Registration Dossier
Registration Dossier
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EC number: 207-274-2 | CAS number: 457-68-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Strating material and the final product which are of very similar structure and functionality are not sensitising.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- patch test
Test material
- Reference substance name:
- Bis(4-fluorophenyl) ketone
- EC Number:
- 206-466-3
- EC Name:
- Bis(4-fluorophenyl) ketone
- Cas Number:
- 345-92-6
- IUPAC Name:
- bis(4-fluorophenyl)methanone
- Details on test material:
- BDF is the final product produced from difluorodiphenly methane and only difference being thje removal of a methyl group for a ketone.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: spf:-derived albino strain
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: DMF
- Concentration / amount:
- 10%, 1% & 0.1%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: DMF
- Concentration / amount:
- 10%, 1% & 0.1%
- No. of animals per dose:
- Unknown
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 3
- Clinical observations:
- No erythematous reactions.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 3.0. Clinical observations: No erythematous reactions..
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- We have classified this material as not sensiting due to our extensive experience in handling this substance and the animal testing completed on a very similar chemical.
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