Registration Dossier

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

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

Additional information

Ethylcentralite did not demonstrate mutagenic activity in any of the tests conducted. Ethylcentralite was not mutagenic in Salmonella Mutagenicity Test using strains TA97, TA98, TA100 and TA1535 or in Bacterial Reverse Mutation Test (acc. to EU method B.13/14 analogous to the OECD TG 471) both in the presence and absence of S9 metabolic activation and in In vitro Mammalian Chromosome Aberration Test on the human peripheral blood lymphocytes without and with metabolic activation and finally Ethylcentralite was not even mutagenic in the In vitro Mammalian Cell Gene Mutation Assay (Thymidine Kinase Locus/TK+/-) in mouse lymphoma L5178Y cells without and with metabolic activation.


Justification for selection of genetic toxicity endpoint
No study was selected, all studies were negative.

Short description of key information:
Ethyl centralit was tested for mutagenicity:


- in Salmonella typhimurium, using a preincubation protocol. Test was performed in the absence of exogenous metabolic activation, and in the presence of liver S-9 from Aroclor-induced male Sprague-Dawley rats and Syrian hamsters,

- in Bacterial Reverse Mutation Test

Four indicator Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and one indicator Escherichia coli WP2 uvrA strain were used with and without metabolic activation using a supernatant of rat liver S9

- in vitro Mammalian Chromosome Aberration Test on the human peripheral blood lymphocytes without and with metabolic activation,

- in vitro Mammalian Cell Gene Mutation Assay (Thymidine Kinase Locus/TK+/-) in mouse lymphoma L5178Y cells without and with metabolic activation

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available data, the substance is not classified for genetic toxicity.