Registration Dossier
Registration Dossier
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EC number: 234-511-7 | CAS number: 12007-56-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- A Bovine Corneal Opacity and Permeability Assay (BCOP) has been conducted on calcium metaborate.
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. As the test item is added directly to the eye, it will be on contact with the aqueous environment of the eye that all members of the category will dissociate to their relevant components, boric acid and calcium ions. It will be the boric acid component of the substance which will drive the eye irritation endpoint. Read-across to the data obtained on calcium metaborate is therefore proposed for the REACH registration of calcium tetraborate negating the need for further animal testing.
A full justification document is attached below
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
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Value:
- -2.2
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Value:
- -3.1
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein retention score
- Value:
- 0.064
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Calcium tetraborate is not an irritant and no classification is required.
- Executive summary:
In a well conducted Bovine Corneal Opacity and Permeability Assay (BCOP), calcium metaborate was topically applied to the epithelium of the bovine cornea for 4 hours. Calcium metaborate did not induce ocular irritation and the results indicated that no classification is required for eye irritation or serious eye damage.
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. As the test item is added directly to the eye, it is expected that the substance will dissociate to its constituent parts upon contact with the eye and it will be the boric acid component of the substance which will drive the eye irritation endpoint. The result obtained for calcium metaborate can therefore be used as read-across data for calcium tetraborate.
It can therefore be concluded that calcium tetraborate is not irritant and no classification is required.
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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