Homosalate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1989 - 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: guideline test with GLP, reliability reduced from 1 to 2 as study is used for read-across

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl salicylate

EC Number:

204-263-4

EC Name:

2-ethylhexyl salicylate

Cas Number:

118-60-5

Molecular formula:

C15H22O3

IUPAC Name:

2-ethylhexyl salicylate

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

The testing was made on three SPF albino female rabbits of the stock Mol: Russian from Møllegaard Breeding Centre ApS, Ejby, DK-4623 LL. Skensved. The rabbits weighed 2300-2600 g and were earmarked with National Wing Bands, During a pre-period of one week and throughout the experiment the rabbits were kept to single PPL cages, 45 × 55 cm, with perforated floor. The rabbits had free access to food pellets "Altromin 2123" from Chr. Petersen A/S, DK-4100 Ringsted and to fresh water. The room temperature was 21 ± 2 °C and the relative humidity 55 ±15%. The air was changed 6 times an hour, and light was on from 6 to 18 hrs. Declaration and analysis certificate of diet mixture weere documented. The rabbits were kept in animal room No. 1.

Test system

Vehicle:

other: Diethyl phthalate (DEP)

Controls:

other: right eyes remained untreated and served as control

Amount / concentration applied:

50% (w/w)

Duration of treatment / exposure:

one hour (eyes were rinsed with 20 ml 0.9% sodium chloride solution after 1 hour examination)

Observation period (in vivo):

1, 24, 48 and 72 hours after the treatment

Number of animals or in vitro replicates:

3 females

Details on study design:

The day before testing both eyes of the animals were examined with an ophthalmoscope to ensure there were no eye defects or irritation. The examination was performed before and after instillation of oculogottae floureaceini (Ph.N,).
Only the left eyes were treated. The right eyes remained untreated and served as control.
About 0.1 ml of the diluted test article was placed in the left eye of each rabbit by gently pulling the lower lid away from the eyeball to form a cup into which the test substance was dropped. The lids were then gently held together for about one second. The eyes were examined and the grade of ocular reaction was recorded 1 hour later. 24 hour later an examination was performed before and after installation of oculoguttao flouresceini. After the examined the eyes were rinsed with 20 ml of a 0.9% sodium chloride solution.The eyes were also examined 48 and 72 hours after the treatment

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24-72hours

Score:

0

Max. score:

4

Remarks on result:

other: no positive reaction at any tested group

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

for all animals

Time point:

other: 24-72hours

Score:

0

Max. score:

2

Remarks on result:

other: no positive response in all animals

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24-72hours

Score:

0.1

Max. score:

3

Reversibility:

fully reversible within: 72hours

Remarks on result:

other: Slight reactions of conjunctiva (redness) were seen in one rabbit at the 1- and 24-hour reading No reactions of the conjunctiva, iris or cornea were observed in any of the rabbits at the 48- and 72-hour readings.

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24-72hours

Score:

0

Max. score:

4

Remarks on result:

other: no positive response in all animals

Irritant / corrosive response data:

Slight reactions of conjunctiva (redness) were seen in one rabbit at the 1- and 24-hour reading. No reactions of the conjunctiva, iris or cornea were observed in any of the rabbits at the 48- and 72-hour readings.

Other effects:

no data

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the experimental condition, it can be concluded that 2-ethylhexyl salicylate in a 50% solution caused no eye irritation to rabbits.

Executive summary:

The primary eye irritant effect of 2-ethylhexyl salicylate in a 50% solution was investigated according to the method recommended in the OECD Guideline No. 405"Acute Eye Irritation/Corrosion". About 0.1 ml of the diluted test article was placed in the left eye of each rabbit by gently pulling the lower lid away from the eyeball to form a cup into which tho test substance was dropped. The lids were then gently held together for about one second. The eyes were examined and the grade of ocular reaction was recorded 1 hour later. 24 hour later an examination was performed before and after installation of oculoguttao flouresceini. After the examined the eyes were rinsed with 20 ml of a 0.9% sodium chloride solution.The eyes were also examined 48 and 72 hours after the treatment. Slight reactions of conjunctiva (redness) were seen in one rabbit at the 1- and 24-hour reading. No reactions of the conjunctiva, iris or cornea were observed in any of the rabbits at the 48- and 72-hour readings.

Based on the description as above, test article in 50% solution did not cause positive eye response in rabbits.