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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
ethyl 2-[3-formyl-4-(2-methylpropoxy)phenyl]-4-methyl-1,3-thiazole-5-carboxylate
EC Number:
700-743-7
Cas Number:
161798-03-4
Molecular formula:
C18H21NO4S
IUPAC Name:
ethyl 2-[3-formyl-4-(2-methylpropoxy)phenyl]-4-methyl-1,3-thiazole-5-carboxylate

Test animals / tissue source

Species:
rabbit
Strain:
other: Japanese white strain
Details on test animals or tissues and environmental conditions:
Following 1 week quarantine and acclimation, the animal were further maintained for 4 days until use.
Were placed in an environmentally conditioned room with temperature within 21-25ºC, a relative humidity within 45-65%, room air ventilation of approximately 15 times/hour, and lighting for 12 hours (from 7:00 to 19:00).

Test system

Amount / concentration applied:
0.1g/eye
Duration of treatment / exposure:
Treatment:
Right eye: Isobutyl derivative
Left eye: None (control)
Observation period (in vivo):
Observation of the eye preceding of treatment:
Both eyes of each animal were examined using BETA 200 ophthalmoscope and the cornea, iris and conjunctiva area were examined to have no abnormalities
Observation of the eye after instillation:
Both eyes of each animal were examined with a slip lamp at 1, 24, 48 and 72 hours after the instillation (at 24 hours, fluorescein test was also performed), and lesions in the cornea, iris and conjunctiva were graded in accordance with Draize's clssification systemfor grading ocular lesions.
Number of animals or in vitro replicates:
Five male rabbits of Japanese white strain (Kbs: JW, clean). 15-16 weeks old weighting 3.01 - 3.25 kg.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Score:
ca. 0
Max. score:
0
Remarks on result:
other: at 1, 24, 48 and 72 hours
Irritation parameter:
iris score
Basis:
mean
Score:
ca. 0
Max. score:
0
Remarks on result:
other: at 1, 24, 48 and 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #1
Score:
ca. 1
Max. score:
1
Remarks on result:
other: Discharge at 1 hour
Irritation parameter:
conjunctivae score
Basis:
mean
Score:
1
Max. score:
1
Remarks on result:
other: at 1, 24, 48 and 72 hours

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
It is concluded from these results that Isobutyl Derivative is evaluated to have no irritant effect on the eyes in rabbits under the present test conditions.