Registration Dossier
Registration Dossier
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EC number: 228-800-7 | CAS number: 6359-50-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 - 19 Mar 1980
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: modified ETAD method
- Version / remarks:
- based on FDA method (1959)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-[2-(2,3-dihydro-2-methyl-1H-indol-1-yl)vinyl]-1,3,3-trimethyl-3H-indolium chloride
- EC Number:
- 228-800-7
- EC Name:
- 2-[2-(2,3-dihydro-2-methyl-1H-indol-1-yl)vinyl]-1,3,3-trimethyl-3H-indolium chloride
- Cas Number:
- 6359-50-8
- Molecular formula:
- C22H25N2.Cl
- IUPAC Name:
- 2-[2-(2,3-dihydro-2-methyl-1H-indol-1-yl)vinyl]-1,3,3-trimethyl-3H-indolium chloride
- Test material form:
- solid: particulate/powder
- Details on test material:
- Common name: Basic Yellow 21 chloride
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hacking & Churchill Ltd., Huntingdon, UK
- Housing: single cage (Type III)
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: 7 - 14 d
- Sex: female
- Number of animals: 6
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25°C
- Humidity (%): 40 - 60% r.h.
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg
- Observation period (in vivo):
- 7 d
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize score
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1, 2, 5, 6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 d
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3, 4
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 d
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 2, 3, 4, 5
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 d
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 1, 6
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 d
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 2, 3, 4, 5, 6
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 d
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1, 5, 6
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: 2, 3, 4
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 d
- Remarks on result:
- probability of severe irritation
- Irritant / corrosive response data:
- Irreversible and diffuse cornea opacity, eye damaging, strong corrosive effects
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The substance caused severe effects in rabbit eyes (diffuse and irreversible cornea opacity). All symptoms described were not reversible within 7 d. The substance is classified as Category 1.
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