Registration Dossier
Registration Dossier
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EC number: 278-137-2 | CAS number: 75214-69-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Mar 1984
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
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:
- Sodium bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-N,N-dimethylbenzene-1-sulphonamidato(2-)]chromate(1-)
- EC Number:
- 278-137-2
- EC Name:
- Sodium bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-N,N-dimethylbenzene-1-sulphonamidato(2-)]chromate(1-)
- Cas Number:
- 75214-69-6
- Molecular formula:
- C36H34CrN10NaO8S2
- IUPAC Name:
- hydroxylamine
- Test material form:
- solid: granular
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Interfauna UK Ltd., Huntingdon, UK
- Weight at study initiation: 3.4 - 3.9 kg (all female)
- Housing: polyethylene cages
- Diet: standard diet "Ssniff K 4" (Ssniff Spezialdiaten GmbH, Soest), approx. 100 - 120 g per animal and day; feeding once per day in the morning.
- Water: tap water was available for ad libitum consumption (between 7 and 19 hrs. from automatic watering apparatus)
- Acclimation period: at least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): approx. 50
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg / animal
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with saline, after 24 h treatment
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:
- 0.78
- 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:
- 1.78
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 d
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- probability of mild irritation
- Irritant / corrosive response data:
- No signs of corrosion observed.
- Other effects:
- Erosions of the nictitating membrane observed at 24/48/72 h in all three animals. Fully reversible within 7 d.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item caused mild to moderate signs of irritation in rabbit eyes (cornea opacity, conjunctivae redness, chemosis), all signs were fully reversible within 7 d. However, the classification criteria of the CLP Regulation were not met. Therefore, the substance is not classifiable.
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