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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
Study period:
1984-10-02 to 1984-10-05
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Complete guideline conform study report available. Study is performed under GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
Hoechst product, now a Clariant (Germany) product. White powder, Formula: C27H45N04. 2.4% N-octadecyl-terephthalamate diamide, 2.8% dimethylphthalamate. Melting point 116-122 °C. Insoluble in water, moderately soluble in acetone, DMSO and DMF.
Specific details on test material used for the study:
Hoechst product, now a Clariant (Germany) product

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
other: 0.9 % polyethyleneglycol
Controls:
not required
Amount / concentration applied:
100 mg test substance moistened with 0.3 mL 0.9 % polyethyleneglycol
Duration of treatment / exposure:
24 hours after application of the test substance into the conjuctival sac of the left eye, the eyes were washed out with lukewarm physiological saline.
Observation period (in vivo):
1, 24, 48 and 72 hours
Duration of post- treatment incubation (in vitro):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
Draize method used for scoring of eye irritation

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
80
Irritation parameter:
iris score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
10
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Score:
0.7
Max. score:
10
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
72 h
Score:
0.1
Max. score:
10
Reversibility:
fully reversible within: 48 h

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this test and the results obtained, it is concluded, that the test substance is not irritant to the eye.
Executive summary:

In order to assess the eye irritating potential of the test substance, 100 mg of

the test item moistened with 0.3 mL of 0.9 % polyethyleneglycol was applied

into the conjunctival sac of the left eye of each of 3 rabbits. The untreated eye

served as control. After 24 hours the treated eye was washed. The assessment

of possible effects to the eyes was performed with the assistance of a lamp 60

minutes, 24, 48 and 72 hours after application of test item. The eye reactions

were assessed according to the numerical scoring system (acc. to Draize). The

description of the degree and nature of irritation and the presence of serious

damage were noted as follows:

- No mortality or signs of systemic toxicity occurred.

- Hyperemia was observed in all three animals at the one hour and 24 hour time

point with a maximum score of 2. This effect was still observed in one animal

with a score of 1 at the 48 hour time point (mean score 0.7 - 1 - 0.3). This effect

was reversible within 72 hours.

- Chemosis of the conjunctiva was observed in two animals one hour (maximal

score 2) and in one animal 24 hours after application (mean score 0 - 0.3 - 0).

This effect was reversible within 48 hours.

- No corneal opacity were observed in all three animals 24, 48 and 72 hours

after application of the test substance (mean score 0-0-0).

- No effects at Iris was observed in all animals 24, 48 and 72 hours after

application of the test substance (mean score 0-0-0).

Under the conditions of this test and the results obtained, it is concluded, that

the test substance is not irritant to the eye.