Registration Dossier
Registration Dossier
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EC number: 202-642-9 | CAS number: 98-15-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 22.10.1991 - 22.11.1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- Number of animals
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study preformed in 1991
Test material
- Reference substance name:
- 3-chloro-α,α,α-trifluorotoluene
- EC Number:
- 202-642-9
- EC Name:
- 3-chloro-α,α,α-trifluorotoluene
- Cas Number:
- 98-15-7
- Molecular formula:
- C7H4ClF3
- IUPAC Name:
- 1-chloro-3-(trifluoromethyl)benzene
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright-White
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Guinea pig, strain: Pirbright-White
- Source: Hoechst AG, Kastengrund, SPF-Zucht
- Weight at study initiation: mean 325 g
- 15 ( female)
ENVIRONMENTAL CONDITIONS
- Diet: Altromin 3112 Haltungsdiät - für Meerschweinchen, Altromin-GmbH, Lage/Lippe, ad libitum
- Water: tap water (ad libitum)
- Temperature: 22 °C +/- 3 °C
- Humidity: 55 % +/- 20 %
- Photoperiod (hrs dark / hrs light): 12 / 12
- Acclimation: > 5 days
- Housing: 5 animal per cage
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 1 %
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0,5 ml
- Day(s)/duration:
- 48 hours
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0,5 ml
- Day(s)/duration:
- 24 hours
- No. of animals per dose:
- 10 (dose group)
5 (control group)
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No positive reactions were observed.
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not sensitizing.
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