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Diss Factsheets

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:
1999
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

Constituent 1
Chemical structure
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

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.