Registration Dossier
Registration Dossier
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EC number: 240-032-4 | CAS number: 15894-70-9
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
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
- Test material form:
- solid: crystalline
- Details on test material:
- Test material contained approximately 31.1% water so the dosing preparations were corrected for water content.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Zeneca
- Age at study initiation: Young adults
- Weight at study initiation: male=234-254g female=188-200g
- Housing: suspended cages (32.5cm x 37.5cm x 23cm) stainless steel
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23°C
- Humidity (%): 40-70%
- Air changes (per hr): 25-30
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Approximately 4cm x 6cm
- Type of wrap if used: gauze patch covered by plastic film and held in position using adhesive bandage and PVC tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): cotton wool soaked in clean warm water
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): amount calculated according to weight and adjusted for water content to give dose of 2000mg/kg
- For solids, paste formed: yes, by addition of 0.3-0.4ml water - Duration of exposure:
- 24h
- Doses:
- 2000mg/kg
- No. of animals per sex per dose:
- 5 male and 5 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: daily observations, weighing days 1, 3, 5, 8, 15
- Other examinations performed: clinical signs, body weight,post mortem examination
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- None of the animals died
- Clinical signs:
- other: There were no signs of toxicity in any animal at any time during the study. Signs of slight skin irritation (e.g. erythema, odema, scabbing) were seen in four males and two females, but had completely regressed by day 8.
- Gross pathology:
- No treatment related macroscopic findings
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The dermal LD50 was >2000 mg/kg to rats
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