1-methoxypropan-2-ol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study methodology followed was equivalent or similar to EU Method B.5 and was conducted in accordance with the Principles of GLP

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:

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

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-methoxypropan-2-ol

EC Number:

203-539-1

EC Name:

1-methoxypropan-2-ol

Cas Number:

107-98-2

Molecular formula:

C4H10O2

IUPAC Name:

1-methoxypropan-2-ol

Details on test material:

- Name of test material (as cited in study report): Methyl proxitol
- Physical state: clear, colourless liquid
- Analytical purity: not specified in the report
- Impurities (identity and concentrations): not specified in the report
- Composition of test material, percentage of components: sec. methyl mono proxitol - 97.7%, prim. methyl mono proxitol - 2.06%, unknowns - 0.01%, propylene oxide - < 0.01%, methanol - 0.12%, water - 0.09%, acidity (as acetic acid) - 0.001%
- Isomers composition: not specified in the report
- Purity test date: not specified in the report
- Lot/batch No.: Indent 9200/9075
- Expiration date of the lot/batch:
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions: stable as per infra-red spectra
- Storage condition of test material: stored in the dark at ambient 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
- Age at study initiation: 4-9 months
- Weight at study initiation: 4785-4956 g
- 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 in the report
- Air changes (per hr): not specified in the report
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 ml of undiluted methyl proxitol

Duration of treatment / exposure:

single exposure

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3 male + 3 female rabbits

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 1, 24, 48, 72 hours and 7 days post-exposure

SCORING SYSTEM: Draize scoring method and Kay and Calandra

TOOL USED TO ASSESS SCORE: visual assessment of eye irritancy was made. In the event of any corneal damage, visualization was aided by the instillation of one drop of 2% fluorescein solution

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: 24, 48 and 72 hours

Score:

0.1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

0

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Remarks:

of 6 animals

Time point:

other: 24, 48 and 72 hours

Score:

1.5

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 6 animals

Time point:

other: 24, 48 and 72 hours

Score:

0.6

Max. score:

1

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

Conjunctival redness, chemosis and discharge, corneal opacity and damage to the iris were assessed and the scores at 1 hour, 24, 48 and 72 hours and 7 days were calculated. Refer to table 1 for further details

Other effects:

The instillation of undiluted methyl proxitol into the conjunctival sac of one eye of each of the six rabbits resulted in severe initial pain

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results of the study, Methyl proxitol was classifed as not irritating to rabbit eye according to EU criteria.

Executive summary:

The instillation of undiluted Methyl proxitol into the conjunctival sac of one eye of each of six rabbits resulted in severe initial pain. The conjunctival redness, chemosis and discharge, corneal opacity and damage to the iris were assessed and the scores at 1 hour, 24, 48 and 72 hours and 7 days were calculated. One rabbit showed transient corneal opacity.

On the basis of the modified Kay and Calandra grading scheme, methyl proxitol was classifed as mildly irritating to rabbit eyes. The group mean 24, 48 and 72 hour scores for redness, chemosis, corneal opacity and iritic effects were 1.5, 0.6, 0.1 and 0, respectively. On the basis of these scores, methyl proxitol was not classified as irritating.