Registration Dossier

Administrative data

Endpoint:
epidemiological data
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restrictions because although a GLP statement and ethical approval was not available the study seemed to be well-conducted.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Shoe-makers' polyneuropathy in Italy: the aetiological problem.
Author:
Abbritti, G; Siracusa, A; Cianchetti, C; et al.
Year:
1976
Bibliographic source:
British Journal of Industrial Medicine 33:92-99.
Reference Type:
publication
Title:
Toxic polyneuropathy of shoe-industry workers: a study of 122 cases
Author:
Cianchetti, C; Abbritti, G; Perticoni, G; et al.
Year:
1976
Bibliographic source:
Journal of Neurology, Neurosurgery, and Psychiatry 39:1151-1161

Materials and methods

Study type:
cohort study (retrospective)
Endpoint addressed:
neurotoxicity
Test guideline
Qualifier:
no guideline available
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): n-hexane

Method

Type of population:
occupational
Ethical approval:
not specified
Details on study design:
METHOD OF DATA COLLECTION
- Type: Interview , Work history, exposure to other chemicals and medical conditions that would cause neurological impairment.


STUDY PERIOD: not available

SETTING: shoe factory

STUDY POPULATION
- Total population (Total no. of persons in cohort from which the subjects were drawn): not available
- Selection criteria: Diagnosed polyneuropathy, no exposure to other chemicals, no medical conditions that would cause neurological impairment.
- Total number of subjects participating in study: 122
- Sex/age/race: not available
- Smoker/nonsmoker: not available
- Total number of subjects at end of study: 122

COMPARISON POPULATION
- Type: none
Exposure assessment:
measured
Details on exposure:
TYPE OF EXPOSURE: Occupational

TYPE OF EXPOSURE MEASUREMENT: Biomonitoring blood for MCV. Samples of solvent that workers are exposed to.

EXPOSURE LEVELS: not available

EXPOSURE PERIOD: not available

POSTEXPOSURE PERIOD: not available

DESCRIPTION OF EXPOSURE GROUPS:
Three groups based on severity in the reduction of the MCV of the peroneal nerve.
Group I had a maximum MCV of less than 35 m/s
Group II had an MCV of 35–44 m/s
Group III had a maximum MCV of 45 m/s or greater

Results and discussion

Applicant's summary and conclusion

Conclusions:
No correlation was identified between severity of neuropathy and length of employment in the factory.
Executive summary:

A group of 122 cases of polyneuropathy among workers in 72 shoe factories was evaluated for severity of neurological impairment in relation to duration of exposure to a mixture of solvents. Every worker with polyneuropathy was questioned about work experience; type of chemical material used on the job; specific job function performed at onset of disease, and in the years previous to onset of disease; symptoms; and the order of appearance and evolution of symptoms. All patients were given an electromyographic examination and were determined to be free of lifestyle or medical conditions such as diabetes and alcoholism that would cause neurological impairment. None of the subjects had a history of exposure to other chemicals that might cause neuropathy, such as lead, arsenic, carbon disulfide, or drugs such as sulfonamides.

The workers were divided into three groups based on severity in the reduction of the MCV of the peroneal nerve. Group I had a maximum MCV of less than 35 m/s; Group II had an MCV of 35–44 m/s; and Group III had a maximum MCV of 45 m/s or greater. No quantitative air measurements were taken, but samples of five glues and two cleaners from five factories in which 20 cases worked were analyzed for several solvents of interest. Six of these samples contained at least 40% n-hexane, with other solvents, such as pentane, 2-methylpentane, 3-methylpentane, toluene, and cyclohexane, usually present. No correlation was identified between severity of neuropathy and length of employment in the factory.