Registration Dossier
Registration Dossier
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EC number: 264-497-8 | CAS number: 63817-45-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Sep 1980
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations, Title 16, Section 1500.42
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- 1-ethyl-2-[1,2,3,4-tetrahydro-1-(2-hydroxyethyl)-2,2,4-trimethyl-6-quinolyl]benz[cd]indolium chloride
- EC Number:
- 264-497-8
- EC Name:
- 1-ethyl-2-[1,2,3,4-tetrahydro-1-(2-hydroxyethyl)-2,2,4-trimethyl-6-quinolyl]benz[cd]indolium chloride
- Cas Number:
- 63817-45-8
- Molecular formula:
- C27H31N2O.Cl
- IUPAC Name:
- 1-ethyl-2-[1-(2-hydroxyethyl)-2,2,4-trimethyl-1,2,3,4-tetrahydroquinolin-6-yl]benzo[cd]indolium chloride
- Test material form:
- solid
- Details on test material:
- Basic Blue 147 Cl
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: W. Ostrop, Meerbusch, Germany
- Weight at study initiation: average 2.4 kg
- Housing: individually
- Diet (e.g. ad libitum): "mümmel z" ad libitum
- Water (e.g. ad libitum): mains water ad libitum
- Acclimation period: 7d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 18°C
- Humidity (%): 40%
- Photoperiod (hrs dark / hrs light): 12h/12h
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 µL of the test substance - Duration of treatment / exposure:
- 1 treatment at 0 h
- Observation period (in vivo):
- 1, 24, 48, 72 h and 8 d
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: fluorescein after 24 h
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1; 2; 4; 5; 6
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 d
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 1;4;5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 d
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 8 d
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Max. score:
- 3
- Remarks on result:
- not determinable
- Remarks:
- test item caused strong corrosive effects that do not allow to determine redness
- Irritation parameter:
- chemosis score
- Basis:
- animal: all animals
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 d
- Remarks on result:
- probability of severe irritation
- Irritant / corrosive response data:
- Strong corrosive effects visible on cornea and iris. Significant edema observed. Not reversible within observation period.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test substance was found to be corrosive to rabbit eyes under the conditions of the test. The substance is classified as Category 1 according to CLP criteria.
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