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Toxicological information

Epidemiological data

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Administrative data

Endpoint:
epidemiological data
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reliability according to OECD SIDS

Data source

Reference
Reference Type:
publication
Title:
The carcinogenic effect of aromatic amines: an epidemiological study on the role of o-toluidine and 4,4'-methylene bis(2-methylaniline) in inducing bladder cancer in man.
Author:
Rubino, GF, Scansetti, G, Piolatto, G & Pira E
Year:
1982
Bibliographic source:
Environ Res., 27, 241-254

Materials and methods

Study type:
cohort study (prospective)
Endpoint addressed:
carcinogenicity
Test guideline
Qualifier:
no guideline required

Test material

Constituent 1
Chemical structure
Reference substance name:
o-toluidine
EC Number:
202-429-0
EC Name:
o-toluidine
Cas Number:
95-53-4
Molecular formula:
C7H9N
IUPAC Name:
o-toluidine

Method

Details on study design:
METHOD OF DATA COLLECTION
- Type: personal records at the factory
STUDY PERIOD:1946-1976
STUDY POPULATION
- Selection criteria: employment in dye factory that used o-toluidine as an intermediate in dye
production process
- Total number of subjects participating in study: 906 men
- Sex/age/race: Male/no data on age/no data on race
- Total number of subjects at end of study: no data
COMPARISON POPULATION
- Details: italian male population for the period within which the study was performed

Results and discussion

Results:
Follow up in the study was 95.8% complete. Amongst the traceable workers, 28.7% had died. 36 deaths occuring from urinary bladder cancer was noted (expected 1.23). 31 of the deaths occured in men (total 610), who were exposed to benzidine, 1-naphthylamine, 2- naphthylamine or a combination of these compounds. Of the 31 deaths, 5 (with expected 0.08) occured in a group of 53 workers, who were solely involved in the manufacture of Fuchsine and Safranine T. Of the 5 cases of death, 3 persons were exposed to a combination of toluene, o-toluidine and 4, 4' methylenebis(2-methylaniline). The other 2 cases were exposed to a combination of o-nitro toluene and 4, 4' methylenebis(2- methylaniline), 2, 5 diaminotoluene and o-aminoazotoluene.

Applicant's summary and conclusion