(2-hydroxypropyl)trimethylammonium formate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November 18, 1976 - December 29, 1976

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Justification for type of information:

The method employed was similar to that described in Section 1500.41. - Hazardous Substances and Articles , Administration and Enforcement Regulations, Federal Register, Vol. 38, No. 187, P. 27019, 27 September 1973.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: The method employed was similar to that described in Section 1500.41. - Hazardous Substances and Articles , Administration and Enforcement Regulations, Federal Register, Vol. 38, No. 187, P. 27019, 27 September 1973.

Deviations:

not specified

Principles of method if other than guideline:

A group of six albino rabbits were clipped over a wide area. One side of the animals' backs was abraded at one site with a lancet sufficiently deep to penetrate the stratum corneum but not enter the derma t o produce bleeding.
The skin of the other side was allowed to remain intact . A 0.5 ml portion of material was applied to an abraded and an intact skin site on the same rabbit.
Gauze patches were then placed over the treated areas and an impervious material was wrapped snugly around the trunks o f the animals t o hold the patches i n place.
The wrapping was removed a t the end o f the twenty-four hour period and the treated areas were examined. Readings were also made after seventy-two hours. The Draize method of scoring was employed.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

(2-hydroxypropyl)trimethylammonium formate

EC Number:

263-503-6

EC Name:

(2-hydroxypropyl)trimethylammonium formate

Cas Number:

62314-25-4

Molecular formula:

C6H16NO.CHO2

IUPAC Name:

(2-hydroxypropyl)trimethylammonium formate

Test material form:

liquid

Specific details on test material used for the study:

DABCO TMR-2

Test animals

Species:

rabbit

Strain:

not specified

Remarks:

Albino

Test system

Type of coverage:

occlusive

Preparation of test site:

other: One side of the animals' backs was abraded at one site with a lancet sufficiently deep to penetrate the stratum corneum but not enter the derma to produce bleeding. The skin of the other side was allowed to remain intact.

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

6 rabbits

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

1

Max. score:

1

Reversibility:

not specified

Remarks on result:

no indication of irritation

Remarks:

both intact and abraded skin sections

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

1

Max. score:

1

Reversibility:

not specified

Remarks on result:

no indication of irritation

Remarks:

both intact and abraded skin sections

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

both intact and abraded skin sections

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Remarks:

both intact and abraded skin sections

Irritant / corrosive response data:

No indications of irritation on both intact and abraded skin sections in all animals.

Other effects:

None reported.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The tested product is not a primary irritant on intact or abraded rabbit skin at applied concentrations of 0.5 ml undiluted test material, occluded for 24 hours.