Registration Dossier
Registration Dossier
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EC number: 701-475-3 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- At physiological pH, all category members dissociate and release boric acid and lithium ions as a result of relevant transformation pathways. It will the boric acid component of the substances which will drive the mammalian toxicity endpoints. In order to minimise animal testing, only one substance in the category was tested, dilithium tetraborate. For all other substances in the category, read-across is proposed.
Data source
Materials and methods
Test material
- Reference substance name:
- Dilithium tetraborate
- EC Number:
- 234-514-3
- EC Name:
- Dilithium tetraborate
- Cas Number:
- 12007-60-2
- Molecular formula:
- B4Li2O7
- IUPAC Name:
- dilithium tetraborate
- Test material form:
- solid: bulk
Constituent 1
Results and discussion
Test results
- Key result
- Species / strain:
- lymphocytes: Humans
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- An in vitro test has been conducted to determine the possible clastogenicity of dilithium tetraborate. Both in the absence and presence of S9-mix Dilithium tetraborate did not induce any statistically significant and biologically relevant increase in the number of cells with chromosome aberrations in two independent experiments. Similar results are expected for the UVCB-Reaction products of boric acid and lithium hydroxide.
- Executive summary:
At physiological pH, all category members dissociate and release boric acid and lithium ions as a result of relevant transformation pathways. It will the boric acid component of the substances which will drive the mammalian toxicity endpoints. In order to minimise animal testing, only one substance in the category was tested, dilithium tetraborate. For all other substances in the category, read-across is proposed.
Negative in vitro results for clastogenicity (chromosome aberration) were obtained for dilithium tetraborate therefore simialr negative results are expected for the UVCB-Reaction products of boric acid and lithium hydroxide. Variations in structure (trigonal vs tetrahedral) between the substances are not expected to lead to any changes in the genetic toxicity.
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