Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
data not available
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The method is in accordance with recognized test guideline. The test conditions and the results are detailed, but there is no information about the purity of the test substance.

Data source

Reference
Reference Type:
publication
Title:
Studies on eye irritation caused by chemicals in rabbits II. Structure-activity relationships and in vitro approach to primary eye irritation of salicylates in rabbits.
Author:
Sugai S, Murata K, Kitagaki T, Tomita I
Year:
1991
Bibliographic source:
Journal of Toxicological Sciences, 16, 111-130

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Draize Test
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
salicylic acid, purity not specified

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Takeo breeder (Shizuka, Japan)
- Age at study initiation: no data
- Weight at study initiation: 2.0-2.2 kg
- Housing: in metal cages (39x40x44 cm)
- Diet: RC4 diet (Oriental Yeast Co., Ltd., Tokyo, Japan), ad libitum.
- Water: ad libitum
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25+/-1 °C
- Humidity (%): 55 +/- 5 %
- Air changes (per hr): no data
- Photoperiod: 12 hrs dark / 12 hrs light


IN-LIFE DATES: no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: right eye
Amount / concentration applied:
Amount applied: 100 mg
Duration of treatment / exposure:
unwashed
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize method (Maximum value of Draize score for cornea, conjunctiva and iris was 80, 20 and 5, respectively)


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: not applicable
Score:
ca. 54.1
Max. score:
80
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Draize score : The sum of value recorded for cornea was divided by the number of observation times
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: not applicable
Score:
10.3
Max. score:
20
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: Draize score: The sum of values was divided by the number of observation times.
Irritant / corrosive response data:
The raw data for each individual animal at each observation time up to removal of each animal from the test were not available.
Iris score was not evaluted due to corneal opacity.
Other effects:
Nothing was reported.

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Salicylic acid induced severe irritation not recovering within 21 days of  treatment. Salicylic acid is therefore classified irritant for the
eyes, with R41: risk of serious damage to eyes, according to EU criteria and is classified category 1 (irreversible effects on the eye) according to the GHS (EU).
Executive summary:

In an eye irritation study (Sugai et al., 1991), 100 mg of salicylic acid were placed into the conjunctival sac of the left eye of female white rabbits, the right one being kept as control. The eyes were examined and the grade of ocular reaction was recorded at 1, 4, 24, 48, 72, 96 hr and 7, 14 and 21 days after administration. Corneal opacity, erythema, chemosis, secreta and iritis were classified according to the Draize method. The sum of values, recorded for cornea, conjunctiva and iris, was divided by the number of observation times and the average scores were used as the grade of eye irritation potential. Results showed that salicylic acid induced severe irritation not recovering within 21 days of treatment.