Registration Dossier
Registration Dossier
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EC number: 202-572-9 | CAS number: 97-32-5
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 GLP and OECD guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
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-methoxy-3-nitro-N-phenylbenzamide
- EC Number:
- 202-572-9
- EC Name:
- 4-methoxy-3-nitro-N-phenylbenzamide
- Cas Number:
- 97-32-5
- Molecular formula:
- C14H12N2O4
- IUPAC Name:
- 4-methoxy-3-nitro-N-phenylbenzamide
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, company breeding colony
- Age at study initiation: 3-5 month
- Weight at study initiation: 3.0 - 3.6 kg
- Housing: AC, single cages
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiät - Kaninchen ad libitum, 15 g hay per day
- Water (e.g. ad libitum): deionised, chlorinated water from an automatic water dispenser ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreted right eye of each animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg per eye
- Concentration (if solution): neat
VEHICLE: no - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiol. saline (37°C)
- Time after start of exposure: 24 h after application and at all reading time points as long as discharges were observed
SCORING SYSTEM:
Cornea: 0-4
Iris: 0-2
Conjunctivae, redness: 0-3
Conjunctivae, chemosis: 0-4
TOOL USED TO ASSESS SCORE: fluorescein / UV-light
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: # 79, 154, 155 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable owing to lack of effects
- Irritation parameter:
- iris score
- Basis:
- animal: # 79, 154, 155 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: reversibility not applicable owing to lack of effects
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: # 79, 154, 155 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h after instillation
- Irritation parameter:
- chemosis score
- Basis:
- animal: # 79, 154, 155 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility not applicable owing to lack of effects
- Irritant / corrosive response data:
- A clear, colourless discharge was observed in one of three animals. All signs of irritation/corrosion were fully reversible within 72 h.
- Other effects:
- No abnormalities detected.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Not seriously eye damaging or eye irritating.
Findings do not meet criteria for classification according to Regulation (EC) No 1272/2008. - Executive summary:
The primary eye irritation potential of the test item was investigated according to OECD guideline 405. The test item (0.1 g) was applied to the intact eye of each of three New Zealand White rabbits. 24 h after application the eyes were rinsed with physiol. saline. The scoring of eye reactions (cornea, iris, conjunctivae redness, conjunctivae chemosis) was performed 1, 24, 48 and 72 h after instillation of the test item. Mean scores were calculated for each animal following grading at 24, 48 and 72 h after instillation of the test material.
The individual mean scores calculated across the scoring times (24, 48 and 72 h after instillation of the test material) were 0.0 (three animals) for cornea, iris and conjunctivae chemosis and 0.7 (three animals) for conjunctivae redness. All signes of irritation were fully reversible within 72 h.
All scores were below the threshold values for classification.
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