Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: meets generally accepted scientific standards, well-documented, and 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 et.al.
Year:
1977
Bibliographic source:
Arh. hig. rada. toksikol 48:205-209

Materials and methods

Type of sensitisation studied:
skin
Study type:
not specified
Test guideline
Qualifier:
no guideline followed
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
occupational
Ethical approval:
not specified
Subjects:
cosmetic company workers
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.
Route of administration:
dermal
Details on study design:
Skin prick tests and patch tests with the test material and common inhalant allergens were performed on all subjects. AMP-100 was dissolved in both water and ethyl alcohol separately at 0.1%, 0.5%, 1%, 2%, 5%, 10%, 20%. Patch tests were applied on the back and read at 48 and 72 hours. Positive results were recorded for erythema, oedema, and blisters.

Results and discussion

Results of examinations:
The prick and patch tests were all negative except for one positive reaction to Dermatophagoides pteronyssinus in a worker on a different production line. All patch tests carried out with substances used in the production line proved negative except for AMP-100 at 10% and 20% dilutions in water and ethyl alcohol. All positive results manifested as erythema with oedema without blistering.

Positive results at 10% and 20% may be considered as irritative responses. There was lack of response to the lower doses (that would have been considered allergenic responses) noted in both the asymptomatic and symptomatic subjects.

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.