Registration Dossier
Registration Dossier
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EC number: 231-397-0 | CAS number: 7531-52-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4.9.2001-2.10.2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This test was scheduled in 2001
Test material
- Reference substance name:
- (S)-pyrrolidine-2-carboxamide
- EC Number:
- 231-397-0
- EC Name:
- (S)-pyrrolidine-2-carboxamide
- Cas Number:
- 7531-52-4
- Molecular formula:
- C5H10N2O
- IUPAC Name:
- (S)-pyrrolidine-2-carboxamide
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: BFA
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- intradermal induction: 1% test substance (because of coloration of the treated skin sites at higher concentrations)
epicutaneous induction: 1% test substance (after pre-treatment of the skin site with 10% sodium lauryl sulphate in vaseline 24 h earlier)
challenge: 0.1%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- intradermal induction: 1% test substance (because of coloration of the treated skin sites at higher concentrations)
epicutaneous induction: 1% test substance (after pre-treatment of the skin site with 10% sodium lauryl sulphate in vaseline 24 h earlier)
challenge: 0.1%
- No. of animals per dose:
- Exposed group - 10 females
Control group - 5 females
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- induction: 0%, challenge: 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: induction: 0%, challenge: 0.1% . No with. + reactions: 0.0. Total no. in groups: 5.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction: 1%, challenge: 0.1%
- 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: induction: 1%, challenge: 0.1% . No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- induction: 0%, challenge: 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: induction: 0%, challenge: 0.1% . No with. + reactions: 0.0. Total no. in groups: 5.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction: 1%, challenge: 0.1%
- 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: induction: 1%, challenge: 0.1% . No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- induction: 1%
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- induction: 1%
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
The animals showed no clinical symptoms of intoxication. The reliability of the experimental technique was checkedwith benzocaine. This positive control substance induced positive skin reactions in 40% of the treated animals.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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