Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

C12-18-alkylbis(hydroxyethyl)methyl, chloride (CAS no 71808-53-2) was tested for genetic toxicity in three in vitro tests. All the three tests showed no indications on genetic toxicity.

The bacterial reverse mutation assay (Ames test), reliability rating 1, showed that C12-18-alkylbis(hydroxyethyl)methyl, chloride (CAS no 71808-53-2) did not cause any substantial increase in revertant colony numbers of any of the five tested strains at any dose level, either in the presence or absence of metabolic activation (S-9 mix). No evidence of mutagenic potential was seen in this study.

 

In thein vitro test on mammalian cell gene mutation in the L5178Y TK +/- mouse lymphoma assay, with reliability rating 1,C12-18-alkylbis(hydroxyethyl)methyl, chloride (CAS no 71808-53-2)was not mutagenic in presence of metabolic activation by S9 mix or after long time exposure without metabolic activation by S9 mix. It can be stated that in the mammalian micronucleus assay and under the experimental conditions reported, the test itemC12-18-alkylbis(hydroxyethyl)methyl, chloride (CAS no 71808-53-2)did not induce structural and/or numerical chromosomal damage in human lymphocytes. Therefore,C12-18-alkylbis(hydroxyethyl)methyl, chloride (CAS no 71808-53-2)is considered to be non-mutagenic with respect to clastogenicity and/or aneugenicity in this in vitro mammalian micronucleus assay.

Justification for selection of genetic toxicity endpoint

C12-18-alkylbis(hydroxyethyl)methyl, chloride (CAS no 71808-53-2) has been tested in three in vitro genotoxicty studies.

The first study available on C12-18-alkylbis(hydroxyethyl)methyl, chloride (CAS no 71808-53-2) is the bacterial reverse mutation assay (Ames test) compliant to OECD Guideline 471, performed under GLP and with reliability rating 1. In the study the bacteria strains TA98, TA100, TA1535, TA1537 and TA102 of S. typhimurium were exposed to C12-18-alkylbis(hydroxyethyl)methyl at different concentrations in the presence and absence of S9. C12-18-alkylbis(hydroxyethyl)methyl (CAS no 71808-53-2) was tested up to the limit concentration of 500 µg/plate in all tester strains used. The positive controls induced the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background. This study is classified as acceptable and C12-18-alkylbis(hydroxyethyl)methyl, chloride (CAS no 71808-53-2) is considered to be non-mutagenic in this bacterial reverse mutation assay.

The second available genetic toxicity study on C12-18-alkylbis(hydroxyethyl)methyl, chloride (CAS no 71808-53-2) is the in vitro mammalian cell gene mutation test in mouse lymphoma L5178Y cells, (OECD Guideline 476), which is GLP compliant and has reliability rating 1. The substance is considered to be non-mutagenic in the mouse lymphoma thymidine kinase locus using the cell line L5178Y. Experiment I with and without metabolic activation and experiment II with metabolic activation were performed as a 4 h short-term exposure assay. Experiment II without metabolic activation was performed as a 24 h long-term exposure assay. In experiment I and II no biologically relevant in

Short description of key information:

C12-18-alkylbis(hydroxyethyl)methyl, chloride (CAS no 71808-53-2) has been tested in three in vitro genotoxicty studies.

The first study available on C12-18-alkylbis(hydroxyethyl)methyl, chloride (CAS no 71808-53-2) is the bacterial reverse mutation assay (Ames test) compliant to OECD Guideline 471, performed under GLP and with reliability rating 1. In the study the bacteria strains TA98, TA100, TA1535, TA1537 and TA102 of S. typhimurium were exposed to C12-18-alkylbis(hydroxyethyl)methyl at different concentrations in the presence and absence of S9 up to the limit concentration of 500 µg/plate in all tester strains used. There was no evidence of induced mutant colonies over background. This study is classified as acceptable and C12-18-alkylbis(hydroxyethyl)methyl, chloride (CAS no 71808-53-2) is considered to be non-mutagenic in this bacterial reverse mutation assay.

The second available genetic toxicity study on C12-18-alkylbis(hydroxyethyl)methyl, chloride (CAS no 71808-53-2) is the in vitro mammalian cell gene mutation test in mouse lymphoma L5178Y cells, (OECD Guideline 476), which is GLP compliant and has reliability rating 1. The substance is considered to be non-mutagenic in the mouse lymphoma thymidine kinase locus using the cell line L5178Y. No biologically relevant increase of mutants was found after treatment with the test item (with and without metabolic activation). Additionally, colony sizing showed no clastogenic effects induced by the test item under the experimental conditions.

The third genetic toxicity study on on C12-18-alkylbis(hydroxyethyl)methyl, chloride (CAS no 71808-53-2) is the in vitro mammalian cell micronucleus test on primary human lymphocytes. The cells were exposed to C12-18 -alkylbis(hydroxyethyl)methyl, chloride up to cytotoxic concentrations. Positive controls induced the appropriate response. There was no evidence of micronuclei frequencies induced over background.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the negative findings in all the three available in-vitro tests for genotoxicity,C12-18-alkylbis(hydroxyethyl)methyl, chloride (CAS no 71808-53-2) does not require classification as a mutagen according to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008.