Butyl methacrylate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Butyl methacrylate

EC Number:

202-615-1

EC Name:

Butyl methacrylate

Cas Number:

97-88-1

Molecular formula:

C8H14O2

IUPAC Name:

butyl methacrylate

Details on test material:

- Name of test material (as cited in study report): n-butylmethacrylat
- Physical state: liquid
- Analytical purity: 99.8%, stabilized with 100 ppm hydroquinonemonomethylether
- Impurities (identity and concentrations): no data
- Purity test date: no data
- Lot/batch No.: no data

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Lippische Versuchstierzucht, Hagemall GmbH & Co. KG
- Age at study initiation: 8-10 W
- Weight at study initiation: no data
- Housing: individually
- Diet (e.g. ad libitum): mümmel z, ssniff/Soest
- Water (e.g. ad libitum): tap water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 2
- Humidity (%): 40 - 50
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

Amount applied: 0.1 ml

Duration of treatment / exposure:

The test eyes were not washed out following the instillation

Observation period (in vivo):

1, 24, 48 and 72 hours as well as 8 days 

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3

Time point:

other: mean 24+48+72 h

Score:

0

Max. score:

4

Remarks on result:

other: Observation time: 8 days

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3

Time point:

other: mean 24+48+72 h

Score:

0

Max. score:

2

Remarks on result:

other: Observation time: 8 days

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #3

Time point:

other: mean 24+48+72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: Observation time: 8 days

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: mean 24+48+72 h

Score:

0

Max. score:

4

Remarks on result:

other: Observation time: 8 days

Results 5

Irritation parameter:

chemosis score

Basis:

animal: #1, #2

Time point:

other: mean 24+48+72 h

Score:

0

Max. score:

4

Remarks on result:

other: Observation time: 8 days

Results 6

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: mean 24+48+72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Remarks on result:

other: Observation time: 8 days

Irritant / corrosive response data:

One hour after dosing, two animals exhibited slight conjunctival redness, chemosis and discharge, which persisted for 24 hours in one animal.  The second animal also exhibited conjunctival redness at 24 hours after dosing.  At 48 hours following dosing all signs of irritation had resolved.  The remaining animal showed no signs of irritation at any time during the test.

Any other information on results incl. tables

Classification of eye irritation studies according GHS-criteria

 

Substance:n-Butyl methacrylate                     CAS: 97-88-1

 

Source: UNTER 88-022

 

 

Animal No.	Corneal opacity/Hornhauttrübung[Scores]			Mean Draize score in 2 of 3 animals	Reversibility [scores]		Hazard category
	after 24 h	after 48 h	after 72 h		in 7 days	in 21 days
1	0	0	0	0	0
2	0	0	0	0	0
3	0	0	0	0	0
				0			none
Animal No.	Iritis/Regenbogenhautentzündung[Scores]			Mean Draize score in 2 of 3 animals	Reversibility [scores]		Hazard category
	after 24 h	after 48 h	after 72 h		in 7 days	in 21 days
1	0	0	0	0	0
2	0	0	0	0	0
3	0	0	0	0	0
				0			none
Animal No.	Conjunctiva redness (erythem) /Bindehautrötung[Scores]			Mean Draize score in 2 of 3 animals	Reversibility [scores]		Hazard category
	after 24 h	after 48 h	after 72 h		in 7 days	in 21 days
1	1	0	0	0.33	0
2	0	0	0	0	0
3	1	0	0	0.33	0
							none

 

Animal No.	Conjunctiva chemosis /Bindehautödem[Scores]			Mean Draize score in 2 of 3 animals	Reversibility [scores]		Hazard category
	after 24 h	after 48 h	after 72 h		in 7 days	in 21 days
1	0	0	0	0	0
2	0	0	0	0	0
3	1	0	0	0.33	0
							none

 

 

Classification: Hazard Category

none

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information not classified Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008

Conclusions:

Classification: not irritating

Executive summary:

In an OECD 405 guideline study, n-butyl methacrylate (0.1 ml) was placed in the conjunctival sac of the right eye of three New Zealand White rabbits.   The lids were then gently held together for one second.   The test eyes were not washed out following the instillation.   The left eye remained untreated for control.   The eyes were examined at 1, 24, 48 and 72 hours as well as 8 days from beginning of test.   Eye irritation was scored for signs of corneal damage (density, area), iris reaction and lesions of the conjunctivae (erythema, chemosis, discharge).   Additionally, the cornea was examined with the aid of fluorescein after recording the observations at 24 hours. One hour after dosing, two animals exhibited slight conjunctival redness, chemosis and discharge, which persisted for 24 hours in one animal.   The second animal also exhibited conjunctival redness at 24 hours after dosing.   At 48 hours following dosing all signs of irritation had resolved.   The remaining animal showed no signs of irritation at any time during the test. n-Butyl methacrylate is considered as slightly irritating to eyes.