Registration Dossier
Registration Dossier
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EC number: 200-941-9 | CAS number: 76-19-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Justification for type of information:
- Saturated perfluorocarbons as a class have near identical toxicological properties.
Note that the tox. testing dates from the '80s, pre-dating concerns about animal testing.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Testing pre-dates LLNA
Test material
- Reference substance name:
- Perfluoroperhydrophenanthrene
- EC Number:
- 400-470-0
- EC Name:
- Perfluoroperhydrophenanthrene
- Cas Number:
- 306-91-2
- Molecular formula:
- C14F24
- IUPAC Name:
- 1,1,2,2,3,3,4,4,4a,4b,5,5,6,6,7,7,8,8,8a,9,9,10,10,10a-Tetracosafluorophenanthrene
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Housed in suspended cages, free access to water and vitamen-c enriched FDI, hay given weekly. Temperature was ca. 21degC, humidity 30 to 70%.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 75%
- Day(s)/duration:
- 7
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Neat
- Day(s)/duration:
- 2 (48 hours)
- Adequacy of induction:
- highest technically applicable concentration used
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 20% anterior and 10% posterior
- Day(s)/duration:
- 1 (24 hours)
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 20
- Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20% and 10%
- No. with + reactions:
- 11
- Total no. in group:
- 20
- Clinical observations:
- Slight odema only
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- Slight odema only
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20% and 10%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- Slight odema only
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- Slight odema only
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- other: No positive control
- Hours after challenge:
- 0
- Group:
- positive control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Clinical observations:
- None
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Conclusions:
- From this and other similar testing we can be confident saturated perfluorocarbons do not cause skin sensitisation.
- Executive summary:
From this and other similar testing we can be confident saturated perfluorocarbons do not cause skin sensitisation.
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