Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference Type:
Airborne Contact Dermatitis from 2-Amino-2-methyl-1-propanol in a Cosmetic Company
Cipolla C, Belisario A, Sassi C et al
Bibliographic source:
Arh hig rada toksikol 48:205-209

Materials and methods

Type of sensitisation studied:
Study type:
other: case report + study in volunteers
Principles of method if other than guideline:
see methods
GLP compliance:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
Specific details on test material used for the study:


Type of population:
Ethical approval:
not specified
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:
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

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.