Registration Dossier
Registration Dossier
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EC number: 204-679-6 | CAS number: 124-09-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The data suggested that hexamethylene diamine has no genotoxic potential in vitro since:
- no reverse gene mutation was observed in all Salmonella typhimurium strains tested both in the presence and in the absence of activation system in several studies according to a weight of evidence strategy (Solvay-CiToxLab, 2015, Zeller, 1980, Koops, 1975, Hébert, 1993). - no HGPRT gene mutation was noted in CHO cells both in the absence and the presence of activation system (Godek, 1985). - no transforming activity was observed for HMD in the absence and the presence of activation system (Schechtman (1980).
- no significant increase in chromosomal aberrations and sister chromatid exchanges were observed with or without metabolic activation (Hébert, 1993).
- no DNA damage and DNA repair were recorded in the Primary Rat Hepatocyte UDS Assay (Myhr, 1981).
The key studies showed that, in vivo:
- no significant increase in the frequency of chromosomal aberrations was observed after acute administration of Hexamethylene diamine. No difference was found between the vehicle control and the test groups when comparing modal numbers or mitotic index in a mammal bone marrow chromosomal aberration test (Farrow, 1984).
- no significant increase in the frequencies of micronucleated normochromatic erythrocytes or polychromatic erythrocytes in male or female mice exposed to Hexamethylene diamine salt (1,6-hexamethylene dihydrochloride) by inhalation for 13 weeks in a micronucleus test (Hébert, 1993).
In all tests (in vitro and in vivo), the toxicity of HMD (including the cytotoxicity) was tested and taken into account for the genotoxicity studies.
Hexamethylene diamine is not considered as genotoxic considering the overall results from the in vitro and in vivo studies.
Short description of key information:
In vivo and in vitro genotoxicity assays on Hexamethylene diamine
showed negative results.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
HMD is not classified in Annex VI of Regulation (EC) 1272/2008 for mutagenic effects. Based on the above data no additional self-classification is proposed.
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