Registration Dossier
Registration Dossier
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EC number: 428-320-1 | CAS number: 71308-16-2
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:
- 1 996
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- rabbit
- Strain:
- other: White russian (Albino)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: males 4-5 months; females 4-5 months
- Weight at study initiation: males 2.08-2.36 kg, females 2.28-2.70 kg
- Housing: individually
- Diet: approx. 120 g/animal x day standard diet sniff K
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-19°C
- Humidity (%): 50-95%
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 15.10.1996 To: 29.10.1996
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- 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 (mortality, clinical signs): 0-6 hours after dosing and once daily thereafter
- Frequency of weighing: day 0 (prior to dosing), day 7 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: gross examination of organs at necropsy.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Mortality was checked twice daily (a.m. and p.m.), on Saturdays, Sundays as well as on business days-off only once daily.
No mortality occured. - Clinical signs:
- After application of the test substance neither signs of intoxication nor mortality occurred
- Body weight:
- no effects
- Gross pathology:
- At necropsy no alterations were detected
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The LD 50 values for male and female rabbits were above a dose of 2000 mg/kg bw.
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