Registration Dossier
Registration Dossier
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EC number: 202-131-0 | CAS number: 92-15-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed OECD and GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2'-methoxyacetoacetanilide
- EC Number:
- 202-131-0
- EC Name:
- 2'-methoxyacetoacetanilide
- Cas Number:
- 92-15-9
- Molecular formula:
- C11H13NO3
- IUPAC Name:
- N-(2-methoxyphenyl)-3-oxobutanamide
- Details on test material:
- - Name of test material (as cited in study report): Acetessig-o-anisidid TTR
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Source: Hoechst AG, Kastengrund, conventional breed
- No of animals: 3
- Labeling: numbered ear tag
- Weight: 3.3-3.8 kg
- Age: 3-5 months
- Air conditioned rooms, single cages
- Temperature: 20 +/- 3 °C
- Humidity: 50 +/- 20 %
- Artificial light: 12 hrs daily
- Feed: Altromin 2123 Haltungsdiät - Kaninchen, ad libitum, as well as about 15 g of hay per day
- Water: deionized, chlorinated water, ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated right eye of each animal served as control
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- Exposure period: 24 h. After the exposure period the treated eye was rinsed with physiol. saline (37°C)
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: mean of animal # 1, 2, 3 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: no effects at any time
- Irritation parameter:
- iris score
- Basis:
- other: mean of animal # 1, 2, 3 each
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- other: initial slight effects were fully reversible within 24h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Reversibility:
- other: initial effects were fully reversible within 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0.7
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- other: mean of animal # 1, 2, 3 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Reversibility:
- other: initial slight effects were fully reversible within 24h
- Other effects:
- One hour after application the conjunctivae showed slight up to discrete swelling and diffuse reddening. One animal showed reddening of the iris. In addition a clear, colorless efflux could be observed.
24 to 48 h after application two respectively one animals showed distinct injected conjunctivae blood vessels. One animal showed a positive fluorescein test. All signs of irritation were fully reversible within 72h.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Based on the findings in this test, the test substance is not eye irritating.
- Executive summary:
The test substance was tested for eye irritating properties according to OECD 405. Following this protocol 100 mg of the undiluted test substance were applied into the conjunctival sac of the left eye of 3 rabbits. The right eye remained untreated and served as control. 24 h after instillation eyes were rinsed with physiol. saline. The eyes of the animals were examined at 1, 24, 48, and 72 h after substance application. Mean scores (mean of 24, 48, 72 h) were calculated for cornea, iris, conjunctivae redness, and conjunctivae chemosis for each animal.
Mean scores for all irritation parameters were below threshold values and were fully reversible within 72 h.
Based on the findings in this test, the test substance is not eye irritating.
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