Registration Dossier
Registration Dossier
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EC number: 264-705-7 | CAS number: 64147-40-6
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
In vitro and in vivo data is available for substances representative of castor oil, dehydrated.
In vitro
Under the National Toxicology Program (Irwin, 1992), castor oil was tested for mutagenicity in a bacterial reverse mutation (Ames) assay, an in vitro mammalian chromosome abberation test in Chinese hamster ovary cells, and a sister chromatid exchange assay in Chinese hamster ovary cells. All results were negative.
Pine nut oil (C16-18 and C18-unsatd.) was negative in bacterial reverse mutation (Ames) assays (Speijers et al., 2009), as was coconut oil (C8-18 and C18-unsatd.) (Biotech index, 1970c; IUCLID 2000a).
In vivo
A micronucleus assay performed on castor oil indicated no significant increase in the frequency of micronucleated erythrocytes in either male or female mice (Irwin, 1992). Palm oil (C16-18 and C18-unsatd.) was also negative in an in vivo chromosomal abberation test (Oliveira et al., 1994).
Adducts formed by glycerides similar to those tested above are not expected to have a different mutagenicity profile compared to individual glycerides.
Based on available data, castor oil, dehydrated is not likely to be mutagenic.
Justification for selection of genetic toxicity endpoint
All studies contribute to the endpoint conclusion therefore no one study was selected.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the above information, castor oil, dehydrated does not qualify for genotoxicity classification according to Directive 67/548/EC or Regulation 1272/2008/EC.
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