Registration Dossier
Registration Dossier
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EC number: 701-475-3 | CAS number: -
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- 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, 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
- 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
Constituent 1
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- >= 150 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 50 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- body weight and weight gain
Results: F1 generation
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 50 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: based on reduced gestation index, marked
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- 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 treatment-related changes were noted the reproductive parameters examined in this study up to the highest dose level tested. The reproduction NOAEL is therefore at least 150 mg/kg.
The NOAEL (Developmental toxicity) was determined to be 50 mg/kg (bw) - this is based on reduced gestation index, marked reductions in post-implantation survival, live litter size, live birth, viability and lactation indices, a high number of total litter losses, and reduced pup birth weight and postnatal growth at 150 mg/kg
The parental NOAEL was determined to be 50 mg/kg (bw) - this is based on reduced body weight gain at gestation and lactation.
Dilithium tetraborate and all other substances in this category rapidly dissociate in aqueous media yielding the same compound, boric acid/borates at physiological pH. It is therefore expected that the UVCB-Reaction products of boric acid and lithium hydroxide will exhibit the same prenatal developmental toxicity. - Executive summary:
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 using doses, no treatment-related changes were noted the reproductive parameters examined in this study (i.e. mating and fertility indices, precoital time, number of implantation sites, estrous cycle, spermatogenic profiling, and histopathological examination of reproductive organs) up to the highest dose level tested ( 150 mg/kg)
Developmental toxicity was observed at 150 mg/kg. There were no explanatory morphological findings in parental reproductive organs. The developmental toxicity at 150 mg/kg was characterized by a reduction in the gestation index, marked reductions in post-implantation survival index, live litter size, live birth index, viability index and lactation index, and reduced birth weight and postnatal growth of pups.
The parental NOAEL based on the outcome of this study is 50 mg/kg (bw). This is based on reduced body weight gain at gestation and lactation.
At physiological pH, both the UVCB-Reaction products of boric acid and lithium hydroxide and dilithium tetraborate 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 including the UVCB-Reaction products of boric acid and lithium hydroxide, read-across is proposed.
A reproductive classification of Category 2 is therefore proposed for all borate substances.
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