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Toxicological information

Eye irritation

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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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: clear colourless liquid
Details on test material:
chemical name: Benzoic acid, 2-hydroxy-, 2-ethylhexyl ester

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

Resultsopen allclose all
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
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
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.
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.