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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well documented and scientifically acceptable

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
About 0.1 ml of the test article solution or vehicle was placed in the left or right eye, respectively, 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 hours later an examination was performed before and after installation of oculoguttae flouresceini. After the examination 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, as well as on day 7.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
OTHER SPECIFICS: The test substance (Menthol racemic) was used in a test concentration of 40 % (60 % vehicle)

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan

Test system

Vehicle:
other: diethylphthalate (DEP)
Controls:
not required
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
up to 7 days
Number of animals or in vitro replicates:
4 female rabbits

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: test substance
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: test substance
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
2.1
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: test substance
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: test substance
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: vehicle
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: vehicle
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
1.9
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
other: vehicle
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: vehicle

Any other information on results incl. tables

Moderate to intense reactions of cornea (diffuse areas of opacity) and conjunctiva (redness, swelling and discharge) were seen in all the rabbits at the 1-, 24-, 48- and 72-hour readings, after treatment with the test article and the vehicle. No reaction was seen in iris. No reactions were seen in any of the rabbits on day 7. As it can be seen from the data, the test article formulation and the vehicle had almost the same eye-irritating potential.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Executive summary:

About 0.1 ml of the test article solution or vehicle was placed in the left or right eye, respectively, 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 hours later an examination was performed before and after installation of oculoguttae flouresceini. After the examination 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, as well as on day 7.

Based on the cornea score = 2.1 a classification as Cat.2, H319 is adequate. However, considering the cornea score = 1.9 of the solvent a classification is not necessary, but taken into account the hole database, a classifiaction as Eye Irrit. 2; : C>25% seems adequate.