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Toxicological information

Eye irritation

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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:
1998
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

Constituent 1
Chemical structure
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

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.