Registration Dossier
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EC number: 612-953-5 | CAS number: 6218-29-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- Aug 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well reported Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- the second observation was performed 24 hours after start of treatment and not 24 hours after removal of the substance (= 20 hours after substance removal)
Test material
- Reference substance name:
- (1S,3aS,3bS,11aS)-1-hydroxy-11a-methyl-1H,2H,3H,3aH,3bH,4H,5H,7H,8H,9H,10H,11H,11aH-cyclopenta[a]phenanthren-7-one
- EC Number:
- 612-953-5
- Cas Number:
- 6218-29-7
- Molecular formula:
- C18 H24 O2
- IUPAC Name:
- (1S,3aS,3bS,11aS)-1-hydroxy-11a-methyl-1H,2H,3H,3aH,3bH,4H,5H,7H,8H,9H,10H,11H,11aH-cyclopenta[a]phenanthren-7-one
- Details on test material:
- - Name of test material (as cited in study report): ZK 47359
- Batch No.: 5412003
- purity: 100%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: liquid paraffin
- Controls:
- yes, concurrent vehicle
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 2 males and 2 females
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 20, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 20, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- No compound-related clinical signs were observed as well as no effect on body weight.
Any other information on results incl. tables
Results of the study:
| Test compound ZK 47359 (500 mg/kg) | Animal number and sex | ||||||
| Location (finding) | Time-point after end of exposure | 692M | 9410M | 9626F | 9629F | ||
| Reddening and scab formation | 1 hour* | 0 | 0 | 0 | 0 | ||
| 20 hours | 0 | 0 | 0 | 0 | |||
| 48 hours | 0 | 0 | 0 | 0 | |||
| 72 hours | 0 | 0 | 0 | 0 | |||
| Individual mean values: | 0 | 0 | 0 | 0 | |||
| Mean value of all animals: | 0 | ||||||
| Swellings | 1 hour* | 0 | 0 | 0 | 0 | ||
| 20 hours | 0 | 0 | 0 | 0 | |||
| 48 hours | 0 | 0 | 0 | 0 | |||
| 72 hours | 0 | 0 | 0 | 0 | |||
| Individual mean values | 0 | 0 | 0 | 0 | |||
| Mean values of all animals | 0 | ||||||
* not included in calculations of mean values
Applicant's summary and conclusion
- Executive summary:
500 mg of the test substance was semi-occlusively applied to the shaved intact skin of 2 male and 2 female rabbits for an exposure period of 4 h. Evaluation of skin irritation was made 1, 20, 48 and 72 h after exposure. The mean values of findings (after 20, 48 and 72 h) was 0 for swelling, reddening and scab formation. No clinical signs and no effects on body weight were observed in the course of the study.
In this skin irritation study Hydroxyestradienon was not irritating to the skin.
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