Toxicological Risk Assessment - Zimpli Kids based on systemic (mg/kg) effects are calculated as 'Point of Departure (PoD)' / 'Systemic Exposure Dose (SED)', where: PoD = Data point

Delphic HSESolutions Ltd

Messy Play / Slime Baff / Slime Play - Yellow, Green, Red, Blue

Report 198408233-4 -Toxicological Risk Assessment

Particle Size:

Appearance:

Boiling Point:

Melting Point: Log Kow:

Water Solubility:

Viscosity:

Vapour Pressure:

Odour:

Specific Gravity:

pH:

Evaporation Rate:

Product ReferenceKK3303, KK3302, KK3301Type of Product:

Physical Form: Semi-SolidClient: Gelicity UK Ltd

Gelicity House, Unit 27Castle Park Industrial EstateFlintCH6 5XA

Slime Making Kit / Leave on

PRODUCT DETAILS

PHYSICAL / CHEMICAL CHARACTERISTICS

This formulation is an overview of the composition, listing only the chemical name and quantities added.For full details on the ingredients including INCI names for cosmetic products, please see Annex I - Raw Material Information.

The Assessment relates only to the formulation as described below. If this information is incorrect, please contact Delphic HSE with the correct information.

The formulation below provides an overview of the composition, listing chemical name and quantities added. For further details please see Annex I - Raw Material Information.

Sodium Acrylate / Acrylamide Copolymer 99.44525085-02-3Vitis Vinifera (Grape) Seed Oil .584929-27-1 ; 8024-22-4+/- CI 47005 (D&C Yellow No.10) .0558004-92-0 / 95193-83-2+/- CI 17200 (D&C Red 33 ) .0553567-66-6+/- CI 42090 (FD&C Blue 1) .0092650-18-2 / 3844-45-9 / 68921-42-6 / 15792-67-3 / 71701-18-3 / 71701-19-4

[Product]Ingredients CAS Number

FORMULATION OVERVIEW

SAFETY WARNINGS / INSTRUCTIONS

This product is intended for external use only and should not be ingested.

Page 1 of 4Report 19840 Messy Play / Slime Baff / Slime Play - Yellow, Green, Red, Blue

No impurities or trace materials have been declared by the manufacturer / person(s) responsible for placing the product on the market

The below information is a list of impurities & trace materials declared by the manufacturer / responsible person as being present within the product.

If no materials are identified it is understood that no impurities or trace materials have been disclosed to Delphic HSE Solutions at the time of review.

[Product]Substances CAS Number

IMPURITIES & TRACE MATERIALS

EXPOSURE SCENARIO

Manufacturers Instructions for Use

Information on Previous Sales / Complaints

Information on User Trials / Product Testing

14kgChildren (3+)

Single Exposure:

Exposure to Neat Product

Combined Exposure:

Diluted in use:50g | 1 time(s) per Day

50g | 3571.429mg/kg/Day

Hands.

Yes - 160Retention Factor: 0.01

.0437m2Surface Area:

Exposure Level: 114.416 mg/cm2

Exposure Time:mg/cm2

Arms. Hands.

.1368m2

36.550

Up to 30 minutes

Intended Consumer:

Body Site(s):

Exposure to Diluted Product:

Body Site(s):

Surface Area:

Exposure Level:

Exposure Time:

Minimum Expected Body Weight:

Rinsed from hands after 2 - 3 minute delay


TOXICOLOGY & REGULATORY ASSESSMENT

Skin Toxicity - Neat Product

Eye Toxicity - Neat Product

Oral Toxicity - Neat Product

Inhalation Toxicity

Product ReviewA toy slime made in batches by the addition of 50g of powder to 8 litres of water and used for play.South Africa and the UAE have no distinct toy regulations however the US/EU/Canada all follow the international toy standard which is based on the EU, ISO EN71 systemand the appropriate parts. The polyacrylamide must not contain any detectable residual acrylamide according to the requirements of EN71-9, although it must be stressedthat EN71-9 is NOT yet an internationally adopted standard. The grade of polymer used should ensure that full polymerisation has been achieved. As the product is dilutedon water and the material of concern - acrylamide - is naturally formed in food when cooked due to the reaction of starch with amino acids found in proteins, principallyAspargine but to a lesser extent Glutamine. Acrylamide has been shown to cause cancer in long term animal studies and is a genotoxic carcinogen that has its' effect bybinding to DNA. It is not the bound material that gives rise to cancer, but incomplete repair of the DNA strand. DNA Repair is a constant and necessary mechanism asDNA damage occurs as a result of solar radiation as well as a large number of chemicals found naturally in food - including acrylamide. Providing that the level of exposuredoes not overload the repair mechanism, then the effect on organisms is controlled. It is only when the natural repair mechanisms are overloaded - as occurs in a longterm carcinogenicity study in animals, that the number of errors in repair reach a significant level and can lead to disease. Providing that the product is not ingested, theneven with the presence of acrylamide, external application is not considered to present a risk to health. Regulatory compliance can be assured by ensuring that the gradeof acrylamide used is suitable for toy use and does not contain any significant amounts of acrylamide so that any regulatory control concentrations can be met.The formulation is representative of products of this type.All of the ingredients are well known and have a history of safe use in the marketplace with no reports of a significant number of adverse reactions.Provided the manufacturer’s instructions are followed, this product will give users the degree of safety that they would reasonably expect.

The product as supplied may cause only minimal skin irritation even if exposure is prolonged or repeated.Exposure to this product is unlikely to result in photo-toxic effects. Unlikely to cause sensitisation following repeated skin contact.Unlikely to produce systemic toxicity following skin contact.

Skin Toxicity - Diluted Product

Contact with the dilute solution is unlikely to cause skin irritation even if contact is prolonged or repeated.Exposure to this product when diluted is unlikely to result in photo-toxic effects.Repeated exposure to the diluted product is unlikely to produce allergy by skin contact.When diluted in use, unlikely to cause systemic toxicity following skin contact.

May cause slight transient eye irritation.

Eye Toxicity - Diluted Product

Accidental exposure of the eye to the diluted product may result in slight eye irritation.

All materials if swallowed in large amounts have the potential to cause injury.If incidentally swallowed in small amounts, the formulation as supplied is unlikely to cause any adverse effects.Not expected to produce systemic toxicity following ingestion. All materials if swallowed in large amounts have the potential to cause injury.

Oral Toxicity - Diluted Product

If swallowed, the diluted product in-use is unlikely to cause any adverse effects.Not expected to produce systemic toxicity following ingestion.

It is unlikely that inhalation will be a route of exposure.


Toxicological & Regulatory Assessor

Delphic HSE Solutions, 1 Blackdown Road, Deepcut, Camberley, Surrey GU16 6SH

Tel: +44 (0)1252 856 700 e-mail: [email protected]

Overall Safety & Compliance

C I Betton, BSc, FSB, CBiol, FIEMA, FRSC, CEnv, EUROTOX Registered Toxicologist 19/Sep/2014

Required Safety Labelling

This product is intended for external use only and should not be ingested.

This toy is not classified as a Dangerous Preparation as per the health criteria of European Directives 67/548/EEC and 1999/45/EC as amended. Taking into account typical exposure of children duringuse, the toy is unlikely to cause harm.This Toy is considered to be compliant with Toxicological Requirements of the Standard on toy safety, AS/NZS ISO 8124This Toy is considered to be compliant with Toxicological Requirements of the Canadian Toy Regulations SOR/2011-17.This toy complies with the EU Toy safety Directive 2009/48/EC and as implemented by EN 71Review of the documented information for the ingredients in the formulation for this product suggests that it is not expected to be Toxic, Highly Toxic, Corrosive, Irritant or a Strong Sensitiser as defined in 16 CFR 1500.3(b)(5), 1500.3(b)(6), 1500.3(b)(7), 1500.3(b)(8) and 1500.3(b)(9). And ASTM F963-08 (ASTM F963-11 from 12th June 2012) Standard Consumer Safety Specification on ToySafety.

CONCLUSIONS & RECOMMENDATIONS

This report consists of 4 pages plus a Raw Materials, Allergens & Exposure Annex. It is only valid as the original, complete document.


Preface to Annexes

Physical/Chemical and Toxicological data presented within these reviews are representative of publicly available data and provided for informational purposesonly. Sources of data are identified (typically in brackets) following each data point, and there may be multiple data points for any given toxicological endpoint.

Margins of Safety (MoS) are calculated where suitable data are available, and may related to mg/kg, μg/cm2 or percentage-based indications of safety.

MoS based on systemic (mg/kg) effects are calculated as 'Point of Departure (PoD)' / 'Systemic Exposure Dose (SED)', where:

PoD = Data point considered to be indicative of a 'safe' level of exposure. This may be an animal-derived No Observed Adverse Effect Level (NOAEL) ora value indicated as being safe to humans. In the case of the latter this would typically be in the form of an ADI (Acceptable Daily Intake) or DNEL (Derived

No Effect Level) established by a governmental or scientific committee / body.

SED = (Product Used (mg) x Retention Factor x Concentration of Material in Product x Dermal Absorption) / intended user body weight (kg)

In the absence of material specific data a dermal absorption of 100% is assumed.Where an animal-derived NOAEL is used as the PoD an MoS greater than 100 is typically considered acceptable for indicating safety to consumers.

For PoD based on established safe levels in humans an MoS of greater than 1 is typically considered as acceptable for indicating safety to consumers.

MoS based on localised (μg/cm2) effects are calculated as 'Point of Departure (PoD)' / 'Dermal Exposure', where:

PoD = Data point considered to be indicative of a 'safe' level of exposure. This would typically be a μg/cm2 value identified from either a Local Lymph NodeAssay (LLNA) or Human Repeat Insult Patch Test (HRIPT).

Dermal Exposure = (Product Used (μg) x Retention Factor x Concentration of Material in Product) / Surface Area of Application

MoS based on percentage data are calculated as 'Point of Departure PoD' / 'Ingredient Concentration in Product', where:

PoD = Data point considered to be indicative of a 'safe' level of exposure. Typically a percentage identified as safe for use within a leave-on consumerproduct, as established by legislation or by a governmental or scientific committee / body.

Ingredient Concentration in Product = Concentration of Material in Finished Product x Retention Factor(As safe levels are typically identified for leave-on products the retention factor is included within the calculation to account for use in rinse-off products)

Retention Factor is an estimation of the amount of product in prolonged contact with the skin under normal conditions of use, and expressed as thedecimal form of a percentage. A retention factor of 1 relates to 100% of the product staying in prolonged contact with the skin and is typically used for all

leave-on products. All other products have retention factors as determined by typical conditions of use, and these are presented on page 3 of theassessment under 'Exposure Scenario'.

Annex I - Raw Material Information

RAW MATERIAL DETAILSANNEX I -

Messy Play / Slime Baff / Slime Play - Yellow, Green, Red, Blue

No points of departure for the calculation of Margins of Safety (MoS) have been identified.

Substance: Sodium Acrylate / Acrylamide CopolymerCAS: 25085-02-3

A partially insoluble polymeric powder, which as supplied will pose a risk of mechanical eye irritation and act as a nuisance dust. May also cause a low level dermal irritation. Once diluted within a formulationwould be expected to pose only a minimal risk of adverse effects. May contain residual acrylamide and sodium acrylate. Acrylamide is not permitted in cosmetics in the EU as an ingredient but may bepresent as a contaminant with a maximum residual acrylamide content in the leave-on product of 0.1ppm and other products at 0.5ppm. For other uses, providing these potential comtaminants are present atlow concentrations, this should not pose a risk to health.

A NOAEL was not available for review. Overall use within a consumer product would not be expected to pose an undue risk of adverse effects.

Function:

Amber gel

7.5 to 8.5

Soluble

101 C - 2 C

Appearance:Melting Point:Boiling Point:pH:Water Solubility:

Overall Toxicity Review:

EINECS: PolymerUnclassified

Not ControlledNot Controlled

Controlled. Acrylamide migration is controlled at the action limit for the final product (must not be detected)Not Controlled

EU Toys EN71 Parts: EU Toys 2009-48:

EU R Phrase Classification:EU GHS Classification:REACh Annex XVII:REACh SVHC:

Sodium Acrylate / Acrylamide CopolymerEU INCI Name:

Europe:

United States:Polymer not listed (Neutron Inc MSDS)TSCA Listing:

Canada:

Australia:

99.445%Concentration in Product:

35.51607143mg/kg1.13781

Daily Body Burden:Dermal Exposure Level: mg/cm2

the acute LD50 (rat) is expected to be > 2000 mg/kg.; Oral: LD50 rat : > 5,000 mg/kg (OECD Guideline 401) (BASF MSDS)May cause slight skin irritation; non-irritant (BASF MSDS)May cause slight eye irritation ; non-irritant (BASF MSDS)

Not listed by IARC, NTP, OSHA, or ACGIH

Acute Tox:Skin Irritancy:Eye Irritancy:

Carcinogenicity:

Chemical Structure Physical/Chemical Characteristics

Regulatory Listings

Toxicological Information

Toxicological Summary

This product may contain the following chemical(s) which are currently listed on the California list of known carcinogens and reproductive toxins: Acrylamide (CASProp 65

Margin(s) of Safety

Report 19840 5Page 1 ofPhysical/Chemical and Toxicological data used in generating these review are representative of publicly available data, and is provided for information purposes only.For further information on any of the data or conclusions reported here, or for information Margins of Safety and how they are Calculated, please contact Delphic HSE.

No points of departure for the calculation of Margins of Safety (MoS) have been identified.

Substance: Vitis Vinifera (Grape) Seed OilCAS: 84929-27-1 ; 8024-22-4

A mixture of fatty acid glycerides with low potential to irritate the skin or eye. Composed mainly of Linoleic acid (72%), Oleic Acid (16%), Palmitic acid (7%) and Stearic acids (4%) with <1% of a number ofother fatty esters and unsaponifiables. Raw toxicity data available for review was limited and a NOAEL could not be identified. However this material, and Grape products in general, find widespread use in avast range of consumer products and form a staple of many human diets. As such use in consumer products is not considered to present a risk to health.

Although a NOAEL was not available for use the long history of safe use of this material is considered sufficient to substantiate its inclusion within consumer products.

Function: Emollient ; Skin Conditioning

Colorless to light yellow viscous liquid

Practically insoluble 7

230°C-12°C

Appearance:Melting Point:Boiling Point:

Water Solubility:Log Kow:


EINECS: 284-511-6UnclassifiedUnclassifiedNot ControlledNot Controlled

Not Listed in EN71-7 and EN71-9EU Toys EN71 Parts:


Vitis Vinifera Seed OilEU INCI Name:

Not Listed as Hazardous according to WHMIS

ListedNot ListedNot Listed

WHMIS Listing:

AICS Listing:NICNAS Listing:AU SUSDP Listing:

Europe:

United States:Not ListedTSCA Listing:

Canada:

Australia:


0.17857143mg/kg0.00572


ListedDSL Listing:


Regulatory Listings



Not listedProp 65

Margin(s) of Safety

Report 19840 Messy Play / Slime Baff / Slime Play - Yellow, Green, Red, Blue 5Page 2 of

Substance: CI 47005 (D&C Yellow No.10)CAS: 8004-92-0 / 95193-83-2

0.019643mg/kg10.0000mg/kg 509.090909

A thoroughly tested food dye with low potential to cause irritancy or allergy. Unlikely to cause adverse effects at the typical concentrations used in cosmetics. Permitted in all cosmetic products in the EU.

Acid Yellow 3 is listed as CI 10316 and CI 47005 in Annex IV, part 1 – list of colouring agents allowed for use in cosmetic products – to Directive 76/768/EEC on cosmetic products. Acid Yellow 3 is a colorantallowed in Europe for food (Directive 94/36/EC, Annex 1, E104 quinoline yellow). It is approved for use in drugs and cosmetics in the USA.

The acceptable daily intake (ADI) was set at 0-10 mg/kg bw/day. The Scientific Committee on Food (SCF), FDA and JECFA established an ADI value of 0-10 mg/kg bw/day, based on a NOEL of 1000 mg/kgbw/day in a long term mouse study corresponding to 2% in the diet. This was based on 2 chronic toxicity and carcinogenicity feeding studies in rats and mice . The evaluation of a reproductive toxicity study byBIBRA concluded that an increase in postnatal mortality and a decrease in postnatal weight gain occurred at and above 0.5%. From these findings, a NOAEL of 50 mg/kg bw/day was deduced SCCNFP.

Function: Colourant

Yellow Powdered solid

Poorly soluble (20% soluble)

Decomposes.Appearance:Melting Point:

Water Solubility:


Maximum Recommended Exposure: Exposure from product: Margin of Safety:Margin(s) of Safety:

EINECS: 305-897-5R22- Harmful if swallowed

Not ControlledNot Controlled

Not listed in EN71 Part 7 & 9Not controlled

EU Toys EN71 Parts:EU Toys 2009-48:


+/- CI 47005EU INCI Name:

Not listed

Listed

WHMIS Listing:

AICS Listing:

Europe:

United States:ListedTSCA Listing:

Canada:

Australia:


0.01964286mg/kg0.00063


ListedDSL Listing:

ORAL (LD50): Acute: 2000 mg/kg [Rat].LD50 (rat) > 2 g/kg bw; LD50 (dog) > 1 g/kg bw; LD50 (rat) > 2 g/kg bw; LD50 (rat) > 5 g/kg bw (SCCNFP/0789/04).It was not a significant contact allergen from Human maximisation tests (SCCNFP/0789/04).

Acid Yellow 3 is a slight irritant to the skin animals (SCCNFP/0789/04).Acid Yellow 3 is slightly irritant to the mucous membranes (SCCNFP/0789/04).

Non-sensitiser in Hartley albino guinea pigs (SCCNFP/0789/04).

Acid Yellow 3 is non-mutagenic in the bacterial reverse mutation assay using Salmonella typhimurium (with metabolic activation) and in the mouse lymphoma assay (with metabolicactivation) (SCCNFP/0789/04).

Acute Tox:

Skin Irritancy:

Eye Irritancy:

Sensitisation:

Genotoxicity:


Regulatory Listings



Not ListedProp 65

Margin(s) of Safety


Substance: CI 17200 (D&C Red 33 ) CAS: 3567-66-6

0.019643mg/kg102.0000mg/kg 5192.72727

The colour pigment is not dermally absorbed; however, it is systematically distributed if ingested. A NOAEL 102 mg/kg bw/d has been reported based on a LOEL 150 mg/kg bw/d for increased levels ofleukocytes and reticulocytes. This effect has been described in several long term studies and there is no consensus for the biological explanation. This could be due to disruption in hematopoiesis but alsoinflammation, anaemia, etc

It has a reasonably low acute toxicity (high oral LD50). It does not induce reprotoxicity, carcinogenicity and genotoxicity. It is not a skin or eye irritant nor a sensitiser.

SCCP (2007) reports that maximum authorised concentration in non-oxidative hair dye formulations is 0.5%. For other types of cosmetic products the exposure have not been considered. Based on the longhistory of safe use in a variety of Consumer Products the incorporation of this material within a formulation is considered unlikely to pose a risk of significant adverse effects.

0.5000% 909.09

Function: Pigment

Red solid/powder

Soluble

Decomposes at 240CAppearance:Melting Point:

Water Solubility:


Maximum Recommended Exposure: 0.000550%Exposure from product: Margin of Safety:Maximum Recommended Exposure: Exposure from product: Margin of Safety:

Margin(s) of Safety:

EINECS: 222-656-9UnclassifiedUnclassifiedNot ControlledNot Controlled

Not listed in EN71 Part 7 & 9Not Controlled

EU Toys EN71 Parts:EU Toys 2009-48:



Not Listed

ListedNot ListedNot Listed

WHMIS Listing:


Europe:

United States:ListedTSCA Listing:

Canada:

Australia:


0.01964286mg/kg0.00063


ListedDSL Listing:

This chemical it is not dermally absorbed. However, it is systemically distributed if ingested as observed in red urine in rats 24 h after exposure in the in vivo MN test. (SCCP, 2007)Oral LD50 > 2000 mg/kg ; Oral dog LD50 > 1 g/kg bw; oral rat LD50 > 3.6 g/kg bw. (SCCP, 2007)Not irritant in rabbits (SCCP, 2007)Not irritant in rabbit eye (SCCP, 2007)Negative in the guinea pig maximisation test (SCCP, 2007)A LOEL was reported at 150 mg/kg bw/d in a 24 months study in rats on the basis of increased numbers of leukocytes and reticulocytes which may indicate disruption of thehematopoiesis in the bone marrow. No NOAEL was available in this study (SCCP, 2007).

Not genotoxic based on negatives in AMes test, MLA and in vivo MN test. All tests followed OECD guidelines. (SCCP, 2007)Negative for carcinogenicity however increased levels of leukocytes were also observed (SCCP, 2007)Negative for reproductive toxicity (SCCP, 2007)

ADME:Acute Tox:

Skin Irritancy:Eye Irritancy:Sensitisation:Repeated Dose:

Genotoxicity:Carcinogenicity:Reprotoxicity:


Regulatory Listings



Not listedProp 65

Margin(s) of Safety


Substance: CI 42090 (FD&C Blue 1)CAS: 2650-18-2 / 3844-45-9 / 68921-42-6 / 15792-67-3 / 71701-18-3 / 71701-19-4

0.003214mg/kg10.0000mg/kg 3111.11111

A dye thoroughly tested for use as a food additive (FD&C Colour in the USA, E133 in the EU) and cosmetic dye. Has low acute toxicity with high oral and subcutaneous LD50s. Unlikely to cause adverseeffects when used in consumer products. Not acutely sensitising or irritating. Acceptable daily intake in the EU is 10mg/kg/day (SCCP opinion).

Not listed in EN71-7 or -9.

A NOAEL was not available for use however, given the long history of safe use in Cosmetics, it would not be expected to pose an undue risk of significant adverse effects under normal conditions of use.

Function: Pigment

Blue Powder

5 to 6 @ 1%

Soluble at 20%-0.32

283Appearance:Melting Point:pH:Water Solubility:Log Kow:


Maximum Recommended Exposure: Exposure from product: Margin of Safety:Margin(s) of Safety:

EINECS: 220-168-0 / 223-339-8 / 272-939-6 / 239-897-0 / 275-866-8 / 275-867-3R36/37/38 (Self-classification)H315, H319 (Self-classification)Not ControlledNot Controlled

Not listed in EN71-7 or 9Not ControlledNot controlled

EU Toys EN71 Parts:EU Toys 2009-48:EU Biocides:



Not Listed

Listed.Not ListedNot Controlled

WHMIS Listing:


Europe:

United States:Listed as 2650-18-2, 3844-45-9, 68921-42-6, 71701-18-3 and 71701-19-4TSCA Listing:

Canada:

Australia:


0.00321429mg/kg0.00010


ListedDSL Listing:

No dermal absorption based on percutaneous absorption test following guideline (SSCNFP, 2004)Very low intestinal absorption based on several studies on rats (SSCNFP, 2004)Mouse LD50 (Subcutanious): 4,600 mg/kg. Body Weight; Rat (oral) LD50): 2,000 mg/kg (SCCNFP, 2004). No data on acute dermal or inhalation exposure (SCCNFP, 2004)Very low or negative in several in vitro assays (SSCNFP, 2004)Transient irritation in rabbits (SCCNFP, 2004)Negative in LLNA (SCCNFP, 2004) 1 mg i.p. in rats (equalling 8 mg/kg bw) was reported to affect kidney. No more details provided by SCCNFP (2004). No other studies available.

Mostly negatives in several studies with Ames and MLA and one positive in Ames and CA (SCCNFP, 2004). However, it should be considered not genotoxic due to a majority ofstudies following guidelines reporting negatives in different endpoints.The studies reviewed by SCCNFP (2004) do not demonstrate reproductive toxicology effects or do not conclude as such due to inadequate quality or lack of information. Sarcomashave been reported after subcutaneous exposure, however it is not classified as a carcinogen by any relevant authority e.g. IARC category 3. Not classifiable as to its carcinogenicityto humans and in fact an ADI has been established.

ADME:

Acute Tox:

Skin Irritancy:Eye Irritancy:Sensitisation:Repeated Dose:

Genotoxicity:

Reprotoxicity:


Regulatory Listings



Not ListedProp 65

Margin(s) of Safety


Documents

Toxicological Risk Assessment - Zimpli Kids based on systemic (mg/kg) effects are calculated as 'Point of Departure (PoD)' / 'Systemic Exposure Dose (SED)', where: PoD = Data point