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Toxicological information

Eye irritation

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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-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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
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
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

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