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EC number: - | CAS number: -
Eye irritation
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:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction mass of methyl N-octadecylterephthalamate and diamide
- IUPAC Name:
- Reaction mass of methyl N-octadecylterephthalamate and diamide
- 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.
Constituent 1
- 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.
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