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EC number: 263-503-6 | CAS number: 62314-25-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 18, 1976 - December 29, 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Justification for type of information:
- The method employed was similar to that described in Section 1500.42. - Hazardous Substances and Articles , Administration and Enforcement Regulations, Federal Register, Vol. 38, No. 187, P. 27019, 27 September 1973.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- Principles of method if other than guideline:
- Six healthy young adult albino rabbits were used in this study. 0.1 ml of the experimental material was instilled in to the right eyes of the test animals while the other eyes remained untreated to serve as controls . The test material was not washed from the eyes.
The treated eyes were examined a t 1, 24, 48 & 72 hrs. as well as 5 & 7 days following instillation of the test material into the eyes. Interpretation of the results was made in accordance with the grading system outlined in the "Illustrated Guide for Grading Eye lrritation By Hazardous Substances". - GLP compliance:
- not specified
Test material
- Reference substance name:
- (2-hydroxypropyl)trimethylammonium formate
- EC Number:
- 263-503-6
- EC Name:
- (2-hydroxypropyl)trimethylammonium formate
- Cas Number:
- 62314-25-4
- Molecular formula:
- C6H16NO.CHO2
- IUPAC Name:
- (2-hydroxypropyl)trimethylammonium formate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- DABCO TMR-2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Remarks:
- Albino
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- The test material was not washed from the eyes.
- Observation period (in vivo):
- 1, 24, 48 & 72 hrs. as well as 5 & 7 days following instillation
- Number of animals or in vitro replicates:
- Six rabbits
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: all animals
- Time point:
- other: all time points 1, 24, 48 & 72 hrs, 5 & 7 days
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- other: all animals
- Time point:
- other: all time points 1, 24, 48 & 72 hrs, 5 & 7 days
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- >= 2 - <= 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- >= 2 - <= 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 5 days
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- The tested substance is a mild ocular irritant with effects fully reversible after 7 days.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The tested substance is a mild ocular irritant with effects fully reversible after 7 days.
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