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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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.

Data source

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
Dilithium tetraborate
EC Number:
234-514-3
EC Name:
Dilithium tetraborate
Cas Number:
12007-60-2
Molecular formula:
B4Li2O7
IUPAC Name:
dilithium tetraborate
Test material form:
solid: bulk

Results and discussion

Effect levels

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

Target system / organ toxicity

Key result
Critical effects observed:
no

Applicant's summary and conclusion

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 the UVCB-Reaction products of boric acid and lithium hydroxide.