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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:
1963
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well documented study result, which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1963
Report date:
1963

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A Choline chloride solution (undiluted) was administered to rabbit eyes for 20 hours.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Choline chloride
EC Number:
200-655-4
EC Name:
Choline chloride
Cas Number:
67-48-1
Molecular formula:
C5H14NO.Cl
IUPAC Name:
2-hydroxy-N,N,N-trimethylethanaminium chloride
Test material form:
other: liquid
Details on test material:
Name of test material (as cited in report): Cholinchlorid 70%ig unverdünnt (Choline chloride 70% solution (undiluted))
Name of Test material: Trimethyl-beta-hydroxyethyl-ammoniumhydrochlorid

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
The substance was administered to rabbit eyes for 20 hours.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as a control
Amount / concentration applied:
no data
Duration of treatment / exposure:
1 h, 24 h, 8 days
Observation period (in vivo):
1 h, 24 h, 8 days
Number of animals or in vitro replicates:
no data
Details on study design:
the test item was applied unchanged to an area of 1 * 50 mm³ of the rabbit eye

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 h
Score:
> 0
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: slight reddening was observed after 1 hour
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
0
Reversibility:
other: not applicable
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 8 days
Score:
0
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
actual number of animals not reported
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: individual results not specified
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
actual number of animals not reported
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: individual results not specified
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
actual number of animals not reported
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: individual results not specified
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
actual number of animals not reported
Time point:
24/48/72 h
Reversibility:
not specified
Remarks on result:
other: individual results not specified

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The study was considered to be of high quality (reliability Klimisch 2). The substance did not show a significant irritation after a single ocular application to the rabbit eye for 20 h. The substance is not considered to be irritating to the eyes.
Executive summary:
The eye irritation potential of the test substance was investigated in rabbits (BASF, 1963). The test substance was administered to the rabbit eye and the resulting effects were evaluated. After 1-hours a slight reddening was noted, which was fully reversible as after 24 hours and after 8 days no findings were reported. The test item can be regarded as not irritating to the eye.