Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: report from secondary source with limited documentation, which meets basic scientific principles

Data source

Reference
Reference Type:
secondary source
Title:
Report on human maximization studies. Report to RIFM.
Author:
Kligman AM
Year:
1973
Bibliographic source:
Cited in: Opdyke, Monographs an fragrance raw materials, Food Cosmet. Toxicol., Vol. 12 (4), 535

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline available
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 25
- Sex: male
Route of administration:
dermal
Details on study design:
ADMINISTRATION
- Vehicle / solvent: petrolatum
- Concentrations: 8 %

Results and discussion

Results of examinations:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0/25
- Number of subjects with negative reactions: 25/25

Summary: not sensitising

Applicant's summary and conclusion