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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Secondary source

Data source

Reference
Reference Type:
secondary source
Title:
Report on human maximization studies
Author:
Epstein W.L.
Year:
1977
Bibliographic source:
Report to RIFM, 16 May 1977; cited in Opdyke DL (ed.) (1979). Fd.|Cosmetic. Toxicol. 17 (Suppl.): 895

Materials and methods

Type of sensitisation studied:
skin
Study type:
not specified
Principles of method if other than guideline:
Kligman AM (1966). The identification of contact allergens by human assay. III. The maximization test. A procedure for screening and rating contact sensitizers. J. Invest. Derm. 47: 393.
Kligman AM and Epstein W (1975). Updating the maximization test for identifying contact allergens. Contact Dermatitis 1: 231.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
3-methylbut-2-en-1-ol
EC Number:
209-141-4
EC Name:
3-methylbut-2-en-1-ol
Cas Number:
556-82-1
Molecular formula:
C5H10O
IUPAC Name:
3-methylbut-2-en-1-ol
Details on test material:
no data

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
26 male volunteers, no further data
Controls:
Challenge applications: additional SLS controls were placed on the left and petrolatum on the right.
Route of administration:
dermal
Details on study design:
The material (RIFM no. 77-460) was tested at a concentration of 10% in petrolatum.
A maximization test was carried out with test material in petrolatum on 26 healthy male inmate volunteers. Application was under occlusion to the same site on the forearms of all subjects for five alternate-day 48 hour periods. Patch sites were pretreated for 24 hours with 5% aqueous sodium lauryl sulfate (SLS) under occlusion for the inital patch only. Following a ten to fourteen day rest period, challenge patches were applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by 30 minute applications of 5% aqueous SLS under occlusion on the left side whereas the test material was applied without SLS treatment on the right side. Additional SLS controls were placed on the left and petrolatum on the right.

Results and discussion

Results of examinations:
Under the test conditions chosen, no sensitization reactions were observed.

Applicant's summary and conclusion