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Description of key information

Read-across to the OECD 405, 431 and 439 studies on dilithium tetraborate is proposed. Based on the effects noted in the OECD 405 study conducted, all members of the category will be classified as Category 1 : H318: Causes serious eye damage.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin corrosion: 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:
At physiological pH, all lithium borates 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. Variations in the structure (trigonal vs tetrahedral) between the substances are not expected to lead to any changes in corrosivity. 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.
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3 minute
Value:
93
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: not corrosive
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
1 hour
Value:
99
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: not corrosive
Interpretation of results:
GHS criteria not met
Conclusions:
An OECD 431 study was conducted on dilithium tetraborate and found to be non-corrosive. Lithium tetrahydroxyborate is also expected to be non-corrosive.
Executive summary:

An OECD 431 study was conducted on dilithium tetraborate and found to be non-corrosive. Variations in the structure (trigonal vs tetrahedral) between the substances are not expected to lead to any changes in corrosivity as at physiological pH, all the substances dissociate to provide the same common compounds. All substances in the category do not meet CLP criteria for classification as skin irritants.

Endpoint:
skin 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:
At physiological pH, all lithium borates 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. Variations in the structure (trigonal vs tetrahedral) between the substances are not expected to lead to any changes in skin 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.
Irritation / corrosion parameter:
% tissue viability
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Conclusions:
In conclusion, an in vitro skin irritation test was conducted according to OECD 439. Dilithium tetraborate was found to be non-irritant and should not be classified according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations. Lithium tetrahydroxyborate is also expected to be non-irritant.
Executive summary:

An in vitro skin irritation test was conducted according to OECD 439. Dilithium tetraborate was found to be non-irritantV. ariations in the structure (trigonal vs tetrahedral) between the substances are not expected to lead to any changes in corrosivity as at physiological pH, all the substances dissociate to provide the same common compounds. All substances in the category do not meet CLP criteria for classification as skin irritants.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
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:
Lithium tetrahydroxyborate and dilithium tetraborate are structural very similar. 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.
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
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 tetrahydroxyborate 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. All substances in the category will be classified as Category 1 - causes serious eye damage.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

An OECD 431 and OECD 439 were conducted on dilithium tetraborate and found to be non-corrosive and non-irritant. Variations in the structure (trigonal vs tetrahedral) between the substances are not expected to lead to any changes in corrosivity/irritancy as at physiological pH, all the substances dissociate to provide the same common compounds. All substances in the category do not meet CLP criteria for classification as skin irritants/corrosion.

An OECD 405 was conducted with dilithium 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.