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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1963
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well documented study result on read-across substance Choline chloride, 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 adminstered to rabbit eyes for 20 hours.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Choline chloride
EC Number:
200-655-4
EC Name:
Choline chloride
Cas Number:
67-48-1
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:
other: 24 hours
Score:
0
Reversibility:
other: not applicable
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 8 days
Score:
0
Reversibility:
other: not applicable

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
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 read-across substance Choline chloride 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.