Registration Dossier

Administrative data

developmental toxicity
Data waiving:
other justification
Justification for data waiving:

Data source

Materials and methods

Results and discussion

Results (fetuses)

Fetal abnormalities

not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Executive summary:

Article 18 of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 20 November on cosmetic products (Cosmetic regulation) provides a testing and marketing ban for cosmetic products and ingredients (cosmetic raw materials) that are tested on animals. Especially article 18(d) prohibits the performance within the Community of all animal testing on cosmetic ingredients or combinations of ingredients. The total testing ban on cosmetic ingredients applies since 11 March 2009. The marketing ban also applies since 11 March 2009 with a final deadline of 11 March 2013 for using results from higher tier tests for risk assessment purposes of cosmetic formulations. In a court case (Case C-244/03) brought forward by France on the cosmetics ban, the EU Advocate-General`s opinion was that ingredients that had been the subject of animal testing under other types of legislation could not subsequently be used in cosmetics. Taking into account that the deadline for the final marketing ban of tested cosmetic ingredients is 11 March 2013, a testing proposal as required by Article 12(1)(d) of Regulation (EC) 1907/2006 REACH for `higher tier` tests will not allow to finalize a developmental toxicity / teratogenicity study before that date.

Therefore and taking the EU Advocate-General`s opinion into account, testing of the registered substance for developmental toxicity / teratogenicity is waived based on legal grounds to not violate the legal requirements of Regulation (EC) No 1223/2009 on Cosmetics.

Although no experimental data from developmental toxicity studies are available for the registered substance, this endpoint is not considered to be of priority concern. Limited data from a reproductive toxicity screening study do not indicate that this substance may exhibite developmental / teratogenic properties. In this study, no test item related developmental toxic findings and/or macroscopic visible teratogenic effects were noted in pubs from parental animals administerd the registered substance up to a dose level of 1000 mg/kg body weight. Also histologically no effects attributable to the test item were noted. Especially there were no abnormal lesions encountered during sperm staging regarding completeness of stages and maturation of cell populations. The histological NOEL has been established at 1000 mg/kg body weight. Additionally, for the structural analogue compound sodium cocoyl sarcosinate feeding of up to 1000 mg/kg per day did not adversely affect the fertility of albino Sherman Wistar rats during a 2 -year oral toxicity study the registered substance is chemically an C8 -12 alkanoyl glycine sodium salt consisting of the naturally occuring amino acid glycine and C8 -12 fatty acid. Such N-acyl amino acids can be considered modified fatty acids with greater solubility and increased acidity of the carboxylic group compared to the parent fatty acid. Furthermore, systemically available registered substance will be metabolically hydrolized into its original components glycine and fatty acids and thus as individual constituents no longer distinguishable from the physilogical and endogenously available pools of respective amino acids and fatty acids of the body. A specific developmental toxicity potential is therefore not deducible for the registered substance. Dermal absorption as a possible major exposure route is considered to be low as well. For comparable N-acyl derivatives of sarcosine, also a naturally occuring amino acid condensated with fatty acids derived from coconut oil, dermal absorption rates of less than 1% of the topically applied dose have been reported (Lanigan, S. R., Final report on the safety assessment of cocoylsarcosine and comparable N-acyl sarcosinates, Int. J. Toxicol 20: 1 -14, 2001). Taking the close structural comparability of sodium cocoyl sarcosinate and sodium lauroyl glycinate into account, the dermal absorption of the registered substance is considered to be low as well.