Registration Dossier
Registration Dossier
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EC number: 604-569-1 | CAS number: 147126-62-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26.06.2006 to 23.10.2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed according to the OECD guideline 405 and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye 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
- Test material form:
- other: White solid
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Approx. 4.5 months at test item administration
- Weight at study initiation: males 2.1 - 2.6 kg
- Housing: individually or X animals/cage
- Diet: ad libitum before and after the exposure period.
- Water: ad libitum before and after the exposure period.
- Acclimation period: 20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 08.08.2006 To: 13.09.2006
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye, which remained untreated, served as a control.
- Amount / concentration applied:
- 100 mg Menthyloxathiolane
- Duration of treatment / exposure:
- 100 mg of the test item per eye were administered and tested in three animals. In 2 of the 3 animals a washout with 20 mL aqueous NaCl solution was carried out
24 hours after instillation. - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: In 2 of the 3 animals a washout with 20 mL aqueous NaCl solution was carried out2.
- Time after start of exposure: 24 hours
TOOL USED TO ASSESS SCORE: The eyes were examined ophthalmoscopically with a slit lamp prior to the administration and 1, 24, 48, 72 hours and 4 to 15 days after the administration. 24 hours, 7 and 14 days after administration the eyes were treated additionally with fluorescein3 and examined.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24h to 5d
- Score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24h to 5d an after 14d
- Score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24h to 5d
- Score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24h and 4d
- Score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24h and 48h
- Score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24h
- Score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1h, 24h, 48h, 7d
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 1h, 24h, 4d, 5d, 10d
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 1h, 5d
- Score:
- 1
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 1h, 24h, 4d, 5d, 6d
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 1h, 24h, 48h, 4d, 5d, 6d
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not specified
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 1h, 24h, 48h, 4d, 5d
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not specified
- Irritant / corrosive response data:
- An irritation index was not determined due to the corrosive effects observed.
Applicant's summary and conclusion
- Interpretation of results:
- Category II
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Corneal opacity (grade 1) was observed in all animals24 hours to 5 days after instillation, in animal no. 2 until 14 days after instillation.
Irritation of the iris (grade 1) was observed in all animals 24 hours after instillation, in animal no. 2 until 48 hours and in animal no. 1 until 4 days
after instillation.
Conjunctival redness was observed in all animals.
- animal no. 1: 24 hours (grade 2), 1 hour and 48 hours to 7 days (grade 1) after instillation;
- animal no. 2: 24 hours to 4 days (grade 2), 1 hour and 5 to 10 days (grade 1) after instillation;
- animal no. 3: 1 hour to 5 days (grade 1) after instillation.
Chemosis was observed in all animals:
- animal no. 1: 24 hours to 4 days (grade 2), 1 hour, 5 and 6 days (grade 1) after instillation;
- animal no. 2: 24 hours (grade 3), 48 hours to 4 days (grade 2), 1 hour, 5 and 6 days (grade 1) after instillation;
- animal no. 3: 24 hours (grade 3), 1 hour and 48 hours to 4 days (grade 2) and 5 days (grade 1) after instillation. - Executive summary:
Based on the above described findings the substance is considered to be irritating to the eyes under the conditions of this study.
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