Registration Dossier
Registration Dossier
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EC number: 263-417-9 | CAS number: 62121-75-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- other: data sharing dispute
- Adequacy of study:
- key study
- Study period:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FDA Mucuous Membrane Test
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- p-[4,5-dihydro-4-[[2-methoxy-5-methyl-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonic acid, sodium salt
- EC Number:
- 263-417-9
- EC Name:
- p-[4,5-dihydro-4-[[2-methoxy-5-methyl-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonic acid, sodium salt
- Cas Number:
- 62121-75-9
- Molecular formula:
- C20H22N4O11S3.xNa C20H(22-x)N4NaxO11S3; x<=2
- IUPAC Name:
- sodium 4-[4-(2-{2-methoxy-5-methyl-4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)-3-methyl-5-oxo-4,5-dihydro-1H-pyrazol-1-yl]benzene-1-sulfonate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- - Test animal weight: 1.5 - 2.0 kg
- One cage per animal
- Feeding: standard food ERKA 8300, ad libitum
- Water: tap drinking water, ad libitum
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg of pure substance (powder) - Duration of treatment / exposure:
- 1 treatment at 0 h
- Observation period (in vivo):
- 72 h
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h after treatment
SCORING SYSTEM:
- cornea: opacity (0 - 4) and effected area (0 - 4)
- iris: viability (0 - 4)
- conjunctiva: erythema (0 - 4), swell (0 - 4), secretion (0 - 4)
0 is no effect, 4 is a severe effect. The sum of all values from cornea, iris and conjunctiva is multiplied
by 2. The mean value for all animals is divided by the number of animals (6). The score is determined at all points of observation (1, 7, 24, 48, 72 h after treatment). The highest score at any point of time
is used for the assessment (worst case).
Overall scoring: 0 - 10: non irritant, 11 - 25: slightly irritant, 26 - 56: moderately irritant, 57 - 110:
severely irritant
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 and 72 h
- Score:
- 10
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 72 h 1 out of 5 rabbits with erythema still showed minimal reddening at 72 h
- Remarks on result:
- no indication of 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:
- 0.61
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h 1 out of 5 rabbits with erythema still showed minimal reddening at 72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.167
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Very slight irritation observed for conjunctivae.
- Other effects:
- None.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No irritation (overall scoring) was observed at 24/72 h mean after a 24h exposure with the pure substance on rabbits. The substance is not considered to be irritating to eyes according to CLP criteria.
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