Registration Dossier
Registration Dossier
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EC number: 406-850-2 | CAS number: 133855-98-8 BAS 480 F
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jul - Aug 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- May, 1981
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- LLNA method had not been implemeted at the time of conduction of the study.
Test material
- Reference substance name:
- (2RS,3RS)-3-(2-chlorophenyl)-2-(4-fluorophenyl)-[(1H-1,2,4-triazol-1-yl)methyl]oxirane
- EC Number:
- 406-850-2
- EC Name:
- (2RS,3RS)-3-(2-chlorophenyl)-2-(4-fluorophenyl)-[(1H-1,2,4-triazol-1-yl)methyl]oxirane
- Cas Number:
- 133855-98-8
- Molecular formula:
- C17 H13 Cl F N3 O
- IUPAC Name:
- 1-{[(2R,3R)-3-(2-chlorophenyl)-2-(4-fluorophenyl)oxiran-2-yl]methyl}-1H-1,2,4-triazole
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source: BASF AG, Ludwigshafen, Germany
- Lot/batch number of test material: N 73
- Purity: 95.12%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: The stability of the test substance in aqua dest. over 24 h was confirmed
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht, Hagemann GmbH & Co. KG, 4923 Extertal 1, FRG
- Age at study initiation: not specified
- Weight at study initiation: 251- 306 g
- Housing: groups of 5
- Diet: ad libitum
- Water: ad libitum, about 2 g of ascorbic acid per 10 l water was added to the drinking water twice a week
- Acclimation period: at least 8 days
- Indication of any skin lesions:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 3070
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 5% in aqua dest. resp. in Freund's adjuvant/aqua dest. (1:1)
- Route:
- other: percutaneous
- Vehicle:
- water
- Concentration / amount:
- 50% in aqua dest.
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25% in aqua dest.
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25% in aqua dest.
- No. of animals per dose:
- control group: 10, test group: 20
- Details on study design:
- RANGE FINDING TESTS: Pretest
In the preliminary test after two 24-h percutaneous occlusive applications within 96 hours up to 50% test substance preparations in aqua dest. (Higher concentrations could not be prepared) no irritant concontration was found.
Applicability: it was possible to inject a 5% test substance preparation in aqua dest. resp. in Freund's adjuvant/aqua dost. (1 : 1) with a syringe.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 6 intradermal injections in groups of two per animal, and 1 percutaneous
- Exposure period: 48 h
- Test groups: TS, Ts+FCA, FCA
- Control group: FCA, FCA+V, V
- Site: shoulder
- Frequency of applications: 0 (id), 0 (perc.)
- Duration: 0-7 d
- Concentrations: 5%, 50%
B. CHALLENGE EXPOSURE
- No. of exposures: 2
- Day(s) of challenge: 21
- Exposure period: 24 h
- Test groups: TS
- Control group: TS
- Site: flank
- Concentrations: 25%
- Evaluation (hr after challenge): 24, 48, and 72 h
- Positive control substance(s):
- not required
Results and discussion
- Positive control results:
- not applicable
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- other: 1st and 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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