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EC number: 236-852-7 | CAS number: 13515-40-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 04 OCT 1983 to 07 OCT 1983.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD TG 405) GLP compliant, observation time not extended to the time point of full reversibility of all effects
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- observation time only till 72 hours after start of exposure, but not until full reversibility of all effects
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-[(4-chloro-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide
- EC Number:
- 236-852-7
- EC Name:
- 2-[(4-chloro-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide
- Cas Number:
- 13515-40-7
- Molecular formula:
- C17H15ClN4O5
- IUPAC Name:
- 2-[(4-chloro-2-nitrophenyl)diazenyl]-N-(2-methoxyphenyl)-3-oxobutanamide
- 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
- Strain: Hoe: HIMK (SPFWiga)
- Source: Hoechst AG, in-hous conventional breeding
- Weight at study initiation: 2.7-3.3 kg
- Housing: individually
- Diet: Altromin 2123 diet for breeding rabbits (Altromin, Lage/Lippe), ad libitum
- Water: deionised, chlorinated water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2
- Humidity (%): 55 +/- 10
- Photoperiod (hrs dark / hrs light): 12 h / 12 h
Test system
- Vehicle:
- other: polyethylene glycol 400
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 100 mg pasted with 0.2 ml polyethylene glycol 400 - 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 ca. 37 °C warm physiol. saline
- Time after start of exposure: 24 h
SCORING SYSTEM: according to OECD TG 405
TOOL USED TO ASSESS SCORE: fluorescein, UV light, magnifying glass
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: cornea opacity was only observed 48 and 72 hours after application, observation time ended at 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks:
- not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks:
- 48 h after application.
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks:
- not applicable
- Irritant / corrosive response data:
- - no iridial effects occurred during the study
- chemosis scores for animal #1,2,3 after 1 h: (2,1,1). After 24, 48 and 72 h scores for all animals were 0.
- redness of the conjunctivae scores for animal #1,2,3 after 1 h: (2,1,1), after 24 h: (1,1,0). After 48 h and 72 h scores for all animals were 0.
- cornea opacity scores for animal #1,2,3 after 1 h and 24 h was 0 for all animals. After 48 h: (1,0,0) and after 72 h: (1,0,0)
- Heavy discharge was observed in every animal one hour after application.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test item did not induce iridial effects under the conditions of this test. Effects on conjunctivae redness and chemosis were sligth to moderate and fully reversible within 72 hours after start of the exposure. One animal showed very slight corneal opacity at 48 and 72 hours after start of the exposure, but not at earlier timepoints. As no corneal effects were observed in the two other animals it can reasonable be assumed that the slight effects seen in this animal would also be reversible within some days. Therefore it is concluded that the test item has not to be classified as an eye irritant according to the classification criteria of Regulation (EC) No 1272/2008.
- Executive summary:
The test material was subject to an Acute Eye Irritation / Corrosion Test in the rabbit according to OECD TG 405. No iridial effects were noted during the study. Very slight corneal opacity was observed in one animal 48 and 72 hours after test substance application but not in the two other test animals at any timepoint. Conjunctival redness was observed in every animal one hour after application, and in two animals 24 hours after application, fully reversible by 48 h after application. Chemosis was observed in every animal only one hour after application but not at later time points.
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