Registration Dossier

Toxicological information

Sensitisation data (human)

Currently viewing:

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Secondary literature, peer-reviewed

Data source

Reference
Reference Type:
secondary source
Title:
Repeated insult patch test of tetrahydro-4-methyl-2-(2-methylpropen-1-yl)pyran in human subjects
Author:
IFF Incorporated
Year:
1964
Bibliographic source:
Cited in: Anonymous (1964); Fragrance raw materials monographs, Food. Chem. Toxicol. 30, Suppl. Issue VIII, 1992, p. 121S-122S; Cited in: RIFM Database, Location 14574

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Repeated Insult Patch Test conducted with volunteers
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no furter data available

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 40
- Sex: 31 females and 9 males
Controls:
no data
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive / semiocclusive /other: no data
- Description of patch: Webril swatch affixed to adhesive elastic bandage
- Vehicle / solvent: 65% Ethanol
- Concentrations: 1.25%
- Volume applied: 0.5 mL
- Removal of test substance: after 24 hours
- Other: The patch was placed on the upper arm of each subject, and was removed after 24 hours. The induction patches were applied to the same site every Monday, Wednesday and Friday until 9 applications of the test material had been made. Reactions were read 24 hours after patch removal, or 48 hours when removed on Saturday. After a rest period of 14 days, challenge patches were applied to a previoulsy untreated test site in the same manner as during the induction phase, and the sites were scored 24 and 72 hours after patch removal.

Results and discussion

Results of examinations:
Little or no skin irritation was observed.
No skin sensitisation reactions were observed.

Applicant's summary and conclusion