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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data is from peer reviewed journals

Data source

Reference
Reference Type:
publication
Title:
Studies on eye irritation caused by chemicals in rabbits--II.
Author:
Syoichiroh SUGAI et.al
Year:
1991
Bibliographic source:
The Journal of Toxicological Sciences, 1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Draize test
Principles of method if other than guideline:
The primary eye irritation potential of the test chemical was evaluated according to Draize method
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Name of test material (as cited in study report): 4-methyl salicylic acid
- Molecular formula : C8H8O3
- Molecular weight : 152.148 g/mol
- Substance type: Organic
- Physical state: Solid
- Purchased from: Tokyo Kasei Kogyo Co. Ltd, Tokyo, Japan

Test animals / tissue source

Species:
rabbit
Strain:
other: Japanese White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Sex: Female
- Source: Takeo Breeder, Shizuoka, Japan
- Age at study initiation: no data available
- Weight at study initiation: 2.0-2.2 kg
- Fasting period before study: no data available
- Housing:metal cages (39*40*44 cm)
- Diet (e.g. ad libitum): RC4 diet (Oriental Yeast Co.Ltd, Tokyo, Japan), ad libitum
- Water (e.g. ad libitum): Water, ad libitum
- Acclimation period: bo data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25±1 deg C
- Humidity (%): 55±5%
- Air changes (per hr): no data available
- Photoperiod (hrs dark hrs light): constant 12 hour light: dark cycle

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100mg
Duration of treatment / exposure:
single exposure
Observation period (in vivo):
1, 4, 24, 48, 72, 96 hours, 7, 14, 21 days after administration of chemical
Duration of post- treatment incubation (in vitro):
no data available
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Corneal opacity, erythema, chemosis, secreta and iritis were classified according to the Draize method. The sum of values recorded for cornea, conjunctivae, iris was divided by the number of observations times and the average scores (Draize score) were used as the grade of eye irritation potential of the test chemical. Maximum value of Draize score for cornea, conjunctivae and iris was 80, 20, 5 respectively.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
21 d
Score:
33.9
Max. score:
80
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
7 d
Score:
0.6
Max. score:
5
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
21 d
Score:
5.1
Max. score:
8
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
4-methylsalicylic acid caused moderate eye irritation recovering within 21 days of treatment

Any other information on results incl. tables

Table 1: Physchem Parameters and Primary Irritation Scores

Name of the test chemical

Log P*

Draize Scores

Cornea

Iris

Conjunctiva

4-methylsalicylic acid

2.82

33.9 (21)

0.6(7)

5.1 (21)

*= Hansch and Leo, 1979, -=not evaluated due to corneal opacity

Figures in parenthesis indicate the days of recovery.

 

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The average Draize scores after 21 days were as follows: CORNEA = 33.9/80, iris = 0.6, conjunctiva = 5.1.
The test chemical caused moderate eye irritation recovering within 21 days of treatment.
Hence, the test chemical can be considered irritating to eyes.
Executive summary:

The primary eye irritation potential of the test chemical was evaluated according to Draize method.

3 female Japanese White rabbits (2.0-2.2 kg) were used for the study. The chemical (if solid= 100 mg, if liquid = 0.1ml) was instilled into the conjunctival sac of the left eye.Right eye (untreated eye) served as blank control.The eyes were examined and the grade of ocular lesions was recorded at 1, 24, 48, 72, 96 hours and 7, 14, 21 days after administration of test chemical.Corneal opacity, erythema, chemosis, secreta and iritis were recorded and classified under Draize method (Draize et.al, 1944)

The sum of values, recorded for cornea, conjunctiva and iris was divided by the number of observation times and the average scores (Draize scores) were used as grades of ocular irritation potential of the chemical.

The maximum value of Draize score are as follows: Cornea =80, Conjunctiva = 20 and Iris = 5

The average Draize scores after 21 days were as follows:CORNEA = 33.9/80, iris = 0.6, conjunctiva = 5.1.

The test chemical caused moderate eye irritation recovering within 21 days of treatment.

Hence,the test chemical can be considered irritating to eyes.