Registration Dossier
Registration Dossier
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EC number: 251-133-8 | CAS number: 32634-95-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- from July to August
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 17-hydroxy-6-methylenepregn-4-ene-3,20-dione 17-acetate
- EC Number:
- 251-133-8
- EC Name:
- 17-hydroxy-6-methylenepregn-4-ene-3,20-dione 17-acetate
- Cas Number:
- 32634-95-0
- Molecular formula:
- C24H32O4
- IUPAC Name:
- 17-Acetoxy-6-methylene-4-pregnene-3,20-dione
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: liquid paraffin
- Concentration / amount:
- Induction: 2.5 w/v%
challenge: 15 w/v%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: liquid paraffin
- Concentration / amount:
- Induction: 2.5 w/v%
challenge: 15 w/v%
- No. of animals per dose:
- control group: 10 (5/sex)
test substance group: 10 (5/sex) - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- challenge 15 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: challenge 15 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- challenge 15 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: challenge 15 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
The intradermal injections (induction procedere) did not produce necrosis and ulcerations at the application site.
Applicant's summary and conclusion
- Executive summary:
In a guinea pig maximization test (GPMT) according to OECD TG 406 the test substance proved to be not senistizing after challenge with 15 % test substance.
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