Registration Dossier

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Patch testing with components of water-based metalworking fluids.
Author:
Greier, J. et al.
Year:
2003
Bibliographic source:
Contact Dermatitis 49, 85-90.

Materials and methods

Study type:
clinical case study
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Method

Type of population:
occupational
Subjects:
A clinical trial of 233 patients with present or past occupational to metalworking fluids (MWF).
Ethical approval:
not specified
Route of exposure:
dermal
Reason of exposure:
intentional, occupational

Results and discussion

Results of examinations:
Only 1 patient reacted positively to AEPD.

Applicant's summary and conclusion

Conclusions:
Only 1 patient reacted positively to AEPD. The importance of AEPD as a MWF allergen still remains to be established.