Registration Dossier
Registration Dossier
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EC number: 202-576-0 | CAS number: 97-36-9
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:
- 1 988
- Report date:
- 1988
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',4'-dimethylacetoacetanilide
- EC Number:
- 202-576-0
- EC Name:
- 2',4'-dimethylacetoacetanilide
- Cas Number:
- 97-36-9
- Molecular formula:
- C12H15NO2
- IUPAC Name:
- 2',4'-dimethylacetoacetanilide
- Details on test material:
- - Name of test material (as cited in study report): Acetessig-m-xylidid
- Product code: HEAT 105
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
- Identification: Numbered earmark
- Weight: 2.1 - 2.6 kg
- Age: approx. 3 to 5 months
- Housing: in air conditioned rooms in single cages
- Temperature: 20 +/- 3 °C
- Rel. humidity: 50 +/- 20 %
- Artificial light: 12 hrs daily
- Feed: Altromin 2123 - rabbit, ad libitum, as well as hay (approx 15 g daily)
- Water: deionised, chlorinated water from automatic dispensers, ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated eye served as control.
- Amount / concentration applied:
- - Amount applied: 100 mg
- Duration of treatment / exposure:
- Exposure period: 24 hrs. At the end of exposure the treated eye was rinsed with physiol. saline (37°C).
- Observation period (in vivo):
- 1, 24, 48, 72 hrs after test substance application
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- - Approx. 24 hrs before the start of study the eyes to be treated where examined for damages to the cornea using ultraviolet light. Eyes were instilled with fluorescin-sodium solution (0.01 %) before
- Eyes were washed with physiol. saline solution (approx 37 °C) 24 hrs after treatment with the test substance and at all other observation times where discharge was observed or the cornea was examined for damages.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- 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 24 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: # 1, 2, 3
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal: # 1, 2, 3
- 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:
- cornea opacity score
- Basis:
- animal: # 1, 2, 3 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: no effcts at any time
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 were examined at 1, 24, 48, and 72 h after substance application. Mean scores (mean of 24, 48, 72h) were calculated for cornea, iris, conjunctivae redness, and conjunctivae chemosis for each rabbit.
Mean scores for cornea, iris, and conjunctivae chemosis were 0 and for conjunctivae redness was 0.3 (in each animal tested). All effects were reversible within 48h.
Based on the findings in this test, the test substance is not eye irritating.
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