Registration Dossier

Administrative data

Endpoint:
health surveillance data
Type of information:
other: medical monitoring
Adequacy of study:
key study
Study period:
1969-2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This statement is made by an experienced occupational physician after serious investigantion of available data of health complaints and adverse reaction reports made on workers working up to 40 years in the production of diphosphorus pantaoxide

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Principles of method if other than guideline:
Supervision by occupational medicine of workers in the production plant over a period from 1969 to 2009 in a retrospective view to cases at all of lung diseases
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Commercial typ of the applicant

Method

Ethical approval:
other: more than 100 men in the age between 18 up to 65
Details on study design:
The study rely on data of the occupational medicine from workers in the diphosphorus pentaoxide production plant in Knapsack Germany.
Since 1969 in average of about 20 employees are working in the plant and are exposed 8 hours a day at 200 days a year to diphosphorus pentaoxide dust in a concentration of about 0.17 +- 0.12 mg/m³.
Some of them worked about 40 year in the plant. The exposure concentrations are measured in the period from 2002 to 2009 and were certainly higher in the time period before.

Some of them worked about 40 year in the plant. The exposure concentrations are measured in the period from 2001 to 2007and were certainly higher in the time period before.

Results and discussion

Results:
In a retrospective view on occupation medical data of production workers exposed with 0.17mg/m³ in the period between 1969 to 2009 no cases at all of lung diseases have been observed .
Since 1997 pulmonary function of about 70 workers are annually examined and documented without any change of pulmonary function concerning diphosphorus pentaoxide dust.

Any other information on results incl. tables

Area Mess-   Date P2O5
conc
mg/m³
P2O5 average 8 hour
mg/m³ 
4 12022009 0,03 0,02
4 19072007 0,06 0,03
4 16012007 0,08 0,04
4 27072005 0,02 0,02
4 5112004 0,10 0,10
4 6122002 0,12 0,12
5 3122007 0,37 0,37
5 21082006 0,12 0,12
5 8032005 0,12 0,12
5 19052004 0,38 0,38
5 5122002 0,12 0,12
3b 19122007 0,13 0,13
3b 11042007 0,14 0,14
3b 9032005 0,09 0,09
3b 24052004 0,42 0,42
3b 2122002 0,10 0,10
3a 19032007 0,33 0,33
3a 18082006 0,16 0,16
3a 21112005 0,29 0,29
3a 21112005 0,15 0,15
3a 8032005 0,20 0,20
3a 5052004 0,31 0,31
3a 2122002 0,23 0,23
average 0,17
varianz 0,12

data of emission controll measurements at the working place in the production plant

Applicant's summary and conclusion

Conclusions:
About 20 persons worked since1969 yearly about 200 days for about 8 hours a day under working conditions with an exposure of about 0.17 +- 0.12mg/m³ diphosphorus pentaoxide (measured in the period 2002 to 2009, certainly higher in the time before), without any lung diseases concerning diphosphorus pentaoxide dust (in total for more than 40 years). In addition since 12 years the pulmonary function of about 70 of these workers has been annually examined without any observation of changes of pulmonary function concerning phosphorus dust.
Executive summary:

About 20 persons worked since1969 yearly about 200 days for about 8 hours a day under working conditions with an exposure of about 0.17 +- 0.12mg/m³ diphosphorus pentaoxide (measured in the period 2002 to 2009, certainly higher in the time before), without any lung diseases concerning diphosphorus pentaoxide dust (in total for more than 40 years). In addition since 12 years the pulmonary function of about 70 of these workers has been annually examined without any observation of changes of pulmonary function concerning phosphorus dust.