Registration Dossier
Registration Dossier
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EC number: 298-791-2 | CAS number: 93839-21-5
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:
- N-[4-(aminocarbonyl)phenyl]-4-nitrobenzamide
- EC Number:
- 298-791-2
- EC Name:
- N-[4-(aminocarbonyl)phenyl]-4-nitrobenzamide
- Cas Number:
- 93839-21-5
- Molecular formula:
- C14H11N3O4
- IUPAC Name:
- N-(4-carbamoylphenyl)-4-nitrobenzamide
- Details on test material:
- - Name of test material (as cited in study report): p-Nitrobenzoylaminobenzamid TTR
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 breeding colony
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 3.2 - 3.6 kg
- Housing: fully air conditioned rooms, single cages (battery housing)
- Diet: Altromin 2123, rabbit diet, ad libitum plus 15 g hay per day
- Water: deionisized, chlorinated water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+-3
- Humidity (%): 50+-20
- Photoperiod: 12 hrs dark /12 hrs light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the untreated right eye served as control
- Amount / concentration applied:
- 100 mg of the test article were applied into the conjunctiva of the left eye
- Duration of treatment / exposure:
- 24 hours
rinsing with physiol. saline at the end of the exposure period - Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: physiologic NaCl-solution (temp. 37°C)
- Time after start of exposure: 24 hours
SCORING SYSTEM:
cornea: 0 - 4; iris: 0 - 2; conjunctivae redness: 0 - 3; conjunctivae chemosis: 0-4
TOOL USED TO ASSESS SCORE: UV lamp / fluorescein-sodium-solution
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: # 7, 100, 164 each
- Time point:
- other: mean of 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of irritation (cornea) at any time
- Irritation parameter:
- iris score
- Basis:
- animal: # 7, 100, 164 each
- Time point:
- other: mean of 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no signs of irritation (iris) at any time
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: # 7, 164 each
- Time point:
- other: mean of 24, 48, and 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: # 100
- Time point:
- other: mean of 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: initial slight effects were fully reversible within 24 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: # 7
- Time point:
- other: mean of 24, 48, and 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: # 100, 164 each
- Time point:
- other: mean of 24, 48, and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: initial slight effects were fully reversible within 24 h
- Irritant / corrosive response data:
- initial slight discharge was fully reversible within 24 h
- Other effects:
- no other effects reported
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 study the test item is considered not to be irrtant to the eye.
- Executive summary:
Eye irritant properties of N-(4-carbamoylphenyl)-4-nitrobenzamide were tested according to OECD 405 (100 mg/eye) in three New Zealand Whiter rabbits. 24 hours after instillation the treated eyes were washed. Mean scores (mean of 24, 48 and 72 h) were calculated for each rabbit.
Only slight effects were obsereved which were fully reversible within 48 h.
Based on the findings in this study the test item is considered not to be irrtant to the eye.
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