Registration Dossier
Registration Dossier
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EC number: 205-047-2 | CAS number: 132-16-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Remarks:
- eye irritation test on rabbits
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- The toxicity of copper is known to be greater than iron so it is considered valid to read-across to the copper complex on the assumption that if the copper complex is not toxic, then the iron complex will not be toxic. Both forms have similar (low) solubility in water and will have equivalent bioavailability.
Further animal testing is not justified.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: eye irritation in rabbits. Method not specified
- Deviations:
- not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper
- EC Number:
- 205-685-1
- EC Name:
- 29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper
- Cas Number:
- 147-14-8
- Molecular formula:
- C32H16CuN8
- IUPAC Name:
- [29H,31H-phthalocyaninato(2-)-kappa~2~N~29~,N~31~]copper
- Test material form:
- solid: crystalline
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- not specified
Test system
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 100 mg of a 46% dispersion
100 mg dye, or 100 mg 25 or 50%
susdye
(applied as Viscoblau BL Teig)pension in water - Duration of treatment / exposure:
- not specified
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- An eye irritation test in rabbits with 100 mg of a 46% dispersion of CuPC (vehicle not mentioned) produced slight opacity with damage to the surface epithelium in 2/6 rabbits. In another test with 100 mg dye, or 100 mg 25 or 50% suspension in water no changes were observed. In a third test with the dye (applied as Viscoblau BL Teig) dulling of the cornea and mild conjunctival reactions were seen in 3/6 rabbits; the total score resulted in the classification : "non irritant".
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