Registration Dossier
Registration Dossier
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EC number: 236-631-5 | CAS number: 13453-69-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- Variations in the structure (trigonal vs tetrahedral) between the substances are not expected to lead to any changes in eye irritation. 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
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 324
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 335
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within:
- Remarks:
- 21 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 336
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal: 324
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal: 335
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal: 336
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 324
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 335
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 336
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal: 324
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal: 336
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal: 335
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not specified
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the not fully recovered effects on the cornea and conjunctivae of one animal after 21 days, dilithium tetraborate should be classified in accordance with the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) / Regulation (EC) No 1272/2008 (including all amendments) as Category 1 - causes serious eye damage. Lithium metaborate is also expected to be an eye irritant and shall be classified in an analogous manner.
- Executive summary:
An OECD 405 was conducted with dilithim tetraborate. Based on the not fully recovered effects on the cornea and conjunctivae of one animal after 21 days, dilithium tetraborate should be classified in accordance with the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) / Regulation (EC) No 1272/2008 (including all amendments) as Category 1 - causes serious eye damage. Variations in the structure (trigonal vs tetrahedral) between the substances are not expected to lead to any changes in corrosivity as at physiological pH as all the substances dissociate to provide the same common compounds. All substances in the category will be classified as Category 1 - causes serious eye damage.
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