Registration Dossier
Registration Dossier
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EC number: 616-291-8 | CAS number: 76114-73-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 2-propynyl butylcarbamate
- EC Number:
- 616-291-8
- Cas Number:
- 76114-73-3
- Molecular formula:
- C8H13NO2
- IUPAC Name:
- 2-propynyl butylcarbamate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hsd Poc:DH
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Intradermal induction: 5 % (= 20 mg test item/animal)
Topical induction: 100 % (= 500 mg test item/animal)
Challenge: 100 % (= 500 mg test item/animal)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- Intradermal induction: 5 % (= 20 mg test item/animal)
Topical induction: 100 % (= 500 mg test item/animal)
Challenge: 100 % (= 500 mg test item/animal)
- No. of animals per dose:
- No of animals in test group: 10 animals
No of animals in negative control group:5 animals
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- red wheal, encrustation, white wheal with red surrounding, white wheal encrustation (after 7 days the following effects were recorded at the injection sites: wheals and encrustations.)
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: red wheal, encrustation, white wheal with red surrounding, white wheal encrustation (after 7 days the following effects were recorded at the injection sites: wheals and encrustations.).
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- red wheal, encrustation, white wheal with red surrounding (after 7 days the following effects were recorded at the injection sites: wheals and encrustations.)
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: red wheal, encrustation, white wheal with red surrounding (after 7 days the following effects were recorded at the injection sites: wheals and encrustations.).
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 100 %. No with. + reactions: 1.0. Total no. in groups: 10.0.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
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