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Diss Factsheets

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
other information

Data source

Reference
Reference Type:
publication
Title:
Cancer of the urinary bladder in highly exposed workers in the production of dinitrotoluenes: a case report
Author:
Harth, V. et al.
Year:
2005
Bibliographic source:
Int Arch Occup Environ Health 78: 677–680

Materials and methods

Study type:
clinical case study
Endpoint addressed:
carcinogenicity
Principles of method if other than guideline:
The cases of urothelial cancer which had occurred under circumstances of Donarit manufacturing were follwed for over a period of 12 years..
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Dinitrotoluene
EC Number:
246-836-1
EC Name:
Dinitrotoluene
Cas Number:
25321-14-6
Molecular formula:
C7H6N2O4
IUPAC Name:
Reaction mass of 1-methyl-2,4-dinitrobenzene and 2-methyl-1,3-dinitrobenzene
Constituent 2
Chemical structure
Reference substance name:
2,3-dinitrotoluene
EC Number:
210-013-5
EC Name:
2,3-dinitrotoluene
Cas Number:
602-01-7
Molecular formula:
C7H6N2O4
IUPAC Name:
1-methyl-2,3-dinitrobenzene
Details on test material:
- Name of test material (as cited in study report): Donarit® from Schoenebeck, Germany, contained approximately 30% technical DNT (75% 2,4-dinitritoluene and 20% 2,6-dinitritoluene)
- Composition of test material, percentage of components: The composition of the remaining 70% of the explosives is not given.

Method

Type of population:
occupational
Subjects:
Case1.
- Number of subjects exposed: 1
- Sex: male
- Age: born 1946
- Known diseases: Urothelium carcinoma of the bladder, pT1, G1-2, diagnosed 11/1998.

Case2.
- Number of subjects exposed: 1
- Sex: male
- Age: no data
- Known diseases: Urothelium carcinoma of the bladder, pT1, G1-2, diagnosed 11/1998.
Route of exposure:
dermal
inhalation
Reason of exposure:
intentional, occupational
Exposure assessment:
estimated
Details on exposure:
Background: The enterprise investigated was a chemical i which only a small number of persons, 60 out of 27000 ( as of 1994) were involved in the production of dinitrotoluene. In these workers, high exposures occurred during the maintenance and cleaning of thedinitrotoluene production machinery.
Case1:
1970–1989 ammonium nitrate, beech wood flour, collodion wool, dinitrotoluene, nitrobenzene, nitroglycol, nitrates, oil, 1989–1994 ‘‘saltpeter’’. Ex-smoker since 1970.

Case2:
1974–1978 and 1979–1992 acid oil, dinitrotoluene, nitrates, nitroglycol, ‘‘saltpeter’’ acid, sulphuric acid.

Case 3:
1973–1974 manually mixing dinitrotoluene explosives (wearing only protection gloves), beech wood flour, collodion wool, dinitrotoluene, nitrobenzene, nitroglycol, ‘‘saltpeter’’, 1974–1990 beech wood flour, collodion wool, dinitrotoluene, nitroglycol, ‘‘saltpeter’’.

Results and discussion

Clinical signs:
The observed 3 cases out of 60 exposed persons is 15.9 fold of the average of incidence of cancer of the urinary bladder during 1998–2000 in the federal state of Sachsen-Anhalt (26.2 per 100,000 inhabitants). Hence, the observation of the present cluster of urothelial cancer in persons highly exposed to dinitrotoluenes underlines the suspicion of human carcinogenicity, pointing to the urothelium as relevant target tissue.

Applicant's summary and conclusion