Choline chloride

Endpoint summary

Description of key information

Skin irritation: dermal application, rabbit, skin of the back and ear, 20h duration and observation after 24h and 8d: not irritating
Eye irritation: rabbit, 50mm³ of the eye, 1h, 24h and 8d: not irritating (slight irritation after 1h, completely reversible)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

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

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.

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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

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

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

The substance was administered to rabbit eyes for 20 hours.

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

There is each one study on skin and eye irritation available, both assessed with Klimisch 2 and well documented.

In the skin irritation study (BASF, 1963), the administration of undiluted 75 % solution of Choline chloride for 20h only led to an ambiguous slightly reddening of the skin of the back, whereas on the ear and after 8 days no changes of the skin of any animal were observed. Hence, the test item can be regarded as not irritating to the skin. In the eye irritation study (BASF, 1963) the test substance was administered to the rabbit eye. After 1 h a slight reddening was noted, which was fully reversible as after 24 hours and after 8 days no findings were reported. Hence, the test item can be regarded as not irritating to the eye. So, the results of both reliable studies are consistent and negative as expected due to the molecular structure of the compound and the pH value, and do not trigger the need for classification as irritating to skin or eye according to Regulation 1272/2008/EC. Furthermore, these studies represent both the demanded in vivo irritation studies under REACH Annex VIII (8.1.1 & 8.2.1). In conclusion, no data gaps are identified, the tonnage-driven data requirements under REACH are fully met and no further testing is required.

Justification for selection of skin irritation / corrosion endpoint:
only study available

Justification for selection of eye irritation endpoint:
only study available

Justification for classification or non-classification

In the skin irritation study (BASF, 1963), the undiluted 75 % solution of choline chloride was tested as not irritating to the skin. In the eye irritation study (BASF, 1963), the test substance was tested as not irritating to the eye, too. So, the results of both reliable studies are consistent and negative as expected due to the molecular structure of the compound and pH value, and do not trigger the need for classification as irritating to skin or eye according to Regulation 1272/2008/EC.