Registration Dossier
Registration Dossier
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EC number: 616-586-1 | CAS number: 78068-85-6
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 2-chloro-1-fluoro-4-(trifluoromethyl)benzene
- EC Number:
- 616-586-1
- Cas Number:
- 78068-85-6
- Molecular formula:
- C7H3ClF4
- IUPAC Name:
- 2-chloro-1-fluoro-4-(trifluoromethyl)benzene
- Reference substance name:
- 1-Chloro-2-fluoro-4-(trifluoromethyl)benzene
- Cas Number:
- 32137-20-5
- Molecular formula:
- C7H3ClF4
- IUPAC Name:
- 1-Chloro-2-fluoro-4-(trifluoromethyl)benzene
- Test material form:
- liquid
Constituent 1
impurity 1
- Specific details on test material used for the study:
- Purity: 89.5 % [a/a]
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Mol:DHegaard) (Moell
- Sex:
- female
- Details on test animals and environmental conditions:
- Origin of test animals: M&B A/S, P.O. box 1079, DK-8680 Ry, Denmark
Body weight at the start of study: 294-353 g, mean 320.7 g, S.D. +/- 17.0 g
Acclimatization: at least seven days
Food: ssniff® R/M-H, ad libitum
Photoperiod: 12 hours light / dark cycle
Relative humidity: 50 ± 20 %
Water: tap water in plastic bottles, ad libitum
Animal maintenance: in transparent macrolon® cages (type IV) on soft wood granulate in an air-conditioned room, 5 animals per cage
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Sesame oil
- Concentration / amount:
- 5 %
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 mL of undiluted test substance
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 mL of undiluted test substance
- No. of animals per dose:
- Control group: 5
Treatment group: 10 - Positive control substance(s):
- yes
- Remarks:
- alpha-Hexylcinnamaldehyde
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Hours after challenge:
- 48
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 10
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study 3-chloro-4-fluorobenzotrifluoride showed no evidence for sensitizing properties.
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