Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The large amount of data on genotoxicity available together with structural knowledge, toxicokinetic and human data provide no evidence for genotoxic or carcinogenic potential of enzymes. From this and from the lack of scientific rationale it can be concluded that neither the mouse lymphoma test nor in vivo mutagenicity tests (micronucleus) can be expected to provide any new knowledge and will only result in the unnecessary use of animals.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
The large amount of data on genotoxicity available together with structural knowledge, toxicokinetic and human data provide no evidence for genotoxic or carcinogenic potential of enzymes. From this and from the lack of scientific rationale it can be concluded that neither the mouse lymphoma test nor in vivo mutagenicity tests (micronucleus) can be expected to provide any new knowledge and will only result in the unnecessary use of animals. Therefore, CDX-049 does not meet the CLP criteria for germ cell mutagenicity.
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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