Registration Dossier
Registration Dossier
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EC number: 288-309-9 | CAS number: 85711-49-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The read-across substance SALATRIM 23CA lot A014 did not produce chromosomal aberrations, indicating a lack of clastogenic potential. This SALATRIM fat failed to produce evidence of mutagenic potential in a mammalian cell line, in agreement with its lack of mutagenicity in bacteria. No evidence of DNA damage was detected with this fat when assessed by unscheduled DNA synthesis.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
The in vitro studies were extended to an in vivo assay measuring the ability of two additional SALATRIM fats to produce micronucleated polychromatic erythrocytes in bone marrow. This in vivo study is significant because the two SALATRIM fats were fed to rats at high doses (10% of the diet) for a prolonged period (13 weeks). This study is also significant because all mechanisms of digestion, absorption, metabolism, distribution, and excretion were operational in the intact animal. Micronucleated polychromatic erythrocytes did not differ between the SALATRIM fats and the corn oil control, and all of the data were within the range of historical control data for this assay. Therefore, the data from the in vivo genetic toxicology assay confirm the data from the in vitro genetic toxicology assays.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
These studies were done to test the hypothesis, that upon structure/activity relationships and review of the scientific literature, the members of the read-across substances the SALATRIM family of structured triacylglycerols should have no capability of interacting with mammalian cell DNA to produce genetic changes. The studies of SALATRIM fats using bacterial test systems, in vitro mammalian cell cultures and an in vivo rat study support the conclusion that SALATRIM fats should possess no genotoxic potential.
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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