Registration Dossier
Registration Dossier
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EC number: 203-677-2 | CAS number: 109-52-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The results of the in vitro gene mutatation assays in both bacteria and mammalian cells (Ames and HPRT) were clearly negative.
Valeric acid produced a significant increase of chromosomal aberrations in an in vitro assay with CHO cells. However, an increase in chromosomal aberrations was observed at similar concentrations with and without S9 and no pH adjustment is reported in this study as recommended in the OECD guideline. Therefore, it is very likely that the observed increase in chromosome aberrations is due to pH-effects.
In an in vitro sister chromatide exchange test with CHO cells a positive response was observed with metabolic activation. However, the concentrations at which a significant increase in SCE was observed with S9 could not be evaluated in the test without S9 due to significant cytotoxicity. Also, no pH adjustment is reported in this study as recommended by the OECD guideline. Therefore, it is very likely that the observed increase in SCE is due to pH-effects.
In an in vivo mouse micronucleus assay, n-Valeric Acid was not activeregarding increases in micronuclei in male or female Swiss-Webster mice. Dosage levels up to 80% of the LD50 dose for males and females did not produce treatment-related genotoxic effects in this test. n-Valeric Acid was interpreted to be inactive as a clastogenic agent in-vivo under the conditions of the micronucleus test system.
Short description of key information:
GLP-studies according to or equivalent to OECD guideline 471, 473, 476, 479 and 474 are available for valeric acid.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Valeric Acid showed clearly negative results in the in vitro gene mutation tests in bacteria and mammalian cells. Some effects of cytogenicity were observed in in vitro assays with CHO cells. It is unclear whether those effects are real genotoxic effects or are due to pH-effects. In an in vivo mouse micronucleus test no genotoxic effects were observed with valeric acid. Hence, no classification for genotoxicity is required for valeric acid.
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