Registration Dossier
Registration Dossier
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EC number: 204-596-5 | CAS number: 123-05-7
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
In vitro studies:
2-ethylhexanal was tested for mutagenicity using the Salmonella/microsome preincubation assay using the standard protocol approved by the National Toxicology Program. The compound was tested at doses of 0 - 666 µg/plate in as many as 5 Salmonella typhimurium strains (TA1535, TA1537, TA97, TA98, and TA100) in the presence and absence of rat or hamster liver S-9. 2-ethylhexanal was negative in these tests with and without S9 metabolic activation (Zeiger et al. 1988; Val. 2)
In vivo studies:
In a micronucleus test performed at 0, 500, 1000 and 2000 mg/kg by gavage in NMRI mice, a weak, but dose-dependent effect was observed. However, the study is not sufficient for endpoint evaluation and was set not assignable due to a low purity of the test substance (BASF 1999; Val. 3). Therefore the study was repeated in both sexes at the limit dose. This follow up study was conducted according to OECD guideline 474 under GLP conditions. There were only minor deviations and the study was fully sufficient for endpoint evaluation. 2-ethylhexanal was tested for micronucleus induction in mouse after single administration of 2000 mg/kg bw. Twelve animals (6M/6F) were treated per test group and analyzed after 24h (5M/5F). A cytotoxic effect was described as the ratio between polychromatic and total erythrocytes. 1M and 1F died after treatment with this dose. No statistically significant enhancement in the frequency of micronuclei after 2-ethylhexanal was observed in this study. The test substance does not induce micronuclei in mouse erythrocytes in vivo (BASF 1999; Val. 1).
Short description of key information:
In a valid Ames-tests, with or without metabolic activation through S9-Mix and an valid in vivo Mammalian Bone Marrow Chromosome Aberration Test (OECD Guideline 474) failed to provide any evidence for a mutagenic effect of 2-ethylhexanal.
In vitro studies:
Ames-Test: negative (NTP standard protocol )
In vivo studies:
Mouse Micronucleus Test: negative (OECD 474)
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
No classification suggested for mutagenicity as criteria of regulations 67/548/EC and 1272/2008/EC are not met.
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