Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
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). These results will also be reported for the REACH registration of Reaction products of boric acid and calcium dihydroxide and lithium hydroxide.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: oral, other
- Remarks:
- OECD TGG 422
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- 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/calcium ions as a result of relevant transformation pathways. It will the boric acid component of the substances which will drive the mammalian toxicity endpoints.
The target UVCB substance has a higher precursor molar ratio for lithium hydroxide than for calcium hydroxide, and therefore the precautionary principle should be applied and read across from dilithium tetraborate where relevant to consider the worst case. - Reason / purpose for cross-reference:
- read-across source
- 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, dilithium tetraborate will dissociate and release boric acid and lithium ions as a result of relevant transformation pathways.
The target UVCB substance has a higher precursor molar ratio for lithium hydroxide than for calcium hydroxide, and therefore the precautionary principle should be applied and read across from dilithium tetraborate where relevant to consider the worst case.
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/calcium ions as a result of relevant transformation pathways. It will the boric acid component of the substances which will drive the mammalian toxicity endpoints.
The target UVCB substance has a higher precursor molar ratio for lithium hydroxide than for calcium hydroxide, and therefore the precautionary principle should be applied and read across from dilithium tetraborate where relevant to consider the worst case.
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 Reaction products of boric acid and calcium dihydroxide and lithium hydroxide.
Reference
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, dilithium tetraborate will dissociate and release boric acid and lithium ions as a result of relevant transformation pathways.
The target UVCB substance has a higher precursor molar ratio for lithium hydroxide than for calcium hydroxide, and therefore the precautionary principle should be applied and read across from dilithium tetraborate where relevant to consider the worst case.
Read-across to the OECD 422 results on dilithium tetraborate is reported for this endpoint.
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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