Registration Dossier
Registration Dossier
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EC number: 202-429-0 | CAS number: 95-53-4
Epidemiological data
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:
- 1 982
- 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
- Reference substance name:
- o-toluidine
- EC Number:
- 202-429-0
- EC Name:
- o-toluidine
- Cas Number:
- 95-53-4
- Molecular formula:
- C7H9N
- IUPAC Name:
- 2-methylaniline
Constituent 1
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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