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EC number: 485-390-4 | CAS number: -
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006-06-20 to 2006-10-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-study according to OECD test guideline 402
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- February 1987
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Animal Breeding Facility, Jai Research Foundation, India
- Age at study initiation: 10 to 11 weeks
- Weight at study initiation:Male : Minimum: 283, Maximum: 298, Female : Minimum: 237, Maximum: 266
- Fasting period before study: no
- Housing: individually in polypropylene rat cages covered with stainless steel grid tops
- Diet: Rat pellet feed (Amrut brand), was provided ad libitum
- Water: Drinking water filtered through an Aquaguard water filter system was provided ad libitum.
- Acclimation period: 6 days prior to dosing.
ENVIRONMENTAL CONDITIONS
- Temperature: :19 to 23 °C
- Humidity: 64 to 67 %
- Air changes: minimum 15 air changes/h
- Photoperiod: photoperiod was 12 h artificial light and 12 h darkness, light hours being 06:00 h -18:00 h
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approx. 10% of body area
- Type of wrap if used: porous gauze dressing and non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing: cotton moistened with distilled water
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied: 2000 mg/kg bw
- Constant volume or concentration used: yes - Duration of exposure:
- 24h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 2, 3 and 6 hours post dermal application on day 0; from day 1 twice/day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: - Statistics:
- not applicable
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no
- Clinical signs:
- none
- Body weight:
- comparable gain in treated and control group
- Gross pathology:
- no findings in treated group
Applicant's summary and conclusion
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