Registration Dossier
Registration Dossier
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EC number: 265-450-4 | CAS number: 65113-95-3
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
All three in vitro genotoxicity studies were carried out according to OECD test guidelines and were negative.
The Bacterial Reverse Mutation Test (Ames Test) was performed according to OECD 471 in the absence and presence of a metabolic activation system and did not induce a significant increase in the number of revertant (his) colonies in the five Salmonella typhimurium tester strains (TA1537, TA1535, TA98, TA100 and TA1538).
The Mammalian Cell Gene Mutation Test (Mouse Lymphoma Test) was performed according to OECD 476 in the absence and presence of a metabolic activation system and did not induce a significant increase in gene mutation frequency.
The Chromosome Aberration Test was performed according to OECD 473 in the absence and presence of a metabolic activation system and did not induce a significant increase in chromosome aberrations in human peripheral lymphocytes.
On the basis that the test substance (Ebanol) is being used to support MTCP Crude on the basis of read-across, MTCP Crude is also considered to be negative for genotoxicity.
Short description of key information:
Genetic Toxicology studies:
Negative Ames test.
Negative Mouse Lymphoma Test.
Negative chromosome Aberration Test.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
According to Directive 67/548/EEC and Regulation (EC) 1272/2008, no classification is warranted for genetic toxicology studies based on the negative Bacterial Reverse Mutation Test, negative Mammalian Cell Gene Mutation Test and the negative Chromosome Aberration Test.
On the basis that the test substance (Ebanol) is being used to support MTCP Crude on the basis of read-across, the MTCP Crude classification for genetic toxicology is also considered to be unclassified.
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