Registration Dossier
Registration Dossier
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EC number: 445-510-8 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V B.6
- GLP compliance:
- yes
- Type of study:
- not specified
- Justification for non-LLNA method:
- not available
Test material
- Reference substance name:
- -
- EC Number:
- 445-510-8
- EC Name:
- -
- Molecular formula:
- C26H32O4
- IUPAC Name:
- Reaction mass of 2-hydroxy-1-{3-[4-(2-hydroxy-2-methylpropanoyl)phenyl]-1,1,3-trimethyl-2,3-dihydro-1H-inden-5-yl}-2-methylpropan-1-one and 2-hydroxy-1-{1-[4-(2-hydroxy-2-methylpropanoyl)phenyl]-1,3,3-trimethyl-2,3-dihydro-1H-inden-5-yl}-2-methylpropan-1-one
Constituent 1
In vivo test system
Test animals
- Species:
- other: Albino Hartley Guinea pig
Study design: in vivo (non-LLNA)
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 15%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 15%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- 14
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 15 % Signs of irritation during induction: Slight erythema (topical induction) was observed during epicutaneous applications Evidence of sensitisation of each challenge concentration: No evidence on sensititation was noted
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
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