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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
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:
Identification of causative chemicals of allergic contact dermatitis using a combination of patch testing in patients and chemical analysis - application to cases from rubber gloves
Author:
Kaniwa M, Isama K, Nakamura A, Kantoh H, Hosono K, Itoh M, Shibata K, Usuda T, Asahi K, Osada T, Matsunaga K, Uleda H
Year:
1994
Bibliographic source:
Contact Dermatitis, 31, 65 -71

Materials and methods

Type of sensitisation studied:
skin
Study type:
case report
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Five cases of allergic contact dermatitis from rubber gloves were investigated using a combination of patch testing in patients and chemical analysis of causative rubber products by gas chromatography (GC) and high-performance liquid chromatography (HPLC).
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Piperidine
EC Number:
203-813-0
EC Name:
Piperidine
Cas Number:
110-89-4
Molecular formula:
C5H11N
IUPAC Name:
piperidine
Specific details on test material used for the study:
- Name of test material (as cited in study report): piperidine
no further data

Method

Type of population:
other: patients with allergic contact dermatitis
Subjects:
- Number of subjects exposed: 4
- Sex: 3 males, one female
- Age: 31, 38, 49, and 51 years
- Race: no data
Clinical history:
ophthalmologist, used surgical gloves: itchy eruption, thereafter, edema, infiltrative erythema and serious eruption appeared on fingers and hands;
gilder: developed contact dermatitis on the hands and arms, sensitive to a brand of rubber work gloves, and to surgical rubber gloves not used before;
nurse: contact dermatitis on the hands, arms and face, sensitive to brands of surgical rubber gloves;
surgeon: contact dermatitis on the hands and forearms, sensitive to surgical rubber gloves.
Controls:
No data
Route of administration:
dermal

Results and discussion

Results of examinations:
Piperidine was confirmed analytical as an ingredient of the rubber material (rubber accelerators) of rubber gloves.
In the patch test performed with piperidine two of the four patients were hypersensitive to piperidine.
Result of the patch test:
- One case showed a positive reaction on day 2 and 3;
- One case on day 3.
- One case showed no positive reaction to the test item.
- No data about the sensitivity to the test item was obtained for one case.

The authors noticed that in addition to other ingredients in rubber gloves, piperidine, which occurs in the quantities up to several 0.3 to 2.5 mg per g should be considered as a cause of allergic contact dermatitis.

Applicant's summary and conclusion