Registration Dossier
Registration Dossier
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EC number: 424-870-1 | CAS number: 27624-67-5
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 92/69/EEC
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 424-870-1
- EC Name:
- -
- Cas Number:
- 27624-67-5
- Molecular formula:
- C14H16N4O9S3
- IUPAC Name:
- 2,4-diamino-5-(2-{4-[2-(sulfooxy)ethanesulfonyl]phenyl}diazen-1-yl)benzene-1-sulfonic acid
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 86 mg
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- not fully reversible within: Changes not fully reversible within 21 days
- Remarks on result:
- probability of severe irritation
- Remarks:
- Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- not fully reversible within: Changes not fully reversible within 21 days
- Remarks on result:
- probability of severe irritation
- Remarks:
- Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: Changes not fully reversible within 21 days
- Remarks on result:
- probability of severe irritation
- Remarks:
- Max. duration: 72 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- not fully reversible within: Changes not fully reversible within 21 days
- Remarks on result:
- probability of severe irritation
- Remarks:
- Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- not fully reversible within: Changes not fully reversible within 21 days
- Remarks on result:
- probability of severe irritation
- Remarks:
- Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- not fully reversible within: Changes not fully reversible within 21 days
- Remarks on result:
- probability of severe irritation
- Remarks:
- Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- not fully reversible within: Changes not fully reversible within 21 days
- Remarks on result:
- probability of severe irritation
- Remarks:
- Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- not fully reversible within: Changes not fully reversible within 21 days
- Remarks on result:
- probability of severe irritation
- Remarks:
- Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- not fully reversible within: Changes not fully reversible within 21 days
- Remarks on result:
- probability of severe irritation
- Remarks:
- Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- not fully reversible within: Changes not fully reversible within 21 days
- Remarks on result:
- probability of severe irritation
- Remarks:
- Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- not fully reversible within: Changes not fully reversible within 21 days
- Remarks on result:
- probability of severe irritation
- Remarks:
- Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- not fully reversible within: Changes not fully reversible within 21 days
- Remarks on result:
- probability of severe irritation
- Remarks:
- Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes not fully reversible within 21 days
- Other effects:
- Residual test material was noted around the treated eye of all animals throughout the study.
Orange-coloured staining was noted in all treated eyesduring the study.
Dulling of the normal lustre of the cornea was noted in two treated eyes one hour after treatment, in all treated eyes at the 24-hour observation and in one treated eye at the 48-hour observation.
No other corneal effects were noted.
Orange-coloured staining prevented accurate evaluation of
the iris in all treated eyes one hour after treatment, in
two treated eyes at the 24-hour observation and in one
treated eye at the 24-hour observation. The staining
persisted in the two surving animals up to and including the
21-day observation. Iridial inflammation was noted in one
treated eye at the 24-hour observation. No other iridial effects were noted.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The substance is classified as a severe eye irritant (H318),
due to persistent staining and effects on the iris.
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