Registration Dossier
Registration Dossier
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EC number: 272-911-3 | CAS number: 68920-03-6 A complex combination obtained by steam distillation of C16-18 and C18-unsatd. glycerides followed by condensation of the steam.
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Short description of key information:
Not considered to be genotoxic.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
The mutagenic potential of 'glycerides C16-18 and C18-unsatd., deodorizer distillates' can be based on information available for its individual constituents. Studies conducted on glycerides, fatty acids, tocopherols and sterols, either in vitro or in vivo, indicate that these substances are not mutagenic. Moreover, predictions from the Toxtree (v.1.6) model revealed no evidence for mutagenic activity of any of the constituents.
These substances all have a long history of safe use in nutritional, cosmetic and/or industrial applications. Some (e.g. certain fatty acids and tocopherols) are GRAS listed in the United States and/or demonstrate anti tumourigenic activity under certain conditions (e.g. tocopherols and squalene; see Section 5.8).
Based on the above information, the substance is not considered to qualify for mutagenicity classification according to Directive 67/548/EC or Regulation (EC) No. 1272/2008.
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