Registration Dossier
Registration Dossier
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EC number: 406-850-2 | CAS number: 133855-98-8 BAS 480 F
Endpoint summary
Administrative data
Description of key information
Epoxiconazole was not found to be a skin sensitizer under the conditions of Guinea Pig Maximisation Test.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- 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.
- 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 - 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 - 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.
- 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
- Positive control results:
- not applicable
- 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
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
The available data on sensitisation do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
