Registration Dossier

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:
other: This is a case study report of sensitization in one individual. There is limited study detail.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1979

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:
Standar human patch test methodology.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
As per the publication.

Method

Type of population:
occupational
Ethical approval:
not specified
Subjects:
One male, 16 years old.
Clinical history:
Patent presented with severe dermatitis on the hands, arms, face, neck and genital area. The patient had been working for nine daya filling undiluted epoxy resins hardeners and reactive diluents in drums.
Controls:
No data from patch testing study.
Route of administration:
dermal
Details on study design:
Standard human patch testing methodology.

Results and discussion

Results of examinations:
Following patch testing exposure, positive dermal responses were observed for a bisphenol A epxy resin at 0.001% in acetone and to 2,3-epoxypropyl neodecanoate (Cardura E) at 0.01% in acetone.

Applicant's summary and conclusion

Conclusions:
2,3-Epoxypropyl neodecanoate elicited a positive dermal response in a male patient previously sensitized to epoxy resins, and/or hardeners and reactive diluents. The positive dermal responses were observed at a concentration of 0.01% 2,3-epoxypropyl neodecanoate (Cardura E) in acetone. This human clinical finding supports the positive result of the guinea pig Maximization test conducted on the test substance.
Executive summary:

A male individual exposed to epoxy resins, epoxy resin hardeners and reactive diluents including 2,3 -epoxypropyl neodecanoate (Cardura E) was patch tested to determine skin sensitivity. The patient elicited positive dermal responses to epoxy resin at 0.001% and to 2,3 -epoxypropyl neodecanoate at a concentration of 0.01%. The data demonstrate that 2,3 -epoxypropyl neodecanoate can elicite a positive dermal reaction in humans previously sensitized to epoxy resins and/or components used in the manufacture of epoxy resins.