Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
other: expert review / secondary source
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Summary of available data

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2004

Materials and methods

Type of sensitisation studied:
skin
Study type:
case report
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Summary of case report and patch testing
GLP compliance:
no
Remarks:
: not relevant

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
occupational
Ethical approval:
not specified

Results and discussion

Results of examinations:
A positive patch test for acrylonitrile was determined in 5 employees of an acrylonitrile processing and production plant who had contact dermatitis.

Any other information on results incl. tables

In a case reported in 1961 (Hashimoto and Kobayashi), skin lesions were observed in humans at the first site of contact with liquid acrylonitrile, which then spread rapidly to other neighbouring regions. Several days after contact the lesions spread to other parts of the body that had not been in contact with the liquid. It was concluded that these later skin lesions were indicative of an allergic type response to the initial exposure to acrylonitrile liquid.

A positive patch test for acrylonitrile was determined in 5 employees of an acrylonitrile processing and production plant who had contact dermatitis. The 8 control indviduals did not show any allergic reaction to acrylonitrile (Bakker et al, 1991).

Applicant's summary and conclusion

Conclusions:
The available human data indicate that acrylonitrile may cause skin sensitisation in exposed workers.
Executive summary:

The limited human data indicate that skin sensitisation may occur following skin contact, however data are scarce. The EU RAR concludes that acrylonitrile should be classified as a skin sensitiser.