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EC number: 429-600-4 | CAS number: 1026988-42-0
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): Basazol Gelb 8511
- Analytical purity: 96 %
- Lot/batch No.: 6123. V. 6781/June 25. 1989
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH
- Weight at study initiation: 200 - 200 g
- Housing: stainless steel wire mesh cages Type DK-III, single housing
- Diet: ad libitum
- Water: ad libitum
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- olive oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 50 cmxcm
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 ml/kg
- Concentration: 50 w/v - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Recording of signs and symptoms several times on the day of application, at least once each workday. Check for moribund and dead animals twice each workday and once on holidays.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Mortality:
- No mortality was observed.
- Clinical signs:
- No clinical signs or symptoms were observed.
- Body weight:
- Males after 7 days: 293 g; after 13 days 315 g
Females after 7 days: 243 g; after 13 days 240 g - Gross pathology:
- No pathologic findings noted.
- Other findings:
- Irritation index could not be determined because of staining due to the colour of the test substance.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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