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

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

Resultsopen allclose all
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
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
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
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.