Registration Dossier
Registration Dossier
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EC number: 226-106-9 | CAS number: 5280-78-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Fed. Reg. 38 No. 187 § 1500.42) = Draize test
- Deviations:
- no
- GLP compliance:
- no
Test material
- Reference substance name:
- N,N'-(2-chloro-1,4-phenylene)bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]
- EC Number:
- 226-106-9
- EC Name:
- N,N'-(2-chloro-1,4-phenylene)bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]
- Cas Number:
- 5280-78-4
- Molecular formula:
- C40H23Cl5N6O4
- IUPAC Name:
- N,N'-(2-chloro-1,4-phenylene)bis{4-[(2,5-dichlorophenyl)diazenyl]-3-hydroxy-2-naphthamide}
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Physical state: red powder
- Analytical purity: no data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: ca. 2.5 kg
- Housing: separately in suspended wire mesh cages
- Diet (e.g. ad libitum): - Diet (e.g. ad libitum): Purina Rabbit Chow ad lib.
- Water (e.g. ad libitum): unspecified; ad lib.
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
Housing in temperature controlled rooms (no further details)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- treatment was once
- Observation period (in vivo):
- 3 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
no rinsing reported
SCORING SYSTEM: OECD Draize Scoring System
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 - 48 -72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 - 48 -72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects
- Remarks on result:
- other: slight redness (score 1) was observed in all animals 1 hour after treatment, while substance residues were also reported
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 - 48 - 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: slight to moderate chemosis (score 1-2) was observed in all animals 1 hour after treatment
- Irritant / corrosive response data:
- Discharge (score 2) was observed in all animals 1 hour after treatment, but was reversible within 24 hrs.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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