Registration Dossier
Registration Dossier
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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: 701-475-3 | CAS number: -
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- genetic toxicity in vivo, other
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
[Specific explanation in addition to field 'Justification for data waiving']
Value used for CSA (genetic toxicity in vitro): Genetic toxicity: no adverse effect observed (negative)
The following information is taken into account for any hazard / risk assessment (genetic toxicity in vivo):
In an OECD 471 Ames test a borderline positive response was observed in strain TA100 for the test material (dilithium tetraborate); however, a clear negative result was obtained in an OECD 473 cytogenicity test. For confirmation of genotoxicity status an OECD 490 Mouse Lymphoma Assay was conducted on dilithium tetraborate which was negative.
As outlined in Figure R.7.7-1 Flow chart of the mutagenicity testing strategy in the Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7a: Endpoint specific guidance, Version 6.0, July 2017, the substance is deemed negative for mutagenicity and no further testing is required.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
