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Toxicological information

Eye irritation

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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:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Dose level
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

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.