COSMETIC PRODUCT SAFETY REPORTmedia.supplychain.nhs.uk/media/documents/MRB1080/... · Sources of information for this review include the client peer reviewed literature and internet

All results relate only to the sample received for All results relate only to the product received for assessmentThis report shall not be reproduced except in full, without the written permission of the author.

Registered in England and Wales: Company Number: 8339437; VAT no. 175040820.Registered address: The Knoll Business Centre, Old Shoreham Road, Hove, East Sussex BN3 7GS.

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Product Type: Shampoo, rinse-off Customer Ref: ---Assessment Ref: CPSR 043/14/RP

Client: PlaneTalking Products Ltd Contact: Jemma Tompkins/ Alison WellsHunton LodgeHunton,Sutton ScotneyHampshire, SO21 3PT

COSMETIC PRODUCT SAFETY REPORT -REGULATION (EC) 1223/2009, COSMETIC PRODUCTS

SHAMPOO

SUMMARY & CONCLUSIONSThis product is a fragranced shampoo in a single use, 7 gram sachet.It was assessed for safety and compliance with Regulation (EC) No 1223/2009 and amendments of the EuropeanParliament and of the Council of 30 November 2009 on cosmetic products (Official Journal L 342, 22 December2009, pp. 59–209).All ingredients satisfy legislation requirements and, taking into consideration the physical-chemical and toxicologicalproperties of each ingredient, exposure to the product and to each ingredient, the type of usage and the intendeduser, it is concluded that this product satisfies legislation requirements and will be safe to use as instructed andunder other reasonably foreseeable conditions of use1.Note: Corrections required to product label (see section 11).If product enters the eye, temporary irritation may be experienced and, if skin is sensitive or damaged, it may causeslight skin irritation. The product is not expected to cause skin sensitization, to be harmful if ingested in smallamounts or to adversely affect the respiratory system. Long term adverse effects are not expected.

CONDITIONS OF USEAvoid eye contact. In the event of eye irritation, rinse thoroughly with water.

WARNINGSRegulation 1223/2009 requirements: None.

R A J PristonB.Sc. Ph.D. MSB. MSCS., Chartered Biologist (CBiol.), UK & EUROTOX Registered Toxicologist.Toxicologist / Cosmetic Safety Assessor - authorised under the Cosmetic Products (Safety) Regulations 2004 (StatutoryInstrument, SI No. 2152), as amended, to conduct and take responsibility for the safety assessment of cosmetic products. Thestatement above has been prepared in accordance with those Regulations and, in particular, paragraphs 4, 9(1)(d), 9(1)(e),9(1)(f), 9(2) and 9(5).

If this product is reported to cause significant adverse reaction amongst consumers the undersigned should be informed for afurther review of this product.

For assessor’s credentials, see section 12.

1 NB. This conclusion is valid only when, on-going, the same or equivalent ingredients are used as reviewed for this assessment.

SHAMPOO

Customer Ref: --- Assessment Ref: CPSR 043/14/RP

All results relate only to the sample received for assessmentThis report shall not be reproduced, except in full, without the written permission of the author

PRISTON SAFETY ASSESSMENTS LTD 26, Quarry Bank, Tonbridge, Kent TN9 2QZ UKRegistered in England and Wales: Company Number: 8339437; VAT no. 175040820.

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1. PURPOSE OF ASSESSMENT

This product was assessed for safety in line with requirements of Regulation (EC) No 1223/2009 and amendments ofthe European Parliament and of the Council of 30 November 2009 on cosmetic products (Official Journal L 342, 22December 2009, pp. 59–209).This report contains a summary of the information that is required in the Product Information File (PIF) as Part 1A ofthe complete Cosmetic Product Safety Report (Annex 1 of Regulation 1223/2009) and a safety assessment,representing Part 1B. The summarized information includes, for example, reports on stability, microbiologicalchallenge, the product MSDS, ingredient MSDS’ and specifications, statements on the absence of animal testing andclinical reports). External, typical, information has also been referred to as appropriate.The client should ensure that Part 1A documents (several of which are referred to in this assessment) are lodgedin the PIF with the Responsible Person.-------------------------------------------------

ANNEX 1, PART A, SUMMARISED MAIN POINTS

2. QUANTITATIVE & QUALITATIVE COMPOSITION

The composition of this product with ingredient trade names and breakdown is in Appendix 1. The following tablelists ingredients in order of decreasing concentration.

EU INCI NAME, CI No CAS No Function(s) as listed in COSING 3 Conc. (% w/w)Aqua 7732-18-5 Solvent 80.00Sodium Laureth Sulfate 9004-82-4 Cleansing, Emulsifying, Foaming,

Surfactant12.00

Isostearamidopropyl Morpholine Lactate 72300-24-4 Antistatic 4.00Cocamidopropyl Betaine 61789-40-0 Surfactant, Foam booster 2.00Cocamide DEA 68603-42-9 Emulsifying, Stabilizing, Foam boosting,

Surfactant1.50

DMDM Hydantoin 6440-58-0 Preservative 0.20Parfum Mixture Parfum 0.20Citric Acid 77-92-9 Buffering, Chelating 0.10Benzyl Salicylate* 118-58-1 Parfum component 0.0297Linalool* 78-70-6 Parfum component 0.0208

*: SCCNFP allergens originating from the Parfum and present in product at ≥0.01%.They must be included in the list of ingredients on the label

3. ORDER OF INGREDIENTS FOR LABEL (EC)

Preface with “INGREDIENTS”List in this order: Aqua, Sodium Laureth Sulfate, Isostearamidopropyl Morpholine Lactate, Cocamidopropyl Betaine,Cocamide DEA, Follow this in any order with: DMDM Hydantoin, Parfum, Citric Acid, Benzyl Salicylate, Linalool.

4. PHYSICAL-CHEMICAL CHARACTERISTICS & STABILITY

Product –i. Physical chemical propertiesThe product is a colourless, slightly perfumed, viscous liquid. It is miscible with water.The stability test report provided (see below) states that the pH is 4.00-8.00. Further information is in the PIF.ii. Stability/Biocompatibility:Report details: See appendix 1.Conditions & observations:

Ambient, 3 month: Examined every 10 days for appearance, colour, fragrance and pH.41+/-1°C, 24h then returned to ambient. Observed for separation.-5-10°C, 24h, then returned to ambient. Observed for separation.

Results/conclusion: No significant changes.

SHAMPOO




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Other: Total bacterial count to be ≤1000cfu/gram. All measurements <10cfu/gram. Fecal Coliform: Not detected. Ingredients:

For details of ingredients, see Appendix 2.

5. MICROBIOLOGY

This shampoo is a water-based liquid. It contains 80% water. Quality

For a product of this type (category 2), manufactured product should meet the following standards:

Products not intended for use on babies, the vicinity of the eyes or on mucous membranes – total viable count(TVC) for aerobic mesophyllic microorganisms should not exceed 1000cfu/g (ml) in 0.1g (ml) of product.

The following organisms are required to be absent in 1g (ml) of the product: Pseudomonas aeruginosa;Staphylococcus aureus; Candida albicans.

Quality was measured (report no: 13/0164; date of test: 2013/03/22). Counts were all <10cfu/ml (see Appendix 2).Similar findings are reported in the Stability study report.

Preservation:A challenge test was conducted to determine effectiveness to control the growth of standard tester strains (Reportno. 13-0164-1, date of test: 2013/03/21). Details are shown in Appendix 2.

Conclusion: The product satisfies the criteria for a dermally applied product.

6. IMPURITIES & PACKAGING MATERIAL

It is understood that this product is manufactured following Good Manufacturing Procedures (e.g. ISO 22716:2007)and that ingredients used throughout will be of a suitable quality. The information provided in MSDS’ and indicatesthat all ingredients are acceptable. Ingredient names are shown in Appendix 1, full documentation must be held inthe Product Information File.The product is packaged in a 7g single use sachets.

7. NORMAL & REASONABLY FORESEEABLE USE

This product is intended for the general public, both sexes. It will be applied to the head with hands and massagedfor approximately 3 minutes. It will be washed out of the hair with copious amounts of water. It is a rinse-offproduct.

Exposure to whole product is calculated for an adult using the approach recommended by the Scientific Committeeon Consumer Safety (SCCS) 2 and the content of the sachet as the amount applied: whole product:

Skin Exposure Systemic Exposure Dose (SED): [Exposure/body weight[kg)]*retention factor

Application site: Head & hands Typical body weight: 60kgSurface area: 1440 cm2 Retention factor: 0.01 (1%)Total amount applied: 7g (7,000mg) Total amount applied: 7g (7,000mg)Amount /cm2/day: 4.86 mg/cm2 SED: 1.17mg/kg bw/day

Ingredients:Exposure to each ingredient/raw material is expected to be in proportion to their concentration in the product.

8. TOXICOLOGY PROFILE OF INGREDIENTS

Sources of information for this review include the client peer reviewed literature and internet providers such asCOSING3. For key toxicological findings of all ingredients, see Appendix 3.

2 The SCCS’ Notes of Guidance for the Testing of Cosmetic Ingredients and their Safety Evaluation, 8th revision. SCCS/1501/12, 11Dec 20123 COSING (the EC Cosmetics database)

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The available physical-chemical and toxicological properties of all ingredients were reviewed with particularattention to potential effects on normal and sensitive skin. Intended and reasonably foreseeable use of thecomplete formulation and any agreed limits/restrictions such as those imposed by cosmetics legislation were takeninto consideration.All ingredients are allowed in this type of product according to current legislation. None of them are, or are knownto contain, a CMR (carcinogen, mutagen or reproductive toxicant). None of them are nanoparticles as defined by theScientific Committee on Consumer Safety (SCCS/1484/12). All ingredients are at a concentration that is below anylimits in legislation.This product contains a single fragrance (details below) in which several of the SCCNFP allergens are present. Theconcentrations of these in the final product are highlighted. Those at ≥0.01% must be included in the list ofingredients on pack4.

Of the ingredients, a number are classified for physical, health and/or environmental hazards under EC Chemicalslegislation. The information in the following table is indicative of the classification of these chemicals5. The otheringredients are not considered to be significantly hazardous.Based on this information, this product may cause skin and eye irritation. It is not expected to cause skinsensitization or to be harmful to health.

EU INCI NAME CAS No. EC C&L6 CLP 7 Conc. (% w/w)Sodium Laureth Sulfate 9004-82-4 R38, 41 H315, H318 12.00Cocamidopropyl Betaine 61789-40-0 R41 H318 2.00Cocamide DEA 68603-42-9 R38, 41 H315, H319 1.50DMDM Hydantoin 6440-58-0 R36/37/38 H315, H319, H335 0.20Citric Acid 77-92-9 R36 H319 0.10Benzyl Salicylate 118-58-1 R36/37/38, 43, 51/53 H317, H411 0.0297Linalool 78-70-6 R36/38, 43 H315, H319 0.0208

4 26 fragrance substances were identified by the SCCNFP and adopted in December 1999. This list was introduced into annex IIIof the Cosmetics Directive by the 7th amendment (2003/15/EC). This list is currently under review (SCCS/1459/11, 26-27 June2012) and additional fragrance allergens may, in future, be required to be included.5 Classification may vary depending upon supplier. If an ingredient shows “harmonised” this means that classification has beenagreed by experts working under REACH legislation.6 http://sitem.herts.ac.uk/aeru/iupac/docs/EU_Risk_Phases_UH.pdf7 http://www.uni-muenster.de/imperia/md/content/physikalische_chemie/praktikum/h_p_phrases.pdf

Properties:

Concentration in product (%): 0.2 Supplier: Classification:

Skin exposure (mg/cm2): 4.86 Max allowed (%): 12.50 47thINCI NAME CAS No Total % w/w IFRA Level MoS over IFRA Expos. to Subst. NESIL MoS over

% ppm Class: 9a level (mg/cm2) (mg/cm2) NESIL

Amyl Cinnamal 122-40-7 0.0009 0.0000 0.02 5.00 2777777.78 0.0000 23.6 269775948.79Anisyl Alcohol 105-13-5 0.0008 0.0000 0.02 5.00 3125000.00 0.0000 1.5 19290123.46Benzyl Alcohol 100-51-6 1.426 0.0029 28.52 5.00 1753.16 0.0001 5.9 42566.33Benzyl Benzoate 120-51-4 0.0707 0.0001 1.41 5.00 35360.68 0.0000 59 8585514.64Benzyl Sa l icylate 118-58-1 14.8516 0.0297 297.03 5.00 168.33 0.0014 17.7 12261.22Cinnamal 104-55-2 0.0001 0.0000 0.00 0.05 250000.00 0.0000 0.59 60699588.48Cinnamyl Alcohol 104-54-1 0.0004 0.0000 0.01 0.40 500000.00 0.0000 3 77160493.83Citra l 5392-40-5 0.1138 0.0002 2.28 5.00 21968.37 0.0000 1.4 126566.72Citronel lol 106-22-9 0.0147 0.0000 0.29 5.00 170068.03 0.0000 29.5 20646118.53Coumarin 91-64-5 1.0002 0.0020 20.00 5.00 2499.50 0.0001 3.5 36001.03Eugenol 97-53-0 0.0169 0.0000 0.34 0.50 14792.90 0.0000 5.9 3591691.63Geraniol 106-24-1 0.3061 0.0006 6.12 5.00 8167.27 0.0000 11.8 396599.73Hexyl Cinnamal 101-86-0 1.5 0.0030 30.00 5.00 1666.67 0.0001 23.6 161865.57Isoeugenol 97-54-1 / 5932-68-3 0.0003 0.0000 0.01 0.02 33333.33 0.0000 0.25 8573388.20D-Limonene 5989-27-5 0.6692 0.0013 13.38 20.0 14943.22 0.0001 - -Lina lool 78-70-6 10.4059 0.0208 208.12 12.4 595.82 0.0010 - -Hydroxyisohexyl 3-CyclohexeneCarboxaldehyde

31906-04-4 1.6 0.0032 32.00 0.2 62.50 0.0002 4 -

a lpha-isomethyl Ionone 127-51-5 0.3256 0.0007 6.51 5.00 7678.13 0.0000 70 2211807.77

IBERCHEM, ChinaDrakya ref 84.1237

R38, 43, 51/53IFRA amendment no.:

Footnote: *: NESIL: No Expected Sensitization Induction Level; MoS: Margin of Safety; IFRA: International Fragrance Research Association. Entries in yellow are ≥0.01%.

Amount in

Liquid, FP 89°C

SHAMPOO




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Total: 15.8505

Calculations of Margin of Safety (MoS) have been determined for all ingredients where this is possible frompublished toxicity information. The method used to do this is:

SED (whole product)*% ingredient = SED (ingredient)MoS = Oral NOAEL (ingredient)/SED (ingredient).

In every case at the highest concentration present (see following table), the MoS is >100 which is considered to beacceptable2.

EU INCI NAME, CI No Conc. (%) SED Oral NOELmg/kg/day

MoS

Aqua 80 0.936 - -Sodium Laureth Sulfate 12 0.1404 250 1780.63Isostearamidopropyl Morpholine Lactate 4 0.0468 Not available -Cocamidopropyl Betaine 2 0.0234 150 6410.26Cocamide DEA 1.5 0.01755 1000 56980.06Parfum 0.2 0.00234 Not available -DMDM Hydantoin 0.2 0.00234 110 47008.55Citric Acid 0.1 0.00117 1200 1025641.03Benzyl Salicylate 0.0297 0.00034749 500 1438890.33Linalool 0.0208 0.00024336 160 657462.20

Footnote: SED = Systemic Exposure Dose; NOEL(NOAEL) = No Effect of No Actual Effect Level established by experiment orassumed by read-across to similar ingredients; MoS = Margin of Safety. Calculation assumes 100% absorption through skin.

In addition, calculations are also presented to compare the concentration of each ingredient with therecommendations of industry (CTFA) and any limits in European cosmetic legislation. All ingredients fall below anyrecommended limits.

9. UNDESIRABLE EFFECTS & SERIOUS UNDESIRABLE EFFECTS

None have been reported to this assessor. Rarely, reports of skin and eye irritation may be received on this type ofproduct.

10. OTHER INFORMATION

-.

ANNEX I, PART B — COSMETIC PRODUCT SAFETY ASSESSMENT

11. REASONING

This product is a single use, fragranced shampoo. It is intended for occasional use. It is not specifically intended forchildren under 3 years of age.The available physical-chemical and toxicological properties of all ingredients were reviewed. Intended andreasonably foreseeable use of the complete formulation and any agreed limits/restrictions such as those imposedby Cosmetics legislation were taken into consideration.All ingredients are suitable for this application. They have a history of safe use in cosmetic products. As a consequence,there is no reason to expect this product to be hazardous to health.It does not contain carcinogens, mutagens, chemicals that are toxic to reproduction or nanoparticles.The preservative present is allowed. The product is able to control the growth of microorganisms as demonstratedin a challenge test. It is calculated that the amount of formaldehyde is less than 0.05%. Thus there is no requirementfor a warning for formaldehyde content to be included on label.The product has been shown to be stable at temperatures up to 40°C for 12 weeks and not to separate in the cold.These conditions represent those of transport, storage and use.

SHAMPOO




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This product satisfies legislation requirements and is expected to be safe to use as instructed and under otherreasonably foreseeable conditions of use.The list of ingredients for the label as provided is incorrect. It should be amended according to section 3 of thisreport.If product enters the eye, temporary irritation may be experienced and, if skin is sensitive or damaged, it may causeslight skin irritation. The product is not expected to cause skin sensitization, to be harmful if ingested in smallamounts or to adversely affect the respiratory system. Long term adverse effects are not expected.

SHAMPOO




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12. ASSESSOR’S CREDENTIALS

SHAMPOO




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SHAMPOO




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APPENDIX 1: PRODUCT COMPOSITION

Shampoo

Raw material (supplier) ingredient CAS Conc. (%)- Aqua 80Zoharpon ETA - 27 (Zohar Dalia) Sodium Laureth Sulfate 12(HUZHOU JIAMEI BIOCHEM. TECH. CO.,

LTD)Isostearamidopropyl Morpholine Lactate 4

Amphosolm CA (Stepan) Cocamidopropyl Betaine 2Ethomeen C/12 (AkzoNobel) Cocamide DEA 1.5DMDM Hydantoin (JEEN) DMDM Hydantoin 0.2(Iberchem) Drakya 84.1237 0.2Various (Science Lab) Citric Acid 0.1Parfum component Benzy Salicylate 0.0297Parfum component Linalool 0.0208

PRODUCT INSPECTION REPORTProduct : shampoo Executive Standard: QB/T 1974-2004 Batch: S13031901 Date of Production: 2013 07 19

Date of Inspection: 2013.07.20 07.30 08.10 08.20 08.30 09.10 09.20 09.30 10.10 10.20

Date of Report: 2013.07.22 08.01 08.12 08.22 09.01 09.12 09.22 10.02 10.12 10.22

S/NINSPECTION

ITEM

CONTENTS OF

INPECTIONINSPECTION RESULT CONCLUSION

1 appearance No foreign body07.20 07.30 08.10 08.20 08.30 09.10 09.20 09.30 10.10 10.20

qualifiedpass pss pass pass pass pass pass pass pass pass

2 color

In accordance

with the provisions of

the color

07.20 07.30 08.10 08.20 08.30 09.10 09.20 09.30 10.10 10.20

qualifiedpass pass pass pass pass pass pass pass pass pass

3 flavor

In accordance

with the provisions of

flavor

07.20 07.30 08.10 08.20 08.30 09.10 09.20 09.30 10.10 10.20


4PH value (25

℃)4.0-8.0

07.20 07.30 08.10 08.20 08.30 09.10 09.20 09.30 10.10 10.20

qualified5.9 5.8 5.9 6.0 5.9 5.8 5.9 5.9 5.9 5.8

Priston Safety

Text Box

APPENDIX 2: STABILITY AND MICROBIOLOGY REPORTS

5 Cold-resistant-5~-10℃,24h,no

separation when back toroom temperature

07.20 07.30 08.10 08.20 08.30 09.10 09.20 09.30 10.10 10.20qualified

pass pass pass pass pass pass pass pass pass pass

6 Heat-resistant

(40±1) ℃,24 h, noseparation of condensatewater when back to room

temperature

07.20 07.30 08.10 08.20 08.30 09.10 09.20 09.30 10.10 10.20


7Total bacterial

count≤1000

07.20 07.30 08.10 08.20 08.30 09.10 09.20 09.30 10.10 10.20

qualified＜10 ＜10 ＜10 ＜10 ＜10 ＜10 ＜10 ＜10 ＜10 ＜10

8 Fecal coliform Not detected

07.20 07.30 08.10 08.20 08.30 09.10 09.20 09.30 10.10 10.20

qualifiednon non non non non non non non non non

Technical ServiceREPORT NO. 13/0164

Certificate of AnalysisREPORT NO: 13/0164SAMPLE RECEIVED: See followingsDATE RECEIVED: 2013/03/21DATE TESTED: 2013/03/22METHOD CODE: Thor TM-205: Total viable count by Miles and Misra technique

Results

No Sample Microbial Growth30C TSA 25C SDA SFB(cfu/mL) (cfu/mL)

1 SHAMPOO <10 <10 <102 SHOWER GEL <10 <10 <10

30C TSA: 30C 48 hrs incubation on Trypticase Soya Agar for detection of bacteria.

25C SDA: 25C 72 hrs incubation on Sabouraud Dextrose Agar for detection of fungi.

SFB: Spore forming bacteria check on TSA/SDA.

Please note that any conclusions and recommendations, either made or implied, are based on information drawn from examination of

the samples identified in this report only.

These results may be influenced by, for example, contamination level variations in raw materials, any stored component solutions and

manufacturing equipment, or changes

in formulation, manufacturing procedure or raw material suppliers.

Thor Specialty Chemical(Shanghai) Co., Ltd

4th Floor Building B, No. 8 Lane 1305 Huajing Road, Xuhui District, Shanghai 200231, P.R. China

PHONE: +86-(0)21-64969989 FAX: +86-(0)21-64969979 eMail: [email protected] http://www.thor.com

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Certificate of AnalysisREPORT NO: 13/0164-1SAMPLE RECEIVED: SHAMPOODATE RECEIVED: 2013/03/21DATE TESTED: 2013/04/03METHOD CODE: CTFA M-3: The Determination of Preservation Adequacy ofWater-Miscible Cosmetic And Toiletry Formulations

Results of surviving organisms (cfu/g) at stated times

ORGANISMS (Mixed)ASSAY TIME Bacteria Fungi

Staphylococcus aureus ATCC 6538 Candida albicans ATCC 10231

Pseudomonas aeruginosa ATCC 9027 Aspergillus niger ATCC 16404

Escherichia coli ATCC 8739

INOCULUM 1.0x106 1.8x105

DAY 7 <10 <10DAY 14 <10 <10DAY 28 <10 <10

The sample tested Passed the requirements of CTFA method for water-misciblecosmetic and toiletry formulation.

CriteriaTest Method Bacteria Moulds & YeastCTFA >3 by 7 days and no increase ≥1 after 7 days and no increase

thereafter thereafter









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Certificate of AnalysisREPORT NO: 13/0164-4SAMPLE RECEIVED: SHOWER GELDATE RECEIVED: 2013/03/21DATE TESTED: 2013/04/03METHOD CODE: CTFA M-3: The Determination of Preservation Adequacy ofWater-Miscible Cosmetic And Toiletry Formulations

Results of surviving organisms (cfu/g) at stated times

ORGANISMS (Mixed)ASSAY TIME Bacteria Fungi

Staphylococcus aureus ATCC 6538 Candida albicans ATCC 10231

Pseudomonas aeruginosa ATCC 9027 Aspergillus niger ATCC 16404

Escherichia coli ATCC 8739

INOCULUM 1.0x106 1.8x105

DAY 7 <10 <10DAY 14 <10 <10DAY 28 <10 <10

The sample tested Passed the requirements of CTFA method for water-misciblecosmetic and toiletry formulation.

CriteriaTest Method Bacteria Moulds & YeastCTFA >3 by 7 days and no increase ≥1 after 7 days and no increase

thereafter thereafter









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APPENDIX 3: INGREDIENT SUMMARIESReport no CPSR 043/14

Product: SHAMPOO

Oral NOAEL (mg/kg/day) -ADI (mg/kg.day) -

Solubility: Completely miscibleFlash point: - Melting point: 0ºCMolecular weight: 18.15

Boiling point: 100ºC

Margin of Safety

Skin Exposure, ingredient (mg/cm2) -SED, ingredient (mg/kg/day) -

3.888000.93600

Formula: H2O

PHYSICAL PROPERTIES:

SUMMARY:

EINECS/ELINC 231-791-2Function Solvent

INGREDIENT EXPOSURE CALCULATIONS:

7732-18-5CAS No

Maximum conc. of ingredient in product (% w/w): 80.000000

Aqua

CIR,Safe level,Rinse-off max (%) -Reg.(EC)1223/2009, Rinse-off max (%) -

Other name Water (USA)

Appearance Clear colourless liquid

Water is a clear liquid used as a universal solvent. Freezing and boiling points, 0ºC and 100ºC respectively. The quality of watermust be monitored according to Good Manufacturing Procedures (GMP) and/or must comply with international Pharmacopeiastandards for water puruty used in drugs, devices and diagnostics. Oral LD50 (rat) >90ml/kg. It represents no significant toxicologicalhazard in this application.

Cosmetics legislation: Not restricted.EU, R-phrases *: Not classifiedNotified Classifications, CLP **: Not classifiedEU REACH status: Exempt


Solubility:Flash point: Melting point: 204'CMolecular weight: 310.0> < 400.0

Boiling point:

Margin of Safety


0.583200.14040

250.0

Formula: (C2H4O)nC12H26O4S.Na


SUMMARY:

EINECS/ELINC 221-416-0, - , 500-234-8, -, 500-223-8, 293-918-8Function Cleansing, Emulsifying, Foaming, Surfactant


3088-31-1, 9004-82-4, 68891-38-3, 1335-72-4, 68585-34-2, 916CAS No


Sodium Laureth Sulfate

1780.63

CIR,Safe level,Rinse-off max (%) - 50.000Reg.(EC)1223/2009, Rinse-off max (%) -

4.17

Other name Alkyl Ether Sulfate C12-14 with EO, sodium salt, Texapo

Appearance Liquid, colourless, odourless

Sodium laureth sulphate is a common surfactant. It has been extensively tested in acute and repeated dose toxicity studies withoutsignificant adverse effects (1). Neat, it is irritating to skin and severely irritating to the eyes. The NOAEL from suchronic rodent studywas 250mg/kg/day !2).The CIR Expert Panel concluded that it is safe to use at the levels observed (50%) but also recommendedthat this only be used at levels that are not irritating (assume <50%). At higher concentrations, they recommended labelling of theproduct with “Avoid contact with eyes. If the product gets into the eyes rinse well with water immediately”.Sodium Laureth Sulfate has potential to be contaminated with nitrosamines. Nitrosamine level must be less than 50ppb. Should usein the presence of an anti-oxidant such as tocopherol.Ref: (1): CIR review JACT 2(5):1-34, 1983; 1/02 IJT 24(S1):85-89, 2005; (2) Review of Stapan,http://www.epa.gov/hpv/pubs/summaries/sodium22/c16316tp.pdf. May 2006.

Cosmetics legislation, Allowed, not controlled.EU, R-phrases *: R38, 41Notified Classifications, CLP **: H315, H318EU REACH status: 01-2119488639-16

Appendix: Page 1 of 5

Product: SHAMPOO


Solubility: SolubleFlash point: Melting point:Molecular weight: 500.75

Boiling point:

Margin of Safety


0.194400.04680

Formula: C28H56N2O5


SUMMARY:

EINECS/ELINC -Function Antistatic


72300-24-4CAS No


Isostearamidopropyl Morpholine Lactate


Other name

Appearance Crystalline, clear

Isostearamidopropyl Morpholine Lactate is the lactic acid salt of isostearamidopropyl morpholine. It is non-ionic surfactant. Whenreviewed by the CIR (1) it was used, principally in hair cosmetics at ~1.5%.Isostearamidopropyl Morpholine Lactate has a low order of acute toxicity, was found to be minimally irritating to rabbit eyes, andmildly irritating to intact and abraded rabbit skin. Sensitization was not seen in clinical tests but some irritancy was noted. It was notmutagenic in the Ames test, with or without metabolic activation, although cell killing was seen at most test concentrations.Morpholine, a component of this ingredient is an irritant and skin sensitizer and is readily nitrosated to form carcinogenicnitrosamines but the CIR did not identify N-nitroso impurities. The CIR commented that mutagenicity data, information on skinpenetration , inhalation data and effects of repeated exposures were not available and so they did not judge the suitability of thisingredient in leave-on cosmetic formulations but they concluded that this ingredient is safe for use at current levels in rinse-offproducts such as shampoos.Ref: CIR review: IJT, April 1999 vol. 18 no. 3 suppl 51-56; MSDS Jan. 1, 2014 from HUZHOU JIAMEI BIOCHEM. TECH. CO., LTD,china

Cosmetic legislation, EC: Not restricted.EU, R-phrases *: Not classifiedNotified Classifications, CLP **: Not classifiedEU REACH status: Not listed in REACH


Solubility: Readily soluble in waterFlash point: 110'C Melting point: -2 'CMolecular weight: -

Boiling point: >100'C

Margin of Safety


0.097200.02340

150.0

Formula: -


SUMMARY:

EINECS/ELINC 263-058-8Function Surfactant, Foam booster


61789-40-0CAS No


Cocamidopropyl Betaine

6410.26


Other name Cocoamidopropyl betaine, Dehyton® K COS/BZ; Epigen BS/F

Appearance White-slightly yellow liquid

Cocamidopropyl Betaine is a co-surfactant and foam booster. It is a soluble, creamy-white liquid with a pH 4-5.5. The CIR ExpertPanel (1) had no concerns over this ingredient in rinse-off products but in leave-on products they recommended a maximum of 3%,based on sensitization but these are thought to have been due to the presence of the impurity 3-dimethylaminopropylamine(DMAPA). Cocamidopropyl Betaine causes eye irritation in the rabbit at 4.5% and skin irritation at 10% but it is not acutely toxic (oralLD50 in rat of>1500mg/kg) and is not a mutagen. Systemic effects in feeding studies and a reproduction study. An oral NOEL fordevelopmental toxicity - 150mg/kg/d (2). For cosmetic use, impurities should meet the following: Dichloroacetic acid <30ppm;Monochloroactic acid <5ppm; Cocaamidopropyldimethylamine (DMAPA)<5000ppm; 3-dimethylaminopropylamine (DMAPA) <15ppm.Nitrosamine level <50ppb.Ref: (1) CIR review: JACT, 10(1) (2)1991; HPV test plan Sept 16, 2004. (Mackam 50ULT = 40-50% Cocamidopropyl Betaine; SurfacB4 MSDS (10-30%).

Cosmetics legislation, EC: Not restricted.EU, R-phrases *: R41Notified Classifications, CLP **: H318EU REACH status: Pre-registered


Product: SHAMPOO


Solubility: InsolubleFlash point: >94'C Melting point:Molecular weight:

Boiling point:

Margin of Safety


0.072900.01755

1000.0

Formula:


SUMMARY:

EINECS/ELINC 271-657-0Function Emulsifying, Stabilizing, Foam boosting, Surfactant


68603-42-9CAS No


Cocamide DEA

56980.06


Other name Coconut Diethanolamide.

Appearance Clear liquid, viscous, yellow

Cocamide DEA is a non-ionic surfactant. It is irritating to skin and eyes, human/non-human. The NOEL for maternal toxicity anddevelopmental effects is 1000mg/kg/day (2).Under EC cosmetic legislation, the secondary amine level (dialkanolamine) of a cosmetic product must not exceed 0.5% (1) and thissubstance must have no more than 5.0%. Additionally, the maximum N-nitrosodialkanolamine content must be no more than 50µg/kg (ppb) It is also required to be stored in nitrite free containers. The concern is over the formation of potentially carcinogenicnitrosamines. This ingredient should also not be used with nitrosating ingredients, nitrites and nitrates. Nitrosamines must be lessthan 50ppb. Should use in the presence of an anti-oxidant such as tocopherol.Ref: (1) Opinion concerning Dialkyl- and Dialkanolamines and their salts in cosmetic products adopted by the SCCNFP during the17th plenary meeting of 12 June 2001; (2) Robust Summaries & Test Plans: Fatty Nitrogen Derived Amides p.228 (2004).

Cosmetics legislation, EC: Restricted (Regulation 1223/2009, Annex III/60).EU, R-phrases *: R38, 41Notified Classifications, CLP **: H315, H319EU REACH status: Pre-registered, Amides, coco, N,N-bis(hydroxyethyl)


Solubility:Flash point: Melting point: 90°CMolecular weight: 188.18

Boiling point: 200°C

Margin of Safety


0.009720.00234

110.0

Formula: C7H12N2O4


SUMMARY:

EINECS/ELINC 229-222-8Function Preservative


6440-58-0CAS No


DMDM Hydantoin

47008.55

CIR,Safe level,Rinse-off max (%) - 1.000Reg.(EC)1223/2009, Rinse-off max (%) - 0.6000 3.00

5.00

Other name 1,3-bis(Hydroxymethyl)-5,5-dimethylimidazolidine-2,4-di

Appearance White non-uniform odourless powder

DMDM Hydantoin is an amide. It has a long history of use as a formaldehyde donor, it is restricted to minimise formaldehydeconcentration. The CIR Expert panel reviewed its use in products in 1988 at which time it was used at up to 1%. They concluded thatit was safe at those levels (1). DMDM Hydantoin has been extensively studied for toxicological properties. It has not been found to besignificantly toxic in acute oral or sub-chronic studies and is a skin sensitizer. In irritation studies results have differed widely but in allcases effects were transient. Conflicting results were also seen in genotoxicity studies. In 2002 the Scientific Committee on CosmeticProducts and Non-Food Products Intended for Consumers (SCCNFP) concluded that the level of formaldehyde in consumerproducts should be limited to 0.2% because of some complaints of skin irritation which was thought to, possibly, be due toformaldehyde release. Based on manufacturers’ data DMDM Hydantoin typically donates 1% free formaldehyde and contains 17%total formaldehyde.Ref: (1) JACT 7(3):245-277, 1988; (2) CoA Mackstat DM from Rhodia, (Formaldehyde, total: 17.8%; free: 0.9%).

Cosmetic legislation, EC: Maximum authorised concentration is 0.6%.All finished products containing formaldehyde or substances that release formaldehyde must be labelled with the warning "containsformaldehyde" where the concentration of formaldehyde in the finished product exceeds 0.05%.EU, R-phrases *: R36/37/38Notified Classifications, CLP **: H315, H319, H335EU REACH status: -


Product: SHAMPOO


Solubility: 60g/100ml at 20'CFlash point: Melting point: 153'CMolecular weight: 191

Boiling point:

Margin of Safety


0.004860.00117

1200.0

Formula: C6H8O7


SUMMARY:

EINECS/ELINC 201-069-1, -Function Buffering, Chelating


77-92-9CAS No


Citric Acid

1025641.03


Other name 1,2,3-Propanetricarboxylic acid, 2-hydroxy-

Appearance White granules, odourless

Citric Acid is a natural substance produced by citrus fruits. It is an alpha-hydroxy acid, similar is structure to lactic and glycolic acidbut less widely used in cosmetic products. It is also a food ingredient (E330). In cosmetic products it is principally a buffering andchelating agent but it, as with the other AHA, is a defoliating agent at high concentrations, breaking down the bonds between live anddead cells. As such it is useful in skin creams to rduce wrinkles etc. Citric acid is of low acute toxicity. In the rat, the NOAEL forrepeated dose toxicity is 1200mg/kg/day with effects limited to changes in blood chemistry and excretion (1). It is not a carcinogen ormutagen and the NOAEL for reproductive effects is 2500mg/kg/day. It is irritating to skin, eyes and the respiratory system but is nota skin sensitizer (1).Ref: (1): SIDS, 11th SIAM, 11 Jan,2001.

Cosmetics legislation, EC: Not restricted..EU, R-phrases *: R36Notified Classifications, CLP **: H319EU REACH status: Registered


Solubility: Slightly solubleFlash point: Melting point: 18-20 °CMolecular weight: 228.24

Boiling point: 168-170°C

14388.90

Margin of Safety


0.001440.00035

500.0

Formula: C14H12O3

5.0


SUMMARY:

EINECS/ELINC 204-262-9Function Perfuming, UV absorbing


118-58-1CAS No


Benzyl Salicylate

1438890.33


Other name Benzoic acid, 2-hydroxy-, phenylmethyl ester

Appearance Colourless liquid

Benzyl Salicylate is a salicylic acid benzyl ester. It occurs naturally in a variety of plants and plant extracts and is present in blends offragrance products. It is a clear liquid with an odour similar to balsam. It has a low acute toxicity and is, at most, slightly irritating. TheScientific Committee on Food reviewed the properties of benzoic acid and its salts (3) and concluded a NOAEL of 500mg/kg/day andan ADI of 0-5mg/kg/day. These are used for calculating margin of safety. There is evidence of it being a skin sensitizer and it is oneof the 26 allergens that must be declared on packaging at specified concentrations (1). IFRA reviewed this ingreients in 2007 (1). It isa weak sensitizer (LLNA EC3: 0.725 (1 study); NOEL-HRIPT for induction: 17.717mg/cm2; WoE NESIL (No Expected SensitizationInduction Level): 17.7mg/cm2. The IFRA standards shows the following maximum concentrations:Cat 1: 0.5%; Cat 2: 0.7%; Cat 3: 2.7%; Cat 4: 8%; Cat 5: 4.2%; Cat 6: 12.8%; Cat 7: 1.3%; Cat 8: 2%; Cat 9: 5%; Cat 10: 2.5%; Cat11: '-.Ref: (2) SCCNFP/0017/98; (1) IFRA standards, 46th; (3) SCF SCF/CS/ADD/CONS/48, Sept 2002.

Cosmetics legislation: Annex III/75. Must be declared at 0.001% (leave-on products) and 0.01% (rinse-off products).EU, R-phrases *: R36/37/38, 43, 51/53Notified Classifications, CLP **: H317, H411EU REACH status: Pre-registered, Benzyl Salicylate


Product: SHAMPOO


Solubility: soluble in water (1000-10000 mg/L)Flash point: 77.2 °C Melting point: > -74 °CMolecular weight: 154.25

Boiling point: 198'C

Margin of Safety


0.001010.00024

160.0

Formula: C10H18O


SUMMARY:

EINECS/ELINC 201-134-4Function Denaturant, Perfuming


78-70-6CAS No


Linalool

657462.20


Other name 3,7-Dimethylocta-1,6-dien-3-ol

Appearance colourless liquid with a pleasant, floral odour

Linalool is a naturally occurring terpene alcohol found in many flowers and spice plants and, according to the EU ScientificCommittee (1), the largest exposure is from its use as a fragrance component, especially in lavender oil. It has other names such asβ-linalool, linalyl alcohol, linaloyl oxide, p-linalool, allo-ocimenol, and 2,6-dimethyl-2,7-octadien-6-ol.Commercially available Linalool (97%) is a weak sensitizer but it is readily oxidised upon storage to strong sensitizers such as linalylhydroperoxide. Oxidized linalool and its hydroperoxide gave positive reactions in 1.8% of more than 1000 patients tested in aEuropean multi-centre study. Linalool is one of the 26 fragrance allergens identified by the SCCNFP (2).Ref: (1) SCCNFP/0760/03; (2) SCCNFP/0017/98; REACH.

Cosmetics legislation, EC: Restricted (Regulation Annex III/84).The presence of the substance must be indicated in the list of ingredients when its concentration exceeds: 0.001% in leave-onproducts, 0.01% in rinse-off products.EU, R-phrases *: R36/38, 43Notified Classifications, CLP **: H315, H319EU REACH status: Full registration, Linalool

Abreviations: CIR: The highest concentration reviewed or agreed to by the Cosmetic Ingredient Expert Panel; IFRA: Recommended maximum level,International Fragrance Research Association; EC: Limits in Annexes of Regulation (EU) 1223/2009; ADI: Acceptable Daily Intake agreed by USFDAand/or WHO JECFA; NOAEL: No Observable Actual Effect Level; SED: Systemic Exposure Dose. *:http://sitem.herts.ac.uk/aeru/iupac/docs/EU_Risk_Phases_UH.pdf; **: http://www.uni-muenster.de/imperia/md/content/physikalische_chemie/praktikum/h_p_phrases.pdf


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COSMETIC PRODUCT SAFETY REPORTmedia.supplychain.nhs.uk/media/documents/MRB1080/... · Sources of information for this review include the client peer reviewed literature and internet