Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26.08.2004 to 21.09.2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed according to the OECD guideline 404 and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
OS Menthol Ester
IUPAC Name:
OS Menthol Ester
Constituent 2
Chemical structure
Reference substance name:
(1R,2S,5R)-2-isopropyl-5-methylcyclohexyl (2R,5R)-5-hydroxy-1,3-oxathiolane-2-carboxylate
EC Number:
604-569-1
Cas Number:
147126-62-3
Molecular formula:
C14H24O4S
IUPAC Name:
(1R,2S,5R)-2-isopropyl-5-methylcyclohexyl (2R,5R)-5-hydroxy-1,3-oxathiolane-2-carboxylate
Constituent 3
Reference substance name:
(2R, 5R)-5-Hydroxy-[1,3]oxathiolane-2- carboxylic acid, 2S-isopropyl-5R-methyl-1Rcyclohexyl ester
IUPAC Name:
(2R, 5R)-5-Hydroxy-[1,3]oxathiolane-2- carboxylic acid, 2S-isopropyl-5R-methyl-1Rcyclohexyl ester
Test material form:
solid: compact

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
- Age at study initiation: X days (at study initiation / at test item administration)
- Weight at study initiation: males > 2 kg, females > 2 kg
- Fasting period before study:
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 14 days
- Temperature (°C): 20°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Preparation of test site:
clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
- Amount(s) applied: 0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours
Number of animals:
3 (Fermale)
Details on study design:
- Area of exposure: 6 cm2
- Type of wrap if used: Rubber dam

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
PRIMARY IRRITATION INDEX (PII): Cumulative Total+ (3 Test Sites X 4 Scoring Intervals): 1.6 RESPONSE CATEGORY: Slight

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the forgoing results, the test article, OS Menthol Ester, was found to be a slight dermal irritant.