Registration Dossier
Registration Dossier
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EC number: 947-523-9 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- (Z)-(carboxymethyl)dimethyl-3-[(1-oxo-9-octadecenyl)amino]propylammonium hydroxide
- EC Number:
- 246-584-2
- EC Name:
- (Z)-(carboxymethyl)dimethyl-3-[(1-oxo-9-octadecenyl)amino]propylammonium hydroxide
- Cas Number:
- 25054-76-6
- Molecular formula:
- C25H48N2O3
- IUPAC Name:
- N-(carboxymethyl)-N,N-dimethyl-3-(oleoylamino)propan-1-aminium hydroxide
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Dihydrogen oxide
- Reference substance name:
- Propane-1,2-diol
- EC Number:
- 200-338-0
- EC Name:
- Propane-1,2-diol
- Cas Number:
- 57-55-6
- Molecular formula:
- C3H8O2
- IUPAC Name:
- propylene glycol
- Reference substance name:
- Sodium chloride
- EC Number:
- 231-598-3
- EC Name:
- Sodium chloride
- Cas Number:
- 7647-14-5
- Molecular formula:
- ClNa
- IUPAC Name:
- sodium chloride
- Test material form:
- liquid
1
2
3
4
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Animals were housed individually in stainless steel cages
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1 mL of undiluted test material
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- The test sample was instilled into the conjunctival sac of the right eye of each rabbit, with the left eye serving as a control. The general technique followed that of the Draize method. At each scoring interval the cornea, iris and conjunctivae were examine dand graded for irritation and injury in accordance with the Draize scoring system.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks:
- 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.416
- Max. score:
- 2
- Reversibility:
- fully reversible within:
- Remarks:
- 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.35
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks:
- 14 days
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Max. score:
- 3
- Reversibility:
- fully reversible within:
- Remarks:
- 14 days
- Remarks on result:
- positive indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- Substance is classiifed as H319 under GHS classification criteria
- Executive summary:
The test sample was instilled into the conjunctival sac of the right eye of each rabbit, with the left eye serving as a control. The general technique followed that of the Draize method. At each scoring interval the cornea, iris and conjunctivae were examine dand graded for irritation and injury in accordance with the Draize scoring system.
Followoijgn gradings over 24, 48 and 72 hours the mean score for cornea opacity, Iritis, conjunctivae redness and swelling was 1.6, 0.41, 1.6 and 1.35, respectively. All effects were fully reversed by the end of the 14 day observation period. Based on the results of this study the test substance is considered to be an eye irritant under GHS classification criteria.
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