Registration Dossier
Registration Dossier
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EC number: 203-383-4 | CAS number: 106-31-0
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
Genetic toxicity in vitro
One key study has been identified to assess the genetic toxicity potential of butyric acid. No evidence was found for a mutagenic/genotoxic potential of butyric acid.
NTP 1991
In a reverse gene mutation assay in bacteria, strains of S. typhimurium (TA 97, TA 98, TA 100, and TA 1535) were exposed to butyric acid at concentrations of 0, 100, 333, 1000, 3333, and 10000 µg/plate in the presence and absence of mammalian metabolic activation (S9 mix from induced rabbit and rat liver) with 20 min preincubation before plating.
Butyric acid was tested up to the limit concentration of 10,000 µg/plate. With the highest concentration, cytotoxicity was observed. The positive controls induced the appropriate responses. Butyric acid did not increase the number of revertants in any of the test strains. There was no evidence of induced mutant colonies over background (NTP, 1991).
Ishidata 1984 (Ames test)
In a reverse gene mutation assay in bacteria according to Ames (1975), strains of Salmonella typhimurium (TA92, TA94, TA98, TA100, TA1535, and TA1537) were exposed to butyric acid (99.9%) in DMSO at 6 graduate concentrations up to 10,000 µg/plate (preincubation assay) in the presence and absence of mammalian metabolic activation (S9 mix from PCB induced male rat liver).
Butyric acid did not show cytotoxicity at 10,000 µg/plate. Data on positive controls are not reported. Butyric acid did not increase the number of revertants in any of the test strains. There was no evidence of induced mutant colonies over background (Ishidata, 1984).
Short description of key information:
Genetic toxicity in vitro
Butyric acid was found not to be mutagenic in two independent in-vitro reverse gene mutation assays in bacteria according to Ames with and without metabolic activation (NTP, 1991; Ishidate, 1984).
Hydrolysis study data, provided in section 5.1.2 will be used to demonstrate that butyric anhydride in an aqueous environment will undergo almost immediate hydrolysis to butyric acid. Thus, study data from butyric acid will be used to satisfy all data points in section 7, as water will be present in all of the studies.
In addition, butyric acid did not show genotoxic potential in vitro in mammalian cells (CHL) without metabolic activation in a Chromosomal Aberration test (Ishidate, 1984).
Genetic toxicity in vivo
No data for butyric acid could be located. Data for n-butanol are used as supporting substance.
Supporting substance: n-butanol
In a valid in vivo mouse micronucleus test, n-butanol did not increase the rate of micronuclei in polychromatic and normochromatic erythrocytes at the three doses tested (BASF, 1998).
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
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