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:
other: Data from SIAR (no raw data available, original data result from well documented scientific reference)

Data source

Referenceopen allclose all

Reference Type:
secondary source
Title:
Malonic Acid Diesters: Dimethylmalonate, 108-59-8; Diethylmalonate, 105-53-3.
Author:
OECD
Year:
2005
Bibliographic source:
SIDS Initial Assessment Report For SIAM 20
Reference Type:
publication
Title:
The identification of contact allergens by human assay.
Author:
Kligman, AM
Year:
1966
Bibliographic source:
J. Invest. Derm. 47, 393-409
Reference Type:
publication
Title:
Report to RIFM, 11th may
Author:
Kligman, AM
Year:
1976
Bibliographic source:
cited in: Opdyke DLJ (1979), Food Cosmet. Toxicol. 17, 363.
Reference Type:
publication
Title:
Updating the maximization test for identifying contact allergens.
Author:
Kligman, Am and Epstein, W
Year:
1975
Bibliographic source:
Contact Dermatitis 1, 231-239.

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Maximization Test According to Kligman, 1966 and Kligman and Eppstein, 1975.
GLP compliance:
not specified

Test material

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

Method

Type of population:
not specified
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 25
- Sex: no data
- Age: no data
- Race: no data
- Demographic information: no data
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: maximization test

ADMINISTRATION
- Vehicle / solvent: petrolatum
- Concentrations: 8%

Results and discussion

Results of examinations:
Tested at a concentration of 8 % in petrolatum, dimethylmalonate produced no sensitization in the maximization test in human subjects.

Applicant's summary and conclusion