Octamethylcyclotetrasiloxane (Cyclotetrasiloxane, D4

1 SCCS/1241/10. Scientific Committee on Consumer safety SCCS. OPINION ON. Cyclomethicone Octamethylcyclotetrasiloxane ( cyclotetrasiloxane , D4). and Decamethylcyclopentasiloxane (Cyclopentasiloxane, D5). The SCCS adopted this opinion at its 7th plenary meeting of 22 June 2010. SCCS/1241/10. Opinion on cyclomethicone (D4 / D5). _____. About the Scientific Committees Three independent non-food Scientific Committees provide the Commission with the scientific advice it needs when preparing policy and proposals relating to consumer safety , public health and the environment. The Committees also draw the Commission's attention to the new or emerging problems which may pose an actual or potential threat. They are: the Scientific Committee on Consumer safety (SCCS), the Scientific Committee on Health and Environmental Risks (SCHER) and the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) and are made up of external experts.

2 In addition, the Commission relies upon the work of the European Food safety Authority (EFSA), the European Medicines Evaluation Agency (EMEA), the European Centre for Disease prevention and Control (ECDC) and the European Chemicals Agency (ECHA). SCCS. The Committee shall provide opinions on questions concerning all types of health and safety risks (notably chemical, biological, mechanical and other physical risks) of non-food consumer products (for example: cosmetic products and their ingredients, toys, textiles, clothing, personal care and household products such as detergents, etc.) and services (for example: tattooing, artificial sun tanning, etc.). Scientific Committee members J rgen Angerer, Ulrike Bernauer, Claire Chambers, Qasim Chaudhry, Gisela Degen, Gerhard Eisenbrand, Thomas Platzek, Suresh Chandra Rastogi, Vera Rogiers, Christophe Rousselle, Tore Sanner, Kai Savolainen, Jacqueline Van Engelen, Maria Pilar Vinardell, Rosemary Waring, Ian R.

3 White Contact European Commission Health & Consumers Directorate C: Public Health and Risk Assessment Unit C7 - Risk Assessment Office: B232 B-1049 Brussels European Union, 2010. ISSN 1831-4767 ISBN 978-92-79-12742-7. ND-AQ-09-014-EN-N. The opinions of the Scientific Committees present the views of the independent scientists who are members of the committees. They do not necessarily reflect the views of the European Commission. The opinions are published by the European Commission in their original language only. 2. SCCS/1241/10. Opinion on cyclomethicone (D4 / D5). _____. ACKNOWLEDGMENTS. Prof. J. Angerer Dr. U. Bernauer Dr. C. Chambers Prof. G. Degen (rapporteur). Dr. Rastogi Prof. V. Rogiers Prof. T. Sanner (chairman). Dr. J. van Engelen Prof. R. Waring Dr. White Keywords: SCCS, scientific opinion, hair dye, cyclomethicone, D4, D5, cyclotetrasiloxane , cyclopentasiloxane, directive 76/768/ECC, CAS 556-67-2 (D4), 541-02-6 (D5), EC 209-136- 7 (D4), 208-764-9 (D5).

4 Opinion to be cited as: SCCS (Scientific Committee on Consumer safety ), Opinion on cyclomethicone D4/D5, 22 June 2010. 3. SCCS/1241/10. Opinion on cyclomethicone (D4 / D5). _____. TABLE OF CONTENTS. ACKNOWLEDGMENTS .. 3. 1. BACKGROUND .. 5. 2. TERMS OF 5. 3. 6. 4. CONCLUSION .. 102. 5. MINORITY 102. 6. REFERENCES .. 102. 4. SCCS/1241/10. Opinion on cyclomethicone (D4 / D5). _____. 1. BACKGROUND. Cyclomethicone (CAS 556-67-2) with the chemical name Octamethylcyclotetrasiloxane has the following functions: antistatic, emollient, humectant, solvent, viscosity controlling and hair conditioning in cosmetic products according to the Inventory. Cyclomethicone is a substance classified as toxic to reproduction category 3 and according to the cosmetic directive 2003/15/EC a safety evaluation for its use in cosmetic products is needed.

5 SCCP concluded in its opinion (SCCP/0893/05) adopted during the 6th plenary meeting of 13 December 2005 that "On the basis of provided data, the SCCP is unable to assess the risk to consumers when Octamethylcyclotetrasiloxane (D4) is used in cosmetic products. Despite the size of the dossier submitted by industry for evaluation, it is unfortunate that the dossier lacked meaningful information/data on actual consumer exposure to D4. The following information is required before any further consideration: * Adequate information on the use of D4 in cosmetics, in particular in different cosmetic products;. * Relevant/appropriate percutaneous absorption studies at different use concentrations;. * Information on the co-use, and hence consumer exposure, of related organosiloxanes, in particular decamethylcyclopentasiloxane (D5). ". The current submission provides the data asked for by SCCP.

6 2. TERMS OF REFERENCE. 1. On the basis of the provided data the SCCP is asked to assess the risk to consumers when Octamethylcyclotetrasiloxane is used in cosmetic products. 2. Does the SCCP recommend any further restrictions with regard to its use in cosmetic products? 5. SCCS/1241/10. Opinion on cyclomethicone (D4 / D5). _____. 3. OPINION. Cyclomethicone is a generic name for several cyclic dimethyl polysiloxane compounds;. according to INCI, it refers not only to Octamethylcyclotetrasiloxane (D4, INCI name: cyclotetrasiloxane ), but also to cyclotrisiloxane (D3), cyclopentasiloxane (D5), cyclohexasiloxane (D6), and cycloheptasiloxane (D7), compounds of the general formula (CH3)2nOnSin where n = 3-7. The safety file submitted to the European Commission concerned D4 and D5 only, therefore only these compounds D4 and D5 will be discussed in the present opinion.

7 In response to the need for additional information expressed by the SCCP (SCCP/0893/05), the applicant provided with submission III of 2006 a study report on in vitro dermal absorption of D4 in pig skin, and a document containing a short paragraph on the co-use of D5 and D4 as well as a summary of the toxicological database for D5. This and the information given in the so-called D5 White Paper of June 2005 were in some respects considered insufficient for a new evaluation of cyclomethicone. SCCS has taken into consideration recent evaluations on health effects of cyclomethicone compounds by the Canadian Ministries for Environment and Health (Ref.: AR8, AR9) the Californian Office of Environmental Health Hazard Assessment (OEHHA) (Ref.: AR10), a Cosmetic Ingredient Review report (Ref.: AR22) and other publications retrieved from the open literature.

8 Aside from qualitative information on the co-use of D4 and D5, the exposure assessment is based on concentrations of these compounds in cosmetics as given in a report by the Norwegian Food safety Authority (Ref.: 83) provided together with submission III. References given in this introduction and in chapter refer to the D4 references listed in chapter Chemical and Physical Specifications Chemical identity Primary name and/or INCI name D4: cyclotetrasiloxane (INCI). D5: Cyclopentasiloxane (INCI). Cyclomethicone (INCI). Chemical names cyclotetrasiloxane (D4). Octamethylcyclotetrasiloxane cyclotetrasiloxane , octamethyl- Cyclopentasiloxane (D5). Decamethylcyclopentasiloxane Cyclopentasiloxane, decamethyl- 6. SCCS/1241/10. Opinion on cyclomethicone (D4 / D5). _____. Trade names and abbreviations Cyclomethicone (D4). SF 1173, Miramil CM4, Tetram re D4, Silbione Tetram re D4, Cyclen D4, Oel Z020, KF 994, Baysilone COM , Dow Corning 244 Fluid Cyclopentasiloxane (D5).

9 AEC Cyclopentasiloxane; Botanisil CP-33; Dow Corning 245 Fluid; KF995; Mirasil CM 5; SF. 1202; Wacker-Belsil CM 040. CAS / EC number D4 D5. CAS: 556-67-2 541-02-6. EC: 209-136-7 208-764-9. Structural formula cyclotetrasiloxane (D4): n=4. Cyclopentasiloxane (D5): n=5. Empirical formula D4 D5. Formula: C8H24O4Si4 C10H30O5Si5. Physical form Clear, colourless liquids Molecular weight D4 D5. Molecular weight: Purity, composition and substance codes D4. Purity of Octamethylcyclotetrasiloxane used in tests is described as unknown or >95%. (maximum ). Purity of the typical octamethyltetracyclosiloxane used in the formulation of cosmetic products is not reported. D5. 7. SCCS/1241/10. Opinion on cyclomethicone (D4 / D5). _____. According to the applicant, the tests used relatively pure samples of D5 (97% - > 99%). with pivotal studies conducted using the same batch of D5 (BxWCO 15338, > 99% pure).

10 Impurities / accompanying contaminants D4. Maximum 5% decamethylcyclopentasiloxane (D5) and maximum 1% hexamethylcyclo- trisiloxane (D3). According to PCPC (former CTFA), up to 1% impurity of homologues with 3, 5, 6 or 7 silicon atoms can be present. D5. No specific data submitted. Solubility D4 D5. Water: 20 g/L at 25 C 17-20 g/L. Partition coefficient (Log Pow). D4 D5. Log Pow: Additional physical and chemical specifications D4 D5. Melting point: C - C. Boiling point: 175 C C. Flash point: / /. Vapour pressure: torr at 20 C torr at 23 C. Density: Viscosity: / cst pKa: / /. Refractive index: / /. Surface tension: / dyne/cm at 25 C. D4. Conversion factor: 1 ppm = 12 mg/m3; 1 mg/m3 = ppm D5. Conversion factor: 1 ppm = mg/m3; 1 mg/m3 = ppm Homogeneity and Stability No data submitted 8. SCCS/1241/10. Opinion on cyclomethicone (D4 / D5).