Registration Dossier

Toxicological information

Epidemiological data

Currently viewing:

Administrative data

epidemiological data
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
2 (reliable with restrictions)

Data source

Reference Type:
Work-related asthma in France: recent trends for the period 2001–2009
Paris C, Ngatchou-Wandji J, Luc A, McNamee R, Bensefa-Colas L, Larabi L, Telle-Lamberton M, Herin F, Bergeret A, Bonneterre V, Brochard P, Choudat D, Dupas D, Garnier R, Pairon JC, Agius RM, Ameille J.
Bibliographic source:
Occup. Environ. Med. 2012; 0: oemed-2011-100487v1-oemed-2011-100487

Materials and methods

Study type:
cohort study (retrospective)
Endpoint addressed:
respiratory sensitisation
Principles of method if other than guideline:
This study was designed to describe recent trends in the incidence of Work Related Asthma (WRA) with respect to industrial activities and the main causal agents (including isocyanates), in France, over the 2001–2009 period, based on a population-based national occupational health network. Several statistical approaches to measure trends were also compared.

Test material

Details on test material:
Commercial diisocyanates of all types are included in this review.


Type of population:
Details on study design:
The French national network of occupational health surveillance and prevention (Réseau national de vigilance et de prevention des pathologies professionnelles (RNV3P)) comprises all 32 occupational health departments located in French University Hospitals. Since 2000, experienced occupational physicians in these departments systematically completed and recorded standardised forms for each referred patient with suspected work-related disease into a nationwide database. Recorded information includes the main diagnosis, comorbid diseases, and main occupational exposure .The strength of the association between a disease and each suspected causal agent is rated by the medical expert on a four-class scale (nil, possible, probable and certain).
Data analysed in this study were exported from the national database after excluding cases with incomplete data as well as data from the first year of recording (2000), which were considered not to be representative of annual collection. Only reports concerning WRA with at least a probable or certain association with one occupational agent, were included.
Statistical methods:
Overall, the incidence of WRA for a given year was defined as the number of observed cases in the validated national database. The proportion of a specific occupational exposure for a given year, was defined by the ratio of the number of outcomes relative to all subjects with WRA.

Four methods were used for trend calculation. 1) the non-parametric Kendall rank correlation test calculation was done between year and number of cases for selected agents and sectors; 2) the method described by McNamee et al,, 2008; 3) a time-series approach, based on time-series plot of the number of cases per month; and 4) the reporting odds ratio (RoR).

Statistical analyses were performed on SAS V.9.2 and R software.

Results and discussion

The study sample comprised 2914 cases of WRA, including 1689 men (58%) and approximately the same age in men and women (40.3 and 39.5 years, respectively). Overall, no marked discrepancies for trend estimates were observed between the four methods.
A significant decrease was observed in the overall number of cases with a ‘definite’ link between exposure and disease. A significant decrease of WRA was observed for some agents such as isocyanates (p=0.007) and only in some industry sectors including the manufacture of plastic products (p=0.011).

Applicant's summary and conclusion

Based on the ‘French national network of occupational disease surveillance and prevention’, this study documents a significant decrease of work-related asthma over the period 2001–2009, for cases related with isocyanate exposures.
Executive summary:

The aim of this study was to describe WRA trends in terms of industrial activities and the main causal agents in over the period 2001–2009. Data were collected from the French national network of occupational health surveillance and prevention (Réseau National de Vigilance et de Prévention des Pathologies Professionnelles(RNV3P)).Several statistical models (non-parametric test, zero-inflated negative binomial, logistic regression and time-series models) were used and compared with assess trends. Over the study period, 2914 WRA cases were included in the network. WRA declined in France over the study period. A significant decrease was observed for some agents such as isocyanates.