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EC number: 200-712-3 | CAS number: 69-72-7
Eye irritation
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:
- 1 991
- 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 substance name:
- Salicylic acid
- EC Number:
- 200-712-3
- EC Name:
- Salicylic acid
- Cas Number:
- 69-72-7
- Molecular formula:
- C7H6O3
- IUPAC Name:
- 2-hydroxybenzoic acid
- Details on test material:
- salicylic acid, purity not specified
Constituent 1
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.
- Irritation parameter:
- iris score
- Remarks on result:
- not determinable
- Remarks:
- could not be determined because of the corneal opacity
- Irritation parameter:
- chemosis score
- Remarks on result:
- other: no data available
- 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:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- 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.
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