Registration Dossier
Registration Dossier
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EC number: 240-185-7 | CAS number: 16044-24-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methanaminium, N-[4-[[4-(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, ethanedioate
- EC Number:
- 241-922-5
- EC Name:
- Methanaminium, N-[4-[[4-(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, ethanedioate
- Cas Number:
- 18015-76-4
- Molecular formula:
- C25H26N2O4
- IUPAC Name:
- Methanaminium, N-[4-[[4-(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, ethanedioate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Basic Green 4 Oxalate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hagemann GmbH & Co. KG, Extertal, Germany
- Weight at study initiation: 2.4 kg (mean)
- Housing: polyethylene cages
- Diet (e.g. ad libitum): "Ssniff K 4" , Ssniff Spezialdiaten GmbH, Soer - approx. 100 - 120 g per animal and day; feeding once per day in the morning
- Water (e.g. ad libitum): ad lib.
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 18
- Humidity (%): approx. 40
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 µL / animal
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 8 d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize system
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3.77
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 d
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- 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:
- chemosis score
- Basis:
- mean
- 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
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: all
- Time point:
- 24/48/72 h
- Max. score:
- 3
- Remarks on result:
- not determinable
- Remarks:
- staining by test substance
- Irritant / corrosive response data:
- The substance is corrosive and causes irreversible eye damage. Conjunctivae redness could not be determined since the substance discoloured the eyes´ surface.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test item caused irreversible eye damage in all animals. The substance is classified as Cat. 1.
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