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Diss Factsheets

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:
June 1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report date:
1984

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3,3,5-trimethylcyclohexyl methacrylate
EC Number:
231-927-0
EC Name:
3,3,5-trimethylcyclohexyl methacrylate
Cas Number:
7779-31-9
Molecular formula:
C13H22O2
IUPAC Name:
3,3,5-trimethylcyclohexyl 2-methylprop-2-enoate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf, Switzerland
- Age at study initiation: 12/13 weeks
- Weight at study initiation: 2.1-2.5 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2
- Humidity (%): 55+/-10
- Air changes (per hr): 10/15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
1, 24, 48 and 72 hours after administration
Number of animals or in vitro replicates:
2 females and 1 male
Details on study design:
A single dose was administered to the left eye of each animal. The right eye remained untreated and was used as the reference control. The application volume was 0.1 ml per animal.
For observation, the eye were not rinsed.

OBSERVATIONS :
-viability : daily
-Body weight : pre-test, day 1 and at the termination of test
-Eye reaction: 1h, 24h, 48h and 72h after administration

The study was terminated 72 hours after administration of the test article.
All rabbits were killed at the end of the observation period.
No macroscopic organ examination was performed.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No corrosion of the cornea was observed at each of the measuring intervals.
After 1h of administration, some effects were observed on the conjunctivae (slight reddened) in 3 rabbits and on the slera (clear visible vessels) on 2 rabbits.
No effect on cornea opacity, iris, conjunctivae (redness and chemosis) were observed in all the rabbits after 24h of administration.
In the area of application, no discoloration of the corea and conjunctivae which could be related to effects of the test article was observed.
Other effects:
No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.
The body weight gain of all rabbits was similar.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
not eye irritating
Conclusions:
Based on these results, 3,3,5 -trimethylcyclohexyl-methacrylate is considered to be not irritating to the eye of rabbit.
Executive summary:

The purpose of this primary eye irritation study was to assess possible irritation potential when single doses of 3,3,5 -trimethylcyclohexyl methacrylate are placed in the conjunctival sac of rabbit eyes.

Under the conditions of this experiment, 3,3,5 -trimethylcyclohexyl methacrylate was found to cause a primary irritation score of 0.3 when applied to the rabbit eye mucosa.

In the area of application, no discoloration of the cornea and conjunctivae was observed which could be related to effects of the test article. No corrosion was observed a each measuring intervals. Mean individual score at 24, 48 and 72h after administration was 0 for cornea opacity, iris, conjunctivae (redness and chemosis) in all the rabbits.

Based on these results, 3,3,5 -trimethylcyclohexyl methacrylate is considered to be not irritating to the eye of rabbit.