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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

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)
Deviations:
yes
Remarks:
summary only, lacking detail
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4-methylstyrene
EC Number:
210-762-8
EC Name:
4-methylstyrene
Cas Number:
622-97-9
Molecular formula:
C9H10
IUPAC Name:
1-methyl-4-vinylbenzene
Test material form:
liquid
Details on test material:
- Name as cited in study report: MCTR-243-77

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
New Zealand White rabbits weighing 2.00 to 2.25 kg.


Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL instilled in to right eye. Left eye served as untreated control. Not stated if wash out performed.
Duration of treatment / exposure:
Once only. Not stated if washout performed.
Observation period (in vivo):
Observed at 1, 24, 48 and 72 hours and 4 and 7 days.
Number of animals or in vitro replicates:
3 male and 3 female
Details on study design:
Signs of ulceration of the cornea, corneal opacity, conjunctivitis, iris irritation, chemosis, tearing and refuse color were recorded.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: All
Time point:
24/48/72 h
Remarks on result:
other: information not available
Irritation parameter:
iris score
Basis:
animal: All
Time point:
24/48/72 h
Remarks on result:
other: information not available
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal: All
Time point:
24/48/72 h
Remarks on result:
other: information not available
Irritation parameter:
iris score
Basis:
mean
Time point:
7 d
Score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
7 d
Score:
0
Irritation parameter:
chemosis score
Basis:
animal: All
Time point:
24/48/72 h
Remarks on result:
other: information not available
Irritant / corrosive response data:
Immediate responses following ocular instillation – All of the rabbits closed the treated eye and preened themselves when returned to their cage. Within five minutes after instillation the rabbits had the right treated eye open. One rabbit vocalized for a few seconds when put back into its cage.

Any other information on results incl. tables

Mean Eye irritation scores for each rabbit:

Rabbit N

Mean of Score at 24, 48 and 72 Hours

Corneal Opacity

Iris Lesion

Conjunctivae

Chemosis

Erythema

Discharge

1

0

0

0

0

0.33

2

0

0

0

1

0.66

3

0

0

0

0.33

0

4

0

0

0

0

0

5

0

0

0

1

0

6

0

0

0

0.33

0.33

Applicant's summary and conclusion

Conclusions:
Under the study conditions, there were signs of immediate discomfort (closing of eye, vocalisation) and slight chemosis, erythema and discharge, However, the maximum scores given were 1 and all signs were reversible within 7 d.
Executive summary:

A study was conducted to determine the eye irritation potential of the test substance in rabbit following a single ocular exposure according to Federal Hazardous Substances Act, September 27, 1973. Three male and 3 female New Zealand White rabbits were exposed to 0.1 mL of the test substance instilled into the right eye. It was not stated whether a wash out was performed. Under the study conditions, there were signs of immediate discomfort (closing of eye, vocalisation) and slight chemosis, erythema and discharge, However, the maximum scores given were 1 and all signs were reversible within 7 d (Adamik, 1977).