Registration Dossier
Registration Dossier
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EC number: 228-809-6 | CAS number: 6359-83-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (US AFDO, 1959)
- GLP compliance:
- no
Test material
- Reference substance name:
- Disodium 2-[[4,5-dihydro-3-methyl-5-oxo-1-(4-sulphonatophenyl)-1H-pyrazol-4-yl]azo]benzoate
- EC Number:
- 228-809-6
- EC Name:
- Disodium 2-[[4,5-dihydro-3-methyl-5-oxo-1-(4-sulphonatophenyl)-1H-pyrazol-4-yl]azo]benzoate
- Cas Number:
- 6359-83-7
- Molecular formula:
- C17H14N4O6S.2Na
- IUPAC Name:
- disodium 2-[[4,5-dihydro-3-methyl-5-oxo-1-(4-sulphonatophenyl)-1H-pyrazol-4-yl]azo]benzoate
- Test material form:
- solid: particulate/powder
1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.5 - 1.9 kg
- Housing: single metal cage
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
- Acclimation period: min. 8 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 19°C
- Humidity (%): 50 - 60% rh
- Photoperiod (hrs dark / hrs light): 10 / 14
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 3 animals: a few seconds, then rinsed with physiological saline
3 animals: no washing - Observation period (in vivo):
- 8 d
- Number of animals or in vitro replicates:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- unrinsed eyes
- Time point:
- 24/48/72 h
- Score:
- 0.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48
- Remarks:
- h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- unrinsed eyes
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- unrinsed eyes
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72
- Remarks:
- h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- unrinsed eyes
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48
- Remarks:
- h
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No effects observed in rinsed eyes
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance did not cause significant signs of eye irritation. Weak signs (redness) were fully reversible within 72 h. The substance is not classifiable according to CLP criteria.
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