COSMETIC PRODUCT SAFETY REPORT - NailEssentialz.com

Product Name: UV LAC Colour Version: 1

Report No: 2/2

Manufacture: Viis Ilusalong OÜ Issue Date: 5.Feburary.2014

COSMETIC PRODUCT SAFETY REPORT

PRODUCT IDENTIFICATION

PRODUCT CATEGORY.: COSMETIC

REQUIRMENTS.: Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products

REFERENCE NUMBER.: UV LAC colour

CLIENT NAME.: Viis Ilusalong OÜ

CONTACT NAMES.: [email protected]

PRODUCT CHARACTERISTICS

PRODUCT NAME.: UV gel polish

TYPE OF PRODUCT.: LEAVE - ON

PHYSICAL STATE.: VISCOUS LIQUID

NOMINAL SIZE.: 15,0ml

TYPE OF PACKAGE.: GLASS BOTTLE

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Report No: 2/2 Manufacture: Viis Ilusalong OÜ Issue Date: 5.Feburary.2014

This safety assessment has been prepared in accordance with the Cosmetic Regulation (EC) No 1223/2009 and with article 39 (transitional provisions). This is the safety assessment of regulated products and their toxicology which is assessed as follows:

§ Quantitative and qualitative composition of the cosmetic product§ Physical/chemical characteristics and stability of the cosmetic product§ Microbiological quality§ Impurities, traces, information about the packaging material§ Normal and reasonably foreseeable use§ Exposure to the cosmetic product / Exposure to the substances§ Toxicological profile of the substances§ Information on the cosmetic product§ The regulatory status of the ingredients for use in cosmetic products

The safety data identified for each ingredient obtained during literature searches in medical and toxicology databases.

Taking into account the information and the present state of knowledge, this product does comply with the annexes to the Cosmetic Regulation (EC) No 1223/2009 requirements. Under normal and reasonably foreseeable conditions of use the product should not cause damage to human health when placed in the market.

The individual ingredients characteristic suggest that interaction of the materials would not lead to any synergistic or unpredictable adverse effects.

This safety assessment is relevant solely to the information and conditions described in this document. Any changes to ingredients and their concentrations of use, or change application use shall be subjected to a new assessment.

This product is considered SAFE and is in compliance with the Cosmetic Regulation (EC) No 1223/2009 requirements. The product must be manufactured according to Good Manufacturing Practice.

5.2.1914

A T Nnolim, MSc, CChem, CSci, EurChem, Dip(IndMicrob) Date EUROTOX Registered Toxicologist 13 Kirkstone Close, Camberley, GU15 1BJ, UK

*This assessment is based solely on the list of ingredients and cosmetic product safety information submitted for toxicological risk assessment, andassumes that this list is accurate and there are no additional ingredients or data which are not listed. If this information is incorrect, please contact the toxicological safety assessor with the correct data.

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Report No: 2/2 Manufacture: Viis Ilusalong OÜ

Issue Date: 5.Feburary.2014

INGREDIENTS

TETRAHYDROFURFURYL METHACRYLATE DI-HEMA TRIMETHYLHEXYL DICARBAMATE

PPG-5 METHACRYLATE

HEMA

HYDROXYPROPYL METHACRYLATE

BUTYL ACETATE

ETHYL ACETATE

ACETONE

NITROCELLULOSE

PHTHALIC ANHYDRIDE

TRIMELLITIC ANHYDRIDE

NEOPENTYL GLYCOL

CITRIC ACID

STYRENE/ACRYLATES COPOLYMER

ACETYL TRIBUTYL CITRATE

PHOSPHORIC ACID

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FORMULATIO

CAS NUMBER

2455-24-5

868-77-9

123-86-4

67-64-1

12691-60-0

58891-19-3

5949-29-1

25153-46-2

77-90-7

7664-38-2

N

MAX CONCENTRATI

ON [%]

50-75

10-25

10-25

5-10

1-5

1-5

1-5

1-5

1-5

0.1-1

0.1-1

0.1-1

0.1-1

0.1-1

0.1-1

0.1-1

© C o p y r i g h t

RESTRICTION

None

None

None

None

None

None

None

None

None

None

None

None

None

None

None

None

None

None

None

None

None

A T N n o l i m 2 0 1 4

72869-86-4

39420-45-6

27813-02-1

141-78-6

9004-70-0

ETHYL TRIMETHYLBENZOYL PHENYLPHOSPHINATEHYDROXYCYCLOHEXYL PHENYL KETONE

84434-11-7

947-19-3

85-44-9

552-30-7

126-30-7ISOPROPYL ALCOHOL

PHENYLBIS(2,4,6- TRIMETHYLBENZOYL)PHOSPHINE OXIDE

67-63-0

162881-26-7

STEARALKONIUM HECTORITE

ADIPIC ACID/FUMARIC ACID/PHTHALIC ACID/TRICYCLODECANE DIMETHANOLCOPOLYMER

25-50

10-25

10-25

10-25

5-10

1-5

None



BENZOPHENONE-12

MAYCONTAIN/[+/-]

CI15850CI 15880

CI 19140

CI 77491

CI 77499

CI 77891

CI 73360

CI 77000

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1843-05-6

5858-81-1

6417-83-0

1934-21-0

1309-37-1 / 1345-27-3

12227-89-3 / 1317-61-9 / 1345-27-3

1260-17-9 / 1328-60-5 / 1343-78-8 / 1390-65-4

7429-90-5

0-0.1 None

All Application

1-5

Purity criteria as set out in Commission Directive 95/45/EC

(E180) 1-5 All Application

All Application

1-5 Purity criteria as set out in Commission Directive 95/45/EC

(E102) All Application



1-5

Purity criteria as set out in Commission Directive 95/45/EC


Purity criteria as set out in Commission

1-5 Directive 95/45/EC (E171)

25% when used as a UV Filter

1-5 All Application

All Application

Purity criteria as set 1-5 out in Commission

Directive 95/45/EC (E120)

All Application


(E173)

CI 75470

2379-74-0

13463-67-7



All Application

14038-43-8 / 12240-15-2 / 1-5 Must be free CI 77510 25869-00-5 from cyanide ions

12769-96-9 / 1302-83-6 / All Application CI 77007 57455-37-5 1-5

All Application


CI 42090 3844-45-9 (E133)

CI 77742 10101-66-3 1-5 All Application

All Application

Purity criteria as set 1-5 out in Commission

Directive 95/45/EC (E153)

CI 77266 1333-86-4 / 7440-44-0

CI 77163 7787-59-9 1-5 All Application

3% in the finished CI 12085 2814-77-9 0.1-1 product

FRAGRANCE

TOXICOLOGICAL ASSESSMENT

OVERALL TOXICOLOGICAL REVIEW

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Perfume Name / Code.: NONE

Allergens Material Cas No Concentration [%] Final Product [%]

Labelling Requirements, any of the 26 allergens listed in Annex III / EC No 1223/2009 must be declared on the packaging when present at the specified concentration and product type as below: Leave – on >0.001% (1000ppm) Rinse – off >0.01% (100ppm)



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One of the ingredients, Phthalic Anhydride, is a rare sensitiser when used as a component of nail polishes. The Allergic reaction is caused at places where the skin is touched with the nail rather than the area around the nail itself. If such a reaction does occur, then the user should be advised to stop using the product.

The solvents will cause drowsiness and/or dizziness if inhaled in large amounts. Providing that adequate ventilation is available, this is not considered likely to present a risk to the health of users.

The NOAELs were not available for all materials within the product, but for these available they are present at concentration where Margin of Safety is satisfactory or has been justified for this type of product’s exposure.

This assessment is based on the maximum percentages of each ingredient across the range of shades and as such does not equal 100%.

EFFECT ON SKIN

May cause a slight skin irritation with prolonged application.

Unlikely to cause photo-allergy.

Unlikely to cause acute or chronic toxicity following skin contact.

The product does contain chemical materials that may cause sensitisation and it therefore should be carefully monitored in the marketplace and the customer feedback closely analysed.

EFFECT ON EYES

May cause severe eye irritation. If the product accidentally enters the mucosa membrane around the eyes it may bind the eyes causing difficult product removal.

EFFECT ON INGESTION

The material is expected to cause an adverse health effect causing even CNS depression when it accidentally enters the GI tract in a large amount. If swallowed may cause some irritation to the mouth and upper GI tract, fatigue, lack of consciousness or even fatality.

EFFECT ON INHALATION

It is likely that inhalation will be the route of exposure. Prolonged inhalation of the product may cause CNS depression, fatigue, coma or even fatality.

INSTRUCTIONS AND SAFETY WARNINGS

Do not apply to irritated, damage or compromised skin / Keep out of reach of children / Keep away from eyes. If product accidentally enters the mucosa membrane around the eyes, wash out with plenty of water and seek medical assistance if the condition persists. This product should not be ingested. Stop using this product if you develop



redness or itching.

PRODUCT EXPOSURE

* The SCCS's Notes of Guidance for the Testing of Cosmetic Substances and their Safety Evaluation 8th Revision, December 2012

INSTRUCTION OF USE

It is clear from the product name.

PHYSICO – CHEMICAL SPECIFICATION

APPEARANCE.: Viscous Liquid SPECIFIC GRAVITY [20ºC] .: Not Given

ODOUR.: Characteristic PARTICLES SIZE.: Not Applicable

pH.: Not Applicable LogKow.: Not Applicable

VISCOSITY [cP].: Not Given BOILING POINT.: Not Applicable

SOLUBILITY.: Insoluble in Water FREEZING POINT.: Not Applicable

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INTENDED AGE GROUP.: 16+ ( Female)

AREA OF APPLICATION.: Nails

EXPOSURE TIME.: Leave - on

*ESTIMATED DAILY AMOUNT APPLIED.: 0.25 g/ day

*SKIN SURFACE AREA.: 15 cm2 (total fingernail area)

PRIMARY / SECONDARY ROUTES OF EXPOSURE.: Skin / Inhalation



MICROBIOLOGICAL SPECIFICATION

PRODUCT STABILITY AND PACKAGING

INGREDIENTS TOXICOLOGICAL PROFILE

TETRAHYDROFURFURYL METHACRYLATE ( film forming), the material is an organic ester with the molecular formula C9H14O3. It is colourless liquid, insoluble in water. According to the CIR review “the material is safe in nail enhancement products when skin contact is avoided. Product should be accompanied with direction to avoid skin contact because of skin sensitisation potential of methacrylates” (CIR Table, 2012). It is however expected that the ester will undergo rapid polymerization to produce an inert polymer. A fully polymerized material would be expected to be biologically inert. Any adverse effect is only likely to occur when unreacted monomers are present in the raw

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MESOPHILIC AEROBIC BACTERIA COUNT.: Not Applicable

MOULDS.: Not Applicable

YEASTS.: Not Applicable

PATHOGENS.: Not Applicable

CHALLENGE TEST.: The product is considered as microbiologically low -risk product. This type of product does not require a challenge test including microbiological specification.

PRODUCT STABILITY.: The product is expected to show no changes to the content and packaging during the storage and customer usage.

PACKAGING SPECIFICATION.: The product is packed in a glass container with the plastic cap. Assuming suitable grades of material used, the packaging is suitable for this type of product application.

PRODUCT DURABILITY.: 12 Months after Manufacturing



materials. The NOAEL was established at 150 mg/kg per day (the highest dose tested). The study result is based on two-generation reproduction study conducted in rats (Santa Cruz Biotechnology, Inc. SDS).

MARGIN OF SAFETY Tetrahydrofurfuryl Methacrylate Daily exposure of product (A) 0.25 g/day *estimated

Mean human body weight: 60kg

Concentration in finished product (C): 75% Dermal absorption (DAp): 100% *estimated as the worst case scenario

NOAEL 150 mg/kg

Systemic Exposure Dose (SED) A x 1000 mg/g x C/100 x DAp/100/60 mg/kg/day

MoS = NOAEL/SED

SED = 0.25 g/day x 1000 x 75 /100 x 100/100/60 SED = 3.125 mg/kg/day MoS = 150 mg/ kg / 3.125mg/kg/day

MoS = 48 Remark: The margin of safety is generally 100 or above for the substance to be considered safe. It is however noted that this substance will be not available in its pure form as it will undergo rapid polymerization in the formula to produce an inert polymer.

*The MoS was calculated based on The SCCS's Notes Of Guidance For The Testing Of Cosmetic Substances AndTheir Safety Evaluation 8th Revision, December 2012

In conclusion, at the given concentration in the final product, the ingredient is not considered to be of toxicological concern when used as intended.

DI-HEMA TRIMETHYLHEXYL DICARBAMATE ( film forming), the material is an organic ester with the molecular formula C9H14O3. It is colourless liquid, insoluble in water. According to the CIR review “the material is safe in nail enhancement products when skin contact is avoided. Product should be accompanied with direction to avoid skin contact because of skin sensitisation potential of methacrylates” (CIR Table, 2012). It is however expected that the ester will undergo rapid polymerization to produce an inert polymer. A fully polymerized material would be expected to be biologically inert. Any adverse effect is only likely to occur when unreacted monomers are present in the raw materials. The NOAELs were not available in order to review however based on a history of safe use in consumer products this material is considered safe when used as intended. In conclusion, at the given concentration in the final product, the ingredient is not considered to be of toxicological concern when used as intended.

PPG-5 METHACRYLATE (film forming, nail conditioning), the material is the polypropylene glycol ester of methacrylic acid. The material is irritating to eyes, skin, and respiratory system (R36/37/38) and may cause sensitization by skin contact (R43) (Esstech Inc, SDS). A fully polymerized material would be expected to be biologically inert. Any adverse effect is only likely to occur when unreacted monomers are present in the raw materials. The NOAELs were not available in order to review however based on a history of safe use in consumer products this material is considered safe when used as intended. In conclusion, at the given concentration in the final product, the ingredient is not considered to be of toxicological concern when used as intended.

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Product Name: UV LAC Colour

Manufacture: Viis Ilusalong OÜ

Version: 1


HEMA (film forming), the material 2-Hydroxyethyl Methacrylate, an artificial nail builder. According to the CIR review “the material is safe in nail enhancement products when skin contact is avoided. Product should be accompanied with direction to avoid skin contact because of skin sensitisation potential of methacrylates” (CIR Table, 2012). It is however expected that the ester will undergo rapid polymerization to produce an inert polymer. A fully polymerized material would be expected to be biologically inert. Any adverse effect is only likely to occur when unreacted monomers are present in the raw materials. The NOAELs were not available in order to review however based on a history of safe use in consumer products this material is considered safe when used as intended. In conclusion, at the given concentration in the final product, the ingredient is not considered to be of toxicological concern when used as intended.

HYDROXYPROPYL METHACRYLATE ( film forming), the material is an organic ester with the molecular formula C9H14O3. It is colourless liquid, insoluble in water. According to the CIR review “the material is safe in nail enhancement products when skin contact is avoided. Product should be accompanied with direction to avoid skin contact because of skin sensitisation potential of methacrylates” (CIR Table, 2012). It is however expected that the ester will undergo rapid polymerization to produce an inert polymer. A fully polymerized material would be expected to be biologically inert. Any adverse effect is only likely to occur when unreacted monomers are present in the raw materials. The NOAELs were not available in order to review however based on a history of safe use in consumer products this material is considered safe when used as intended. In conclusion, at the given concentration in the final product, the ingredient is not considered to be of toxicological concern when used as intended.

BUTYL ACETATE ( solvent, masking ), the material is a naturally occurring and synthetically produced solvent with the molecular formula C6H12O2. Classified as Highly flammable (R11 ), Repeated exposure may cause skin dryness or cracking (R66) and Vapours may cause drowsiness and dizziness ( R67 ). Has very low oral toxicity with LD50 of 13100 mg/ kg/ bw. Butyl acetate is a permitted direct food additive. Not skin sensitizer guinea pig maximization test). The NOAEL was established at 900 mg/ kg bw in a 90 day study in rats (gavage) (IUCLID Data).

MARGIN OF SAFETY Butyl Acetate

Daily exposure of product (A) 0.25 g/day *estimated


Concentration in finished product (C): 20 % 100%

Dermal absorption (DAp): *estimated as the worst case scenario

NOAEL 900 mg/kg


MoS = NOAEL/SED

SED = 0.25 g/day x 1000 x 20 /100 x 100/100/60 SED = 0.84 mg/kg/day MoS = 900 mg/ kg / 0.84mg/kg/day

MoS = 1071

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*The MoS was calculated based on The SCCS's Notes Of Guidance For The Testing Of Cosmetic Substances And Their Safety Evaluation 8th Revision, December 2012 ** FDA Maximum(Recommended) Daily Dose Database, Version 4b, Updated 15 February 2008


ETHYL ACETATE ( solvent, perfuming ), the material is a widely used synthetic solvent with the molecular formula C4H8O2. Classified as Highly flammable (R11 ), Irritating to eyes (R36 ), Repeated exposure may cause skin dryness or cracking ( R66 ) and Vapours may cause drowsiness and dizziness ( R67 ). Has a low oral toxicity with LD50 of 5620 mg/ kg/ bw. Not skin sensitizer guinea pig maximization test). The NOAEL was established at 900 mg/ kg bw in a 90 day study in rats (gavage) (IUCLID Data).

MARGIN OF SAFETY Ethyl Acetate





NOAEL 900 mg/kg


MoS = NOAEL/SED

SED = 0.25 g/day x 1000 mg/g x 15 /100 x 100/100/60 SED = 0.625 mg/kg/day MoS = 900 mg/ kg / 0.625 mg/kg/day

MoS = 1440

*The MoS was calculated based on The SCCS's Notes Of Guidance For The Testing Of Cosmetic Substances And Their Safety Evaluation 8th Revision, December 2012


NITROCELLULOSE ( film forming), the material is a highly flammable ingredient obtained by treating cellulose with nitric acid; used as a film-forming agent in cosmetics and personal care products. The molecular formula [C6H10- xO5-x(ONO2)X]n (2 < x < 2,4). Oral LD50 in rats and mice > 5 g rams/kg (Human Health And Ecological Hazard Results Report). May cause slight irritation, as well as fissures and parched skin (Votorantium MSDS). The NOAELs were not available in order to review however based on a history of safe use in consumer products this material is considered safe when used as intended. In conclusion, at the given concentration in the final product, the ingredient is not considered to be of toxicological concern when used as intended.

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ACETONE ( solvent, denaturing), the material is an aliphatic ketone with molecular formula C3H6O. Classified as Irritating to eyes (R36), Repeated exposure may cause skin dryness or cracking (R66) and Vapours may cause drowsiness and dizziness (R67). The NOAEL was established at 100 mg/kg/bw in a 90 day study in rats (gavage) (IUCLID Data).

MARGIN OF SAFETY Acetone Daily exposure of product (A) 0.25 g/day *estimated




NOAEL 100 mg/kg


MoS = NOAEL/SED


MoS = 160



ETHYL TRIMETHYLBENZOYL PHENYLPHOSPHINATE (UV absorber), the material is used to produce curing films in the polymerisation process in synthetic coatings. According to ECHA the Notified classification and labelling according to CLP criteria website the chemical has been proposed for the classification as Skin Sens. 1B by one notifies (http://clp-inventory.echa.europa.eu , accessed on 4th Dec 2013). Found to have a low acute oral toxicity with LD50 > 5000 mg/ kg bw. Not irritating to skin and eyes (rats). No mutagenic effect was found in various tests with bacteria and mammalian cell culture (BASF SDS). The NOAELs were not available in order to review however based on a history of safe use in consumer products this material is considered safe when used as intended. In conclusion, at the given concentration in the final product, the ingredient is not considered to be of toxicological concern when used as intended.

PHENYLBIS(2,4,6-TRIMETHYLBENZOYL)PHOSPHINE OXIDE (photoinitiator), the material is used to produce curing films in the polymerisation process in synthetic coatings. Classified as May cause sensitization by skin contact (R43) and May cause long-term adverse effects in the aquatic environment (R53) (ESIS Data). Virtually nontoxic after a single ingestion and after a single skin contact. Has a low acute oral toxicity with LD50 > 2000 mg/ kg bw. Not irritating to skin and eyes (rats). Not mutagenic (BASF SDS). The NOAELs were not available in order to review however based on a history of safe use in consumer products this material is considered safe when used as intended. In conclusion, at the given concentration in the final product, the ingredient is not considered to be of toxicological concern when used as intended.

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1-HYDROXYCYCLOHEXYL PHENYL KETONE (binding), the material is classified as Irritating to eyes (R36) (Alfa Aesar, A Johnson Matthey Company SDS). It is in a powder form. Has a low dermal acute toxicity LD50 Dermal - rat - male and female - > 5,000 mg/kg. Not a skin sensitiser (Maximisation Test - guinea pig). Negative in Ames test (Aldrich Sigma SDS). The NOAELs were not available in order to review however based on a history of safe use in consumer products this material is considered safe when used as intended. In conclusion, at the given concentration in the final product, the ingredient is not considered to be of toxicological concern when used as intended.

PHTHALIC ANHYDRIDE (polymer compound), the material is a potent allergen and is classified as Harmful if swallowed (R22), Irritating to respiratory system and skin (R37/38), Risk of serious damage to eyes ( R41), May cause sensitization by inhalation and skin contact (R42/43). This chemical material is a rare sensitiser when used as a component of nail polishes. The Allergic reaction is caused at places where the skin is touched with the nail rather than the area around the nail itself (Contact Dermatitis. 2007 Mar;56(3):172-3). If such a reaction does occur, then the user should be advised to stop using the product.

TRIMELLITIC ANHYDRIDE (polymer compound), the material is a potent allergen and is classified as Irritating to respiratory system (R37), Risk of serious damage to eyes ( R41), May cause sensitization by inhalation and skin contact (R42/43). This chemical material is a rare sensitiser when used as a component of nail polishes. The Allergic reaction is caused at places where the skin is touched with the nail rather than the area around the nail itself (Contact Dermatitis. 2007 Mar;56(3):172-3). If such a reaction does occur, then the user should be advised to stop using the product.

NEOPENTYL GLYCOL (solvent, plasticiser), the material is an organic compound with the molecular formulation C5H12O2. It is in solid form which is easily soluble in water. Has low acute oral toxicity with LD50 > 6400 mg/kg bw (IUCLID Data). Irritating to skin and to eyes. Not sensitisating to skin based on guinea pig test. The NOAEL were established at 1000 mg/kg bw based on one generation study in rats with reference to IUCLID Data.

MARGIN OF SAFETY Neopentyl Glycol Daily exposure of product (A) 0.25 g/day *estimated


Concentration in finished product (C): 5% 100%


NOAEL 1000 mg/kg


MoS = NOAEL/SED


MoS = 5000

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ISOPROPYL ALCOHOL (Antifoaming, Perfuming, Solvent, Viscosity Controlling ), the material is a common solvent used in consumer products with chemical formula C3H8O. Classified as irritating to eyes, Vapours may cause drowsiness and dizziness and highly flammable (R36, R67, R11). Not a skin sanitizer when tested on guinea pig - buehler test (IUCLID Data). The reproductive toxicity NOAEL was established at 1000 mg/ kg bw in a two generation study in rats (gavage) (IUCLID Data).

MARGIN OF SAFETY Isopropyl Alcohol Daily exposure of product (A) 0.25 g/day *estimated




NOAEL 1000 mg/kg


MoS = NOAEL/SED


MoS = 5000



STEARALKONIUM HECTORITE (gel forming, viscosity controlling), the material is produced from hectorite, a naturally occurring mineral and a principal constituent of bentonite clay. Not classified as hazardous to human health. The NOAELs were not available in order to review however based on a history of safe use in consumer products this material is considered safe when used as intended. In conclusion, at the given concentration in the final product, the ingredient is not considered to be of toxicological concern when used as intende

ADIPIC ACID/FUMARIC ACID/PHTALIC ACID/TRICYCLODECANE DIMETHANOL COPOLYMER ( film forming) . The material is the copolymer of Adipic Acid (q.v.), Fumaric Acid (q.v.), phthalic acid and tricyclodecane dimethanol. Not classified as hazardous to human health. The material is expected to have minimal allergenic and irritant properties. A fully polymerized material would be expected to be biologically inert. Any adverse effect is only

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likely to occur when unreacted monomers are present in the raw materials. The NOAELs were not available in order to review however based on a history of safe use in consumer products this material is considered safe when used as intended. In conclusion, at the given concentration in the final product, the ingredient is not considered to be of toxicological concern when used as intended.

CITRIC ACID (buffering, chelating, masking), the material is an alpha hydroxy acid used in personal care products to adjust the acidity or promote skin peeling and re-growth in the case of anti-aging products. Citric acid is naturally found in citric fruits and juices, providing the characteristic acidic taste. Classified as irritating to eyes, skin and respiratory track (R36/37/38). The SCCS opinion stated that high concentrations of AHA (10 % at a low pH) could increase the skin’s sensitivity to the sun (SCCNFP/0799/04). The NOAEL was established at less than 241 mg/kg bw in a teratogenicity study in rats (IUCLID Data)

MARGIN OF SAFETY Citric Acid Daily exposure of product (A) 0.25 g/day *estimated


Concentration in finished product (C): 1% 100%


NOAEL 241mg/kg


MoS = NOAEL/SED


MoS = 54444



STYRENE/ACRYLATES COPOLYMER (film former), the material is is a polymer of styrene and a monomer consisting of acrylicacid, methacrylic acid or one of their simple esters. A fully polymerized material would be expected to be biologically inert. Any adverse effect is only likely to occur when unreacted monomers are present in the raw materials. The NOAELs were not available in order to review however based on a history of safe use in consumer products this material is considered safe when used as intended. In conclusion, at the given concentration in the final product, the ingredient is not considered to be of toxicological concern when used as intended.

PHOSPHORIC ACID (buffering), the material is a caustic inorganic acid. It is classified as Causes burns (R43) with its specific concentration limit C ≥ 25 % (ESIS Data). Has acute oral toxicity LD50 1530 mg/kg bw and dermal with LD50 2740 mg/kg/bw (IUCLID Data).

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The NOAELs were not available in order to review however based on a history of safe use in consumer products at a low level this material is considered safe when used as intended. In conclusion, at the given concentration in the final product, the ingredient is not considered to be of toxicological concern when used as intended.

BENZOPHENONE-12 (UV absorber), the material is octabenzone, an organic compound with the formula (C6H5)2CO. Used to preven from the UV light damage to the product. Has low oral acute toxicity with LD50 >5000 mg/kg bw. Found to be skin sensitiser when tested on guinea pig (IUCLID Data). The NOAELs were not available in order to review however based on a history of use in consumer products this material is considered safe when used at very low level. In conclusion, at the given concentration in the final product, the ingredient is not considered to be of toxicological concern when used as intended.

ACETYL TRIBUTYL CITRATE ( masking, perfuming, plasticiser), the material is an aliphatic ester with the molecular formula C20H34O8. Not classified as hazardous to human health. Has LD50 Intraperitoneal - mouse - > 4,000 mg/kg (Sigma Aldrich). A 13 week study in rats with an in utero exposure has identified a NOAEL of 100 mg/kg bw/day (Tracing Papers PVC Review).

MARGIN OF SAFETY Acethyl Tributyl Citrate





NOAEL 100 mg/kg


MoS = NOAEL/SED


MoS = 2380



CI 15850 (colouring agent), that is allowed for use in all cosmetic products with no limitation to the field of application and the concentration. Unlikely to give rise to skin irritation when used in cosmetic products. Not associated with allergy. In conclusion, at the given concentration in the final product, the ingredient is not considered to be of toxicological concern when used as intended.

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Job No: 22 Product Name: UV LAC Colour Version: 1



CI 19140 (colouring agent), that is allowed for use in all cosmetic products with no limitation to the field of application and the concentration. Must comply with the Purity criteria as set out in Commission Directive 95/45/EC (E102). Unlikely to give rise to skin irritation when used in cosmetic products. Not associated with allergy. In conclusion, at the given concentration in the final product, the ingredient is not considered to be of toxicological concern when used as intended.


CI 77491 (colouring agent), that is allowed for use in all cosmetic products with no limitation to the field of application and the concentration. Must comply with the purity criteria as set out in Commission Directive 95/45/EC (E 172). Unlikely to give rise to skin irritation when used in cosmetic products. Not associated with allergy. In conclusion, at the given concentration in the final product, the ingredient is not considered to be of toxicological concern when used as intended.

CI 77891 (colouring agent), that is allowed for use in all cosmetic products with no limitation to the field of application and the concentration. When used as a UV Filter is allowed at its maximum authorised concentration of 25%. Unlikely to give rise to skin irritation when used in cosmetic products. Not associated with allergy. In conclusion, at the given concentration in the final product, the ingredient is not considered to be of toxicological concern when used as intended

CI 73360 (colouring agent), that is allowed for use in all cosmetic products with no limitation to the field of application and the concentration. Must be free from cyanide ions Unlikely to give rise to skin irritation when used in cosmetic products. Not associated with allergy. In conclusion, at the given concentration in the final product, the ingredient is not considered to be of toxicological concern when used as intended

CI 12085 (colouring agent), that is allowed for use in all cosmetic products with no limitation to the field of application however with a maximium concentration of 3% in the finished products. Not associated with allergy. In conclusion, at the given concentration in the final product, the ingredient is not considered to be of toxicological concern when used as intended.


CI 77000 (colouring agent), that is allowed for use in all cosmetic products with no limitation to the field of application and the concentration. Must comply with the purity criteria Purity criteria as set out in Commission Directive 95/45/EC (E 173). Unlikely to give rise to skin irritation when used in cosmetic products. Not associated with allergy. In conclusion, at the given concentration in the final product, the ingredient is not considered to be of toxicological concern when used as intended

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CI 77510 (colouring agent), that is allowed for use in all cosmetic products with no limitation to the field of application and the concentration. Must be free from cyanide ions Unlikely to give rise to skin irritation when used in cosmetic products. Not associated with allergy. In conclusion, at the given concentration in the final product, the ingredient is not considered to be of toxicological concern when used as intended.


CI 42090 (colouring agent), that is allowed for use in all cosmetic products with no limitation to the field of application and the concentration. Must comply with the purity criteria Purity criteria as set out in Commission Directive 95/45/EC (E 133). Unlikely to give rise to skin irritation when used in cosmetic products. Not associated with allergy. In conclusion, at the given concentration in the final product, the ingredient is not considered to be of toxicological concern when used as intended.


CI 77266 (colouring agent), that is allowed for use in all cosmetic products with no limitation to the field of application and the concentration. Must comply with the purity criteria Purity criteria as set out in Commission Directive 95/45/EC (E 153). Unlikely to give rise to skin irritation when used in cosmetic products. Not associated with allergy. In conclusion, at the given concentration in the final product, the ingredient is not considered to be of toxicological concern when used as intended.


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