p-tert-butylstyrene

Eye irritation

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:

guideline study with acceptable restrictions

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

Test material information

Constituent 1

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-ethenyl-4-methylbenzene

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

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Results 6

Irritation parameter:

cornea opacity score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 7

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Results 8

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Results 9

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Results 10

Irritation parameter:

iris score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Results 11

Irritation parameter:

iris score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Results 12

Irritation parameter:

iris score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

fully reversible

Results 13

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 14

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 15

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 16

Irritation parameter:

chemosis score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 17

Irritation parameter:

chemosis score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 18

Irritation parameter:

chemosis score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 19

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

2

Reversibility:

not specified

Results 20

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.66

Max. score:

4

Reversibility:

not specified

Results 21

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Results 22

Irritation parameter:

conjunctivae score

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Results 23

Irritation parameter:

conjunctivae score

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

Results 24

Irritation parameter:

conjunctivae score

Basis:

animal #6

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

fully reversible

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).