Registration Dossier
Registration Dossier
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EC number: 424-250-9 | CAS number: -
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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An LLNA-skin sensitisation study does not need to be conducted because adequate data from an in vivo (non-LLNA) study is already available.
Test material
- Reference substance name:
- Yellow MGi 1301
- IUPAC Name:
- Yellow MGi 1301
- Test material form:
- solid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 5 % in water
- Day(s)/duration:
- Day 1
- Route:
- intradermal
- Vehicle:
- other: emulsion with Freund's complete adjuvant and physiological saline
- Concentration / amount:
- 5 %
- Day(s)/duration:
- Day 1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 50 % in water
- Day(s)/duration:
- Day 8
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 50 % in water
- Day(s)/duration:
- Day 22
- No. of animals per dose:
- 5 in control group
10 in test group - Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamaldehyde
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- only vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- only vehicle
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- induction with 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- induction with 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- induction with 5 % in PEG 400
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- induction with 5 % in PEG 400
- No. with + reactions:
- 7
- Total no. in group:
- 10
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified within the CLP Regulation (EC 1272/2008)
- Conclusions:
- Not skin sensitizer.
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