Methenamine

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2004

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: dissertation (non GLP, non guideline)

Data source

Reference

Reference Type:

other: dissertation

Title:

Allergien durch Hexamethylentetramin - Eine Querschnittuntersuchung in einer Produktionsanlage

Author:

Topcu, M.

Year:

2004

Bibliographic source:

Inaugural-Dissertation zur Erlangung des Doktorgrades der Medizin einer Hohen Medizinischen Fakultät der Ruhr-Universität Bochum

Materials and methods

Type of sensitisation studied:

skin

Study type:

survey

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Public avaialble literature. No guideline indicated. For details on method see materials and methods section.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Methenamine

EC Number:

202-905-8

EC Name:

Methenamine

Cas Number:

100-97-0

Molecular formula:

C6H12N4

IUPAC Name:

1,3,5,7-tetraazatricyclo[3.3.1.1³,⁷]decane

Test material form:

solid: crystalline

Method

Type of population:

occupational

Ethical approval:

not specified

Subjects:

17 industrial workers of the methenamine production site of INEOS Paraform GmbH & Co. KG (formerly Degussa) in Mainz, Germany (8 persons with strong exposure, 5 shift leaders, and 4 Managers and technicans).
Control group: 16 workers from the same company (10 had rarely contact with the test substance).

Clinical history:

A questionnaire about clinical history (sensitisation data) was answered by all workers.

Controls:

Control group: 16 workers from the same company (10 had rarely contact with the test substance).

Route of administration:

other: dermal and inhalation

Details on study design:

The following parameters were investigated:
- patch tests
- concentration of total IgE
- lung function
- exposition monitoring

Results and discussion

Results of examinations:

- A skin sensitisation potential of methenamine was observed in two persons exposed to high doses of the test substance and in one former worker of the plant.

- patch tests: no positive results in treatment and control group.

- concentration of total IgE: not significantly difference between exposure and control group.

- lung function: not significantly difference between exposure and control group.

- exposure monitoring: geometric mean between 1.5 and 0.3 mg/m3 total dust (depending of workplace)

Applicant's summary and conclusion

Conclusions:

Methenamine was shown to cause skin sensitisation effects to humans. No correlation between exposure to methenamine and occurrace of allergic asthma can be seen.

Executive summary:

Based on these results no correlation between exposure to methenamine and occurrace of allergic asthma can be seen. The number of subjects was too small for a complete evaluation.

A skin sensitisation potential of methenamine was observed in two persons exposed to high doses of the test substance and in one former worker of the plant.