Registration Dossier
Registration Dossier
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EC number: 949-050-3 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- other: experimental data on similar substance
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Trisodium bis[2-hydroxy-5-nitro-3-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]benzenesulphonato(3-)]cobaltate(3-)
- EC Number:
- 289-068-2
- EC Name:
- Trisodium bis[2-hydroxy-5-nitro-3-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]benzenesulphonato(3-)]cobaltate(3-)
- Cas Number:
- 85959-73-5
- Molecular formula:
- C32H22CoN8O16S2.3Na
- IUPAC Name:
- trisodium;cobalt(3+);(2Z)-2-[(5-nitro-2-oxido-3-sulfonatophenyl)hydrazinylidene]-3-oxo-N-phenylbutanimidate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Age: 15-16 weeks
Body weight: 2.4 -2.8 kg
Source: Kelintierfarm Madoerin AG, Fuellinsdorf CH
Acclimation: 4 days under test conditions after veterinary control.
Accomodation: Caged singly in stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret Gmbh, Emmendingen FRG D
Air conditioned with 10-15 air chnages per hour and hourly monitored environment with temperature of 22°C and with a humidity of 40-70%.
Animals were exposed to artificial light for 12 hours daily, Music/light period.
Diet: Pelleted standard Kliba 341, Batch 11/85 rabbit maintenance diet (Kliba, Klingentalmuehle AG, Kaiseraugst CH) was fed ad libitum. The food was analysed and the results of contaminats are attached to the study report.
Water: community tap water from Itingen ad libitum. The water was analysed and the results are attached to the study report.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the right eye serves as control
- Amount / concentration applied:
- 0.1 g of the test substance
- Duration of treatment / exposure:
- no data
- Observation period (in vivo):
- up to 14 days
- Number of animals or in vitro replicates:
- 2 males / 1 females
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- male and female
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 66
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis
- Basis:
- animal: 64
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis
- Basis:
- animal: 65
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis
- Basis:
- animal: 66
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- No corrosion of cornea was observed at any of the measuring intervals.
- Other effects:
- Coloration: in the area of application a clear visible brownish disocloration of the cornea and conjunctivae was observed which could be related to the color of the test article.
Toxic symptoms / mortality: no acute symptoms were observed during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The tested substance needs to be considered irritant for rabbits eyes under Regulation CE 1272/2008.
- Executive summary:
The ocular reactions were determined followign OECD 405.
The tested substance is considered to be irritant for the rabbits eyes based on the results needs to be classified as H319, Causes serious eye irritation under Regulation 1272/2008.
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