP, MA, or ISP has not been tested for its health effects as a whole then information on each ingredient listed is to be provided and the EP, MA, or ISP is to be classified using the processes that are described in the GHS.

EP, MA, or ISP versus ingredient information

Ingredients may interact with each other in the body resulting in different rates of absorption, metabolism and excretion. As a result, the overall toxicity of the EP, MA, or ISP may be different from its ingredients. Information on interactions are to be included if relevant and readily available.

It is necessary to consider whether the concentration of each ingredient is sufficient to contribute to the overall health effects of the EP, MA, or ISP. The information on toxic effects is to be presented for each ingredient, except:

a) if the information is duplicated it is not necessary to list this more than once. For example, if two ingredients both cause vomiting and diarrhea, it is not necessary to list this twice. Overall, the EP, MA, or ISP is described as causing vomiting and diarrhea;

b) if it is unlikely that these effects will occur at the concentrations present. For example, when a mild irritant is diluted in a non-irritating solution, there comes a point where the overall EP, MA, or ISP will be unlikely to cause irritation;

c) predicting the interactions between ingredients is extremely difficult, and where information on interactions is not available, assumptions are to not be made and instead the health effects of each ingredient are to be listed separately.

Other information

Other relevant information on adverse health effects are to be included even when not required by the GHS classification criteria.

Appendix II


Section 12 Ecological information 12 Ecological

information a) Ecotoxicity (aquatic and terrestrial, where available) b) Persistence and degradability c) Bioaccumulative potential d) Mobility in soil e) Other adverse effects

The information in this section should be included if it is available.

The information that is to be provided in this section is to enable evaluation of the environmental impact of the active ingredient(s), EP, MA, or ISP - if it were released to the environment. This information can assist in handling spills, and evaluating waste treatment practices, control of release, accidental release measures, and transport.

GHS environmental information

A concise but complete and comprehensible description of the various eco-toxicological (environment) properties, and the available data used to identify those properties, is to be provided. The basic properties, for which data is to be provided, are: ecotoxicity; persistence and degradability; bio-accumulative potential; mobility in soil; and other adverse effects. These properties are to always be listed on the SDS. Species, media, units, test duration and test conditions are to be clearly indicated. If data for any of these properties are not available, they are to still be listed on the SDS with a statement that data are not available.

Some eco-toxicological properties are active ingredient(s) specific (bioaccumulation, persistence and degradability). The information is to therefore be given, where available and appropriate, for each relevant ingredient of the EP, MA, or ISP (those which are required to be listed in Section 3 of the SDS).

Provide also a short summary of the data given in relation to the hazard classification criteria. Where data are not available for classification, this is to be clearly stated on the SDS for each basic property concerned. Additionally, if data are available showing that the active ingredients, EP, MA, or ISP does not meet the criteria for classification, it is to be stated on the SDS that the active ingredients, EP, MA, or ISP has been evaluated and, based on available data, does not meet the classification criteria. Additionally, if an active ingredients, EP, MA, or ISP is found to be not classified for other reasons, for example, due to technical impossibility to obtain the data, or inconclusive data, this is to be clearly stated on the SDS.

Ecotoxicity

Information on ecotoxicity can be provided using data from tests performed on aquatic and/or terrestrial organisms. This is to include relevant available data on both acute and chronic aquatic toxicity for fish, crustaceans, algae and other aquatic plants. In addition, ecotoxicity data on other organisms (including soil micro-and macro-organisms) such as birds, bees and plants, is to be included when available. Where the active ingredients, EP, MA, or ISP has inhibitory effects on the activity of micro-organisms, the possible impact on sewage treatment plants is to be mentioned.

Appendix II


Persistence and degradability

Persistence and degradability is the potential for the active ingredients or the appropriate constituents of an EP, MA, or ISP to degrade in the environment, either through biodegradation or other processes, such as oxidation or hydrolysis. Test results relevant to assess persistence and degradability are to be given where available.

If degradation half-lives are quoted it is to be indicated whether these half-lives refer to abiotic transformation (for example, hydrolysis, phototransformation) or biotransformation. The potential of the active ingredients or certain constituents of an EP, MA, or ISP to degrade in sewage treatment plants is to also be mentioned.

Bio-accumulative potential

Bioaccumulation is the potential for the active ingredients or certain constituents of an EP, MA, or ISP to accumulate in biota and, possibly, pass through the food chain. Test results relevant to assess the bio-accumulative potential are to be given. This is to include reference to the octanol-water partition coefficient (Kow) and bio-concentration factor (BCF), if available.

Mobility in soil

Mobility in soil is the potential of active ingredients or the constituents of the EP, MA, or ISP, if released to the environment, leach to groundwater or runoff from the site of release. The potential for mobility in soil is to be given where available. Information on mobility can be determined from relevant mobility data such as adsorption studies or leaching studies. Leaching and mobility can be predicted from models.

Where real data on the active ingredients, EP, MA, or ISP is available this data is to take precedence over models and predictions.

Other adverse effects

Information on any other adverse effects to the environment is to be included where available, such as ozone depletion potential, photochemical ozone creation potential, endocrine disrupting potential and/or global warming potential.

Section 13 Disposal considerations 13 Disposal

considerations Description of waste residues and information on their safe handling and methods of disposal, including the disposal of any contaminated packaging


Disposal methods

Provide information for proper disposal, recycling or reclamation of the active ingredients, EP, MA, or ISP and/or its container to assist in the determination of safe and environmentally

Appendix II


preferred waste management options, consistent with the requirements of the Pest Control Products Act. For the safety of persons conducting disposal, recycling or reclamation activities, please refer to the information in section 8 (exposure controls and personal protection) of the SDS. This includes disposal information to:

a) Specify disposal containers and methods; b) Discuss physical/chemical properties that may affect disposal options; c) Discourage sewage disposal; and d) Where appropriate, identify any special precautions for incineration or landfill.

Section 14 Transport information 14 Transport

information 1) UN number 2) UN proper shipping name 3) Transport hazard class(es) 4) Packing group, if applicable 5) Environmental hazards (for example, Marine pollutant (Yes/No)) 6) Transport in bulk (according to Annex II of MARPOL 73/78 and the IBC Code) 7) Special precautions which a user needs to be aware of or comply with in connection with transport or conveyance either within or outside their premises


This section provides basic GHS classification information for the transporting/shipment of a hazardous active ingredient(s), EP, MA, or ISP by road, rail, sea or air. Where information is not available or relevant this is to be stated.

United Nations (UN) Number

Provide the UN Number (that is, the four figure identification number of the substance or article) from the UN Model Regulations 4.10 Provide the Canadian specific Transportation of Dangerous Goods (TDG) information here and/or in Section 15.

UN Proper Shipping Name

Provide the UN proper shipping name from the UN Model Regulations. For active ingredients, EP, MA, or ISP the UN proper shipping name is to be provided in this sub-section if it has not appeared as the Product identifier or national or regional identifiers.

10 See: http://www.unece.org/trans/danger/publi/unrec/rev13/13nature_e.html

Appendix II


Transport hazard class (es)

Provide the transport class (and subsidiary risks) assigned to the active ingredients, EP, MA, or ISP according to the most predominant hazard that they present in accordance with the UN Model Regulations.

Packing group, if applicable

Provide the packing group number from the UN Model Regulations, if applicable. The packing group number is assigned to certain active ingredients in accordance with their degree of hazard.

Environmental hazards

Indicate whether the active ingredients, EP, MA, or ISP is a known marine pollutant according to the International Maritime Dangerous Goods (IMDG) Code, and if so, whether it is a “marine pollutant” or a “severe marine pollutant”.

Special precautions for user

Provide information on any special precautions that a user needs to be aware of, or needs to comply with in connection with transport.

Transport in bulk according to Annex II of UN the International Convention for the Prevention of Pollution from Ships, 1973, as modified by the Protocol of 1978 (MARPOL 73/78) and the International Code for the Construction and Equipment of Ships carrying Dangerous Chemicals in Bulk (IBC Code).11

This sub-section only applies when cargoes are intended to be carried in bulk according to the following International Maritime Organization (IMO) instruments: Annex II of MARPOL 73/78 and the IBC Code.

Provide the product name as required by the shipment document and in accordance with the name used in the lists of product names given in Chapters 17 or 18 of the IBC Code or the latest edition of the International Maritime Organization (IMO), Marine Environment Protection Committee (MEPC) MEPC.2/Circular. Indicate ship type required and pollution category.

11 See: http://www.imo.org/en/Publications/Pages/Home.aspx

Appendix II


Section 15 Regulatory information 15 Regulatory

information 1) Safety, health and environmental regulations specific for the product in question 2) Label reference 3) Label hazard elements 4) Description of differences between label and SDS

Describe any other regulatory information on the active ingredient, EP, MA, or ISP that is not provided elsewhere in the SDS (for example whether the active ingredient(s), EP, MA, or ISP is subject to the Montreal Protocol, the Stockholm Convention or the Rotterdam Convention).

Provide the safety, health and environmental regulations specific for the product in question

Provide relevant national and/or regional information on the regulatory status of the active ingredient(s), EP, MA, or ISP (including its ingredients) under relevant safety, health and environmental regulations. This is to include whether the active ingredient(s), EP, MA, or ISP (including its ingredients) are subject to any prohibitions or restrictions within Canada or provinces and territories, and/or regions, into which it is being supplied.

Describe any other Canadian specific regulatory information

Registrants are to include the following statement (or similar):

“Read the approved label, authorized under the Pest Control Products Act, prior to using or handling the pest control product”

Registrants are to include the label hazard communications information, including any environmental label statements, Canadian container disposal requirements, and a brief explanation for any differences between that information and the SDS information.

Registrants are to include the following statement (or similar):

“This chemical is a pest control product registered by Health Canada Pest Management Regulatory Agency and is subject to certain labelling requirements under the Pest Control Products Act. These requirements differ from the classification criteria and hazard information required for GHS-consistent safety data sheets. Following is the hazard information required on the pest control product label:”

If the pest control product contains an allergen, including allergens as formulants as listed on the List of Pest Control Product Formulants and Contaminants of Health or Environmental Concern, the allergen label statement is to be also included in this section.

Registrants are to include any other relevant Canadian specific regulatory information applicable to the product such as any Transportation of Dangerous Goods (TDG) requirements, or conditions under the Canadian Environmental Protection Act (CEPA).

Appendix II


Section 16 Other information 16. Other

information The date of the latest revision of the SDS

Provide information relevant to the preparation of the SDS in this section. This is to incorporate other information that does not belong in sections 1 to 15 of the SDS, including information on preparation and revision of the SDS such as:

a) the date of preparation of the latest revision of the SDS, when revisions are made to an SDS, unless it has been indicated elsewhere, clearly indicate where the changes have been made to the previous version of the SDS. Registrants are to maintain an explanation of the changes and be willing to provide it upon request; and

b) a key/legend to abbreviations and acronyms used in the SDS; and c) key literature references and sources for data used to compile the SDS.

Appendix III


Appendix III PMRA Hazard Class and the Comparable GHS Hazard Class (or classes)

The following tables compare the hazard classes used for label elements required by the Pest Control Products Act and Regulations to the corresponding GHS hazard classes and GHS label communication elements.

The GHS label elements are to be provided in Section 2 of a SDS. It is expected that Section 15 will include the label hazard communication elements and a description of the differences.

Note that the information contained in this Appendix III is not a direct cross-walk from Pest Control Products Act hazard class to the GHS hazard class. To determine the Pest Control Products Act hazard class and the GHS hazard class different methods and ranges must be used. Appendix III is not a substitute for classifying in GHS. For more complete information on classifying in the GHS see: Globally Harmonized System of Classification and Labelling of Chemicals (GHS), 5th ed. 2013. New York: United Nations. (http://www.unece.org/trans/danger/publi/ghs/ghs_rev05/05files_e.html)

Comparable crosswalk examples

Example 1: flammable aerosol hazard

A registered pest control product label may indicate flammable aerosol with the signal words “caution” and “flammable” and use the symbol for caution and flammable.

Using the GHS classification that same product may use the signal word “warning” and hazard statement “flammable aerosol” and have no symbol.

Example 2: acute oral toxicity

The label of a pest control product that is acutely toxic via the oral route may have the signal word “Caution” and the hazard statement “Poison” and the accompanying skull and crossbones symbol contained with the black inverted triangle-shaped border.

Using the GHS classification, that same product may have the signal word “Warning” and the hazard statement “Harmful if swallowed” accompanied by the exclamation point symbol contained within the red border in the shape of a square set at a point.

Appendix III


Summary Table of PMRA Hazard Classes that have label elements, and the Comparable GHS Hazard Classes

PMRA GHS Physical hazards: Flammable Gases Flammable Gases Flammable Aerosols Flammable Aerosols Flammable Liquids Flammable Liquids Gases Under Pressure Gases Under Pressure Corrosive to Metals Corrosive to Metals Acute health hazards: Oral or Dermal Oral or Dermal Inhalation (Dusts and Mists) Inhalation (Vapours, Gases, Dusts and Mists) Skin Corrosion/Irritation Skin Corrosion/Irritation Serious Eye Damage/Eye Irritation Serious Eye Damage/Eye Irritation Skin Sensitization Skin Sensitization Acute environmental hazards: Acute Aquatic Toxicity Acute Aquatic Toxicity

Appendix III


Criteria for physical hazards

Flammable Gases

Flammable Gases (closest existing classification criteria) Criteria Pressurized product:

Ignition of spray forms a flame projection of ≥ 45 cm or flashback to the container occurs

Pressurized product: Ignition of spray forms a flame projection of 15-45 cm

Pressurized product: ignition of the spray occurs and forms a flame projection of < 15 cm

Precautionary Symbols and Signal Words

Danger

Extremely Flammable

Warning

Flammable

Caution

Flammable

Flammable Gases (GHS classification criteria) Criteria: A gas with a flammable range with air at 20oC and a standard pressure of 101.3 kPa. (GHS Hazard Class: Flammable Gases – Chapter 2.2) Sub-Criteria: Category 1: gas that is ignitable

in a mixture of ≤13% (vol) in air, or has a flammable range of ≥12% points

Category 2: other gases having a flammable range while mixed in air

Symbol

(None)

Signal Word Danger Warning Hazard Statement Extremely flammable gas Flammable gas

Appendix III


Flammable Aerosols

Flammable Aerosols (existing classification criteria) Criteria Pressurized product:

Ignition of spray forms a flame projection of ≥ 45 cm or flashback to the container occurs

Pressurized product: Ignition of spray forms a flame projection of 15-45 cm

Pressurized product: ignition of the spray occurs and forms a flame projection of < 15 cm


Danger

Extremely Flammable

Warning

Flammable

Caution

Flammable

Flammable Aerosols (GHS classification criteria) Criteria: Aerosol dispenser: non-refillable receptacle containing a gas under pressure with a release device to eject solid or liquid particles in suspension in gas, as a foam, paste, powder or liquid or in a gaseous state. (GHS Hazard Class: Flammable Aerosols – Chapter 2.3) Sub-Criteria: Category 1:

≥ 85% flammable components and ∆ Hc ≥ 30 kJ/g, or Ignition distance ≥ 75 cm (spray aerosol), or in the foam test, flame height ≥ 20 cm and flame duration ≥ 2 s; or flame height ≥ 4 cm and flame duration ≥ 7 s

Category 2: Ignition distance ≥15 cm (spray aerosol), or ∆ Hc ≥ 20 kJ/g (spray aerosol), or In the enclosed space ignition test, the time equivalent ≤ 300 s/m3 or deflagration density ≤ 300 g/m3 (spray), or In the foam test, flame height ≥ 4 cm and flame duration ≥ 2 s

Symbol

Signal Word Danger Warning Hazard Statement Extremely flammable aerosol Flammable aerosol

Appendix III


Flammable Liquids

Flammable Liquids (existing classification criteria) Criteria: Non-pressurized liquids Sub-Criteria: flashpoint ≤ -6 oC flashpoint ≤ 10 oC flashpoint ≤ 27 oC Precautionary Symbols and Signal Words

Danger

Extremely Flammable

Warning

Flammable

Caution

Flammable

Flammable Liquids (GHS classification criteria) Criteria: Category 1:

Liquid with flashpoint ≤ 23

oC and initial boiling point ≤ 35 oC

Category 2: Liquid with flashpoint ≤ 23

oC


oC


oC

Symbol

(None)

Signal Word Danger Danger Warning Warning Hazard Statement Extremely

flammable liquid and

vapour

Highly flammable liquid and

vapour

Flammable liquid and

vapour

Combustible liquid

Appendix III


Gases Under Pressure

Gases Under Pressure (existing classification criteria) Criteria All pressurized products Precautionary Symbol and Signal Word

Caution

Explosive Gases Under Pressure (GHS classification criteria) Criteria: Gases contained in a receptacle at a pressure not less than 200 Pa at 20°C or as a refrigerated liquid. (GHS Hazard Class: Gases Under Pressure – Chapter 2.5) Sub-Criteria: Category 1:

Compressed Gas

Category 2: Liquified Gas

Category 3: Refrigerated Liquified Gas

Category 4: Dissolved Gas

Symbol

Signal Word Warning Warning Warning Warning Hazard Statement Contains gas

under pressure; may

explode if heated

Contains gas under

pressure; may explode if

heated

Contains refrigerated

gas; may cause cryogenic

burns or injury

Contains gas under

pressure; may explode if

heated

Appendix III


Corrosive to Metals

Corrosive to Metals (existing classification criteria) Criteria: ≥ 20% organic acid,

or ≥ 10% mineral acid or alkali material

5-10% mineral acids or alkali materials, or 5-20% organic acids, or liquids containing ≥10% available chlorine, or pH ≤ 0.5, or pH ≥ 13.5

1-5% mineral acids or alkali materials, or 1-5% organic acids, or solids containing > 1% available chlorine, or pH of 0.5-2.5 or 11.5-13.5


Danger

Corrosive

Warning

Corrosive

Caution

Corrosive Corrosive to Metals (GHS classification criteria) Criteria: Chemical action that materially damages or destroys metals with a corrosion rate on steel or aluminum surfaces exceeding 6.25 mm per year at a test temperature of 55 °C. (GHS Hazard Class: Corrosive to Metals – Chapter 2.16) Symbol

Signal Word Warning Hazard Statement May be corrosive to metals

Appendix III


Criteria for acute health relative toxicity categories

Acute Toxicity – Oral or Dermal

Acute Toxicity – Oral or Dermal (existing classification criteria) Criteria: LD50 ≤ 500 mg/kg body

weight LD50 ≤ 1000 mg/kg body weight

LD50 ≤ 2000 mg/kg body weight


Danger

Poison

Warning

Poison

Caution

Poison Acute Toxicity – Oral or Dermal (GHS classification criteria) Criteria: Oral Category 1:

LD50 ≤ 5 mg/kg Category 2: LD50 ≤ 50 mg/kg

Category 3: LD50 ≤ 300 mg/kg


Criteria: Dermal Category 1: LD50 ≤ 50 mg/kg




Symbol

Signal Word Danger Danger Danger Warning Hazard Statement - Oral

Fatal if swallowed

Fatal if swallowed

Toxic if swallowed

Harmful if swallowed

Hazard Statement - Dermal

Fatal in contact with skin

Fatal in contact with skin

Toxic in contact with skin

Harmful in contact with skin

Appendix III


Acute Toxicity – Inhalation (Dusts and Mists)

Acute Toxicity – Inhalation (Dusts and Mists) (existing classification criteria) Criteria: LC50 ≤ 0.05 mg/L LC50 ≤ 0.50 mg/L LC50 ≤ 2.00 mg/L Precautionary Symbols and Signal Words

Danger

Poison

Warning

Poison

Caution

Poison Acute Toxicity – Inhalation (GHS classification criteria) Criteria: Category 1: Category 2: Category 3: Category 4:

Dusts and Mists

LC50 ≤ 0.05 mg/L

LC50 ≤ 0.50 mg/L

LC50 ≤1.00 mg/L

LC50 ≤ 5.00 mg/L

Gases LC50 ≤ 100 ppmV

LC50 > 100 and ≤ 500 ppmV

LC50 > 500 and ≤ 2500 ppmV

LC50 > 2500 and ≤ 20000 ppmV

Vapours LC50 ≤ 0.5 mg/L

LC50 ≤ 0.5 and ≤ 2.0 mg/L

LC50 ≤ 2.0 and ≤ 10 mg/L

LC50 ≤ 10 and ≤ 20 mg/L

Symbol

Signal Word Danger Danger Danger Warning Hazard Statement

Fatal if inhaled Fatal if inhaled Toxic if inhaled

Harmful if inhaled

Appendix III


Skin Corrosion/Irritation

Skin Corrosion/Irritation (existing classification criteria) Criteria using animal test data

Severely to extremely irritating Mean Draize scores of ≥5.1 - 8.0 for erythema/ eschar and for oedema for 24, 48, and 72 hour assessments for all animals on test (usually 6)

Moderately irritating Mean Draize scores of ≥3.1 - 5.0 for erythema/eschar and for oedema for 24, 48 and 72 hour assessments for all animals on test (usually 6)

Mildly irritating Mean Draize scores of ≥1.6 - 3.0 for erythema/eschar and for oedema for 24, 48 and 72 hour assessments for all animals on test (usually 6)


(no symbol)

Danger

Skin Irritant

(no symbol)

Warning

Skin Irritant

(no symbol)

Caution

Skin Irritant

Skin Corrosion/Irritation (continued) (classification criteria) Criteria using physical/chemical properties

Contains 10% or more mineral acids or alkali material; Contains 20% or more organic acids

Contains 5-10% mineral acids or alkali materials; Contains 5-20% organic acids; Liquids containing ≥ 10% available chlorine; pH ≤ 0.5 or ≥ 13.5

Contains 1-5% mineral acids or alkali materials; Contains 1-5% organic acids; Solids containing ≥ 1% available chlorine; pH 0.5-2.5 or 11.5-13.5

Liquid products containing 4-10% available chlorine

Liquid products which contain 1-4% available chlorine


Danger

Corrosive

Warning

Corrosive

Caution

Corrosive

Caution

Irritant

Caution

(None)

Appendix III


Skin Corrosion/Irritation (GHS classification criteria) Criteria: Categories 1A, 1B &

1C: Corrosive in ≥ 1/3 animals in 1 hour to ≤ 4 hours (≤ 14 days observation)

Category 2: Mean Draize score of 2.3-4.0 for erythema/eschar or for oedema for 24, 48 and 72 hour assessments in at least 2/3 animals; grading on 3 consecutive days if reactions delayed

Category 3:

Symbol

No symbol

Signal Word Danger Warning Warning Hazard Statement Causes severe skin

burns and eye damage Causes skin irritation Causes mild skin

irritation

Appendix III


Serious Eye Damage/ Eye Irritation

Serious Eye Damage/ Eye Irritation (existing classification criteria) Criteria using animal test data

Severely to extremely irritating (including irreversibility) Maximum average score of ≥ 50 - 110 for effects to cornea, iris and conjunctivae

Severely to extremely irritating (including irreversibility)

Maximum average score of ≥ 50 - 110 for effects to cornea, iris and conjunctivae

Mildly irritating Maximum average score of ≥ 15 - 24 for effects to cornea, iris and conjunctivae


(No Symbol)

DANGER

Corrosive to Eyes

(No Symbol)

WARNING

Eye Irritant

(No Symbol)

CAUTION

Eye Irritant Serious Eye Damage/ Eye Irritation (continued) (existing classification criteria) Criteria using physical/ chemical properties

Contains 10% or more mineral acids or alkali material; Contains 20% or more organic acids;

Contains 5-10% mineral acids or alkali materials; Contains 5-20% organic acids; Liquids containing 10% or more available chlorine pH ≤ 0.5 or ≥ 13.5

Contains 1-5% mineral acids or alkali materials; Contains 1-5% organic acids; Solids containing over 1% available chlorine pH between 0.5 - 2.5 or 11.5 - 13.5

Liquid products which contain ≥ 4% - ≤ 10% available chlorine

Liquid products which contain ≥1% - ≤4% available chlorine


DANGER

Corrosive

WARNING

Corrosive

CAUTION

Corrosive

CAUTION

Irritant

CAUTION

(None)

Appendix III


Serious Eye Damage/ Eye Irritation (GHS classification criteria) Criteria: Category 1

Irreversible eye effects (or not expected to reverse) in 21 days in at least 1 test animal; Mean scores (24, 48, 72 hours) in 2/3 test animals consisting of corneal opacity ≥ 3 and/or iritis ≥ 1.5

Category 2A Eye effects, which fully reverse in 21 days, characterized by at least 2/3 test animals with corneal opacity ≥ 1; iritis ≥ 1; conjunctival redness ≥ 2; conjunctival oedema (chemosis) ≥ 2 Calculated as mean scores or grading at 24, 48 and 72 hours

Category 2B Same criteria as for Category 2A, however effects are fully reversible within 7 days

Symbol

(None)

Signal Word Danger Warning Warning Hazard Statement

Causes serious eye damage Causes serious eye irritation Causes eye

irritation

Skin Sensitization

Skin Sensitization (existing classification criteria) Criteria: Substance induces an allergic response following skin contact Precautionary Symbol and Signal Word

(No Symbol)

Potential Skin Sensitizer

Skin Sensitization (GHS classification criteria) Criteria: Evidence in humans that the substance can induce sensitization by skin contact in a substantial number of persons. Positive results from an appropriate animal test (GHS Hazard Class: Respiratory or Skin Sensitization – Chapter 3.4) Symbol

Signal Word Warning Hazard Statement May cause an allergic skin reaction

Appendix III


Criteria for the acute environment hazards

Acute Aquatic Toxicity

Acute Aquatic Toxicity (PMRA classification criteria) If risk to the surrogate species of aquatic organisms tested including algae, aquatic vascular plants, aquatic invertebrates, or fish identified in the acute or chronic risk assessment results in the requirement of a buffer zone OR if the acute LC50 for the surrogate species of aquatic organisms tested, including algae, aquatic vascular plants, aquatic invertebrates, or fish is ≤ 1 mg/L, the following label statement is required “Toxic to aquatic organisms”. No symbol is currently used. Acute Aquatic Toxicity (GHS classification criteria) Criteria: Category 1:

96hr LC50 (fish) ≤ 1 mg/L and/or, 48hr EC50 (crustacean) ≤ 1 mg/L and/or, 72 or 96hr ErC50 (algae or other

aquatic plants) ≤ 1 mg/L

Category 2: 96hr LC50(fish) >1 but ≤ 10 mg/L and/or, 48hr EC50 (crustacean)

>1 but ≤ 10 mg/L and/or 72 or 96hr ErC50 (algae or other aquatic

plants) >1 but ≤ 10 mg/L

Category 3: 96hr LC50(fish) >10 but ≤ 100 mg/L and/or 48hr EC50 (crustacean) >10 but ≤ 100 mg/L and/or 72 or 96hr ErC50 (algae or other

aquatic plants) >10 but ≤ 100 mg/L

Symbol

Environment12

(None) (None)

Signal Word Warning (None) (None) Hazard Statement

Very toxic to aquatic life

Toxic to aquatic life

Harmful to aquatic life

12 The GHS environment symbol is provided for information only and does not need to be included in the

SDS to be consistent with this guideline.

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