Registration Dossier
Registration Dossier
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EC number: 279-301-6 | CAS number: 79817-70-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Referenced as Method B5 in Commision Directive 84/449/EEC
- GLP compliance:
- yes
- Remarks:
- Good Laboratory Practice, The United Kingdom Compliance Programme, Department of Health 1989
Test material
- Reference substance name:
- 1',2'-dihydro-6'-hydroxy-3,4'-dimethyl-2'-oxo-1,3'-bipyridinium chloride
- EC Number:
- 279-301-6
- EC Name:
- 1',2'-dihydro-6'-hydroxy-3,4'-dimethyl-2'-oxo-1,3'-bipyridinium chloride
- Cas Number:
- 79817-70-2
- Molecular formula:
- C12H13N2O2.Cl
- IUPAC Name:
- 6'-hydroxy-3,4'-dimethyl-2'-oxo-1',2'-dihydro-1,3'-bipyridinium dichloride
- Test material form:
- liquid
- Details on test material:
- Active su
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- not specified
- Amount / concentration applied:
- A volume of 0.1 ml of the test material was instilled into the conjunctival sac of the right eye
- Duration of treatment / exposure:
- The upper and lower eyelids were held together for about one second immediately after instillation.
- Observation period (in vivo):
- Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48, 72 hours follwing treatment.
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 1 h
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness, chemosis and discharge
- Basis:
- mean
- Time point:
- 24/48/72 h
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material did not produce positive criteria in any rabbit according to the EEC labellng regulations and was classified as NON-IRRITANT to the rabbit eye. No symbol and risk phrase are therefore required
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