5 Final Report on the Safety Assessment of Potassium-Coco-Hydrolyzed Animal Protein and Triethanolamine-Coco-Hydrolyzed Animal Protein

Abstract

Potassium and TEA-Coco-Hydrolyzed Animal Proteins (PCHAP and TEA-CHAP) are salts of the condensation product of coconut acid and hydrolyzed animal protein. They are used in cosmetic products as detergents, foamers, and levelers.

Acute oral toxicity studies showed that both PCHAP and TEA-CHAP were practically nontoxic when ingested. Both ingredients at concentrations of 10%-100% were practically nonirritating to moderately irritating when instilled in the eyes of rabbits. Both were nonirritating to mildly irritating when applied at concentrations of 10%-50% to the skin of rabbits. Guinea pig sensitization studies with both PCHAP and TEA-CHAP were negative.

PCHAP and TEA-CHAP, at concentrations of 2% 10% were nonirritating to practically nonirritating in humans. In a repeated insult patch test, PCHAP gave a positive sensitization reaction in two of 168 subjects; two additional subjects showed cumulative irritation and one other was reported to have a nonspecific irritation. One subject out of 28 tested did not demonstrate significant irritation or sensitivity to either PCHAP or TEA-CHAP, but was photosensitized to both ingredients.

On the basis of the available information, the Panel concludes that Potas-sium-Coco-Hydrolyzed Animal Protein and TEA-Coco-Hydrolyzed Animal Protein are safe as cosmetic ingredients in the present practices of use as recorded in this report.

References

1. COSMETIC, TOILETRY AND FRAGRANCE ASSOCIATION (CTFA). (1974). CTFA Cosmetic Ingredient Descriptions: Potassium and TEA-Coco-Hydrolyzed Animal Proteins.

2. CTFA. (February 18, 1981). Submission of unpublished data on Potassium-Coco-Hydrolyzed Animal Protein and TEA-Coco-Hydrolyzed Animal Protein.

3. CTFA. (1979). Submission of data in support of safety of Potassium-Coco-Hydrolyzed Animal Protein and Related Compounds. Prepared by the CTFA Sub-Task Force. Summary of Unpublished Data.

4. INTERNATIONAL BIO-RESEARCH LABORATORIES (IBRL). (1977). CTFA submission of data in support of safety of Potassium-Coco-Hydrolyzed Animal Protein and Related Compounds. Prepared by the CTFA Sub-Task Force. Protein Derivatives-Their Properties and Application.

5. FOOD AND DRUG ADMINISTRATION (FDA). (1981). Cosmetic product formulation data. Computer printout, Washington, DC: Food and Drug Administration.

6. INOLEX LABORATORIES. (November 6, 1976). CTFA submission of data in support of safety of Potassium-Coco-Hydrolyzed Animal Protein and Related Compounds. Prepared by the CTFA Sub-Task Force. Acute Oral Toxicity, Primary Skin Irritation and Sensitization.

7. ROSNER-HIXSON LABORATORIES. (November 22, 1977). CTFA submission of data in support of Potassium-Coco-Hydrolyzed Animal Protein and Related Compounds. Prepared by the CTFA Sub-Task Force. Acute Oral Toxicity and Primary Skin and Eye Irritation.

8. IBRL. (January, 1977). CTFA submission of data in support of safety of Potassium-Coco-Hydrolyzed Animal Protein and Related Compounds. Prepared by the CTFA Sub-Task Force. Acute Oral Toxicity and Primary Skin Irritation.

9. IBRL. (May, 1977). CTFA submission of data in support of safety of Potassium-Coco-Hydrolyzed Animal Protein and Related Compounds. Prepared by the CTFA Sub-Task Force. Primary Skin and Eye Irritation and Sensitization.

10.

10. IBRL. (November, 1977). CTFA submission of data in support of safety of Potassium-Coco-Hydrolyzed Animal Protein and Related Compounds. Prepared by the CTFA Sub-Task Force. Primary Eye Irritation.

11.

11. IBRL. (September, 1977). CTFA submission of data in support of safety of Potassium-Coco-Hydrolyzed Animal Protein and Related Compounds. Prepared by the CTFA Sub-Task Force. Eye Irritation.

12.

12. IBRL. (June, 1977). CTFA submission of data in support of safety of Potassium-Coco-Hydrolyzed Animal Protein and Related Compounds. Prepared by the CTFA Sub-Task Force. Eye Irritation.

13.

13. KEMRON LABORATORIES. (December 7, 1977). CTFA submission of data in support of Potassium-Coco-Hydrolyzed Animal Protein and Related Compounds. Prepared by the CTFA Sub-Task Force. Acute Oral Toxicity and Primary Skin and Eye Irritation.

14.

14. KEMRON LABORATORIES. (February, 1978). CTFA submission of data in support of Potassium-Coco-Hydrolyzed Animal Protein and Related Compounds. Prepared by the CTFA Sub-Task Force. Eye Irritation.

15.

15. KEMRON LABORATORIES. (February, 1978). CTFA submission of data in support of Potassium-Coco-Hydrolyzed Animal Protein and Related Compounds. Prepared by the CTFA Sub-Task Force. Eye Irritation.

16.

16. TOKYO MEDICAL AND DENTAL UNIVERSITY. (July 9, 1971). CTFA submission of data in support of Potassium-Coco-Hydrolyzed Animal Protein and Related Compounds. Prepared by the CTFA Sub-Task Force. Human Patch Test.

17.

17. MUNICIPAL CLINICS OF DORTMUND. (January, 1977). CTFA submission of data in support of safety of Potassium-Coco-Hydrolyzed Animal Protein and Related Compounds. Prepared by the CTFA Sub-Task Force. Human Patch Test.

18.

18. Nilzen, A. (February 16, 1965). Submission of data by CTFA. Report from Allergies Laboratories to Chemische Fabrik Grunau GmbH. Stockholm, Sweden.

19.

19. FOOD AND DRUG RESEARCH LABS (FDRL). (March 31, 1982). CTFA submission of unpublished safety data.

20.

20. MUNICIPAL CLINICS OF DORTMUND. (June 26, 1981). Submission of data by CTFA. Communication from M. Trannier to Grunau Chemical Factor, Inc.

21.

21. STEPAN CHEMICAL COMPANY. (October 25, 1979). CTFA submission of data in support of safety of Potassium-Coco-Hydrolyzed Animal Protein and Related Compounds. Prepared by the CTFA Sub-Task Force. Correspondence to CTFA. Occupational Exposure.

22.

22. CTFA. (1979). Submission of data in support of safety of Potassium Coco-Hydrolyzed Animal Protein and Related Compounds. Prepared by the CTFA Sub-Task Force. CTFA Summary of Product Usage.