Registration Dossier
Registration Dossier
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EC number: 236-631-5 | CAS number: 13453-69-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- Systemic mammalian toxicity will be influenced by the degree to which the substances are capable of being absorbed via the appropriate route of exposure.
At physiological pH, the substances 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:
- Lithium metaborate
- EC Number:
- 236-631-5
- EC Name:
- Lithium metaborate
- Cas Number:
- 13453-69-5
- Molecular formula:
- BHO2.Li
- IUPAC Name:
- lithium metaborate
Constituent 1
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 500 mg/kg bw
- Based on:
- test mat.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- At physiological pH, the substances 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. Read-across to the result for dilithium tetraborate is proposed for this endpoint which quotes an oral LD50 value for dilithium tetraborate in Wistar rats in the range of 300-2000 mg/kg body weight. The same result is therefore quoted for lithium metaborate.
- Executive summary:
The oral LD50 value of dilithium tetraborate in Wistar rats was established to be within the range of 300-2000 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value was considered to be 500 mg/kg body weight.
Based on these results, dilithium tetraborate should be classified as Category 4 based on GHS criteria. Variations in structure (trigonal vs tetrahedral) between the substances are not expected to lead to any changes as at physiological pH as all the substances dissociate to provide the same common compounds. It can be concluded that all substances in the category including lithium metaborate should be classified as acute toxicity, category 4.
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