2-ethoxybenzoic acid

Eye irritation

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. Structure-activity relationships and in vitro approach to primary eye irritation of salicylates in rabbits.

Author:

Syoichoiroh Sugai, Kyoji MURATA, Tadaharu KITAGAKI, Isao TOMITA

Year:

1991

Bibliographic source:

Journal of Toxicological Sciences, 16, 111-130, 1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Draize method

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

Test material information

Constituent 1

Reference substance name:

Salicylic acid

EC Number:

200-712-3

EC Name:

Salicylic acid

Cas Number:

69-72-7

Molecular formula:

C7H6O3

IUPAC Name:

salicylic acid

Test material form:

solid: particulate/powder

Details on test material:

- Name of test material (as cited in study report):Salicylic acid
- Molecular formula:C7H6O3
- Molecular weight:138.12 g/mole
-Substance type: organic
- Physical state: solid

Test animals / tissue source

Species:

rabbit

Strain:

other: Japanese White

Details on test animals or tissues and environmental conditions:

SEX: female
Source: Takeo breeder (Shizuoka, Japan)
- Age at study initiation: no data available
- Weight at study initiation: 2.0 -2.4 kg
- Fasting period before study:no data available
- Housing: housed in 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:

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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

not mentioned

Observation period (in vivo):

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

Number of animals or in vitro replicates:

3

Details on study design:

TEST SITE
- Area of exposure: conjunctival sac of the left eye

Scoring System: 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

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

21 d

Score:

54.1

Max. score:

80

Reversibility:

not fully reversible within: 21 days

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

21 d

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: couldnot be determined due to corneal opacity

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

21 d

Score:

10.3

Max. score:

20

Reversibility:

not fully reversible within: 21 days

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

The average Draize scores after 21 days was as follows: CORNEA = 54.1/80, iris = couldnot be determined, conjunctiva = 10.3/20.
Salicylic acid induced severe eye irritation not recovering within 21 days of treatment.

Any other information on results incl. tables

Table 1: Physchem Parameters and Primary Irritation Scores

Log P*	Draize Scores
	Cornea	Iris	Conjunctiva
2.32	54.1 (>21)	-(-)	10.3 (>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 test chemical induced severe eye irritation not recovering within 21 days of treatment.
Hence, the test chemical can considered to be irritating to female Japanese White rabbit 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 = 54.1/80, iris = could not be determined, conjunctiva = 10.3/20.

The test chemical induced severe eye irritation not recovering within 21 days of treatment.

Hence the test chemical can be assessed as irritating to rabbit eyes.