slime play kk3301 - slime baff kk3302 - messy play kk3303 ... · pdf...

$: Slime Play KK3301 - Slime Baff KK3302 - Messy Play KK3303 ... · PDF file0lfurelrorjlfdo4xdolw\ 3uhvhuydwlyh(iilfdf\ 7klvsurgxfwlvdqk\gurxvdqglqkhuhqwo\krvwlohwrwkhjurzwkriplfur rujdqlvpv$
Slime Play / Slime Baff / Messy Play

Gelicity UK Ltd.

5866

1 / 14

Product name Slime Play / Slime Baff / Messy Play

Product Code KK3301 / KK3302 / KK3303

Company (Customer) Name Gelicity UK Ltd.

Company (Customer)Address

Gelicity House, Unit 27, Castle Park Industrial Estate, Flint,CH6 5XA, United Kingdom

Company (Customer) Phone 01352 731010

Company (Customer) Fax

Company (Customer)Responsible Contact

Other Contact Details

ADSL Reference 5866

CPSR Completion Date 15-10-2014 14:53:30

The product is safe for use in the stated application, and complies with EC Regulation 1223/2009. This assessment is conditional on theResponsible Person complying with the conditions in the notes and any other purity restrictions listed.

Date and signature of safety assessor.

Signed:

Date: October 15, 2014

Page 2/14 5866 Slime Play / Slime Baff / Messy PlayKK3301 / KK3302 / KK3303

2 / 14

PART A

Quantitative & Qualitative Composition of the Cosmetic Product

INCI Chemical name CAS EINECS Concentration inFormulation %

(w/w)

ACRYLAMIDE/SODIUMACRYLATE COPOLYMER

2-Propenoic acid, sodium salt,polymer with 2-propenamide

25085-02-3 polymer 99.445000%

Function ANTISTATIC FILM FORMING

EU 2013 Regs III/66

VITIS VINIFERA SEED OIL Vitis Vinifera Seed Oil is the fixedoil, consisting primarily of theglycerides of the fatty acids,obtained by pressing the seeds ofthe Red Grape, Vitis Vinifera L.,Vitaceae

84929-27-1 /8024-22-4

284-511-6 / - 0.500000%

Function EMOLLIENT SKIN CONDITIONING

EU 2013 Regs Not Controlled

CI 17200 Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate and its permitted lakes andsalts

3567-66-6 222-656-9 0.055000%

Function COSMETIC COLORANT

EU 2013 Regs IV/1, 37 III/254

CI 47005 1H-Indene-1,3(2H)-dione,2-(2-quinolinyl)-, sulfonated,sodium salts; D & C Yellow no. 10

8004-92-0 /94891-32-4 /95193-83-2 /68814-04-0

- / 305-632-3 /305-897-5 / -

0.055000%


EU 2013 Regs IV/1


3 / 14

INCI Chemical name CAS EINECS Concentration inFormulation %

(w/w)

CI 42090 Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)]amino]-2'-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt

3844-45-9 223-339-8 0.009000%


EU 2013 Regs IV/1

Fragrance / Parfum Information

Name of Fragrance NONE PRESENT

Code of Fragrance

Fragrance Manufacturer

Physical/Chemical Characteristics & Stability of the Cosmetic Product

Physical Descriptionof the Product

Crystals

Aroma Characteristic

Colour Various

Taste N/A

pH of Product N/A

Viscosity N/A

Specific Gravity N/A

Stability A stability test has not been supplied

INCI Physical Description Chemical description

ACRYLAMIDE/SODIUMACRYLATE COPOLYMER

White granular solid 2-Propenoic acid, sodium salt, polymer with2-propenamide Specific Gravity: ~0.75pH: ~6-8 for 1% solutionFlash point: >200°C


4 / 14

INCI Physical Description Chemical description

VITIS VINIFERA SEED OIL Clear, pale yellow to green liquid with acharacteristic odour

A highly polyunsaturated triglyceride oil obtainedfrom the pressed seed of Vitis Vinifera L.,Vitaceae Free Fatty Acid (% as oleic): 0.5% MaximumSpecific Gravity @ 20° C: 0.9150 - 0.9240Refractive Index: 1.473 - 1.476Iodine Value: 123 - 143Peroxide Value: 10 Meq/kg MaximumMiscible with mineral oil and isopropyl esters.Insoluble in water.FATTY ACID PROFILE: (%)Palmitic C16:0 6 - 8Stearic C18:0 2.0 - 4.5Oleic C18:1 15 - 25Linoleic C18:2 62 - 75

CI 47005 Yellow powder Emp. Formula : C18H10NNaO5S (principalcompound)Mol weight : 375.3 g/mol (monosulfonic) 477.0 g/mol (disulfonic)Melting point : >150ºC (decomposition)Boiling point : /Density : /Rel. vap. dens. : /Vapour Press. : /Log Pow : 0.720% soluble in water, 5% soluble in saline, 2.5%soluble in DMSO, 2% in standard formulation.

CI 17200 Dark red/brown powder Formula: C16H11N3Na2O7S2Molecular weight: 467Log Pow: ≤ 0.5 (extrapolated)Solubility: Water: > 2.5%; DMSO: > 10%; Ethanol: <1%

CI 42090 Dark Violet powder Emp. Formula : C37H34N2Na2O9S3Mol weight : 792.86Melting point : 283°CBoiling point : 1184 °C (calculated by QSAR) *Density : /Rel. vap. dens. : /Vapour Press. : 1.0 E-36 hPa (calculated byQSAR) *Log Pow : -0.32 (calculated by QSAR)Solubility: Water : > 20% (w/w) (pH 5.1)DMSO : > 10% (w/w)Acetone/water (1:1) : > 10% (w/w)Ethanol/water (4:6) : > 10% (w/w)


5 / 14

Microbiological Quality

Preservative Efficacy This product is anhydrous and inherently hostile to the growth of micro-organisms. Microbialchallenge testing is not required.

Plate Count

Impurities, Traces & Packaging

Description of the Packaging& Suitability for Use

Packaging materials have not been submitted.

Notes of Impurities,Traces in the INCI

No impurities of concern have been identified in the raw material data supplied

Normal & Reasonably Foreseeable Use

Description of IntendedApplication & Directions for Use

The product is added to a bath. It is a rinse-off product.

Exposure to the Cosmetic Product

Site of Application Area of body - area of head

Surface Area of Application (cm2)

9000

Amount Applied (g) per day 0.873g

Duration Rinse-off

Frequency 1/day

Retention Factor 0.1

Exposure Routes Dermal (incidental ocular and oral)

Target Population Baby 15kg

Calculated relative dailyexposure (mg/kg bw/day)

58.2

Typical consumer use of the product is taken from the SCCS’s Notes of Guidance and the EPA Exposure Factors Handbook


6 / 14

Exposure to the Substances

INCI Calculated RelativeDaily Exposure

Concentration % (w/w) Dermal Absorption Systemic ExposureDosage

ACRYLAMIDE/SODIUMACRYLATECOPOLYMER

58.2 99.445000% 100.000000% 57.87699

VITIS VINIFERA SEEDOIL

58.2 0.500000% 100.000000% 0.291

CI 47005 58.2 0.055000% 100.000000% 0.03201

CI 17200 58.2 0.055000% 100.000000% 0.03201

CI 42090 58.2 0.009000% 100.000000% 0.005238

Exposure data and method of calculation taken from the SCCS’s Notes of Guidance. The conventional conservative approach of assuming adermal absorption of 100% is taken where appropriate

Toxicological Profile of the Substances

Local Toxicity

INCI Eye Irritant Skin Irritant SkinIrritant

Skin Sensitizer Photo Sensitizer


Minimal Minimal No No


No No No No

CI 47005 Slight Slight No No

CI 17200 No No No No

CI 42090 Slight Moderate No No

Margin of Safety and Comments


7 / 14

INCI Margin of Safety (MOS) NOAEL SED


No Data No data 57.87699


6117 1780 0.291

CI 47005 1562 50 0.03201

CI 17200 781 25 0.03201

CI 42090 120466 631 0.005238

INCI General Safety Comments Data Reference


Acrylamide/Sodium Acrylates Copolymer is apolymer of 2-Propenoic acid, sodium salt with2-propenamide. It functions as a film former andanti-static in cosmetics and personal careproducts. It has a very low order of acute toxicity.It is a minimal ocular and dermal irritant but is not asensitiser. It is not classified as carcinogenic,mutagenic or reprotoxic. Its use in personal careproducts is regulated under Annex III/66 of theCosmetic Regulations such that (a) Body leave-onproducts Maximum residual acrylamide content0.1mg/kg, (b) Other products Maximum residualacrylamide content 0.5mg/kg.

SCCS 0011/98 - Opinion concerning AcrylamideResidues in CosmeticsMSDS for Magnafloc® LT27AG from BASFCORPORATION


Vitis Vinifera Seed Oil is the fixed oil, consistingprimarily of the glycerides of the fatty acids,obtained by pressing the seeds of the Red Grape,Vitis Vinifera L., Vitaceae. When used in cosmeticsand personal care products, Vitis Vinifera (Grape)Seed Oil functions as a skin-conditioning agentand emollient. It is practically non-toxic and is notan irritant or sensitiser. It is not a carcinogen, amutagen, or reproductive toxin. It is safe to use inits current application.

"Vitis Vinifera (Grape) Ingredients as Used inCosmetics", CIR, February 17, 2012Technical Data sheet for VITIS VINIFERA (GRAPE)SEED OIL from Jeen International Corp.


8 / 14


CI 47005 CI 47005 or D&C Yellow 10 is a mixture of thedisodium salt of the mono- and disulfuric acids of2(2-quinolyl)-1H-indene-1,3(2H)-dione. It is used asa colourant in cometics and personal careproducts. It is of very low acute toxicity and isgenerally well tolerated in chronic exposure tests.Some effects seen in rat pups during long-termtests have lead to a cautious ADI of 0.5 mg/kgbw/day based on a NOAEL of 50 mg/kg bw. It isslightly irritating but not a sensitiser. It is not acarcinogen, genotoxin, or reprotoxin. It is apermitted food additive in the EU (E 104) where itmust conform to the specifications listed in thefood regulations. In the USA it is subject tocertification by the FDA and permitted forcolouring cosmetics and personal care productsincluding products intended to be used on thelips, however it is not permitted for use in productsintended for use in the area of the eye. CI 47005is considered safe in its present use andconcentration.

"OPINION OF THE SCIENTIFIC COMMITTEE ONCOSMETIC PRODUCTS AND NON-FOODPRODUCTS INTENDED FOR CONSUMERSCONCERNING ACID YELLOW 3 COLIPA n° C54",Adopted by the SCCNFP during the 28th plenarymeeting of 25 May 2004, SCCNFP/0789/04"Scientific Opinion on the re-evaluation ofQuinoline Yellow (E 104) as a food additive", EFSAPanel on Food Additives and Nutrient Sourcesadded to Food (ANS), EFSA Journal 2009;7(11):1329

CI 17200 CI 17200 is the Colour Index number of a redmonoazo dye also known as D&C Red 33 or AcidRed 33. It is used as a colorant in cosmetics andpersonal care products. It has a low acute toxicityprofile and is reasonably well tolerated over longterm use. It is not an irritant or sensitiser. It is notcarcinogenic, mutagenic, or a reproductive /developmental toxin. In the E.U. when used as ahair dye substance in non-oxidative hair dyeproducts it is restricted to a maximumconcentration of 0.5%. CI 17200 is consideredsafe in its current use and concentration.

SCCP (Scientific Committee on ConsumerProducts), Opinion on AcidRed 33, 18 December 2007


9 / 14


CI 42090 CI 42090 is a synthetic dye produced usingaromatic hydrocarbons from petroleum. It is alsoknown as FD&C Blue No. 1. In addition to its use incosmetics and personal care products, CI 42090is commonly used as a food colouring (E 133 inEurope). Although it has previously been bannedin Austria, Belgium, Denmark, France, Germany,Greece, Italy, Spain, Sweden, and Switzerlandamong others it has been certified as a safe foodadditive in the EU and is today legal in most of thecountries. It has an extremely low level of acuteand chronic toxicity and is not generally an irritantor a sensitiser. It has the capacity for inducing anallergic reaction in individuals with pre-existingmoderate asthma. CI 42090 is listed in Annex IV,Part I (colouring agent allowed for use in cosmeticproducts) of the Cosmetics Directive of theEuropean Union and may be used in all cosmeticsand personal care products provided it conformsto the specifications listed in the food regulations.When used in cosmetic products in the EuropeanUnion it must be called CI 42090. When used as ahair dye substance in a non-oxidative hair dyeproduct it is restricted by Annex III/1,190 to amaximum concentration of 0.5% in the finishedproduct.

"Evaluation and opinion on Acid Blue 9", THESCIENTIFIC COMMITTEE ON COSMETICPRODUCTS AND NON-FOOD PRODUCTS,SCCNFP/0787/04, 23 April 2004

Undesirable Effects & Serious Undesirable Effects

None reported

Information on the Cosmetic Product

No further information submitted.

PART B

Assessment conclusion


10 / 14

*** PROVISIONAL *** No product specification, stability, or packaging materials information has been provided for this product. The followingassessment is contingent on this information being supplied and found to be satisfactory.Colours have been assessed at their maximum concentration. This conservative approach ensures the highest safety of theproduct in its several shades.

The evaluation of the data available on the product and the information about the ingredients for the claimed use do not indicatea significant risk to users that outweighs any benefits of use. The clinical data indicate very low incidence of adverse events

The product is safe for use in the stated application, and complies with EC Regulation 1223/2009. This assessment is conditionalon the Responsible Person complying with the conditions in the notes and any other purity restrictions listed.

Labelled warnings and instructions of use

CAUTION! Children under 5 years must be supervised by an adult due to small parts. This is a non-edible product. Not to beeaten. WARNING! Product will be slippery, take care when entering and exiting the bath. DO NOT STAND UP. Avoid contact witheyes, if contact occurs, rinse with plenty of cold water. Seek medical advice if any problem persists.For sensitive skin, test a smallamount on the skin first. Keep packaging for future reference.Wash off thoroughly after use. DO NOT EAT. WILL NOT CLOGDRAINS.

Reasoning

The toxicological data given in Part A section 8 indicate that the ingredients are safe for their intended use.

In general, the final product would not be considered an irritant or potential skin sensitiser if the total concentration of irritantingredients is less than 10% and the total concentration of skin sensitisers is less than 1%. These levels are not exceeded in theproduct. The product does not contain any known photosensitising ingredients.

Assessor’s credentials and approval of part B

Mark Richard Bowes-Cavanagh BSc (Hons) App. Chem CSci CChem MRSCAddress: Green Pastures, Totnes Road, Collaton St. Mary, Paignton, Devon,U.K.

Further Education 1991 - 1994 University Of Plymouth. Drake Circus, Plymouth.2nd Class BSc (HONS) - Degree in Applied Chemistry.

Specially Qualified In Qualitative & quantitative analysis of Material, Bio-organic, Analytical, Environmental, Physical, Organicand Inorganic chemistry.Close liaison with industrial processes and particular attention was given on GLP and all inferencesrecorded.Synthetic work and analysis using FTIR, IP, GC-MS, GC, HPLC, H-NMR, ICP--MS and bioassaypreparations.Final year dissertation entitled "Isothiocyanates of the Larval Cabbage Root Fly (D.Radicum) Attractants"

Career History 2000-Present Advanced Development & Safety Laboratories Ltd Paignton, Devon. TQ4 7PW.

Technical Director

Analysis and Signing-Off of Safety Assessments in accordance to Cosmetics Directives, EU, ASEAN,Canada and FDA and to 2013 regulations.Presentation of new products or raw materials to customers including point of sale, including new


11 / 14

actives from In-Cosmetics and other trade shows.Negotiation of price points and order details with both internal departments and customers throughprocurement or sales.Research & Development of new products, including sourcing of new ingredients, componentry andfragrance.Sourcing of all packaging connected to new products, enabling product to arrive on time at third partymanufacturers.Management of bank accounts and supplier credit accounts.Legal paperwork to enable smooth transfer of product to Far East and FDA in USA though their internalgoverning bodies.Creation of website and update including ePDQ selling facility.Collation of orders with manufacturers including Quality Control and adherence to specifications.Organizing Trade Shows including NEC Fairs, Regional shows and Oversea Trade shows e.g. HongKong Beauty Show.Consultancy with manufacturers to establish new ranges for both them and feasibility to be successfulon the market.Preparation of stability testing on all products including product compatibility.Strategy planning for both ECL and with consultancy to clients on better systems within theirorganizations including training.

1999 - 2000 The Bodyline Group Plc, Paignton, Devon. TQ4 7QZ.

Technical Manager2010-2012 LF Beauty

To manage the team to ensure products are developed to specified standards to meet customer andcompany requirements ensuring that all relevant technical standards are applied.Lead the R&D team and ensure close working relationships between R&D and key internaldepartments: NPD, Process, Commercial, PurchasingManage workload to ensure product developments are in line with critical paths.To keep abreast of new technology with a view to:- introduction into existing products- introduction into new products- use in innovation presentations- use in technical bulletinsEnsure that products developed by R&D are:- Market focused- Legal (according to claim and composition)- Safe to use- Stable (will not separate, discolour etc.)- Can be manufactured consistently to specificationAssess external testing product development requirements. Ensure testing is focused, best value andaccurately costed.To liaise with customers in order to provide them with required levels of technical support, backed bythe supply of all data, samples and specifications.To liaise with outside suppliers in order to:- find new sources of innovation- find equivalent raw materials at competitive costs- tested externally, where internal facilities are inadequate for the purpose- at minimum costAssist as necessary in the development of the R&D budget.Ensure R&D spending is in line with agreed budgets and that external testing is properly targeted.Undertake succession planning within the department and ensure that sufficient developmentaltraining takes place.To reduce failure rate in process through managing pilot production programme and troubleshootingbulk production issues.The management, leadership, performance management, development, recruitment and training of allstaff within the function to ensure that department performance and customer service are optimised.


12 / 14

Technical Manager1999 - 2000 The Bodyline Group Plc, Paignton, Devon. TQ4 7QZ

Direct involvement with sales in initiating new projects and servicing the account.Upgrading the company’s capabilities in order to achieve ISO 9001 by March 2000.Appearance on The Shopping Channel to promote Bodyline Products because of my technical salesskills.Organized trade shows for Bodyline Group including, NEC Cosmetic Fair, Frankfurt show.Operating and maintaining a discipline factory environment with close control of logistical planning.Close liaison with technical departments of all customers to ensure product quality and safety isparamount.Develop customer accounts to enable maximum potential for both the customer and the company.Drive the dynamic creative engine of the company to achieve franchise Bodyline shops in Europe andOceania.Increase bottom line profit by efficiently programming in projects and maximizing the workforce toachieve manufacturing wages lower ever before.Maximize output due to cash flow considerations enabling Bodyline to invest in other project ventures.Evaluate customer requirements to measure Bodylines to achieve maximum profit margin and toenable projects capability of achieving product goal or sub-contracting to other contacts.Close liaison with suppliers to accomplish cost saving initiatives to complete within the critical path.Organizing meetings between departments and collaborating with managers to ensure a smoothproject path.

Research & Development Chemist1999 - 1995 The Bodyline Group Plc, Paignton, Devon. TQ4 7QZ.

Formulated a more comprehensive range of products to promote the Bodyline range within the costparameters and our animal testing declaration (1985).Achieved suspensions for sophisticated skin care and innovative designs.Produced varied emulsified systems according to customer requirements and production facilities.Introduced new systems into the Research & Development arena to achieve high standards inconjunction with EEC directives on stability and safety of products.Researched into most commercially used preservatives within cosmetic sector according to product,cost and customers needs.Initiate point of sale and manufacturing information for customers on recommended applications andbenefits of product.Oversee Quality Assurance to answer customer enquiries and required contingency measures.Evaluation of all additives in product to achieve maximum stability and safety, to prolong shelf-life.

Zeneca Environmental Laboratory, Brixham, Devon.

Work Experience in Vertebrae Laboratory monitoring temperature, pH and other environmentalparameters.

Achievements Member of the Royal Society Of Chemistry and a "Chartered"Chemist and Scientist.Member of The Society Of Cosmetic Scientists.Member of the British Toxicology Society

Date and signature of safety assessor.

Signed:


13 / 14

Date: October 15, 2014

This assessment is based on information supplied by the client, raw material manufacturers and published information in recognisedauthoritative sources. Whilst best endeavours have been used to check the accuracy of this information, the undersigned cannot be heldresponsible for any erroneous information supplied and used for preparing this assessment.

Powered by TCPDF (www.tcpdf.org)


Powered by TCPDF (www.tcpdf.org)

14 / 14

slime play kk3301 - slime baff kk3302 - messy play kk3303 ... · pdf...

Documents