Registration Dossier
Registration Dossier
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EC number: 273-499-8 | CAS number: 68987-56-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- Remarks:
- This study was carried out to confirm a previous study, that indicated the LD50 was > 2000 mg/kg, where 40 % of the male rats died at 2000 mg/kg. Doses were selected on the basis of clinical observations and time of onset of signs or death previously.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Disodium tetraborate, anhydrous
- EC Number:
- 215-540-4
- EC Name:
- Disodium tetraborate, anhydrous
- Cas Number:
- 1330-43-4
- Molecular formula:
- B4Na2O7
- IUPAC Name:
- Disodium tetraborate
- Details on test material:
- - Name of test material: Dehybor® anhydrous Borax
- Physical state: White powder
- Analytical purity: > 99 %
- Lot/batch No.: 5C152748
- Stability: Stable
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD.BR
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK.
- Age at study initiation: 5-8 weeks old
- Weight at study initiation: 143-198 g
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Amount of vehicle: Adjusted to weight of animal
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg - Doses:
- 1600; 2500 mg/kg bw
- No. of animals per sex per dose:
- Five males per dose.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs - Statistics:
- No data
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Mortality:
- None
- Clinical signs:
- No deaths occurred. No effects at 1600 mg/kg. At 2500 mg/kg, piloerection observed in one animal that recovered by day 2. No other adverse effects were observed.
- Body weight:
- No data
- Gross pathology:
- No data
- Other findings:
- No data
Applicant's summary and conclusion
- Interpretation of results:
- other: No data
- Remarks:
- Criteria used for interpretation of results: other: No data
- Conclusions:
- The LD50 for male rats administered the test substance by oral gavage was > 2500 mg/kg bw.
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