Registration Dossier

Diss Factsheets

Administrative data

genetic toxicity in vivo, other
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
Justification for type of information:
[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