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epa.govt.nz Application for the modified reassessment of a hazardous substance Under Section 63A of the Hazardous Substances and New Organisms Act 1996 Chemical Review 2015: A modified reassessment of a range of substances for which new information was obtained in 2015 Application number: APP202961 Applicant: Chief Executive, Environmental Protection Authority

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Page 1: Application for the modified reassessment of a hazardous ... · Address: EPA, Level 10, 215 Lambton Quay, Private Bag 63002, Wellington 6140 Phone: 04 474 5403 Fax: 04 914 0433 Email:

epa.govt.nz

Application for the modified reassessment of a hazardous substance

Under Section 63A of the Hazardous Substances and New Organisms Act 1996

Chemical Review 2015: A modified reassessment of a range of substances for which new information was obtained in 2015

Application number: APP202961

Applicant: Chief Executive, Environmental Protection Authority

Page 2: Application for the modified reassessment of a hazardous ... · Address: EPA, Level 10, 215 Lambton Quay, Private Bag 63002, Wellington 6140 Phone: 04 474 5403 Fax: 04 914 0433 Email:

Chemical Review 2015 (APP202961) 2

Applicant’s details

Name: Allan Freeth, Chief Executive

Address: EPA, Level 10, 215 Lambton Quay, Private Bag 63002, Wellington 6140

Phone: 04 474 5403

Fax: 04 914 0433

Email: [email protected]

Applicant’s contact person

Name: Gayle Holmes

Address: EPA, Level 10, 215 Lambton Quay, Private Bag 63002, Wellington 6140

Phone: 04 474 5463

Fax: 04 914 0433

Email: [email protected]

Signature of Applicant

31 July 2019

Allan Freeth Date

Chief Executive

Environmental Protection Authority

Page 3: Application for the modified reassessment of a hazardous ... · Address: EPA, Level 10, 215 Lambton Quay, Private Bag 63002, Wellington 6140 Phone: 04 474 5403 Fax: 04 914 0433 Email:

Chemical Review 2015 (APP202961) 3

Background

The Environmental Protection Authority regularly receives new information from stakeholders regarding the

classifications and controls of substances. EPA staff also note where changes to approvals are needed.

Where those changes are not minor or technical, these changes require a reassessment or a modified

reassessment of the approval of the substance under the HSNO Act 1996 (“the Act”)

The Chemical Review is intended as a means of making changes to a number of approvals at once, taking

into account the new information available to the EPA. This is undertaken as a modified reassessment under

section 63A of the Act. This application makes recommendations to change some or all of the following

aspects of the approvals in this application:

The approval name of the substance

The hazard classification(s) applied to the substance

The controls applied to the substance

The controls changes proposed are largely as a result of changes to the hazard classifications of the

substances in this application. These consist of changes to the default controls, as well as changes in

variations of controls, to fit current practise based on recent approvals.

It is important to note that the proposals of EPA staff may or may not be supported by the

decision-making committee for this application. The decision-making committee can choose to

accept, reject or modify the recommendations. For this reason the EPA encourages submissions on

the proposed changes. Additionally, note that a modified reassessment under section 63A of the Act

may not revoke an approval given to a hazardous substance under this Act to import or manufacture

the substance (section 63A (2)(b) of the Act).

Grounds for reassessment

Grounds for reassessment have been obtained as part of the Grounds application, APP202227. A

decision-making committee determined that there were grounds for the reassessment of the substances

listed in the application for grounds for reassessment.

Substances in application

The substances covered by this application are identified in Appendices 1 and 2. These are grouped as

follows:

Appendix 1: Substances for which there is new information.

Page 4: Application for the modified reassessment of a hazardous ... · Address: EPA, Level 10, 215 Lambton Quay, Private Bag 63002, Wellington 6140 Phone: 04 474 5403 Fax: 04 914 0433 Email:

Chemical Review 2015 (APP202961) 4

Appendix 2: Confidential substances, where a component of a substance appears in Appendix 1, but the

presence of the component in the substance is confidential.

These appendices note the name of the substance, the approval number, the current and proposed

classifications, and the proposed changes to the controls. In Appendix 1, an explanation of the reasoning for

the classification and/or controls changes is given. For Appendix 2, the corresponding explanation is only

provided in the confidential appendix to this application.

Substances for which there is new information

This section discusses the changes to substances likely to be of particular importance to submitters or where

the EPA seeks further information. Included in this section are a range of single chemical approvals and

approvals for mixtures. Where changes recommended for a substance affect mixtures containing that

substance, changes proposed to affected mixtures are also detailed. Changes that may be of particular note

to submitters are:

Benzaldehyde (approval number HSR001395)

The classification of this chemical is proposed to be downgraded from a 3.1C flammable liquid classification

to a 3.1D combustible liquid classification. A number of other changes to the classification are proposed in

line with information in the EU REACH registration dossier. These changes will affect many

benzaldehyde-containing products using group standard approvals. Companies with products that contain

benzaldehyde are encouraged to determine how the proposed changes will affect their products.

Butylated hydroxytoluene (approval number HSR002784)

Based on new information, the staff propose that:

the 6.1D acute oral toxicity classification is removed;

the 9.3C vertebrate ecotoxicity classification is removed;

the sensitisation (6.5B), reproductive/developmental toxicity (6.8C) and specific target organ

toxicity (6.9B) classifications are removed;

the aquatic ecotoxicity hazard classification increases from 9.1D to 9.1A.

Several default controls will be removed as they are no longer applicable, as well as the corresponding

changes associated with the increased ecotoxicity classification. These changes will result in changes to the

hazard classifications of a number of substances with individual approvals, and will also affect many

products using group standard approvals. Companies with products that contain butylated hydroxytoluene

are encouraged to determine how the proposed changes will affect their products.

Furfuryl alcohol (approval number HSR002998)

Based on new information from a number of sources, the staff propose that:

the acute toxicity classifications are increased from 6.1D (oral, dermal, inhalation) to 6.1B

(inhalation) and 6.1C (oral, dermal); and

Page 5: Application for the modified reassessment of a hazardous ... · Address: EPA, Level 10, 215 Lambton Quay, Private Bag 63002, Wellington 6140 Phone: 04 474 5403 Fax: 04 914 0433 Email:

Chemical Review 2015 (APP202961) 5

the following classifications are added:

o 3.1D (combustible liquid);

o 6.1E (respiratory irritation);

o 6.3A (skin irritation);

o 8.3A (eye damage);

o 6.7B (carcinogenicity);

o 6.9A (specific target organ toxicity - inhalation);

o 6.9B (specific target organ toxicity - oral);

o 9.3B (vertebrate ecotoxicity).

These changes will affect a number of substances with individual approvals, and will also affect many

products using group standard approvals. Companies with products that contain furfuryl alcohol are

encouraged to determine how the proposed changes will affect their products.

Iodocarb (approval number HSR002733)

Based on new information, the classification of this approval is proposed to:

upgrade the eye irritant classification (6.4A) to eye damage (8.3A);

remove the skin irritant classification (6.3B);

remove the specific target organ toxicity classifications for oral (6.9B) and dermal (6.9B)

exposure;

add specific target organ toxicity classification for inhalation exposure (6.9A (inhalation)).

These changes will affect a number of substances with individual approvals, and will also affect many

products using group standard approvals given the widespread use of iodocarb as a water-soluble

preservative in the paints and coatings, wood preservatives, personal care and cosmetics industries.

Companies with products that contain iodocarb are encouraged to determine how the proposed changes will

affect their products.

N-Methylpyrrolidinone (approval number HSR001384)

This approval currently has a 6.8A reproductive toxicity classification. However, this classification has not

consistently been applied to mixtures containing N-methylpyrrolidinone. A number individual approvals for

substances that contain >0.1% N-methylpyrrolidinone are proposed to be revised to include a 6.8A

classification. Companies with products using group standard approvals that contain N-methylpyrrolidinone

are encouraged to check that their products are classified correctly.

Propazine (approval number HSR003357)

The classification of this approval is proposed to be revised by removing the 6.7B carcinogenicity

classification in line with information in the US EPA assessment. These changes will affect several

propazine-containing substances with individual approvals.

Sulfur (approval number HSR001284)

The classification of this approval is proposed to be revised in line with information in the EU REACH

registration dossier by adding acute toxicity classifications 6.1E (oral, dermal, inhalation) and a skin irritant

Page 6: Application for the modified reassessment of a hazardous ... · Address: EPA, Level 10, 215 Lambton Quay, Private Bag 63002, Wellington 6140 Phone: 04 474 5403 Fax: 04 914 0433 Email:

Chemical Review 2015 (APP202961) 6

classification and removing the eye irritant classification. These changes will affect a number of

sulfur-containing substances with individual approvals, and will also affect many products using group

standard approvals. Companies with products that contain sulfur are encouraged to determine how the

proposed changes will affect their products.

Confidential Substances

Confidential Appendix 2 contains approvals where a component changing in classification is not, to the

EPA’s knowledge, publicly disclosed as being in the approved substance.

Controls Codes

Appendix 3 lists the text of the controls referred to by their control codes in appendices 1 and 2.

Submissions

Electronic submissions are encouraged. Please send your submissions to:

Environmental Protection Authority

Private Bag 63002

Wellington 6140

Email: [email protected]

Phone: +64 4 916 2426

Fax: +64 4 914 0433

All submissions must be received by 5pm, 25 September 2019

Any submissions received will be used to inform a decision-making committee to assist their evaluation of

the proposed changes. Confidential information may be provided in a separate document attached to the

main submission.

In accordance with section 54 of the Act, submitters must state the reasons for making the submission, and

whether the person making the submission wishes to be heard at a public hearing. The submission may also

state any particular decision sought.

Page 7: Application for the modified reassessment of a hazardous ... · Address: EPA, Level 10, 215 Lambton Quay, Private Bag 63002, Wellington 6140 Phone: 04 474 5403 Fax: 04 914 0433 Email:

Chemical Review 2015 (APP202961) 7

Appendix 1. Substances for which there is new information

Table 1: Approved substances with proposed changes

Substances affected Approval

numbers

Current

classification

Proposed

classification Effect on controls Justification for change

Benzaldehyde

CAS# 100-52-7

HSR001395 3.1C, 6.1D (oral),

6.1D (dermal),

6.3B, 6.5B, 9.1D,

9.2D, 9.3C

3.1D, 6.1D (oral),

6.3B, 6.4A, 9.1D,

9.2D, 9.3C

Remove:

HSW8-1, HSW10-1,

HSW10-4, HSW10-10,

HSW10-13, HSW10-15,

HSW13-7.

The flashpoint of benzaldehyde is 63-64 ºC, above the

threshold of 60 ºC for classification as 3.1C. Therefore we

propose to downgrade this to 3.1D

The current acute dermal toxicity classification of 6.1D is

based on a rabbit study indicating an LD50 of 1250 mg/kg.

However, this is more correctly expressed as being > 1250

mg/kg, given the study summary and supporting

information in the EU registration dossier. We consider that

there is no sufficient information to warrant classification as

6.1D (dermal) at this time, and so propose to change this

classification to ND.

Based on animal studies the addition of 6.4A and removal

of the 6.5B classification is proposed.

Benzenesulphonic acid,

4-[[1-[[(2-methylphenyl)-

amino]carbonyl]-2-

oxopropyl]azo]-3-nitro-,

calcium salt (2:1)

CAS# 12286-66-7

Pigment Yellow 62

HSR007202 6.7A Non-hazardous,

carcinogenicity is

ND (no data)

Remove:

all controls.

The original classification was based on the substances

being identified as an azo dye, some of which have been

associated with carcinogenicity. This substance is more

correctly referred to as an azo pigment and it does not

have structural similarity to the azo dyes associated with

carcinogenicity.

The REACH registration for this substance states that this

substance has no GHS classifications.

No data is available on carcinogenicity. We propose

removing this classification as there is no evidence to

justify classification.

Page 8: Application for the modified reassessment of a hazardous ... · Address: EPA, Level 10, 215 Lambton Quay, Private Bag 63002, Wellington 6140 Phone: 04 474 5403 Fax: 04 914 0433 Email:

Chemical Review 2015 (APP202961) 8

Substances affected Approval

numbers

Current

classification

Proposed

classification Effect on controls Justification for change

Butylated

hydroxytoluene

CAS# 128-37-0

Synonyms:

BHT

Phenol, 2,6-bis(1,1-

dimethylethyl)-4-methyl-

HSR002784 6.1D (oral), 6.5B,

6.8C, 6.9B (oral),

9.1D, 9.3C

9.1A Remove:

HSW2-4, HSW3-1,

HSW3-2, HSW4-2,

HSW13-3, HSW13-7,

HSW13-8, HSW13-9,

HSW16-1.

New information has become available that supports

revising the hazard classifications of this substance. This

new data does not support the acute toxicity, sensitiser,

reproductive/developmental toxicity and specific target

organ toxicity classifications.

New data provided supported the increase of the

ecotoxicity classification of this substance from 9.1D to

9.1A. This was based on the aquatic toxicity value found in

the Daphnia magna acute test and the fact that this

substance is bioaccumulative and not readily degradable.

There are no studies available for birds, thus the 9.3C

classification is based on the acute toxicity data with

mammals. The LD50 value (> 2930 mg/kg) indicates that

there is no reason to classify this substance for vertebrate

ecotoxicity.

Dioctyltin dilaurate or

(Stannane, dioctylbis[(1-

oxododecyl)oxy]-)

CAS# 3648-18-8

HSR007500 3.1C 6.9A (oral) Remove:

HSW2-2, HSW5-1,

HSW8-1, HSW8-2,

HSW10-1, HSW10-3,

HSW10-4, HSW10-5,

HSW10-10, HSW10-12,

HSW10-13, HSW10-15,

HSW11-1.

Add:

HSW13-2, HSW13-3,

HSW13-8, HSW13-9,

HSW13-14.

New information was provided to the EPA relating to dioctyl

tin oxide (CAS No 870-18-6) that indicates that the

substance warrants classification as a target organ toxicant

by the oral route. The staff consider that it is appropriate to

use a ‘read-across’ argument to apply this classification to

dioctyltin dilaurate.

The EU REACH dossier for this substance includes an

experimental value of 198 ºC as justification for not

classifying the substance as a flammable liquid. We

therefore propose to remove the 3.1C classification.

Page 9: Application for the modified reassessment of a hazardous ... · Address: EPA, Level 10, 215 Lambton Quay, Private Bag 63002, Wellington 6140 Phone: 04 474 5403 Fax: 04 914 0433 Email:

Chemical Review 2015 (APP202961) 9

Substances affected Approval

numbers

Current

classification

Proposed

classification Effect on controls Justification for change

Furfuryl Alcohol

CAS# 98-00-0

Synonyms include:

2-furanmethanol

Furfuranol

2-hydroxymethylfuran

HSR002998 6.1D (oral, dermal,

inhalation)

3.1D, 6.1B

(inhalation), 6.1C

(oral, dermal),

6.1E (respiratory

irritation), 6.3A,

6.7B, 6.9A

(inhalation), 6.9B

(oral), 8.3A, 9.3B

Add:

HPC-2, HPC-4A,

HPC-4B;

HSW4-1, HSW5-1,

HSW8-2, HSW10-3,

HSW10-5, HSW10-12,

HSW11-1, HSW13-1,

HSW13-4, HSW13-5,

HSW13-7, HSW13-13,

HSW13-15, HSW13-16,

HSW13-17, HSW19-1.

We undertook a full review of the classification of furfuryl

alcohol. This included a range of publications, studies and

the EU CLP GHS classifications.

A 3.1D classification should be added as this substance

has a flashpoint of 65°C.

The acute toxicity classifications are proposed to be

changed on the basis of study data. There was a lack of

complete data and so the lowest LD50 value was used for

classification in each case. Rat and mice studies also

indicated this substance may cause respiratory irritation so

a 6.1E (respiratory irritation) classification is proposed.

The results of a series of animal studies indicate that 6.3A,

8.3A, 6.7B and 6.9 classifications are also warranted.

A 9.3B classification is proposed based on the acute oral

toxicity study in rats.

Furfuryl alcohol, >25% in

a non-hazardous diluent

HSR007402 6.1D (oral, dermal,

inhalation)

3.1D, 6.1B

(inhalation), 6.1C

(oral, dermal),

6.1E (respiratory

irritation), 6.3A,

6.7B, 6.9A

(inhalation), 6.9B

(oral), 8.3A, 9.3B

GTL gasoil

CAS# 848301-67-7

HSR100066 6.1E (oral), 6.7B,

9.1B

6.1E (oral), 9.1B Remove:

HSW13-3.

GTL Gasoil was previously classified 6.7B based on the

classifications of diesel fuel in the absence of other

available information. Shell provided new information on

the genotoxicity of GTL Gasoil which indicated that this

substance was not carcinogenic. Thus the 6.7B

classification should be removed.

Hydrogen peroxide,

8-20% aqueous solution

HSR001450 5.1.1C, 6.1E (oral),

6.9B (oral,

inhalation), 8.3A,

9.1D

5.1.1C, 6.1E (oral),

6.9B (oral,

inhalation), 8.3A

Remove:

HPC-4A, HPC-4B.

Hydrogen peroxide is classified as 9.1D. Based on our

mixture rules the cut-off for applying a 9.1D classification to

mixtures of hydrogen peroxide is a concentration of >25%.

As the concentration of hydrogen peroxide in this

substance is under 25%, this substance should not have

the 9.1D classification.

Page 10: Application for the modified reassessment of a hazardous ... · Address: EPA, Level 10, 215 Lambton Quay, Private Bag 63002, Wellington 6140 Phone: 04 474 5403 Fax: 04 914 0433 Email:

Chemical Review 2015 (APP202961) 10

Substances affected Approval

numbers

Current

classification

Proposed

classification Effect on controls Justification for change

Hydroperoxide,

1,1-dimethylethyl,

70% aqueous solution

CAS# 75-91-2

Synonyms:

Tert-butyl hydroperoxide

TBHP

HSR001365

5.2F, 6.1C

(dermal), 6.1D

(inhalation), 6.1D

(oral), 6.6B, 6.9B

(oral), 8.2C, 8.3A,

9.1B, 9.3B

3.1C, 5.2F, 6.1C

(dermal), 6.1B

(inhalation), 6.1D

(oral), 6.5B, 6.6B,

6.9B (oral), 8.2C,

8.3A, 9.1B, 9.3B

Add:

HSW4-1, HSW10-1,

HSW10-3, HSW10-4,

HSW10-5, HSW10-10,

HSW10-12, HSW10-13,

HSW10-15, HSW11-1,

HSW13-4, HSW19-1.

New information is available from EU registration of this

substance.

This substance has a boiling point of 89 °C and a flashpoint

of 43 °C which corresponds to a 3.1C classification.

Under the conditions of a rat study the 4h rat LC50 for

TBHP was 500 ppm, corresponding to 1843 mg/m3

(vapour), so 6.1B (inhalation) classification is warranted.

TBHP was also found to cause delayed contact

sensitisation in Guinea pigs and we therefore propose to

add a 6.5B classification to this substance.

Iodocarb

CAS# 55406-53-6

Synonyms:

3-iodo-2-propynylbutyl

carbamate

IPBC

HSR002733

6.1D (oral),

6.1C (inhalation),

6.3B, 6.4A, 6.5B,

6.9B (dermal),

6.9B (oral), 9.1A,

9.3C

6.1D (oral),

6.1C (inhalation),

8.3A, 6.5B,

6.9A (inhalation),

9.1A, 9.3C

No change. New information is available relating to the classification of

iodocarb, in particular publications from the EU including a

RAC review and a CLH harmonised classification proposal.

Based on the new information, several changes should be

made to the classifications of iodocarb.

The 6.3B classification should be removed based on the

result of a skin irritation/corrosion study presented in the

EU RAC review.

New data has been provided to the EPA that demonstrates

that the effect on the eye should be upgraded from irritant

(6.4A) to corrosive (8.3A). This was based on testing

results where there was no sign of recovery in the

incidence or severity of effects prior to termination of the

study, so the reversibility requirements to classify as an eye

irritant are not met. This is corroborated by the EU CLP

GHS classification of iodocarb.

We propose that the 6.9B dermal and oral classifications

be removed. This is based on the results of studies that

found that no changes or no functional changes were

observed in repeated dose dermal or oral studies

respectively.

Page 11: Application for the modified reassessment of a hazardous ... · Address: EPA, Level 10, 215 Lambton Quay, Private Bag 63002, Wellington 6140 Phone: 04 474 5403 Fax: 04 914 0433 Email:

Chemical Review 2015 (APP202961) 11

Substances affected Approval

numbers

Current

classification

Proposed

classification Effect on controls Justification for change

Iodocarb should be classified as 6.9A (inhalation) based on

studies demonstrating increased incidence of

histopathological changes in the larynx, with a lowest

observed effect concentration of 0.0067 mg/L.

Protim Antimould HSR000017 6.1D (oral), 6.4A,

6.5B, 6.9B (oral),

9.1A, 9.3C

6.1D (oral), 8.3A,

6.5B, 6.9A

(inhalation), 9.1A,

9.3C

No change. Changes based on changes to iodocarb.

Ready to use liquid

containing 2.5 g/litre

cyproconazole and

1 g/litre iodocarb

(Substance A)

HSR000632 6.4A, 6.7B, 6.8C,

6.9B, 9.1A

6.4A, 6.7B, 6.8C,

9.1A

No change. Changes based on mixture rules.

Ready to use liquid

containing 2.5 g/litre

cyproconazole and

1 g/litre iodocarb

(Substance B)

HSR000635 9.1B 6.8B, 9.1B Add:

HSW2-4, HSW3-1,

HSW3-2, HSW4-2,

HSW13-3, HSW13-8,

HSW13-9, HSW16-1.

Changes based on mixture rules.

Emulsifiable

concentrate

containing 603

g/litre didecyl

dimethyl ammonium

chloride and 71

g/litre iodocarb

(Substance A)

HSR000832 3.1C, 6.1C

(inhalation), 6.1C

(oral), 6.1E

(dermal), 6.5B,

6.7B, 6.9B

(dermal), 6.9B

(oral), 8.2B, 8.3A,

9.1A, 9.3B

3.1C, 6.1C

(inhalation), 6.1C

(oral), 6.1E

(dermal), 6.5B,

6.7B, 6.9B

(inhalation), 8.2B,

8.3A, 9.1A, 9.3B

No change. Changes based on iodocarb.

Page 12: Application for the modified reassessment of a hazardous ... · Address: EPA, Level 10, 215 Lambton Quay, Private Bag 63002, Wellington 6140 Phone: 04 474 5403 Fax: 04 914 0433 Email:

Chemical Review 2015 (APP202961) 12

Substances affected Approval

numbers

Current

classification

Proposed

classification Effect on controls Justification for change

Emulsifiable

concentrate

containing 330

g/litre of iodocarb

HSR000859 6.1C (inhalation),

6.1E (oral), 6.3B,

6.4A, 6.5B, 6.9B,

9.1A

6.1C (inhalation),

6.1E (oral), 8.3A,

6.5B,

6.9A (inhalation),

9.1A, 9.3C

No change. Changes based on iodocarb.

Emulsifiable

concentrate

containing 36 g/litre

carbendazim, 20-21

g/litre iodocarb and

460 g/litre sodium

orthophenylphenate

HSR000874 6.1D (oral), 6.3A,

6.5B, 6.6A, 6.8A,

6.9A, 8.1A, 8.3A,

9.1A, 9.2B, 9.3C

6.1D (oral), 6.3A,

6.5B, 6.6A, 6.8A,

6.9A (oral), 6.9B

(inhalation), 8.1A,

8.3A, 9.1A, 9.2B,

9.3C

No change. Changes based on iodocarb and including all routes of

exposure.

Soluble concentrate

containing 500

g/litre benzalkonium

chloride, 50 g/litre

iodocarb and

50 g/litre

propiconazole

HSR000876 6.1D (oral), 6.1D

(dermal), 6.5A,

6.5B, 6.9B, 8.2C,

8.3A, 9.1A, 9.3B

6.1D (oral), 6.1D

(dermal), 6.5B,

6.9B (oral,

inhalation), 8.2B,

8.3A, 9.1A, 9.3B

Add:

HSW13-1, HSW13-13,

HSW13-15, HSW13-16,

HSW13-17.

Changes based on iodocarb, mixture rules and including all

routes of exposure.

Emulsifiable

concentrate

containing 40 g/litre

iodocarb and 120

g/litre orthophenyl

phenol

HSR000878 3.1D, 6.1D (oral),

6.3A, 6.5B, 6.9B

(oral), 8.3A, 9.1A,

9.2B, 9.3C

3.1D, 6.1D (oral),

6.3A, 6.5B, 6.9B

(oral, inhalation),

8.3A, 9.1A, 9.2B,

9.3C

No change. Changes based on iodocarb.

Page 13: Application for the modified reassessment of a hazardous ... · Address: EPA, Level 10, 215 Lambton Quay, Private Bag 63002, Wellington 6140 Phone: 04 474 5403 Fax: 04 914 0433 Email:

Chemical Review 2015 (APP202961) 13

Substances affected Approval

numbers

Current

classification

Proposed

classification Effect on controls Justification for change

Soluble concentrate

containing 500

g/litre benzalkonium

chloride, 50 g/litre

guazatine and

50 g/litre iodocarb

HSR000886 6.1C (oral), 6.5A,

6.5B, 6.7B, 6.9B,

8.2C, 8.3A, 9.1A,

9.3B

6.1D (oral),

6.1D (dermal),

6.1D (inhalation),

6.5B, 6.9B (oral

and inhalation),

8.2B, 8.3A, 9.1A,

9.3B

Remove:

HPC-2;

HSW13-5.

Changes based on iodocarb, mixture rules and including all

routes of exposure.

Emulsifiable

concentrate

containing

0.65 g/litre 5-chloro-

2-methyl-

4-isothiazolin-3-one,

600 g/litre didecyl

dimethyl ammonium

chloride 70 g/litre

iodocarb and 0.18

g/litre 2-methyl-

4-isothiazolin-3-one

HSR000892 3.1C, 6.1C (oral),

6.5B, 6.8B, 8.2B,

8.3A, 9.1A, 9.3B

3.1C, 6.1C (oral),

6.5B, 6.8B, 6.9B

(inhalation), 8.2B,

8.3A, 9.1A, 9.3B

No change. Changes based on iodocarb.

Soluble concentrate

containing 245

g/litre benzalkonium

chloride, 87 g/litre

boric acid and

23 g/litre iodocarb

HSR000900 6.1D (oral), 6.1E

(dermal), 6.5A,

6.5B, 6.8B, 6.9A,

8.2C, 8.3A, 9.1A,

9.3C

6.1D (oral), 6.1E

(dermal), 6.5B,

6.8B, 6.9A (oral),

6.9B (dermal),

6.9B (inhalation),

8.2B, 8.3A, 9.1A,

9.3C

Add:

HSW13-1, HSW13-13,

HSW13-15, HSW13-16,

HSW13-17.

Changes based on iodocarb, mixture rules and including all

routes of exposure.

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Chemical Review 2015 (APP202961) 14

Substances affected Approval

numbers

Current

classification

Proposed

classification Effect on controls Justification for change

Emulsifiable

concentrate

containing 0.6 g/litre

5-chloro-2-methyl-

4-isothiazolin-3-one,

311.1 g/litre didecyl

dimethyl ammonium

chloride, 36.5 g/litre

iodocarb and 0.2

g/litre 2-methyl-4-

isothiazolin-3-one

HSR000903 3.1C, 6.1C (oral),

6.5B, 6.8B, 6.9A,

8.2B, 8.3A, 9.1A

(F), 9.3B

3.1C, 6.1C (oral),

6.5B, 6.8B,

6.9A (oral), 6.9B

(inhalation), 8.2B,

8.3A, 9.1A, 9.3B

No change. Changes based on iodocarb.

TF3 Substance A HSR002459 3.1D, 6.1C (oral),

6.1E (dermal),

6.5A, 6.5B, 6.8A,

6.9B (oral), 8.2C,

8.3A, 9.1A, 9.3B

3.1D, 6.1C (oral),

6.1E (dermal),

6.5A, 6.5B, 6.8A,

6.9B (oral, dermal

and inhalation),

8.2C, 8.3A, 9.1A,

9.3B

No change. Changes based on iodocarb and including all routes of

exposure.

TF3 Substance B HSR002460 3.1D, 6.1D (oral),

6.1E (dermal),

6.5A, 6.5B, 6.8A,

6.9B (oral), 8.2C,

8.3A, 9.1A, 9.3B

3.1D, 6.1D (oral),

6.1E (dermal),

6.5A, 6.5B, 6.8A,

6.9B (oral, dermal

and inhalation),

8.2C, 8.3A, 9.1A,

9.3B

No change. Changes based on iodocarb and including all routes of

exposure.

Blue Control IC HSR002472 6.1B (inhalation),

6.3B, 6.5B, 6.7B,

6.9A (oral), 6.9B

(dermal), 8.3A,

9.1A, 9.2C, 9.3B

6.1B (inhalation),

6.5B, 6.7B, 6.9A

(oral), 6.9A

(inhalation), 8.3A,

9.1A, 9.2B, 9.3B

No change. Changes based on iodocarb and mixture rules.

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Chemical Review 2015 (APP202961) 15

Substances affected Approval

numbers

Current

classification

Proposed

classification Effect on controls Justification for change

Ready to use liquid

containing 2.5 g/litre

cyproconazole and

1 g/litre iodocarb

(Substance C)

HSR007703 6.5B, 6.8B, 9.1B 6.5B, 6.8B,

6.9B (oral), 9.1B

No change. Changes based on iodocarb and mixture rules.

Linflo 450 HSR000938 6.1E (oral), 6.4A,

6.8B, 6.9A (oral),

9.1A, 9.2A

6.1E (oral), 6.4A,

6.8B, 6.9A (oral),

9.1A, 9.2A, 9.3B

No change. Substance should have a 9.3B classification based on

mixture rules and the 9.3B classification of the component

linuron.

N-Methylpyrrolidinone

CAS# 872-50-4

Synonyms:

NMP

1-methyl-2-pyrrolidinone

HSR001384 6.1E (oral), 6.3A,

6.4A, 6.8A

No changes to

classifications.

No change. N-Methylpyrrolidinone has a 6.8A classification. However,

this has not been applied to all of the mixtures containing

this substance.

A 6.8A classification is proposed to be added to affected

mixtures containing ≥ 0.1% N-methylpyrrolidinone that do

not currently have a 6.8A classification.

Oils, Fish

CAS# 8016-13-5

Synonyms:

Fish oil

Fats and glyceridic oils,

fish

HSR005575 5.1.1C Remove 5.1.1C Remove:

all controls.

As no data can be found to support the 5.1.1C

classification, it should not apply to this substance and

should be removed. The substance will then be considered

non-hazardous.

Page 16: Application for the modified reassessment of a hazardous ... · Address: EPA, Level 10, 215 Lambton Quay, Private Bag 63002, Wellington 6140 Phone: 04 474 5403 Fax: 04 914 0433 Email:

Chemical Review 2015 (APP202961) 16

Substances affected Approval

numbers

Current

classification

Proposed

classification Effect on controls Justification for change

Oxalic acid

CAS# 144-62-7

HSR002710 6.1D (oral, dermal,

inhalation), 6.8C,

6.9B (dermal),

8.1A, 8.2C, 8.3A,

9.3B

6.1D (oral), 6.1E

(respiratory

irritation), 6.9B

(oral, dermal),

8.1A, 8.2C, 8.3A,

9.3B

No change. Data from the US EPA re-registration eligibility decision

(RED) and the EU registration dossier has been used to

review the classifications of this substance. This new data

indicates that the acute toxicity of this substance can be

downgraded. This is based on studies outlined in the RED

which showed no deaths occurred from inhalation or

dermal exposure but reported that this substance was

irritating to the respiratory tract.

Available reproductive and developmental studies showed

that oxalic acid does not warrant a 6.8C classification for

reproductive/developmental effects on or via lactation.

Data from the US EPA and EU also indicated that this

substance has chronic renal toxicity from excessive or

prolonged exposure. This occurs via the oral route and is

the basis of adding the 6.9B (oral) classification.

Oxirane, methyl-

CAS# 75-56-9

Synonyms include:

Propylene oxide

Epoxypropane

Methyloxirane

Oxirane

HSR001220 3.1A, 6.1C

(inhalation), 6.1D

(oral, dermal),

6.3A, 6.4A, 6.6A,

6.7B, 6.8B, 6.9B

(inhalation), 9.1C,

9.3B

3.1A, 6.1C (dermal,

inhalation), 6.1D

(oral), 6.1E

(respiratory

irritant), 6.4A,

6.6A, 6.7A, 6.8B,

9.1C, 9.3B

No change. New information has been provided which justifies a review

of the classifications of this substance, including

information in the EU CLH dossier. This includes a study

that reports a LC50 value of 950 mg/kg for dermal exposure

which supports upgrading the dermal acute toxicity from

6.1D to 6.1C.

The new studies available do not support the classification

of this substance as a skin irritant. This classification

should be removed.

There is also study data that supports classification of this

substance as a known or presumed human carcinogen, so

the 6.7B classification should be changed to 6.7A.

This substance is a respiratory tract irritant. This

classification should come under 6.1E but was previously

classified under 6.9 (inhalation). We propose to replace the

6.9 (inhalation) classification with 6.1E (respiratory irritant).

Page 17: Application for the modified reassessment of a hazardous ... · Address: EPA, Level 10, 215 Lambton Quay, Private Bag 63002, Wellington 6140 Phone: 04 474 5403 Fax: 04 914 0433 Email:

Chemical Review 2015 (APP202961) 17

Substances affected Approval

numbers

Current

classification

Proposed

classification Effect on controls Justification for change

2-Phenoxyethanol

CAS# 122-99-6

HSR003045 6.1D (oral, dermal,

inhalation), 6.4A,

6.8B, 9.3C

6.1D (oral), 6.4A,

9.3C

No change. Data is available in the EU including REACH registration,

CLP GHS classifications, and a SIDS Initial Assessment

Report which indicate that no classification for reproduction

or developmental toxicity is warranted.

Based on the EU registrations, no classifications are

warranted for acute inhalation and acute dermal toxicity

and we propose that these classifications also be removed.

1,3-Propanediol,

2,2-dimethyl-

CAS# 126-30-7

Synonyms:

Neopentyl glycol

HSR003955 6.1D (oral), 6.4A 6.4A Remove:

HSW2-2, HSW5-2,

HSW13-3.

The original classification was based on SDS data. New

data has become available due to REACH registration

which shows the 6.1D classification is not warranted (LD50

> 6400 mg/kg reported).

Propazine

CAS# 139-40-2

HSR003357 6.1D (oral,

inhalation), 6.1E

(dermal), 6.3B,

6.4A, 6.7B, 9.1A,

9.2A, 9.3C

6.1D (oral,

inhalation), 6.1E

(dermal), 6.3B,

6.4A, 9.1A, 9.2A,

9.3C

No change. This substance was originally classified as a carcinogen

(6.7B) based on EU and US EPA classifications. However,

the US EPA removed this classification after a rat study

determined carcinogenicity to be species specific

(Sprague-Dawley rat) and not operative in humans. Based

on the US EPA assessment, the 6.7B classification should

be removed.

Suspension

concentrate

containing

494 g/litre propazine

HSR000387 6.1D (inhalation),

6.1E (oral), 6.3B,

6.4A, 6.7B, 9.1A,

9.2A

6.1D (inhalation),

6.1E (oral), 6.3B,

6.4A, 9.1A, 9.2A,

9.3C

No change. See above for reasoning for removing 6.7B.

Substance should have a 9.3C classification based on

mixture rules and the 9.3C classification of the component

propazine.

Wettable powder

containing 500 g/kg

propazine

HSR000399

6.1D (inhalation),

6.1E (oral), 6.3B,

6.4A, 6.7B, 9.1A,

9.2A

6.1D (inhalation),

6.1E (oral), 6.3B,

6.4A, 9.1A, 9.2A,

9.3C

No change. See above for reasoning for removing 6.7B.

Substance should have a 9.3C classification based on

mixture rules and the 9.3C classification of the component

propazine.

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Chemical Review 2015 (APP202961) 18

Substances affected Approval

numbers

Current

classification

Proposed

classification Effect on controls Justification for change

Sulfur

Sulfur, excluding formed

sulfur

CAS# 7704-34-9

HSR001284 4.1.1B, 6.4A 4.1.1B,

6.1E (oral, dermal,

inhalation), 6.3A

Add:

HSW13-3.

The current classification of this substance differs from the

EU Reach registration. New information indicates that this

substance has acute toxicity properties through dermal,

inhalation and oral routes.

The new information also supports the classification of this

substance as a skin irritant and supports removal of the

eye irritant classification.

Wettable powder

containing 350 g/kg

copper as copper

oxychloride and 240

g/kg sulphur

HSR000510 6.1D (oral), 6.4A,

6.5B, 6.9B (oral),

9.1A, 9.3C

6.1D (oral), 6.3A,

6.5B, 6.9B (oral),

9.1A, 9.3C

No change. See above for reasoning for removing 6.4A and adding

6.3A.

Granular material

containing 7.5 g/kg

pendimethalin

HSR000548 6.3B, 6.4A, 9.1A,

9.2A, 9.3C

6.3B, 6.4A, 6.5B,

9.1A, 9.2A, 9.3C

Add:

HSW13-3, HSW13-7.

Substance should have a 6.5B classification based on

mixture rules and the 6.5B classification of the component

pendimethalin.

Wettable powder

containing 115 g/kg

carbaryl, 250 g/kg

copper as copper

oxychloride and 284

g/kg sulphur

HSR000594 6.1D (oral), 6.4A,

6.5B, 6.7B, 6.9B

(oral), 9.1A, 9.2B,

9.3C, 9.4B

6.1D (oral), 6.3A,

6.5B, 6.7B, 6.9B

(oral), 9.1A, 9.2B,

9.3C, 9.4A

No change. See above for reasoning for removing 6.4A and adding

6.3A.

Substance should have a 9.4A classification based on

mixture rules and the 9.4A classification of carbaryl.

Suspension

concentrate

containing 720 - 800

g/litre sulphur

(Substance A)

HSR000666 6.4A, 9.1D 6.1E (oral),

6.1E (dermal),

6.3A, 9.1D

Add:

HSW13-3.

See sulfur for reasoning for all changes.

Page 19: Application for the modified reassessment of a hazardous ... · Address: EPA, Level 10, 215 Lambton Quay, Private Bag 63002, Wellington 6140 Phone: 04 474 5403 Fax: 04 914 0433 Email:

Chemical Review 2015 (APP202961) 19

Substances affected Approval

numbers

Current

classification

Proposed

classification Effect on controls Justification for change

Water dispersible

granule or wettable

powder containing

800 g/kg sulphur

HSR000741 6.4A, 9.1D 6.1E (oral),

6.1E (dermal),

6.1E (inhalation),

6.3A, 9.1D

Add:

HSW13-3.

See sulfur for reasoning for all changes.

Water dispersible

granule containing

800 g/kg sulphur

HSR000816 9.1D 6.1E (oral),

6.1E (dermal),

6.1E (inhalation),

6.3A, 9.1D

Add:

HSW2-4, HSW3-1,

HSW3-2, HSW4-2,

HSW13-3, HSW13-8,

HSW13-9, HSW16-1

See sulfur for reasoning for all changes.

Cream containing

7 – 13 g/kg copper

sulphate, 275 - 360

g/kg sulphur and

15 - 25 g/kg tar

acids

HSR002023 6.1E (oral), 6.3A,

6.4A, 6.5B, 6.6B,

6.8B, 6.9B (oral),

6.9B (dermal), 9.1A

6.1E (oral), 6.1D

(inhalation), 6.3A,

6.4A, 6.5B, 6.6B,

6.8B, 6.9B (oral),

6.9B (dermal),

9.1A, 9.3C

No change. See sulfur for reasoning for changes except for 9.3C which

was added based on mixture rules.

Flammable liquid

containing 20 - 40

g/litre linseed oil,

120 - 160 g/litre

sulphur and

700 - 800 g/litre

turpentine

HSR002162 3.1C, 6.1D

(dermal), 6.1D

(oral), 6.3A, 6.4A,

6.5B, 9.1C

3.1C, 6.1D

(dermal), 6.1D

(oral), 6.1D

(inhalation), 6.3A,

6.4A, 6.5B, 9.1C

No change. See sulfur for reasoning for change.

Liquid containing 3 -

7 g/litre neomycin

sulphate, 0.4 - 1.4

g/litre prednisolone,

3 - 7 g/litre sulphur

and 26 - 50 g/litre

zinc oxide

HSR002281 6.5B, 9.1A No changes

proposed

No change.

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Chemical Review 2015 (APP202961) 20

Substances affected Approval

numbers

Current

classification

Proposed

classification Effect on controls Justification for change

Suspension

concentrate

containing 720 - 800

g/litre sulphur

(Substance B)

HSR007707 6.4A, 6.5B, 9.1D 6.1E (oral), 6.1E

(dermal), 6.3A,

6.4A, 6.5B, 6.9B

(oral), 9.1C, 9.2C

No change. See sulfur for reasoning for all changes except for 6.9B,

9.1C and 9.2C classifications which were added based on

mixture rules and the classifications of confidential

components.

Sulgran 80% WG HSR100627 6.3B, 6.4A, 9.1D 6.1E (oral),

6.1E (dermal),

6.1E (inhalation),

6.3A, 9.1D

Add:

HSW13-3.

See sulfur for reasoning for all changes.

Sodium

dioctylsulphosuccinate

CAS# 577-11-7

HSR003166 6.1D (oral), 6.3A,

8.3A, 9.1D, 9.3C

6.3A, 8.3A, 9.1D No change. Name to be updated to sodium dioctylsulfosuccinate

A REACH dossier is available that shows that the most

relevant acute toxicity LD50 is > 2100 mg/kg in rat (clinical

signs were observed but no mortality). As a result we

propose that this substance not be classified for 6.1 or 9.3.

Soluble concentrate

containing

190 – 250 g/litre fatty

acids (potassium salts)

HSR000690 9.1D No change. No change. Name change to “Soluble concentrate containing

180 – 250 g/litre fatty acids (potassium salts)”. This

name change is required as the amount of fatty acids in

one of the original products of this transfer approval was

miscalculated. The name change ensures that the original

products fit the approval name of the substance.

Page 21: Application for the modified reassessment of a hazardous ... · Address: EPA, Level 10, 215 Lambton Quay, Private Bag 63002, Wellington 6140 Phone: 04 474 5403 Fax: 04 914 0433 Email:

Chemical Review 2015 (APP202961) 21

Appendix 2. Affected mixtures containing confidential components

The approvals listed in this appendix are affected mixtures that contain one or more of the substances listed in appendix 1 of this application form, and

which accordingly require changes to classification and/or controls. For these mixtures, the presence of the specific substance(s) that drive

classification changes may be confidential. As such this table intentionally does not identify the component(s) driving the classification changes in the

affected mixtures and supporting comments are similarly withheld from public view. The full details are disclosed within the confidential appendix to this

application.

Table 2: Affected mixtures containing confidential components

Approval number Approval name Component

changing in

classification

Current

classification

Proposed

classification

Controls changes

HSR000026 RB-2-100 Refer to confidential

appendix

3.1D, 6.9B (oral), 9.1A 3.1D, 6.1E

(aspiration hazard),

6.9B (oral), 9.1A

No change.

HSR000154 Soluble concentrate

containing 195 g/litre

acephate. Also contains

ethylene glycol

Refer to confidential

appendix

6.1D (oral), 6.3A,

6.4A, 6.8A, 6.8C,

6.9A, 9.1D, 9.3C, 9.4B

6.1D (oral), 6.3A,

6.4A, 6.8A, 6.9A (oral

and inhalation),

6.9B (dermal), 9.1C,

9.3C, 9.4B

No change.

HSR000157 Emulsifiable concentrate

containing 45 g/litre

acephate and 39 g/litre

triforine

Refer to confidential

appendix

3.1D, 6.1E (oral),

8.2B, 8.3A, 6.8A,

6.8C, 6.9B, 9.1D,

9.3C, 9.4B

3.1D, 6.1E (oral),

8.2B, 8.3A, 6.8A,

6.9B (oral, dermal,

inhalation), 9.1C,

9.3C, 9.4B

No change.

HSR000158 Emulsifiable concentrate

containing 22.5 g/litre

acephate and 19.5 g/litre

triforine

Refer to confidential

appendix

6.1E (oral), 6.3A,

8.3A, 6.8A, 6.8C,

6.9B, 9.3C, 9.4C

6.3A, 8.3A, 6.8A,

6.9B (oral, dermal,

inhalation), 9.1C,

9.3C, 9.4C

No change.

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Chemical Review 2015 (APP202961) 22

Approval number Approval name Component

changing in

classification

Current

classification

Proposed

classification

Controls changes

HSR000022 Hy-D BEADLET Refer to confidential

appendix

6.1E (inhalation),

6.1E (oral), 6.5B,

6.8B, 6.9A (oral),

9.1C

6.1E (inhalation), 9.1C Remove:

HSW13-3, HSW13-7.

HSR007880 Pyradym Refer to confidential

appendix

6.1E (oral), 6.3B,

6.5A, 6.5B, 6.8C, 6.9B

(inhalation), 6.9B

(oral), 9.1A, 9.4A

6.1E (aspiration

hazard), 6.3B, 6.5A,

6.5B, 6.9B

(inhalation), 6.9B

(oral), 9.1A, 9.4A

Add:

Label variation 1 -

potential for pyrethrin

to cause paresthesia.

HSR101120 Pygar Refer to confidential

appendix

3.1D, 6.1E (aspiration

hazard), 6.3B, 6.5A,

6.5B, 6.9B

(inhalation), 8.3A,

9.1A, 9.3C, 9.4B

3.1D, 6.1E (aspiration

hazard), 6.3B, 6.5A,

6.5B, 6.9B (oral),

6.9B (inhalation),

8.3A, 9.1A, 9.4B

Add:

Label variation 1 -

potential for pyrethrin

to cause paresthesia.

HSR000333 Ready to use liquid

containing 20.9 g/litre

esbiothrin. Also contains

hydrocarbons

Refer to confidential

appendix

3.1D, 6.1E (oral),

6.3B, 6.8C, 6.9B,

9.1A, 9.4C

3.1D, 6.1E

(aspiration hazard),

6.3B, 6.9B (oral),

9.1A, 9.3C, 9.4C

No change.

HSR001629 Repair Mortar Resin Refer to confidential

appendix

3.1B, 6.1D

(inhalation), 6.1E

(oral), 6.3B, 6.4A,

6.5B, 6.8C, 6.9B

(inhalation), 6.9B

(oral), 9.1C

3.1B, 6.1D

(inhalation), 6.1E

(oral), 6.3B, 6.4A,

6.5B, 6.9B

(inhalation), 6.9B

(oral), 9.1D

No change.

HSR001680 IGB4130NC Refer to confidential

appendix

6.1D (oral), 6.8C,

6.9B, 9.1A, 9.2C,

9.3C, 9.4A

No change No change.

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Chemical Review 2015 (APP202961) 23

Approval number Approval name Component

changing in

classification

Current

classification

Proposed

classification

Controls changes

HSR007786 DWC0111 Refer to confidential

appendix

6.3B, 6.5B, 6.6B,

6.8B, 6.8C, 9.1A,

9.2C, 9.4C

6.1D (oral), 6.3B,

6.5B, 6.6B, 6.8B,

6.8C, 6.9B (oral),

9.1A, 9.2C, 9.3C,

9.4C

No change.

HSR100103 NTNCS2 Refer to confidential

appendix

3.1D, 6.3A, 6.4A,

6.8A, 6.8C, 6.9B

(oral), 9.1A, 9.2B,

9.3B, 9.4A

3.1D, 6.3A, 6.4A,

6.8A, 6.9B (oral),

9.1A, 9.2B, 9.3B, 9.4A

No change.

HSR100069 BEPO1621RH Refer to confidential

appendix

6.3A, 6.4A, 6.8A,

6.8C, 9.1A, 9.2C,

9.3C, 9.4A

6.3A, 6.4A, 6.8A,

9.1A, 9.2C, 9.3C, 9.4A

No change.

HSR100394 KSI777 Refer to confidential

appendix

6.1D (oral), 6.5B,

6.6B, 6.8A, 6.8C,

6.9A (oral), 9.1A,

9.2C, 9.3B, 9.4A

6.1D (oral), 6.5B,

6.6B, 6.8A,

6.9A (oral), 9.1A,

9.2C, 9.3B, 9.4A

No change.

HSR100414 Movento OD Refer to confidential

appendix

6.4A, 6.5B, 6.8B,

6.8C, 6.9B

(inhalation), 9.1B

6.4A, 6.5B, 6.8B,

6.9B (inhalation), 9.1B

No change.

HSR100639 Polynate Bee attractant

controlled release

dispensers

Refer to confidential

appendix

6.3A, 6.4A, 6.5B,

6.8C, 6.9B (oral)

6.3A, 6.4A, 9.1C Add:

HPC-4A, HPC-4B.

Remove:

HSW13-7.

Page 24: Application for the modified reassessment of a hazardous ... · Address: EPA, Level 10, 215 Lambton Quay, Private Bag 63002, Wellington 6140 Phone: 04 474 5403 Fax: 04 914 0433 Email:

Chemical Review 2015 (APP202961) 24

Approval number Approval name Component

changing in

classification

Current

classification

Proposed

classification

Controls changes

HSR100703 Nexan Abamectin

Pour On

Refer to confidential

appendix

6.1D (oral), 6.1E

(dermal), 6.3B, 6.4A,

6.5B, 6.8B, 6.8C, 6.9B

(inhalation),

6.9B (oral), 9.1A,

9.2C, 9.3C, 9.4A

6.1D (oral), 6.1E

(dermal), 6.3B, 6.4A,

6.8B, 6.8C, 6.9B

(inhalation),

6.9B (oral), 9.1A,

9.2C, 9.3C, 9.4A

Remove:

HSW13-7.

HSR100790 SCJ-12-120164 Refer to confidential

appendix

6.1E (oral), 6.3B,

6.5B, 6.8C, 6.9B

(oral), 9.1A, 9.4A

6.1E (aspiration

hazard), 6.3B, 6.9B

(oral), 9.1A, 9.4A

Remove:

HSW13-7.

HSR100932 Warlock Insecticide Refer to confidential

appendix

3.1D, 6.1E

(inhalation), 6.1E

(aspiration hazard),

6.3B, 6.4A, 6.8A,

6.8C, 6.9B (oral),

9.1A, 9.3B, 9.4A

3.1D, 6.1E

(inhalation), 6.1E

(aspiration hazard),

6.3B, 6.4A, 6.8A,

6.9B (oral), 6.9B

(narcotic effects),

9.1A, 9.3C, 9.4A

No change.

HSR100392 RF-011 Refer to confidential

appendix

6.3B, 6.5A, 6.5B,

6.8C, 6.9B

(inhalation), 9.1A,

9.3C, 9.4A

6.3B, 6.5A, 6.5B,

6.9B (oral and

inhalation), 9.1A, 9.4A

No change.

HSR007640

J57.23A Refer to confidential

appendix

3.1C, 6.1C (dermal),

6.1D (oral), 6.3B,

6.4A, 6.9B (oral),

9.1A, 9.3C

3.1C, 6.1D (oral),

6.3B, 6.4A, 6.8B, 6.9B

(oral), 9.1A, 9.3C

Remove:

HPC-2;

HSW13-1, HSW13-5,

HSW13-7, HSW13-13,

HSW13-15,

HSW13-16,

HSW13-17.

Page 25: Application for the modified reassessment of a hazardous ... · Address: EPA, Level 10, 215 Lambton Quay, Private Bag 63002, Wellington 6140 Phone: 04 474 5403 Fax: 04 914 0433 Email:

Chemical Review 2015 (APP202961) 25

Approval number Approval name Component

changing in

classification

Current

classification

Proposed

classification

Controls changes

HSR007641

J57.23B Refer to confidential

appendix

3.1C, 6.1C (dermal),

6.1D (oral), 6.3B,

6.4A, 6.5B, 6.9B

(oral), 9.1A, 9.3C

3.1C, 6.1D (oral),

6.3B, 6.4A, 6.5B,

6.8B, 6.9B (oral and

inhalation), 9.1A,

9.3C

Remove:

HPC-2;

HSW13-1, HSW13-5,

HSW13-13,

HSW13-15,

HSW13-16,

HSW13-17.

HSR007642 J57.23C Refer to confidential

appendix

3.1C, 6.1C (dermal),

6.1D (oral), 6.1D

(inhalation), 6.3B,

6.4A, 6.5B, 6.9B

(oral), 9.1A, 9.3C

3.1C, 6.1D (oral),

6.1D (inhalation),

6.3B, 6.4A, 6.5B,

6.8B, 6.9B (oral and

inhalation), 9.1A,

9.3C

Remove:

HPC-2;

HSW13-1, HSW13-5,

HSW13-13,

HSW13-15,

HSW13-16,

HSW13-17.

HSR100818 KShield Concentrate Refer to confidential

appendix

6.3A, 6.4A, 6.5B, 9.1A No change No change.

HSR000545 Emulsifiable concentrate

containing 240 g/litre

oxyfluorfen

(Substance A)

Refer to confidential

appendix

3.1D, 6.1E (oral),

6.3A, 6.4A, 6.8B,

6.9B, 9.1A, 9.2A

3.1D, 6.1E (oral), 6.1E

(aspiration hazard),

6.3A, 6.4A, 6.8A,

6.9B (oral), 9.1A, 9.2A

Add:

HSW13-14.

HSR000459 Emulsifiable concentrate

containing 250 g/litre

triadimenol

Refer to confidential

appendix

3.1D, 6.1D (oral),

6.8B, 6.9A (oral),

9.1C, 9.3C

3.1D, 6.1D (oral),

6.8A, 6.9A (oral),

9.1C, 9.3C

No change.

Page 26: Application for the modified reassessment of a hazardous ... · Address: EPA, Level 10, 215 Lambton Quay, Private Bag 63002, Wellington 6140 Phone: 04 474 5403 Fax: 04 914 0433 Email:

Chemical Review 2015 (APP202961) 26

Approval number Approval name Component

changing in

classification

Current

classification

Proposed

classification

Controls changes

HSR002251 Cream containing

0.3 – 0.7% cetrimide and

0.3 – 0.7% chlorhexidine

gluconate

Refer to confidential

appendix

6.3B, 6.5B, 6.8B, 9.1B 6.3B, 6.5B, 9.1B No change.

HSR001652 Thermal 980 Negative

Developer for Thermal

News

Refer to confidential

appendix

6.3B, 6.8B, 6.9B

(dermal), 6.9B (oral),

8.3A

6.3B, 6.9B (dermal),

6.9B (oral), 8.3A

No change.

HSR002702 SD-1005 Refer to confidential

appendix

6.4A, 6.5B,

6.9B (oral), 9.1A, 9.4B

6.1E (oral), 6.3A,

6.5B, 6.9B (oral),

9.1A, 9.4B

No change.

Page 27: Application for the modified reassessment of a hazardous ... · Address: EPA, Level 10, 215 Lambton Quay, Private Bag 63002, Wellington 6140 Phone: 04 474 5403 Fax: 04 914 0433 Email:

Chemical Review 2015 (APP202961) 27

Appendix 3. Controls codes for changes in Appendices 1 and 2

The default EPA control codes are listed below in Table 3.

Some controls are varied using standard variations to match current practice in setting controls. The

variations referred to in this document are listed in Table 4 below.

Table 3: EPA Control codes used in this application

Control

code EPA Notice Control description

LAB EPA Labelling

Notice 2017 Requirements for labelling of hazardous substances

PKG EPA Packaging

Notice 2017 Requirements for packaging of hazardous substances

SDS EPA Safety Data

Sheet Notice 2017 Requirements for safety data sheets for hazardous substances

DIS EPA Disposal

Notice 2017 Requirements for disposal of hazardous substances

HPC-1

EPA Hazardous

Property Controls

Notice 2017 Part 1 Hazardous Property Controls preliminary provisions

HPC-2

EPA Hazardous

Property Controls

Notice 2017 Part 2 Certain substances restricted to workplaces only

HPC-3

EPA Hazardous

Property Controls

Notice 2017 Part 3 Hazardous substances in a place other than a workplace

HPC-4A

EPA Hazardous

Property Controls

Notice 2017 Part 4A Site and storage controls for class 9 substances

HPC-4B

EPA Hazardous

Property Controls

Notice 2017 Part 4B Use of class 9 substances

HPC-4C

EPA Hazardous

Property Controls

Notice 2017 Part 4C Qualifications required for application of class 9 pesticides

Page 28: Application for the modified reassessment of a hazardous ... · Address: EPA, Level 10, 215 Lambton Quay, Private Bag 63002, Wellington 6140 Phone: 04 474 5403 Fax: 04 914 0433 Email:

Chemical Review 2015 (APP202961) 28

Table 4: HSNO Variations to control codes used in this application

Control

code HSNO Act Control

Label

variation 1

Section 77 variation

to Labelling Notice

The substance label must include a warning of the effects of paraesthesia

and how to avoid it.

The requirements in Table 5 below are not set for a substance under its approval but apply in their own right

under the HSW legislation according to the classification of the substance. They are listed in this document

for information purposes only.

Table 5: HSW Requirements referred to in this application

Code Regulation Description

HSW2-1 Reg 2.1-2.4 Workplace labelling of hazardous substance containers

HSW2-2 Reg 2.5-2.10 Signage

HSW2-3 Reg 2.11 Safety data sheets

HSW2-4 Reg 2.12-2.14 Packaging

HSW3-1 Reg 3.1 Inventory

HSW3-2 Reg 3.2-3.3 Managing risks associated with hazardous substances

HSW4-1 Reg 4.1-4.4 Compliance certificates for certified handlers

HSW4-2 Reg 4.5-4.6 Information, instruction, training and supervision

HSW5-1 Reg 5.2-5.5 Fire extinguishers

HSW5-2 Reg 5.6-5.13 Emergency response plans

HSW7-1 Reg 7.1-7.11 Controlled substance licences

HSW8-1 Reg 8.1-8.2 Compliance certification

HSW8-2 Reg 8.3-8.4 Requirements for public transportation of class 1 to 5 substances

HSW10-1 Reg 10.3 General controls on class 2, 3, and 4 substances

HSW10-2 Reg 10.4 Substances that must be secured

HSW10-3 Reg 10.5 Requirement to segregate class 2, 3, and 4 substances

HSW10-4 Reg 10.6-10.7 Duty of PCBU to establish a hazardous area

HSW10-5 Reg 10.8-10.20 Requirements to prevent unintended ignition of class 2.1.1, 2.1.2 and 3.1

substances

HSW10-10 Reg 10.26 Duty of PCBU to establish hazardous substance location

HSW10-12 Reg 10.30-10.33 Secondary containment for class 3 and 4 pooling substances

Page 29: Application for the modified reassessment of a hazardous ... · Address: EPA, Level 10, 215 Lambton Quay, Private Bag 63002, Wellington 6140 Phone: 04 474 5403 Fax: 04 914 0433 Email:

Chemical Review 2015 (APP202961) 29

HSW10-13 Reg 10.34-10.35 Requirement to have compliance certificate if class 2.1.1, 2.1.2, or 3.1

substance present at hazardous substance location

HSW10-15 Reg 10.37 Requirement for transit depot

HSW11-1 Part 11 Controls relating to adverse effects of unintended ignition of class 2 and 3.1

substances

HSW13-1 Reg 13.3-13.4 Records of application for class 6 substances

HSW13-2 Reg 13.7 Duty of PCBU who directs work using class 6, 8.1, 8.2, or 8.3 substances

to ensure equipment is appropriate

HSW13-3 Reg 13.8 Duty of PCBU who directs work using class 6 and 8 substances to ensure

personal protective equipment used

HSW13-4 Reg 13.9, 13.11 Certain substances to be under personal control of certified handler or

secured

HSW13-5 Reg 13.10 Substances not requiring a certified handler to be secured

HSW13-6 Reg 13.12-13.13 Controlled substance licences for certain class 6 substances

HSW13-7 Reg 13.14-13.16 Transportation of certain class 6 and 8 substances

HSW13-8 Reg 13.17 Prohibition on use of substance in excess of tolerable exposure limit

HSW13-9 Reg 13.18 Duty of PCBU to ensure prescribed exposure standards for class 6

substances not exceeded

HSW13-10 Reg 13.19-13.21 Vertebrate toxic agent requirements

HSW13-11 Reg 13.22 Duties of PCBU who directs work using antifouling paints

HSW13-12 Reg13.23-25 Restricted entry intervals

HSW13-13 Reg 13.26-13.29,

13.34-13.37 Storage and segregation of certain class 6 or 8 substances

HSW13-14 Reg 13.30-33 Secondary containment requirements for class 6 and 8 pooling substances

HSW13-15 Reg 13.34,

13.38-13.39

Duty of PCBU to establish hazardous substance location and compliance

certificate requirements where certain class 6 or 8 substances present

HSW13-16 Reg 13.40-13.44 Separation of hazardous substance locations holding class 6 and 8

substances

HSW13-17 Reg 13.45 Additional emergency management requirements for certain class 6 or 8

substances

HSW15-1 Part 15 Requirements for gases under pressure

HSW16-1 Part 16 Requirements for tank wagons and transportable containers

HSW17-1 Part 17 Requirements for stationary container systems

HSW19-1 Part 19 Tracking hazardous substances