Registration Dossier
Registration Dossier
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EC number: 225-172-6 | CAS number: 4698-11-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2.1.2001 - 2.2.2001
- 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
Test material
- Reference substance name:
- 10-methoxy-5H-dibenz[b,f]azepine
- EC Number:
- 225-172-6
- EC Name:
- 10-methoxy-5H-dibenz[b,f]azepine
- Cas Number:
- 4698-11-7
- Molecular formula:
- C15H13NO
- IUPAC Name:
- 10-methoxy-5H-dibenzo[b,f]azepine
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: polyethylene glycol 400
- Concentration / amount:
- intradermal induction:
- 1:1 w:w mixture of Freunds' Complete Adjuvant with water for injection
- 5% test substance
- 1:1 w:w mixture of 10% test substance and Freunds' Complete Adjuvant
epicutaneous induction: 50% test substance (after pre-treatment with 10% sodium dodecyl sulfate (SDS) 24 h prior to epicutaneous induction)
challenge: 50%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: polyethylene glycol 400
- Concentration / amount:
- intradermal induction:
- 1:1 w:w mixture of Freunds' Complete Adjuvant with water for injection
- 5% test substance
- 1:1 w:w mixture of 10% test substance and Freunds' Complete Adjuvant
epicutaneous induction: 50% test substance (after pre-treatment with 10% sodium dodecyl sulfate (SDS) 24 h prior to epicutaneous induction)
challenge: 50%
- No. of animals per dose:
- test substance group: 10
negative control group: 5
positive control group: 10
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- induction: 0%; challenge: 50%
- 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: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- intradermal induction: 5%; epicutaneous induction 50%; challenge: 50%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: intradermal induction: 5%; epicutaneous induction 50%; challenge: 50%. No with. + reactions: 3.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- induction: 0%; challenge: 50%
- 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: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- intradermal induction: 5%; epicutaneous induction 50%; challenge: 50%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: intradermal induction: 5%; epicutaneous induction 50%; challenge: 50%. No with. + reactions: 8.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Skin reactions varying between grades 1 and 2, were observed in eight experimental animals in response to the 50% test substance concentration. No skin reactions were evident in the control animals. Yellow staining was observed at the test substance treated skin sites of both groups at 24 and 48 hours after challenge. This staining did not hamper the scoring of the skin reactions.
The skin reactions observed in response to a 50% test substance concentration in eight (of the ten) experimental animals in the challenge phase were considered indicative of sensitisation, based on the absence of any response in the control animals. These results indicate a sensitisation rate of 80 per cent. As positive control substance, alpha hexylcinnamic aldehyde was used. The positive control resulted in 10/10 positive reactions.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: Skin Sens. 1, H317
EU: Xi, R43
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