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EC number: 234-522-7 | CAS number: 12007-92-0
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards with acceptable restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: This study was carried out to comply with US EPA-FIFRA guidelines at the time and carried out by the US Food and Drug Laboratories to GLP.
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Reference substance 001
- EC Number:
- 601-808-1
- Cas Number:
- 12179-04-3
- Molecular formula:
- Na2B4O7.5H2O
- Details on test material:
- - Name of test material: Sodium tetraborate pentahydrate
- Physical state: White powder
- Analytical purity: > 99 %
- Lot/batch No.: USB-12-84
- Stability: Stable
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: LaCrosse Industries Inc., Schenectady , New York.
- Weight at study initiation: Males: 2.19 +/- 0.27kg; females: 2.29 +/- 0.28kg
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- not specified
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Area not specified. The back of each rabbit was clipped free of fur prior to treatment.
- Type of wrap if used: Not specified
REMOVAL OF TEST SUBSTANCE
- Washing: Moist towel
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount applied: Dosage to 2 g/kg bw - Duration of exposure:
- 24 h
- Doses:
- Dosage to 2 g/kg bw
- No. of animals per sex per dose:
- Five/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Other examinations performed: Clinical signs, pathlogy - Statistics:
- Not relevant – Limit test.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- None
- Clinical signs:
- other: Clinical changes included anorexia and decreased activity in four rabbits, diarrhoea and soft stools in 3 rabbits and nasal discharge in three rabbits.
- Gross pathology:
- The only finding in one rabbit was abdominal cavity filled with fluid.
- Other findings:
- No data
Applicant's summary and conclusion
- Interpretation of results:
- other: EU GHS criteria not met
- Conclusions:
- Acute dermal limit study carried out to comply with US EPA-FIFRA guidelines at the time and carried out by the US Food and Drug Laboratories to GLP. The LD50 was > 2000 mg/kg bw indicating no acute dermal toxicity.
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