Carbamic acid, (2-hydroxypropyl)-, compd. with 1-amino-2-propanol (1:1)

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

other information

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference Type:

secondary source

Title:

Final Report on the Safety Assessment of Diisopropanolamine, Triisopropanolamine, Isopropanolamine, and Mixed isopropanolamine

Author:

Cosmetic Ingredient Review

Year:

1987

Bibliographic source:

Journal of the Americal College of Toxicology, Volume 6, No. 1, 53-76, 1987

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Draize repeat insult patch test for skin sensitization and photosensitization

Test material

Test material information

Constituent 1

Reference substance name:

1-aminopropan-2-ol

EC Number:

201-162-7

EC Name:

1-aminopropan-2-ol

Cas Number:

78-96-6

IUPAC Name:

1-aminopropan-2-ol

Constituent 2

Reference substance name:

1-amino-2-propanol

IUPAC Name:

1-amino-2-propanol

Method

Type of population:

general

Subjects:

150 male and female volunteers (no further information)

Route of administration:

dermal

Details on study design:

0.2 ml volume of an aqueous solution containing 2% isopropanolamine was applied to patches, and the patches were applied occlusively to the lower backs of 150 volunteers for 48 to 72 hours three times a week for 3 weeks. Sites were scored at patch removal. A challenge patch was applied 2 weeks later to a naive site. It was scored at 48 and 96 h on a scale of 0-4.

Results and discussion

Results of examinations:

not sensitizing

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 150

Applicant's summary and conclusion

Executive summary:

In a modified Draize repeat insult patch test a 2 % aqueous solution of isopropanolamine was tested for skin sensitizing effects in 150 male and female human volunteers. Three times a week for three weeks 0.2 ml of the solution on a patch were applied occlusively for 48 to 72 hours on the lower back of each volunteer. A challenge patch was applied 2 weeks later to a naive site. Effects to the skin were scored at 48 and 96 h. Isopropanolamine did not induce allergic contact dermatitis.