Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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.

Diss Factsheets

Administrative data

Description of key information

The oral LD50 value of calcium metaborate in Wistar rats was established to exceed 2000 mg/kg body weight.

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. Read-across to the result for calcium metaborate is proposed for calcium tetraborate.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

The oral LD50 value of calcium metaborate in Wistar rats was established to exceed 2000 mg/kg body weight.  Therefore calcium metaborate does not fulfil the criteria for classification according to Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) / Regulation (EC) No 1272/2008. 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 calcium tetraborate should no tbe classified.