2-methoxy-1-methylethyl acetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study methodology followed was equivalent or similar to OECD TG 405 and the report contained sufficient information to permit a meaningful evaluation of study results

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Principles of method if other than guideline:

not applicable

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-methoxy-1-methylethyl acetate

EC Number:

203-603-9

EC Name:

2-methoxy-1-methylethyl acetate

Cas Number:

108-65-6

Molecular formula:

C6H12O3

IUPAC Name:

2-methoxy-1-methylethyl acetate

Details on test material:

- Name of test material (as cited in study report): Methyl Proxitol Acetate
- Substance type: solvent
- Physical state: colourless clear liquid
- Analytical purity: Comparisons of the infra-red spectra revealed no changes
- Impurities (identity and concentrations): Alcohol: 0.016% m/m, water: 200 ppm, HAC: 180 ppm, Unknowns: < 0.1% m/m, Peroxides: 1-12 ppm
- Composition of test material, percentage of components: MPA-1: 1.27% m/m, MPA-2: 98.6% m/m
- Lot/batch No.: U5126
- Expiration date of the lot/batch: not specified
- Stability under test conditions: stable
- Storage condition of test material: stored in the dark at room temperature

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: in-house breeding colony
- Age at study initiation: 4-9 months
- Weight at study initiation:
- Housing: individual
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-19 °C
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 hours light:dark cycle

IN-LIFE DATES: From: April 9, 1985 To: June 7, 1985

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 ml of undiluted Methyl Proxitol Acetate

Duration of treatment / exposure:

single

Observation period (in vivo):

1 hour, 24, 48 and 72 hours and 7 days

Number of animals or in vitro replicates:

3 rabbits/sex

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: immediate after instillation

SCORING SYSTEM: Draize method

TOOL USED TO ASSESS SCORE: In the event of any corneal damage visualization was aided by the instillation of 1 drop of 2% fluorescein solution

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of all 6 animals (3 male + 3 female)

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: no changes observed

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of all 6 animals (3 male + 3 female)

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

not specified

Remarks on result:

other: no changes observed

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of all 6 animals (3 male + 3 female)

Time point:

24/48/72 h

Score:

1.2

Max. score:

3

Reversibility:

fully reversible

Remarks:

7 days, except in 1 animal

Remarks on result:

other: none

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of all 6 animals (3 male + 3 female)

Time point:

24/48/72 h

Score:

0.2

Max. score:

4

Reversibility:

fully reversible

Remarks:

7 days

Remarks on result:

other: none

Irritant / corrosive response data:

The instillation of undiluted Methyl Proxitol Acetate into the conjunctival sac of one eye of each of the six rabbits resulted in severe initial pain. The group mean 24, 48 and 72 hour scores were 1.1 for redness, 0.2 for chemosis and 0 for corneal opacity and iritic effects

Other effects:

not applicable

Any other information on results incl. tables

none

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study, Methyl Proxitol Acetate is not classified as an irritant

Executive summary:

In this eye irritation study in rabbits, groups of 3 male and 3 female New Zealand white rabbits (4-9 months) were instilled with 0.1 ml of undiluted Methyl Proxitol Acetate (one eye only) into the lower conjunctival sac and the lids held together for a few seconds to prevent loss of material. The eyes were not washed. A visual assessment of eye irritancy was made at 1 hour, 24, 48 and 72 hours and 7 days after instillation, following the method of Draize and the scores so obtained were assessed as per the EU/EEC criteria and the Kay and Calandra technique. The instillation of undiluted Methyl Proxitol Acetate into the conjunctival sac of one eye of each of the six rabbits resulted in severe initial pain. The group mean 24, 48 and 72 hour scores were 1.1 for redness, 0.2 for chemosis and 0 for corneal opacity and iritic effects. Under the conditions of the study, Methyl Proxitol Acetate is not classified as an irritant