Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1965
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non GLP, number of participants only 50, test concentrations low. Limited amount of detail.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1965
Report Date:
1965

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Patch tests were conducted on fifty human subjects according to the method of Shelanski and Shelanski (Procedures of the Toilet Goods Association, Number 19, 1953)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Substance type: Organic

Method

Type of population:
general
Subjects:
50 volunteers
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Vehicle / solvent: dimethyl phthalate
- Concentrations: 0.5% w/v

Results and discussion

Results of examinations:
None of the fifty subjects reacted to any of the 15 applications or to the challenge application.

Applicant's summary and conclusion

Conclusions:
From the results obtained in this study on the fifty subjects used, the test item tested as a 0.5% w/v solution in dimethyl phthalate, was found to be neither a primary; irritant nor a fatiguing agent to any of the subjects tested. This material did not produce sensitization in any of the subjects tested.