Registration Dossier
Registration Dossier
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EC number: 609-765-0 | CAS number: 39987-85-4
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- other information
- Study period:
- Dec 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- - time-points of evaluation were 20, 44 and 68 hours instead of 24, 48 and 72 hours after end of exposure
- GLP compliance:
- yes
Test material
- Reference substance name:
- 39987-86-5
- EC Number:
- 609-766-6
- Cas Number:
- 39987-86-5
- IUPAC Name:
- 39987-86-5
- Reference substance name:
- M-DOC
- IUPAC Name:
- M-DOC
- Reference substance name:
- 21-Hydroxy-16 alpha-methyl-4-pregnene-3,20-dione
- IUPAC Name:
- 21-Hydroxy-16 alpha-methyl-4-pregnene-3,20-dione
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- migrated information: paste
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Controls:
- other: the untreated skin served as control
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 4 days
- Number of animals:
- 2 males and 2 females
Results and discussion
Any other information on results incl. tables
The mean values of findings relevant for classification (reddening, scab formation and swelling of the skin) at the time-points 20, 44 and 68 hours after the end of administration were 0.
Applicant's summary and conclusion
- Executive summary:
A single dermal administration of the test substance (0.5 g applied as a paste) for 4 hours to male and female rabbits was tolerated without any local irritations. The mean values of findings relevant for classification (reddening, scab formation and swelling of the skin) at the time-points 20, 44 and 68 hours after the end of administration were 0.
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