Registration Dossier
Registration Dossier
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EC number: 234-511-7 | CAS number: 12007-56-6
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:
- A OECD 423 study on calcium metaborate exists to determine the acute toxicity of the substance.
Calcium metaborate, as well as calcium tetraborate and all other substances in this category rapidly dissociate in aqueous media yielding the same compound, that is boric acid/borates at physiological pH. It will be the boric acid component of the substances which will drive the mammalian toxicity endpoints. Hence, all toxicity data obtained for calcium metaborate can be used as read-across data for the REACH registration of calcium tetraborate negating the need for further animal testing.
A full category justification document is attached to this dossier.
Data source
Materials and methods
Test material
- Reference substance name:
- Calcium tetraborate
- EC Number:
- 234-511-7
- EC Name:
- Calcium tetraborate
- Cas Number:
- 12007-56-6
- Molecular formula:
- B4CaO7
- IUPAC Name:
- calcium tetraborate
Constituent 1
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Calcium tetraborate does not meet the CLP classification for acute toxicity.
- Executive summary:
The oral LD50 value of calcium metaborate in Wistar rats was established to exceed 2000 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight. Based on these results, calcium metaborate does not have to be classified and has no obligatory labelling requirement for acute oral toxicity.
Calcium metaborate, as well as calcium tetraborate and all other substances in this category rapidly dissociate in aqueous media yielding the same compound, that is boric acid/borates at physiological pH. It will be the boric acid component of the substances which will drive the mammalian toxicity endpoints. Hence, all toxicity data obtained for calcium metaborate can be used as read-across data for the REACH registration of calcium tetraborate negating the need for further animal testing.
Therefore, it can be concluded that calcium tetraborate will not meet the CLP criteria for acute toxicity.
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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