Registration Dossier
Registration Dossier
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EC number: 246-745-7 | CAS number: 25234-60-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November / December 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- DRAIZE test
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Dose level
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-lauroyloxyethyltrimethylammonium chloride
- EC Number:
- 246-745-7
- EC Name:
- 2-lauroyloxyethyltrimethylammonium chloride
- Cas Number:
- 25234-60-0
- Molecular formula:
- C17H36NO2.Cl
- IUPAC Name:
- [2-(dodecanoyloxy)ethyl]trimethylazanium chloride
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Housing and feeding conditions:
The temperature of the experimental animal room was 20°C. The relative humidity was 50%. Lighting was artificial, the sequence was 12 hours light, 12 hours dark. Food and water was provided at discretion.
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- physiological saline with 2000 ppm of the test substance 2-lauroyloxyethyltrimethylammonium chloride
- Duration of treatment / exposure:
- 4 d
- Observation period (in vivo):
- daily
- Number of animals or in vitro replicates:
- 8
- Details on study design:
- One minute after application the treated eye was rinsed with 10-20 mL of lukewarm physiological saline, at one half of the test animals (4 animals).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: all
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- even after 96h
- Irritation parameter:
- iris score
- Basis:
- animal: all
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- even after 96h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: all
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- even after 96h
- Irritation parameter:
- chemosis score
- Basis:
- animal: all
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Remarks:
- even after 96h
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- After daily application of the test substance 2-lauroyloxyethyltrimethylammonium chloride in physiological saline no eye irritation could be observed, after overall 4 days. The test substance can be stated as non-irritating for the eyes.
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