Registration Dossier
Registration Dossier
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EC number: 296-664-6 | CAS number: 92908-35-5
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:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): Fixapret CP konz., PBG = 10073662, after Concentration
- Physical state:liquid (high viscous)
- Analytical purity: 89.6 %
- Lot/batch No.: 000335MCA0
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River WIGa GmbH, Sulzfeld, Germany
- Age at study initiation: male 8 weeks; female 12 weeks
- Housing: single housing
- Diet (e.g. ad libitum): VRF 1(P); SDS Special Diets Services (Altrip) Germany
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 26
- Humidity (%): 20 - 80 %
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: about 40 cm²
- % coverage: 10
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours
- 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
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality occurred
- Clinical signs:
- other: No systemic clinical sings were observed during clinical examination
- Gross pathology:
- No abnormalities were noted.
- Other findings:
- Local effects:
Slightly yellowish discoloration of the application site was observed on study day 1 until study day 9 in all animals after application.
Applicant's summary and conclusion
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