Registration Dossier
Registration Dossier
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EC number: 427-090-8 | CAS number: 116044-44-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- A mixture of: ethyl (2R,3R)-3-isopropylbicyclo[2.2.1]hept-5-ene-2-carboxylate; ethyl (2S,3S)-3-isopropylbicyclo[2.2.1]hept-5-ene-2-carboxylate
- EC Number:
- 427-090-8
- EC Name:
- A mixture of: ethyl (2R,3R)-3-isopropylbicyclo[2.2.1]hept-5-ene-2-carboxylate; ethyl (2S,3S)-3-isopropylbicyclo[2.2.1]hept-5-ene-2-carboxylate
- Cas Number:
- 116044-44-1
- IUPAC Name:
- bis(ethyl (2R,3R)-3-(propan-2-yl)bicyclo[2.2.1]hept-5-ene-2-carboxylate)
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:
- propylene glycol
- Concentration / amount:
- Induction: 5% in propylene glycol (PG) and 5% in PG/FCA followed by undiluted epicutaneous application
Challenge: 1%, 10% and 100% in PG
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- Induction: 5% in propylene glycol (PG) and 5% in PG/FCA followed by undiluted epicutaneous application
Challenge: 1%, 10% and 100% in PG
- No. of animals per dose:
- 20 test animals
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100
- No. with + reactions:
- 10
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100. No with. + reactions: 10.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10. No with. + reactions: 14.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1. No with. + reactions: 8.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100
- No. with + reactions:
- 9
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100. No with. + reactions: 9.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10
- No. with + reactions:
- 13
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10. No with. + reactions: 13.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1
- No. with + reactions:
- 7
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1. No with. + reactions: 7.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10, 10, 1
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10, 10, 1. No with. + reactions: 2.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100, 10, 1
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100, 10, 1. No with. + reactions: 4.0. Total no. in groups: 10.0.
Applicant's summary and conclusion
- Interpretation of results:
- other: moderate sensitiser
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