2-amino-2-methylpropanol

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Airborne Contact Dermatitis from 2-Amino-2-methyl-1-propanol in a Cosmetic Company

Author:

Cipolla C, Belisario A, Sassi C et al

Year:

1997

Bibliographic source:

Arh hig rada toksikol 48:205-209

Materials and methods

Type of sensitisation studied:

skin

Study type:

other: case report + study in volunteers

Principles of method if other than guideline:

see methods

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-amino-2-methylpropanol

EC Number:

204-709-8

EC Name:

2-amino-2-methylpropanol

Cas Number:

124-68-5

Molecular formula:

C4H11NO

IUPAC Name:

2-amino-2-methylpropan-1-ol

Specific details on test material used for the study:

AMP-100

Method

Type of population:

occupational

Ethical approval:

not specified

Subjects:

cosmetic company workers: 2 symptomatic (clinical cases), 8 asymptomatic

Clinical history:

Two cases of airborne contact dermititis were noted in a cosmetic company during the hair dye production using AMP-100. Subjects suffered for months from periorbital oedema and facial erythema which worsened during work hours and improved with time away from work.
Eight additional asymptomatic workers from the same company were studied concurrently. Two of these were working on the same production line but were asymptomatic, the other six, also completely asymptomatic, were working on different production lines.

Route of administration:

dermal

Details on study design:

Skin prick tests and patch tests with AMP-100, other substances in the production line and common inhalant allergens were performed on all subjects. AMP-100 was dissolved in both distilled water and ethanol separately at 0.1, 0.5, 1, 2, 5, 10 and 20%. Patch tests were applied on the back and read at 48 and 72 hours. Positive reactions were graded as follows:
- erythema alone: +
- erythema and oedema: ++
- erythema and oedema and blisters: +++

Results and discussion

Results of examinations:

Controls (other allergens):
All tests were negative except for one positive reaction to Dermatophagoides pteronyssinus in a worker on a different production line.

AMP-100 results:
Positive reactions to patch tests were only noted at 10% and 20% AMP-100, in both distilled water and ethanol. These occurred in all test subjects: 2 workers from AMP-100 use line with symptoms, 2 workers from same production line without symptoms, and 6 workers from a different production line. Severity of reactions did not significantly differ between workers from AMP-100 use line (4 workers) and other production lines (6 workers):
Mean grades across both solvents (ethanol and water):
- AMP-100 use line, 4 workers: grades + to ++, mean score 1.5+ at 10% and 1.9+ at 20%.
- Other production lines, 6 workers: grades + to ++, mean score 1.3+ at 10% and 1.6+ at 20%.

Positive results may be considered as irritative responses and not skin sensitization because:
- There was no reaction to concentrations <=5% in any worker
- Workers with pre-existing exposure to AMP before patch testing (AMP-100 use line) did not show significantly more severe skin reactions than workers without pre-existing exposure to AMP before patch testing (other production lines)

Applicant's summary and conclusion

Conclusions:

The authors conclude that under these conditions, AMP-100 causes airborne irritative contact dermatitis, favored in this study by elevated production temperatures and high ambient humidity.
The 2 cases do not represent a skin sensitisation mechanism.