Registration Dossier
Registration Dossier
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EC number: 252-772-5 | CAS number: 35869-64-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 7-day observation period
- GLP compliance:
- no
Test material
- Reference substance name:
- N,N'-(2-chloro-1,4-phenylene)bis[4-[(4-chloro-2-nitrophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]
- EC Number:
- 252-772-5
- EC Name:
- N,N'-(2-chloro-1,4-phenylene)bis[4-[(4-chloro-2-nitrophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]
- Cas Number:
- 35869-64-8
- Molecular formula:
- C40H23Cl3N8O8
- IUPAC Name:
- N,N'-(2-chloro-1,4-phenylene)bis{4-[(4-chloro-2-nitrophenyl)diazenyl]-3-hydroxy-2-naphthamide}
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Physical state: brown powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Porton strain bred on the premises
- Age at study initiation: 10-12 weeks
- Weight at study initiation: ca. 2.23 kg for males and 2.55 kg for females
- Housing: caged singly in an experimental room
- Diet (e.g. ad libitum): commercial irradiated diet (Styles-Oxoid); ad libitum
- Water (e.g. ad libitum): sterile filtered drinking water; ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1°C
- Humidity (%): 50-70%
- Photoperiod (hrs dark / hrs light): 10/14
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- continuously (3 animals without rinsing) or 30 second (3 animals with rinsing)
- Observation period (in vivo):
- up to 7 days
- Number of animals or in vitro replicates:
- 3 without rinsing and 3 with rinsing
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eyes of 3 rabbits were each rinsed with 10 ml lukewarm water for 1 min (only the rabbits without washing are further considered for assessment, because they are closer to the guideline conditions)
- Time after start of exposure: about 30 seconds after treatment
SCORING SYSTEM: comparable to the OECD scoring system after 1, 6, 24, 48, and 72 hours, and after 7 days.
TOOL USED TO ASSESS SCORE: hand-slit lamp
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-48-72-hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-48-72-hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24-48-72-hours
- Score:
- 0.11
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: redness score of 1 was observed in one animal after 24 hours, but was completely reversible within 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-48-72-hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Only chemosis (in all 3 animals without washing; scores 2, 2 and 1, respectively after 1 hours) and conjunctivae redness (in 2/3 animals after 1 hour [scores, each 1]; in 3/3 animals after 6 hours [1, 2 and 1 respectively]; and in 1/3 animals after 24 hours [1]) were observed, but were fully reversible within 6 and 48 hours, respectively. It therefore can be assumed that the test substance is not irritating to the rabbit eye.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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