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EC number: 219-730-8 | CAS number: 2512-29-0
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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- Toxicological Summary
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- Acute Toxicity
- Irritation / corrosion
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- Additional toxicological data

Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 08 NOV 1988 to 15 NOV 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD TG 405; EU method B5), in compliance with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-[(4-methyl-2-nitrophenyl)azo]-3-oxo-N-phenylbutyramide
- EC Number:
- 219-730-8
- EC Name:
- 2-[(4-methyl-2-nitrophenyl)azo]-3-oxo-N-phenylbutyramide
- Cas Number:
- 2512-29-0
- Molecular formula:
- C17H16N4O4
- IUPAC Name:
- 2-[(4-methyl-2-nitrophenyl)diazenyl]-3-oxo-N-phenylbutanamide
- Test material form:
- solid: nanoform, no surface treatment
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, Germany
- Age at study initiation: abour 3-5 months
- Weight at study initiation: 2.1 - 3.6 kg
- Housing: single
- Diet: mixed feed (Altromin 2123), ad libitum, and about 15 g hay daily
- Water: deionized, chlorinated water, 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:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 100 mg - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiologic saline solution
- Time after start of exposure: 24 h
SCORING SYSTEM:
Scores were read 1, 24, 48 and 72 h after test substance application as well as after 7 days.
TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein at 24 and 72 h reading
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #2 and #3
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant since no effect
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animals #2 and #3
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not relevant since no effect
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant since no effect
- Irritant / corrosive response data:
- - no corneal effects were observed.
- iris scores for animal #1,2,3 after 1h: (0,1,0), after 24 h: (1,0,0). After 48 h, 72 h and 7 days scores for all animals were 0.
- conjunctivae redness scores for animal #1,2,3 after 1 h: (2,2,1), 24 h: (2,1,1), 48 h: (2,2,1), 72 h: (1,0,0) and 7 days: (0,0,0)
- chemosis scores for animals #1,2,3 after 1 h: (2,2,2), 24 h: (2,0,0). After 48 h, 72 h and 7 days scores for all animals were 0.
All effects were completely reversible within 7 days. - Other effects:
- No other effects reported
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test material is slightly irritating to the eyes when tested under the conditions of the OECD guideline 405. Chemosis was seen at 1 (all animals) and 24 h (one animal), being reversible within 48 h. Redness of the conjunctivae was also seen in all animals in the 1 h reading, being fully reversibly after 7 days. Animal #2 had an iris score of 1 in the 1 h reading, animal #1 in the 24 h reading. These effects were fully reversible within 48 h. No corneal effects were observed.
The effect does not result in a classification of the test item according to the classification criteria of Regulation (EC) No 1272/2008. - Executive summary:
The test item was subject to an Acute Eye Irritation/Corrosion Test in the rabbit according to OECD TG 405.
Chemosis was observed in all three animals 1 h after application. The effect was fully reversible within 48 h. Conjunctival redness was observed in all three animals up to 72 h after application , reversible by seven days. Iridial effects were noted in one animal up to 24 h. Corneal opacity was not oberved in any animal.
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