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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
Study period:
1977-03-11
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is considered to be a reliability 2 since it predates GLP but is similar to OECD TG 405.
Justification for type of information:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
α-methylcyclohexylmethyl acetate
EC Number:
236-798-4
EC Name:
α-methylcyclohexylmethyl acetate
Cas Number:
13487-27-9
Molecular formula:
C10H18O2
IUPAC Name:
α-methylcyclohexylmethyl acetate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: One eye of each animal remained untreated and served as the reference control.
Amount / concentration applied:
Amount applied: 0.1 mL
Duration of treatment / exposure:
Single instillation on Day 1
Observation period (in vivo):
at least one week
Number of animals or in vitro replicates:
6 animals
Details on study design:
STUDY DESIGN
The test material was applied undiluted in 6 animals.

TREATMENT
Similar to OECD 405. The test substance is placed in the conjunctival sac of one eye of each animal after gently pulling the lower lid away from the eyeball. The lids are then gently held together for about one second. The other eye serves at control.

OBSERVATIONS
The eyes of each animal were examined approximately 1, 24, 48 and 72 hours and 5, and 7 days after instillation of the test substance. The irritation scores and a description of all other (local) effects were recorded.

SCORING SYSTEM:
Eye irritation was scored according to Draize at al., 1944.
Cornea score: Opacity (max score 4) x Area of cornea involved (max score 4) x 5 = maximum score of 80
Iris score: iris lesion (max score 2) x 5 = maximum score of 10
Conjunctiva score: (Redness (max score 3) + Chemosis (max score 4) + Discharge (max score 3) x 2 = maximum score of 20

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean 24, 48, and 72 hours
Score:
1.67
Max. score:
80
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: Score according to Draize et al., 1944. average scores 24h, 48h and 72h were 5, 0, and 0, respectively
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean 24, 48, and 72 hours
Score:
0
Max. score:
10
Remarks on result:
other: Score according to Draize et al., 1944
Irritation parameter:
conjunctivae score
Remarks:
redness, chemosis and discharge
Basis:
mean
Time point:
other: mean 24, 48, and 72 hours
Score:
4.33
Max. score:
20
Reversibility:
fully reversible within: 5 days
Remarks on result:
other: Score according to Draize et al., 1944. average scores 24h, 48h and 72h were 8.67, 2.33, and 2, respectively
Irritant / corrosive response data:
Immediate: discomfort was moderate with eyes tightly closed.
10 min: Slight erythema, copious discharges.
1 hr.: Slight erythema, copious discharges.
24 hr.: Areas of barely perceptible corneal dullness, slight to moderate erythema, copious discharge.
48-72 hr.:Gradual improvement.
120 hr.: All scored zero.

Any other information on results incl. tables

Ocular Irritant response data (for the undiluted test substance)

 

Time after administration

 

1 hour

24 hours

48 hours

72 hours

Animal

1

2

3

4

5

6

1

2

3

4

5

6

1

2

3

4

5

6

1

2

3

4

5

6

Cornea score

0

0

0

0

0

0

5

5

5

5

5

5

0

0

0

0

0

0

0

0

0

0

0

0

Iris score

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Conjunctivae score (redness, chemosis and discharge

8

8

8

8

8

8

10

10

8

8

8

8

4

2

2

2

2

2

2

2

2

2

2

2

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Remarks:
according to CLP Regulation (EC) 1272/2008
Conclusions:
In a skin irritation study with rabbits, performed similar to OECD 404, slight irritation was observed, which was fully reversible within 5 days. Based on the results of this study, the substance is considered to be not irritating to skin
Executive summary:

The substance was tested in an eye irritation test similar to OECD 405. 0.1 mL undiluted test substance was placed in the conjuctival sac of 6 new Zealand white rabbits. The effects were scored 1, 24, 48, 72, 120, and 168 hours after application according to Draize et al., 1944. No effects on the iris were observed. The cornea score was 5 out of 80 for all animals at the 24 hour time point and was fully reversible within 48 hours. The conjunctivae scores after 24h, 48h and 72h were 8.67, 2.33, and 2 out of 20, respectively. The effects on the conjunctivae were reversible within 5 days. Under the conditions of the test, the substance is not eye irritating.

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