Registration Dossier
Registration Dossier
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EC number: 451-540-2 | CAS number: -
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Strain: Sprague-Dawley (SPF) ; 5 /sex – 1 treated group
- Age/Bodyweight at start: 9-week old; 294 +/-5g (males); 221+/-6g (females)
- Temperature: 22+/-2°C; RH: 30-70%; Light/dark cycle: 12h/12h; ventilation: Approx. 12 cycles/h
- Caging: 1 rat/sex/cage, on stainless steel lids
- Food and water ad libitum
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- - application on dorsal clipped area (approx. 10% of body surface)
- test item moistened with purified water
- test item held in contact with the skin for 24h by a gauze pad and hypoallergenic aerated semi-occlusive adhesive dressing - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 male and 5 female
- Control animals:
- no
- Details on study design:
- - 2-week observation period after dosing
- monitoring: clinical signs (incl. cutaneous reactions) and mortality, bodyweight
- terminal kill on Day 15: macroscopic examination
Results and discussion
- Preliminary study:
- Not applicated.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- other: mortality
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality.
- Clinical signs:
- None (incl. cutaneous reactions).
- Body weight:
- Transient body weight loss in 2/5 females.
- Gross pathology:
- No macroscopic abnormality.
- Other findings:
- None.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Lethal dose > 2000mg/kg via dermal application .
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