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Registration Dossier
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EC number: 443-400-4 | CAS number: -
Toxicological information
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Performed in a GLP laboratory, not performed in accordance with OECD or EU test guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4100 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- -
- EC Number:
- 443-400-4
- EC Name:
- -
- Cas Number:
- 181696-73-1
- Molecular formula:
- C16H15NO2
- IUPAC Name:
- 4,5-Dihydro-5-methyl-3,4-diphenyl-5-isoxazolol
- Test material form:
- other: White solid
- Details on test material:
- - Name of test material (as cited in study report): SC-66285
- Physical state: White solid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Crl:(HA)BR/Charles River Laboratories, Inc.
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc., Portage, Michigan
- Age at study initiation: Young adult
- Weight at study initiation: 350 - 550 g
- Housing: Individually, in suspended, stainless steel cages
- Diet (e.g. ad libitum): Guinea Pig Diet #5026 (PMI Feeds, Inc.) ad libitum.
- Water: Ad Ii bi tum:
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-26°C
- Humidity (%): of 50% ±20%
- Photoperiod (hrs dark / hrs light): 12-hour light/Iz-hour dark cycle.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Sterile water, mineral oil, FCA, w/v suspension of hexylcinnamaldehyde in mineral oil and suspension of hexylcinnamaldehyde in 1: 1 FCA in sterile water.
- Concentration / amount:
- 5% (W/V) per intradermal injection.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Sterile water, mineral oil, FCA, w/v suspension of hexylcinnamaldehyde in mineral oil and suspension of hexylcinnamaldehyde in 1: 1 FCA in sterile water.
- Concentration / amount:
- 5% (W/V) per intradermal injection.
- No. of animals per dose:
- Five animals for test group 1 and 10 animals for test group 2.
- Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 per animal.
- Exposure period: 48 hours
- Test groups: 2
- Control group: yes, 10 males.
- Site: Anterior, medial and posterior sites
- Frequency of applications: single treatment
- Duration: 48 hours
- Concentrations: 5% w/v suspension of test material
B. CHALLENGE EXPOSURE
- No. of exposures: one per test animal
- Day(s) of challenge: Day 22
- Exposure period: 24 hours
- Site: Left side of each animal
- Concentrations: 25% w/w mixture of test material in petrolatum or the control material (petrolatum).
- Evaluation (hr after challenge): 24 hours - Challenge controls:
- Petrolatum
- Positive control substance(s):
- yes
- Remarks:
- hexylcinnamaldehyde
Results and discussion
- Positive control results:
- Based on these results, hexylcinnamaldehyde is considered to be an extreme dermal sensitizer in guinea pigs when tested by the Magnusson and Kligman maximization assay.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% (w/w)
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% (w/w). No with. + reactions: 1.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% (w/w)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% (w/w). No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: None.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0% test substance, 100% Petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0% test substance, 100% Petrolatum. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0% test substance, 100% Petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0% test substance, 100% Petrolatum. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- Based on the findings in this study, relative to those observed historically with a known sensitizer, SC-66285 is considered to be a weak dermal sensitizer in guinea pigs when tested by the Magnusson and Kligman maximization assay.
- Executive summary:
SC-66285 is considered to be a weak dermal sensitizer in guinea pigs when tested by the Magnusson and Kligman maximization assay.
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