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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin 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 skin 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

Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
The substance was administered dermally to rabbit skin (back) for 20 hours.
The substance was administered dermally to rabbit ears for 20 hours.

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated skin served as a control
Amount / concentration applied:
no data
Duration of treatment / exposure:
20 hours
Observation period:
24 hours and 8 days after the application for 20 h
Number of animals:
no data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
ca. 0
Reversibility:
fully reversible
Remarks on result:
other: ambiguous slight redness was observed on the back of the animals
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours and 8 days after application
Score:
0
Reversibility:
other: not applicable
Remarks on result:
other: no irritation was found on the ears after 20 hour applications
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 8 days
Score:
ca. 0
Reversibility:
fully reversible
Remarks on result:
other: ambiguous slight redness was observed on the back of the animals
Irritation parameter:
erythema 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:
edema 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
Irritant / corrosive response data:
ambigous slight redness of the skin was observed after a 20 hours application and a 24 hour / 8 days observation period.

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 dermal application to rabbit skin for 20 h. The substance is not considered to be irritating to the skin.
Executive summary:
The skin irritation potential of the test substance was investigated in rabbits (BASF, 1963). The test substance was administered to the back or to the ears for 20 hours and the resulting effects were evaluated. After 24 -hours an ambigous slight reddening of the skin of the back, or for the ears after 24 hours and also after 8 days no changes of the skin of any animal were observed. The test item can be regarded as not irritating to the skin.