Registration Dossier
Registration Dossier
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EC number: 206-764-3 | CAS number: 373-44-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Reverse Gene Mutation Assay:
The test substance octamethylenediamine was investigated according to OECD TG471 and 472 for its potential to cause gene mutation in Salmonella typhimurium strains (TA98, TA100, TA1537, TA1535 and TA1538) and Escherichia coli WP2 uvrA (Engelhardt and Hoffmann, 1999). The Standard plate test (SPT) was performed with test concentrations of 20 - 5000 µg/plate and concentrations of 4 - 1500 µg/plate were used in the Preincubation test (PIT). Due to the good water solubility of the substance, auqa dest. was used as vehicle. The test was performed with and without a metabolic activation system. For this purpose, the mammalian liver post-mitochondrial fraction (S-9) was prepared from 5 male Sprague-Dawley rats with a single intraperitoneal injection of Aroclor 1254 according to Ames et.al. A bacteriotoxic effect (reduced his- or trp- background growth, decrease in the number of his+ or trp+ revertants, reduction in the titer) was observed in the standard plate test from about 2,500 μg/plate onward. In the preincubation assay bacteriotoxicity was observed depending on the strain and test conditions from about 100 μg - 500 μg/plate onward. Up to the highest investigated dose, no relevant increase of the revertant colony numbers was obtained in any Salmonella typhimurium strain as well as in the E.coli strain in comparison with the corresponding controls. In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test material caused neither base-pair substitutions, nor frameshift mutations. Therefore these test results revealed no indication of gene mutagenic activity.
Short description of key information:
Reverse Gene Mutation Assay (BASF SE, 1999, OECD 471 + 472): negative
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the negative well-conducted in vitro study, a classification of genetic toxicity is not warranted according to EU directive 67/548/EEC and EU classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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