Registration Dossier
Registration Dossier
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EC number: 429-040-0 | CAS number: 272460-97-6
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)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- other: Not specified - from "429-04-0_endpoints_PV512082-22" provided by ECHA
- Justification for non-LLNA method:
- From "429-04-0_endpoints_PV512082-22" provided by ECHA
Test material
- Reference substance name:
- -
- EC Number:
- 429-040-0
- EC Name:
- -
- Cas Number:
- 272460-97-6
- Molecular formula:
- C30H26O4S2
- IUPAC Name:
- 1-{4-[(4-benzoylphenyl)sulfanyl]phenyl}-2-methyl-2-(4-methylbenzenesulfonyl)propan-1-one
- Test material form:
- solid
- Details on test material:
- Nature of substance: ESACURE 1001
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- other: at 2.5% in cottonseed oil and in FCA.
- Concentration / amount:
- 0.1 mL/injection site of test material
Challenge
- Route:
- intradermal
- Concentration / amount:
- In booster. 0.3 mL/patch of test material at 25% in acetone.
Concentration of test material and vehicle used for each challenge:
0.2 mL/patch of test material at 25% in acetone
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 20
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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