Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Dehydroacetic acid (DHA): 1. Acute and chronic toxicity
Author:
Spencer HC, Rowe VK & McCollister DD
Year:
1950
Bibliographic source:
J. Pharmacol. Exp. Therap., 99; 57-68

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
- Principle of test: Patch test
- Parameters observed: skin reaction after application of the test substance
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3-acetyl-6-methyl-2H-pyran-2,4(3H)-dione
EC Number:
208-293-9
EC Name:
3-acetyl-6-methyl-2H-pyran-2,4(3H)-dione
Cas Number:
520-45-6
Molecular formula:
C8H8O4
IUPAC Name:
3-acetyl-6-methyl-2H-pyran-2,4(3H)-dione

Method

Type of population:
general
Ethical approval:
no
Subjects:
- Number of subjects exposed: 200
- Sex: 100 females, 100 males
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Vehicle / solvent: water
- Concentrations: 65% (w/v)
- Volume applied: impregnated

EXAMINATIONS
- Other: visual observation

Results and discussion

Results of examinations:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 200
- Number of subjects with irritating reactions: 0

Applicant's summary and conclusion