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Description of key information

No general systemic treatment related effects for males or females were reported in a 28 -day repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) of dilithium tetraborate by oral gavage in rats. The NOAEL (male and female) is equal or greater than 150 mg/kg(bw).  At physiological pH, both lithium tetrahydroxyborate and dilithium tetraborate will dissociate and release boric acid and lithium ions as a result of relevant transformation pathways. Read-across to the OECD 422 results on dilithium tetraborate is reported for this endpoint.  

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
repeated dose toxicity: oral, other
Remarks:
OECD TGG 422
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
Systemic mammalian toxicity will be influenced by the degree to which the substances are capable of being absorbed via the appropriate route of exposure.

At physiological pH, the substances 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. 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.
Key result
Dose descriptor:
NOAEL
Effect level:
>= 150 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: No adverse effects reported in the organ systems.
Remarks on result:
not determinable due to absence of adverse toxic effects
Key result
Critical effects observed:
no
Conclusions:
No general systemic treatment related effects for males or females were reported in a 28 -day repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) of dilithium tetraborate by oral gavage in rats. The NOAEL (male and female) is equal or greater than 150 mg/kg(bw). At physiological pH, both lithium tetrahydroxyborate and dilithium tetraborate will dissociate and release boric acid and lithium ions as a result of relevant transformation pathways. Read-across to the OECD 422 results on dilithium tetraborate is reported for this endpoint.
Executive summary:

Systemic mammalian toxicity will be influenced by the degree to which the substances are capable of being absorbed via the appropriate route of exposure.

 

At physiological pH, the substances 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. 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.

No general systemic treatment related effects for males or females were reported in a 28 -day repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) of dilithium tetraborate by oral gavage in rats. The NOAEL (male and female) is equal or greater than 150 mg/kg(bw). These results will also be reported for the REACH registration of lithium tetrahydroxyborate.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

In a combined 28 -day repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) of dilithium tetraborate by oral gavage in rats, no repeated dose adverse effects were reported. Therefore the classification criteria (STOT-RE) as according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) / Regulation (EC) No 1272/2008 (including all amendments) are not fulfilled.

At physiological pH, both lithium tetrahydroxyborate and dilithium tetraborate will dissociate and release boric acid and lithium ions as a result of relevant transformation pathways. The same classification is proposed for lithium tetrahydroxyborate.