tert-butyl methacrylate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1994-01-24 until 1994-02-07

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference 1

Reference Type:

other: amendment to study report

Title:

Unnamed

Year:

1995

Report date:

1995

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

tert-butyl methacrylate

EC Number:

209-548-7

EC Name:

tert-butyl methacrylate

Cas Number:

585-07-9

Molecular formula:

C8H14O2

IUPAC Name:

tert-butyl 2-methylprop-2-enoate

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source (supplier): BASF
- LOT number of test material: LAB.-J.-NO. 387
- Purity: not specified

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Refrigerator, exclusion of light
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions and during storage: The stability of the test substance over the study period was proved by reanalysis. The result was reported in the form of an amendment (12 January 1995). According to the analytical determination, dated December 07, the test substance was stable over the study period. The sample appeared to be homogeneous.

FORM AS APPLIED IN THE TEST
- The unchanged test substance was applicated once to the conjunctival sac of the right eyelid of the test animals.

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach/Main, Germany
- Age at study initiation: young adult (not further specified)
- Weight at study initiation: 3.67 - 4.37 kg
- Housing: single housing
- Diet: Kliba Labordiaet 341, Klingenthalmuehle AG, Kauseraugst, Switzerland, about 130 g per animal per day
- Water: about 250 ml tap water per animal per day
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 20-24°C
- Humidity: 30-70%
- Air changes (per hr): not specified
- Photoperiod:12 H/12 H (6.00 a.m.- 6.00 p.m./6.00 p.m. - 6.00 a.m.)

IN-LIFE DATES: not specified

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of each tested animal

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Duration of treatment / exposure:

unwashed

Observation period (in vivo):

8 days

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: The substance was not washed out.

SCORING SYSTEM: Draize scoring (for more details please refer to "Any other information on materials and methods incl. tables")

TOOL USED TO ASSESS SCORE: not specified

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

mean

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

cornea opacity score

Remarks:

mean

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

cornea opacity score

Remarks:

mean

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

iris score

Remarks:

mean

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

iris score

Remarks:

mean

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

iris score

Remarks:

mean

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

conjunctivae score

Remarks:

mean

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 8 days

Remarks on result:

positive indication of irritation

Results 8

Irritation parameter:

conjunctivae score

Remarks:

mean

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Results 9

Irritation parameter:

conjunctivae score

Remarks:

mean

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 8 days

Remarks on result:

positive indication of irritation

Results 10

Irritation parameter:

chemosis score

Remarks:

mean

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 11

Irritation parameter:

chemosis score

Remarks:

mean

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 12

Irritation parameter:

chemosis score

Remarks:

mean

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The numerical scores awarded to the eye reactions elicited by the test substance are given in Table 1.

Any other information on results incl. tables

Table 1: TABULATION OF IRRITANT RESPONSE DATA FOR EACH INDIVIDUAL ANIMAL AT EACH OBSERVATION TIME AS WELL AS CALCULATION OF THE MEANS.

Animal	Reading	Opacity	Iritis	Redness	Chemosis	Symptoms
1	1 h	0	0	2	1	discharge score 3; small retractions of the eye lids
2	1 h	0	0	0	0
3	1 h	0	0	1	0	discharge score 1
1	24 h	0	0	2	0	small retractions of the eye lids
2	24 h	0	0	0	0
3	24 h	0	0	2	1	discharge score 1
1	48 h	0	0	2	0	small retractions of the eye lids
2	48 h	0	0	0	0
3	48 h	0	0	2	0	discharge score 1
1	72 h	0	0	2	0	small retractions of the eye lids
2	72 h	0	0	0	0
3	72 h	0	0	2	0	discharge score 1
1	8 d	0	0	0	0
2	8 d	0	0	0	0
3	8 d	0	0	0	0
mean	24 - 72 h	0.00	0.00	1.33	0.11

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

Under the test conditions chosen and considering the described findings the test substance does give indication of an irritant property to the eye.

Executive summary:

The potential of the test substance to cause damage to the conjunctiva, iris or cornea was assessed according to a OECD TG 405 conform and GLP compliant study. The unchanged test substance was applicated once to the conjunctival sac of the right eyelid of three white Vienna rabbits. Exposure to the test susbstance produced conjunctival redness in 2/3 animals by all scoring intervals (24, 48 and 72 hours). One animal showed chemosis by the 24-hour scoring interval. The findings were reversible in all animals within 8 days after application. Under the test conditions chosen and considering the described findings the test substance does give indication of an irritant property to the eye.