Registration Dossier
Registration Dossier
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EC number: 604-569-1 | CAS number: 147126-62-3
Skin irritation / corrosion
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:
- 2 004
- 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
- Reference substance name:
- OS Menthol Ester
- IUPAC Name:
- OS Menthol Ester
- 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
- 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
Constituent 1
Constituent 2
Constituent 3
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.
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