Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Study reports lacks sufficient detail to assign reliability

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1966
Report Date:
1966

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: Maximazation Test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
A chemical product with multiple components including butynediol was tested for sensitivity in adult males in accordance with the maximatization technique. The males that developed a sensitivity to the product were challenged patch tested with the individual components and the percentage of males showing sensitivity was recorded.

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
25 healthy adult males.
Route of administration:
dermal
Details on study design:
Five, 48-hour occlusive applications of the product formulation were made to the same site of each test subject. Two weeks later, each subject was challenged with a 25% acqueous solution of the product. Fifteen subjects who developed sensitivity to the product were challenged patch tested with the individual components of the product, which were reported to include butynediol, butenediol, and 1% formalin.

Results and discussion

Results of examinations:
Twenty-two of the 25 test subjects showed a postive sensitivity to the product formulation. Reactions were reported to be intense and indicative of a high degree of sensitization. Fifteen of these "sensitized" subjects showed the following rate of response to the individual components of the product formulation: butynediol (13 of 15), butenediol (0 of 15), and formalin (5 of 15). The reactions to butynediol were reported as intense, while those to formalin were reported as mild.

Applicant's summary and conclusion

Conclusions:
The product 4577 was considered to have a high allergic potential and the principal allergenic component was identified as 4579 (butynediol).