Registration Dossier
Registration Dossier
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EC number: 617-345-3 | CAS number: 82543-14-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- Jul 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well reported GLP study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
- Principles of method if other than guideline:
- combined acute dermal toxicity and local irritation study; single dermal application of test substance (application volume 0.4 - 0.6 ml; 439-587 mg/animal) to male and female rats; exposure for 24 hours; values for reddening, scab formation and swelling of the skin obtained 1 h after removal of the bandage and the substance and 24, 48 and 72 h after the end of administration.
- GLP compliance:
- yes
Test material
- Reference substance name:
- 5-hydroxy-15β,16β-methylene-3β-pivaloyloxy-5β-androst-6-en-17-one
- EC Number:
- 617-345-3
- Cas Number:
- 82543-14-4
- Molecular formula:
- C25H36O4
- IUPAC Name:
- 5-hydroxy-15β,16β-methylene-3β-pivaloyloxy-5β-androst-6-en-17-one
- Details on test material:
- - Name of test material (as cited in study report): ZK 90504
- Batch No.: 21608604
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- water
- Remarks:
- bidest. water
- Controls:
- no
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 14 days
- Number of animals:
- 3/sex
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Other effects:
- No mortalities or macroscopic pathological signs were observed. Shortly after administration females showed some clinical signs such as hyperactivity, vocalization and spastic gait. No compound-related clinical signs were observed in females from 3 hours after administration onwards, males were without findings over the whole study period.
Applicant's summary and conclusion
- Executive summary:
The single dermal administration of Enpivalat to male and female rats at a dose of 2000 mg/kg (application volume 0.4 - 0.6 ml; 439-587 mg/animal) was tolerated without any mortality or macroscopic pathological signs. Shortly after administration females showed some clinical signs such as hyperactivity, vocalization and spastic gait. No compound-related clinical signs were observed in females from 3 hours after administration onwards, males were without findings over the whole study period. The test substance was tolerated without any local skin irritations.
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