Registration Dossier
Registration Dossier
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EC number: 305-644-9 | CAS number: 94891-43-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979-02-05 to 1979-02-08
- 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: FDA-gudieline
- Version / remarks:
- (Federal register 38; No. 187, 27.9.1973, p 27019)
- GLP compliance:
- no
Test material
- Reference substance name:
- Nickel, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chlorosulfonyl derivs., reaction products with 2-[(4-aminophenyl)sulfonyl]ethyl hydrogen sulfate monosodium salt, sodium salts
- EC Number:
- 305-644-9
- EC Name:
- Nickel, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chlorosulfonyl derivs., reaction products with 2-[(4-aminophenyl)sulfonyl]ethyl hydrogen sulfate monosodium salt, sodium salts
- Cas Number:
- 94891-43-7
- Molecular formula:
- C32 H16 N8 Ni . C8 H11 N O6 S2 . 2 Na
- IUPAC Name:
- Nickel, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chlorosulfonyl derivs., reaction products with 2-[(4-aminophenyl)sulfonyl]ethyl hydrogen sulfate monosodium salt, sodium salts
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Remarks:
- Albino-Himalayan-rabbit (Hoe: HIMK (SPFWiga))
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: inhouse
- Weight at study initiation: 1.5 - 2.5kg
- Housing: individually housed
- Diet (e.g. ad libitum): ad libitum (ERKA 8300 (Futtermittelwerk Robert Koch oHG))
- Water (e.g. ad libitum): 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): 0.1mL undiluted test item
- Concentration (if solution): undiluted test item - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 1, 7, 24, 48, 72h after application
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): 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, p51,1975
TOOL USED TO ASSESS SCORE: magnifying-glass, prior to observation time 48 and 72h: one drop of 1:10000 (=0.01%) Fluorecein-sodium solution
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
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.17
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.06
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Other effects:
- Nictitating membrane and mucous membrane were colored greenish-blue
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance was considered to be not eye irritant. The substance is not classifiable according to CLP criteria.
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