Registration Dossier
Registration Dossier
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EC number: 239-471-4 | CAS number: 15454-74-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- (1987)
- Deviations:
- yes
- Remarks:
- The second eye which must serve to control is not stated in study report
- GLP compliance:
- yes
Test material
- Reference substance name:
- Bis(5-oxo-L-prolinato-N1,O2)copper
- EC Number:
- 239-471-4
- EC Name:
- Bis(5-oxo-L-prolinato-N1,O2)copper
- Cas Number:
- 15454-74-7
- Molecular formula:
- C10H12CuN2O6
- IUPAC Name:
- bis(5-oxo-L-prolinato-N1,O2)copper
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
- Duration of treatment / exposure:
- Single application
- Observation period (in vivo):
- 1, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not mentioned
TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- other: animal sacrified day-4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- other: animal sacrified day-4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Reversibility:
- other: animal sacrified day-4
- Remarks on result:
- not determinable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- other: animal sacrified day-4
- Other effects:
- animal sacrificed on day 4 due to severity of lesions; iris score at 72h was not readable due to the severity lesions.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Under the test conditions, the product is classified Eye Dam.1, H318 according CLP and GHS criteria
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