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Administrative data

Key value for chemical safety assessment

Additional information

In Vitro:

In a study conducted by San and Olson (1991), the test substance, Busan 11-M1, was investigated for its ability to induce mutagenic activity when tested in an in vitro reverse mutagenicity test using four strains of the bacteria Salmonella typhimurium, specifically TA 98, TA 100, TA 1535, TA 1537 and TA 1538. The study was conducted both in the presence and absence of metabolic activation using S9 mix from Aroclor-induced rats. No evidence of mutagenicity was seen under the conditions of this study.

In a study conducted by Bigger and Clarke(1991), the test substance, Busan 11-M1, was investigated for its ability to induce mutagenic activity when tested in an in vitro L5178Y TK+/- mouse lymphoma mutagenesis assay. The study was conducted both in the presence and absence of metabolic activation using S9 mix from Aroclor-induced rats. No evidence of mutagenicity was seen under the conditions of this study.

In Vivo:

In a study conducted by Putman and Young (1992), the test substance, Busan 11-M1, was examined for its ability to increase the incidence of micronucleated polychromatic erythrocytes in bone marrow when administered via IP injection to male and female ICR mice. The test animals were exposed to concentrations of the test substance 11.3, 22.5 and 45 mg/kg bw at 10 ml/kg bw. They were then observed for 24, 48 and 72 days following treatment to determine the effects. Under the conditions of this study, Busan 11-M1 did not induce a significant increase in the incidence of micronucleated polychromatic erythrocytes in bone marrow and was concluded to be negative in the micronucleus test.  Based on this result, the test substance does not require classification for genotoxicity according to Regulation EC No. 1272/2008.


Justification for selection of genetic toxicity endpoint
A weight of evidence approach is used for this endpoint; a number of negative studies in vitro and in vivo are available. Studies were performed using Busan 11-M1.

Short description of key information:
Studies of bacterial and mammalian cell mutation in vitro and a mouse bone marrow micronucleus assay are available for the submission substance.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

No classification is proposed for mutagenicity in the absence of any indication of mutagenicity from any of the studies presented.