Methyl acetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09.02.1988 - 16.02.1988

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:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Remarks:

QAU statement available

Test material

Test material information

Constituent 1

Reference substance name:

Methyl acetate

EC Number:

201-185-2

EC Name:

Methyl acetate

Cas Number:

79-20-9

Molecular formula:

C3H6O2

IUPAC Name:

methyl acetate

Details on test material:

- Name of test material (as cited in study report): Methylacetat
- Substance type: liquid
- Physical state: clear and colourless
- Analytical purity: 99.9% (w/w)

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: HOECHST AG, Kastengrund, conventional breeding
- Age at study initiation: ca. 3 - 5 months
- Weight at study initiation: 2.1 - 2.6 kg
- Housing: in fully conditioned rooms in single cages (batteries)
- Diet: Altromin 2123 Haltungsdiät - Kaninchen, ad libitum plus hay
- Water: deionised and dechloronosed water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 50 +/- 20 %
- Photoperiod: 12 hours dark / 12 hours light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated right eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount applied (volume or weight with unit): 0.1 ml applied into the left eye
- Concentration (if solution): pure test substance

Duration of treatment / exposure:

evaluation after 1, 24, 48 and 72 hours after application

Observation period (in vivo):

3 days plus an additional examination after 7 days

Number of animals or in vitro replicates:

3 rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): treated eyes were washed with a sodium chloride solution on each examination date
- Time after start of exposure: 24 hours after application and on each examination date if the treates eyes still showed secretion


SCORING SYSTEM: accordin to guideline


TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: mean values of the examinations after 24, 48 and 72 hours

Score:

1.3

Max. score:

1.7

Reversibility:

fully reversible within: 7 days after application

Remarks on result:

other: see table 1 for scores per each animal

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 7 days after appliocation

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24 h

Score:

1

Reversibility:

fully reversible within: 7 days after application

Results 4

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 48 and 72h

Score:

2

Reversibility:

fully reversible within: 7 days after application

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48 h

Score:

1

Reversibility:

fully reversible within: 7 days after application

Results 6

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

72 h

Score:

2

Reversibility:

fully reversible within: 7 days after application

Results 7

Irritation parameter:

iris score

Basis:

mean

Time point:

other: mean values of the examinations after 24, 48 and 72 hours

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days after application

Remarks on result:

other: see table 1 for scores per each animal

Results 8

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 7 days after application

Results 9

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 7 days after application

Results 10

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 7 days after application

Results 11

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: mean values of the examinations after 24, 48 and 72 hours

Score:

2.7

Max. score:

3

Reversibility:

fully reversible within: 7 days after application

Remarks on result:

other: At 24 and 72 hours after application, conjunctivae of the animals showed white discoloration, bleedings and partly ablations. See table 1 for scores per each animal

Results 12

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48 h

Score:

3

Reversibility:

fully reversible within: 7 days after application

Results 13

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

72 h

Score:

2

Reversibility:

fully reversible within: 7 days after application

Results 14

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24 h

Score:

3

Reversibility:

fully reversible within: 7 days after application

Results 15

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 48/72h

Score:

2

Reversibility:

fully reversible within: 7 days after application

Results 16

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

3

Reversibility:

fully reversible within: 7 days after application

Results 17

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: mean values of the examinations after 24, 48 and 72 hours

Score:

1.8

Max. score:

2

Reversibility:

fully reversible within: 7 days after application

Remarks on result:

other: see table 1 for scores per each animal

Results 18

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48 h

Score:

2

Reversibility:

fully reversible within: 7 days after application

Results 19

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

72 h

Score:

1

Reversibility:

fully reversible within: 7 days after application

Results 20

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24 h

Score:

3

Reversibility:

fully reversible within: 7 days after application

Results 21

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 48/72h

Score:

1

Reversibility:

fully reversible within: 7 days after application

Results 22

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24 h

Score:

3

Reversibility:

fully reversible within: 7 days after application

Results 23

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

48 h

Score:

2

Reversibility:

fully reversible within: 7 days after application

Results 24

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

72 h

Score:

1

Reversibility:

fully reversible within: 7 days after application

Any other information on results incl. tables

Table 1: Irritant response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 1	Max. score: 1	Max. score: 3	Max. score: 4
60 min	1/1/1	1/1/1	2/2/1	4/4/3
24 h	1/1/1	1/1/1	3/3/3	2/3/3
48 h	1/2/1	1/1/1	3/2/3	2/1/2
72 h	1/2/2	1/1/1	2/2/3	1/1/1
Average 24h, 48h, 72h	1.3	1.0	2.7	1.8
Maximum average score	1.7	1.0	3.0	2.0
Reversibility*)	c	c	c	c
Average time (unit) for reversion	7 days	7 days	7 days	7 days

 

*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results, methyl acetate is classified as irritant (Xi) and has to be labelled with R36 (irritant to eyes).

Executive summary:

Methyl acetate was applied to the rabbit's eye.The test concentration was 0.1 ml test substance per eye. Effects were examined after 1, 24, 48 and 72 hours after application. Due to the fact that effects were still observed 72 hours after application, an additional examination took place 7 days after application. At this time point, no effects were observed anymore. Based on the results, methyl acetate has to be classified as irritant to eyes.

In-vitro testing is not required.