Registration Dossier
Registration Dossier
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EC number: 219-949-9 | CAS number: 2580-78-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 to 08 February 1979
- 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:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register 38, No. 187
- Principles of method if other than guideline:
- Federal Register 38, No. 187
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-(3-(4-amino-9,10-dihydro-3-sulpho-9,10-dioxoanthracen-4-yl)aminobenzenesulphonyl)vinyl) disodium sulphate
- EC Number:
- 219-949-9
- EC Name:
- 2-(3-(4-amino-9,10-dihydro-3-sulpho-9,10-dioxoanthracen-4-yl)aminobenzenesulphonyl)vinyl) disodium sulphate
- Cas Number:
- 2580-78-1
- Molecular formula:
- C22H18N2O11S3.2Na C22H18N2Na2O11S3
- IUPAC Name:
- disodium 1-amino-9,10-dioxo-4-[(3-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)amino]-9,10-dihydroanthracene-2-sulfonate
- Details on test material:
- Reactive Blue 19
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- SPF Himalayan Albino Rabbits: Hoe:HIMK(SPFWiga)
Food: ERKS 8300
Supplier: Futtermittelwerke Robert Koch oHG Hamm
Water: Tap water
Food and water ad libitum
Single housing
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- up to 72 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- The test item was applied to the left eye of each rabbit. The contra-lateral eye served as intra-individual control. Evaluation 1, 7, 24, 48, and 72 hours after test item application by means of a magnifying lens. After 24 hours the eyes were rinsed with physiological saline solution. At 48 and 72 hours evaluation, fluorescein staining was used to verify the absence of corneal lesions.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.83
- Max. score:
- 4
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.17
- Max. score:
- 3
- 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:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 6 rabbits
- Time point:
- 24/48/72 h
- Score:
- 0.28
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 28
- Max. score:
- 110
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 7 hours
- Score:
- 22
- Max. score:
- 110
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 14
- Max. score:
- 110
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 8
- Max. score:
- 110
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 2
- Max. score:
- 110
- Irritant / corrosive response data:
- All animals: Nictitating membranes and conjunctive bluish stained up to 24 hours
Cornea minimally bluish stained in 5 rabbits on Day 1, still visible in 3 rabbits on Day 3. Due to the short post-observation period an the fact that the staining proved already to be reversible in 2 rabbits up to the end of the observation time. Full reversibility of the staining within a 21 day post-observation time is very likely.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Classification according to EU: no classification necessary
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