Registration Dossier
Registration Dossier
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EC number: 224-638-6 | CAS number: 4433-79-8
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:
- 1 992
- Report date:
- 1992
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:
- 4'-chloro-2',5'-dimethoxyacetoacetanilide
- EC Number:
- 224-638-6
- EC Name:
- 4'-chloro-2',5'-dimethoxyacetoacetanilide
- Cas Number:
- 4433-79-8
- Molecular formula:
- C12H14ClNO4
- IUPAC Name:
- N-(4-chloro-2,5-dimethoxyphenyl)-3-oxobutanamide
- Details on test material:
- - Name of test material (as cited in study report): Naphthol AS-IRG
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Source: Chemisch pharmazeutische Fabrik Dr. K. Thomae, 7950 Biberach
Animal identification: numbered ear tags
Weight: 2.7 - 3.4 kg
Age: about 3 - 5 months
Housing: in fully air-conditioned rooms, separate cages (arranged in a battery)
Temperature: 18 +/- 3 °C
Relative humidity: 55 +/- 20 %
Lighting time: 12 hrs per day
Diet: Altromin 2123 maintenance diet - rabbits (Altromin GmbH, Lage/Lippe), ad libitum and hay (approx. 15 g daily)
Water: deionised, chlorinated water from automatic water dispensers, ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated eye served in each case as a control
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- Exposure period is 24 hrs. 24 h after application treated eyes were washed out with physiological saline.
- Observation period (in vivo):
- 72 hrs total (observations at 1, 24, 48 and 72 hrs after application)
at 24hrs and 72hrs the eyes were also examined for corneal lesions under UV light after instillation of one drop of 0.01& fluorescin-sodium solution - Number of animals or in vitro replicates:
- 3
- Details on study design:
- Washing with physiol saline: 24 hrs after application and at all other designated examination times at which the treated eyes still showed discharge or at wich a corneal examination with fluorescine-sodium solution took place.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: mean of animal # 61, 66, 178 each
- Time point:
- other: mean of 24, 48, 72 hrs
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: no effects at any time
- Irritation parameter:
- iris score
- Basis:
- other: mean of animal # 61, 66, 178 each
- Time point:
- other: mean of 24, 48 and 72 hrs
- Score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- other: no effects at any time
- Irritation parameter:
- chemosis score
- Basis:
- other: mean of animal # 61, 66, 178 each
- Time point:
- other: mean of 24, 48 and 72 hrs
- Score:
- 0
- Reversibility:
- fully reversible within: 24 hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: # 61
- Time point:
- other: mean of 24, 48 and 72 hrs
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: # 66
- Time point:
- other: mean of 24, 48 and 72 hrs
- Score:
- 0.3
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: # 178
- Time point:
- other: mean of 24, 48 and 72 hrs
- Score:
- 0
- Reversibility:
- fully reversible within: 24 hrs
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 a 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 48 h.
Based on the findings in this test, the test substance is not eye irritating.
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