Registration Dossier
Registration Dossier
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EC number: 214-688-7 | CAS number: 1185-81-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The key in vitro Ames study (Thompson, 2010) was performed in compliance with GLP and in accordance with the OECD 471 guideline. The study was therefore assigned a reliability score of 1, in accordance with the criteria outlined in Klimisch (1997) and deemed adequate for assessment.
The test material was considered to be non-mutagenic under the conditions of this test.
Short description of key information:
The key in vitro Ames study (Thompson, 2010) was performed in compliance with GLP and in accordance with the OECD 471 guideline.
Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and Escherichia coli strain WP2uvrA-were treated with the test material using both the Ames plate incorporation and pre-incubation methods at seven dose levels, in triplicate, both with and without the addition of a rat liver homogenate metabolising system (10% liver S9 in standard co-factors). No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, either with or without metabolic activation or exposure method.
The test material was considered to be non-mutagenic under the conditions of this test.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the available data at this tonnage level no classification is required for this substance. However, it should also be noted that in line with the Summary Record of the Technical Committee on the Classification and Labelling, Meeting of the Technical Committee on the Health Effects of New Substances, Pesticide, Existing Chemicals, and on General Issues, Ispra, 14 -17 November 2005. The Final Conclusion reached by the ECB was that a general entry with Nota H of Repr. Cat. 2; R60-61, Muta. Cat. 3; R68 for dibutyltin salts should be accepted.
With this in mind and according to directive 67/548/EEC the substance is assigned the classification Mutagenicity category 3 and labelled with R68 – possible risk of irreversible effects. According to Regulation (EC) no 1272/2008 the test substance would be classified as Muta. 2 with the Hazard statement: H341: Suspected of causing genetic defects and should be accompanied with the signal word 'Warning'.
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