Registration Dossier
Registration Dossier
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EC number: 700-941-3 | CAS number: 1512859-54-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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:
- Cuprate(4-), [2-[[4-chloro-6-[ethyl[3-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-5-(hydroxy-kO)-6-[2-[2-[2-[2-(hydroxy-kO)-5-sulfophenyl]diazenyl-kN1]-4,5-dimethoxyphenyl]diazenyl-kN2]-1,7-naphthalenedisulfonato(6-)]-, hydrogen sodium (1:2:2)
- EC Number:
- 700-941-3
- Cas Number:
- 1512859-54-9
- Molecular formula:
- C37H28ClCuN9O19S5 . 2 Na . 2 H
- IUPAC Name:
- Cuprate(4-), [2-[[4-chloro-6-[ethyl[3-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-5-(hydroxy-kO)-6-[2-[2-[2-[2-(hydroxy-kO)-5-sulfophenyl]diazenyl-kN1]-4,5-dimethoxyphenyl]diazenyl-kN2]-1,7-naphthalenedisulfonato(6-)]-, hydrogen sodium (1:2:2)
- Details on test material:
- Nature of substance: Powder.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- water
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50mg - Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: 1 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Max. score:
- 1
- Remarks on result:
- other: Max. duration: 1 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
- Other effects:
- No chenges in behavior were observed clinically in all rabbits during the 72-hour study period. The test substance was flushed out at one hour after dosing by normal saline. The body weight change during the study interval was in the normal range.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The study results indicated an irritating effect occurred when "Everzol SB45" treated to the eyes after test substance administration and the ocular reactions observed during study period were reversible. Based on OECD Guidelines for the Testing of Chemicals #405 (2002), "Everzol SB45" is judged to be a positive irritant to the eyes in rabbits.
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