Registration Dossier
Registration Dossier
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EC number: 279-356-6 | CAS number: 79953-85-8
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:
- guideline study
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)
- Version / remarks:
- (adopted May 12, 1981)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3,3'-[(2,5-dimethyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(5-chloro-o-tolyl)benzamide]
- EC Number:
- 226-107-4
- EC Name:
- 3,3'-[(2,5-dimethyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(5-chloro-o-tolyl)benzamide]
- Cas Number:
- 5280-80-8
- Molecular formula:
- C44H38Cl4N8O6
- IUPAC Name:
- 3,3'-{(2,5-dimethyl-1,4-phenylene)bis[imino(1,3-dioxobutane-2,1-diyl)diazene-2,1-diyl]}bis[4-chloro-N-(5-chloro-2-methylphenyl)benzamide]
- Test material form:
- solid: particulate/powder
- Details on test material:
- Lot no. 057249.28
Test item stability garantueed by sponsor
Test material received April 18, 1983
- Storage: Room temperature
Constituent 1
- Specific details on test material used for the study:
- - Lot/batch No.: 057249.28
- Stability under test conditions: stable
- Storage condition of test material: room temperature
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, Fuellinsdorf / Switzerland
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 2410 - 2660 g
- Housing: individually
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau / Switzerland; ad libitum
- Water: ad libitum
- Acclimation period: 5 days (23 June, 1983 - 27 June, 1983)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- see observation period (no washing conducted)
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: not done
SCORING SYSTEM: according to OECD 405
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- (animal 1 -3)
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 - 48 h
- Remarks on result:
- other: see table below for details
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- (animal 1 - 3)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects observed
- Remarks on result:
- other: see table below for details
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- (animal 1 - 3)
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 - 48 h
- Remarks on result:
- other: see table below for details
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- (animal 1 - 3)
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 - 72 h
- Remarks on result:
- other: see table below for details
- Other effects:
- The body weight development was not affected by the application of the test article. No other reactions to treatment were recorded during the whole observation period.
Any other information on results incl. tables
Table 1: Evaluation of the eye reactions
| Animal | Reading | Cornea Opacity | Iris | Conjunctiva | |
| Redness | Chemosis | ||||
| 1 | 1 h | 0 | 0 | 0 | 0 |
| 2 | 1 h | 1 | 0 | 1 | 0 |
| 3 | 1 h | 1 | 0 | 2 | 1 |
| 1 | 24 hrs | 0 | 0 | 0 | 1 |
| 2 | 24 hrs | 0 | 0 | 0 | 0 |
| 3 | 24 hrs | 1 | 0 | 1 | 1 |
| 1 | 48 hrs | 0 | 0 | 0 | 0 |
| 2 | 48 hrs | 0 | 0 | 0 | 0 |
| 3 | 48 hrs | 0 | 0 | 0 | 1 |
| 1 | 72 hrs | 0 | 0 | 0 | 0 |
| 2 | 72 hrs | 0 | 0 | 0 | 0 |
| 3 | 72 hrs | 0 | 0 | 0 | 0 |
| 1 | 7 days | 0 | 0 | 0 | 0 |
| 2 | 7 days | 0 | 0 | 0 | 0 |
| 3 | 7 days | 0 | 0 | 0 | 0 |
| 1 | 24/48/72 hrs | 0 | 0 | 0 | 0.3 |
| 2 | 24/48/72 hrs | 0 | 0 | 0 | 0 |
| 3 | 24/48/72 hrs | 0.3 | 0 | 0.3 | 0.7 |
| mean animal 1-3 | 24/48/72 hrs | 0.1 | 0.0 | 0.1 | 0.3 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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