Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Bacterial Mutagenicity (WoE, OECD 471, Ames): negative with and without metabolic activation

RA from source substances (Z)-N-methyl-N-(1-oxo-9-octadecenyl)glycine (CAS 110-25-8), N-(1-oxooctadecyl)sarcosine (CAS 142-48-3) and Sodium N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate (CAS 3624-77-9)

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No data on the genetic toxicity are available for the target substance (Z)-N-methyl-N-(1-oxo-9-octadecenyl)glycine, compound with 2,2',2''-nitrilotri(ethanol) (1:1) (CAS 17736-08-2). Therefore, read across from the relevant source substances (Z)-N-methyl-N-(1-oxo-9-octadecenyl)glycine (CAS 110-25-8), N-(1-oxooctadecyl)sarcosine (CAS 142-48-3) and Sodium N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate (CAS 3624-77-9) was applied.

A bacterial gene mutation assay (Ames test) was performed with (Z)-N-methyl-N-(1-oxo-9-octadecenyl)glycine (CAS 110-25-8) according to OECD TG 471 and in compliance with GLP (LAUS, 2007). The strains Salmonella typhimurium TA 97a, TA 98, TA 100, TA 102 and TA 1535 were tested in two independent experiments according to the plate incorporation and pre-incubation procedure in the absence and presence of a metabolic activation system (Aroclor 1254-induced rat liver S9-mix). The experiments were conducted each in 4 replications at concentrations from 50 to 5004 µg/plate (vehicle: DMSO). No increase in the number of revertant colonies was noted in any of the bacterial strains, with and without metabolic activation system. No cytotoxicity was recorded in any tester strain up to and including the highest dose tested. Appropriate positive and vehicle controls were included in the study and gave the expected results. Under the conditions of the study, the test substance did not induce mutations in the bacterial mutation assay in the absence and presence of a metabolic activation system in any of the strains tested.

Another bacterial gene mutation assays (Ames test) was performed with N-(1-oxooctadecyl)sarcosine (CAS 142-48-3) according to OECD TG 471 and in compliance with GLP (LAUS, 2012a). The strains Salmonella typhimurium TA 97a, TA 98, TA 100, TA 102 and TA 1535 were tested in two independent experiments according to the plate incorporation and pre-incubation procedure in the absence and presence of a metabolic activation system (Aroclor 1254-induced rat liver S9-mix). The experiments were conducted each in 4 replications at concentrations from 53 to 5005 µg/plate in the first experiment and 323 to 4792 µg/plate in the second experiment (vehicle: water). No increase in the number of revertant colonies was noted in any of the bacterial strains, with and without metabolic activation system. No cytotoxicity was observed up to the highest dose tested. The included positive and vehicle controls showed the expected results. Under the conditions of the study, the test substance did not induce mutations in the bacterial mutation assay in the absence and presence of a metabolic activation system in any of the strains tested.

A bacterial gene mutation assays (Ames test) was performed with Sodium N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate (CAS 3624-77-9) following OECD TG 471 and in compliance with GLP (LAUS, 2012b). The strains Salmonella typhimurium TA 97a, TA 98, TA 100, TA 102 and TA 1535 were tested in two independent experiments according to the plate incorporation and pre-incubation procedure in the absence and presence of a metabolic activation system (Aroclor 1254-induced rat liver S9-mix). The experiments were conducted each in 4 replications at concentrations from 50 to 5004 µg/plate (vehicle: water). No increase in the number of revertant colonies was noted in any of the bacterial strains, with and without metabolic activation system. No cytotoxicity was observed up to the highest dose tested. The included positive and vehicle controls showed the expected results. Under the conditions of the study, the test substance did not induce mutations in the bacterial mutation assay in the absence and presence of a metabolic activation system in any of the strains tested.

Justification for classification or non-classification

The available data on relevant read-across source substances for genetic toxicity do not meet the criteria for classification according to Regulation (EC) No 1272/2008 (CLP) based on the available data in bacteria. Nevertheless, no final decision on classification for genetic toxicity according to Regulation (EC) 1272/2008 can be made without consideration of data on chromosomal aberration and mutagenicity in mammalian cells/in vivo. The available data are therefore conclusive but not sufficient for classification according to the data requirements of Annex VII of REACH Regulation.