Registration Dossier
Registration Dossier
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EC number: 947-389-1 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- (+)-trans-2-methoxycyclohexan-1-ol
- Cas Number:
- 7429-40-5
- Molecular formula:
- C7H14O2
- IUPAC Name:
- (+)-trans-2-methoxycyclohexan-1-ol
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, FRG
- Age at study initiation: young adult animals
- Weight at study initiation: 2.75 - 3.34 kg
- Housing: single housing (stainless steel wire mesh cage)
- Diet (e.g. ad libitum): about 130 g per animal per day (Kliba-Labordiaet, Lingentalmuehle AG, Kaiseraugst, Switzerland)
- Water (e.g. ad libitum): abour 250 ml tap water per animal per day
- Acclimation period:at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light):12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- animal 1: 15 days
animal 2 + 3: 14 days - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): the substance was washed out with tap water about 24 hours after application ony by the animals 2 and 3
- Time after start of exposure: 24 h
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 15 or 14 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 15 or 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.2
- Reversibility:
- fully reversible within: 15 or 14 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 15 or 14 days
Any other information on results incl. tables
Readings |
Animal |
Corneal opacity |
Iris |
Conjunctiva erythema |
Conjunctiva edema |
Symptoms |
1 h |
1 |
0 |
0 |
2 |
2 |
|
2 |
1 |
1 |
2 |
3 |
PC, DB |
|
3 |
1 |
1 |
2 |
3 |
DB |
|
24 h |
1 |
1 |
1 |
3 |
2 |
S, PC |
2 |
1 |
1 |
2 |
2 |
PC, DB |
|
3 |
1 |
1 |
2 |
2 |
PD, DB |
|
48 h |
1 |
1 |
1 |
2 |
2 |
S, PC, DB, LC |
2 |
1 |
1 |
2 |
2 |
PC, DB |
|
3 |
1 |
1 |
2 |
2 |
PC, DB |
|
72 h |
1 |
1 |
1 |
2 |
2 |
S, PC, DB, LC |
2 |
1 |
1 |
2 |
2 |
PC |
|
3 |
1 |
1 |
3 |
2 |
SR, S, PC, DB |
|
8 d |
1 |
0 |
0 |
1 |
1 |
S |
2 |
1 |
0 |
0 |
0 |
PC, MV |
|
3 |
1 |
1 |
2 |
1 |
SR, PC, MV |
|
15 d |
1 |
0 |
0 |
0 |
0 |
|
2 |
0 |
0 |
0 |
0 |
|
|
3 |
0 |
0 |
0 |
0 |
|
|
Mean |
1 |
1.0 |
1.0 |
2.3 |
2.0 |
|
2 |
1.0 |
1.0 |
2.0 |
2.0 |
|
|
3 |
1.0 |
1.0 |
2.3 |
2.0 |
|
|
Mean |
|
1.0 |
1.0 |
2.2 |
2.0 |
|
SR: small retractions in the eyelids
S: suppuration
PC: pupil contracted
MV: marginal vasularization of the cornea
DB: Discharge of blood
LC: loss of corneal tissue
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the test conditions chosen and considering the described findings trans-2-methoxycyclohexanol (Rac.) gives indication of an irritant property to the eye.
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