Registration Dossier
Registration Dossier
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EC number: 277-539-5 | CAS number: 73570-52-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 3,7-bis(diethylamino)phenoxazin-5-ium tetrachlorozincate (2:1)
- EC Number:
- 264-355-5
- EC Name:
- 3,7-bis(diethylamino)phenoxazin-5-ium tetrachlorozincate (2:1)
- Cas Number:
- 63589-47-9
- Molecular formula:
- C20H26N3O.1/2Cl4Zn
- IUPAC Name:
- bis[3,7-bis(diethylamino)phenoxazin-5-ium] tetrachlorozincate(2-)
- Test material form:
- solid: particulate/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: Hacking & Churchill Ltd. Huntingdon, UK
- Housing: single cage
- Weight: 3.5 - 3.8 kg
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): as lib.
- Acclimation period: 7 d
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
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 21 d
- Number of animals or in vitro replicates:
- 3 female rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline
SCORING SYSTEM: Draize system
TOOL USED TO ASSESS SCORE:fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 d
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 21
- Remarks on result:
- probability of severe irritation
- Irritant / corrosive response data:
- Conjunctivae redness and chemosis not fully reversible within 21 d in 2/3 animals.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Based on an OECD 405 study with rabbits, the substance causes severe damage to eyes. The substance is classifiable according to GHS Category 1 due to the lack of reversibility within 21 d (conjunctivae redness and chemosis).
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