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EC number: 263-856-6 | CAS number: 63105-49-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979-10-29 to 1979-11-01
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FDA Guideline (Federal register 38, No. 187, 27.9.1973, p.27019)
- GLP compliance:
- no
Test material
- Reference substance name:
- Trisodium [5-acetamido-4-hydroxy-3-[[2-hydroxy-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonato(5-)]cuprate(3-)
- EC Number:
- 263-856-6
- EC Name:
- Trisodium [5-acetamido-4-hydroxy-3-[[2-hydroxy-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonato(5-)]cuprate(3-)
- Cas Number:
- 63105-49-7
- Molecular formula:
- C20H14CuN3O15S4.3Na C20H14CuN3Na3O15S4
- IUPAC Name:
- trisodium [5-acetamido-4-hydroxy-3-[[2-hydroxy-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonato(5-)]cuprate(3-)
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Remarks:
- Albino Himalayan (strain: Hoe:HIMK SPFWiga)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: inhouse
- Weight at study initiation: 1.6 - 2.0 kg
- Housing: individual
- Diet (e.g. ad libitum): standard food ERKA 8300 (Futtermittelwerk Robert Koch oHG), ad libitum
- Water (e.g. ad libitum): ad libitum
In-life period from 1979-10-29 to 1979-11-01
Test system
- Vehicle:
- physiological saline
- Remarks:
- 0.05 mL to moisten the powder
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg test substance pasted with 0.05 ml physiological saline - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- after 1, 7, 24, 48 and 72 h
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological saline
- Time after start of exposure: 24h
SCORING SYSTEM: according to "Appraisal of the Safety of Chemicals in Foods, drugs and Cosmetics", FDA, Austin Texas; p.51, 1975 (equivalent to Draize scoring)
TOOL USED TO ASSESS SCORE: magnifying glass 1, 7, 24, 48 and 72 h after test substance application; after 48 and 72h instillation of one drop 0.01% fluorescein-sodium (1:10000)
Results and discussion
In vivo
Resultsopen allclose all
- 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
- 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:
- 0.17
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis 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:
- Slight redness and swelling was observed in 5 and 4 rabbit eyes, respectively, 1 hour after test substance administration. This test item-related redness reversed within 48 hours.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not considered to be an eye irritant. Weak signs of irritation (redness) occurred but were fully reversible within 48 h. The substance is not classifiable according to CLP criteria.
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