Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given

Data source

Reference
Reference Type:
publication
Title:
Monographs on Fragrance Raw Materials
Author:
Opdyke, D.L.J.
Year:
1981
Bibliographic source:
Fd Cosmet. Toxicol. Vol. 19, pp237-254

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Human Maximization test with 25 volunteers according to Kligman and Epstein, 1975 (Contact Dermatitis 1975:1:231-239)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- RIFM No.: 77-62
- Analytical purity: no specified

Method

Type of population:
general
Subjects:
- Number of subjects exposed: 25
Controls:
Petrolatum for challenge control
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)


ADMINISTRATION
- Type of application: occlusive
- Test site: back and forearm
- Description of patch: 2 cm square of cotton cloth patch, sealed with plastic tape (Blenderm) and overlapping stripes (Micropore or Dermiclear)
- Volume applied: 0.3 g
- Vehicle / solvent: petrolatum
- Concentrations: 5% for induction; 1% for challenge
- Testing/scoring schedule: 5 times 24 h for induction; 48 h for challenge


EXAMINATIONS
- Grading/Scoring system: scoring of the challenge 72 and 96 h after challenge application

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
- Number of subjects with equivocal reactions: 0/25
- Number of subjects with irritating reactions: 0/25

Any other information on results incl. tables

No sensitization reaction was found.

Applicant's summary and conclusion