Registration Dossier

Diss Factsheets

Toxicological information

Health surveillance data

Currently viewing:

Administrative data

Endpoint:
health surveillance data
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
other: Medical records: reliability not applicable

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2011

Materials and methods

Study type:
health record from industry
Endpoint addressed:
repeated dose toxicity: inhalation
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Companies involved with production and packaging have provided medical data to support the hypothesis that there is no concern for workers exposed during these operations.
Inhalation exposure is the only relevant route of exposure during manufacturing and packaging activities.
GLP compliance:
no
Remarks:
Medical data: GLP not applicable

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentasodium triphosphate
EC Number:
231-838-7
EC Name:
Pentasodium triphosphate
Cas Number:
7758-29-4
Molecular formula:
H5O10P3.5Na
IUPAC Name:
pentasodium triphosphate
Details on test material:
Sodium tri polyphosphate as manufactured

Method

Type of population:
occupational
Ethical approval:
not applicable
Details on study design:
Medical data from four sites covering both manufacturing and packaging of STPP were provided in an anonymous form.
The data was reviewed and reported

Results and discussion

Any other information on results incl. tables

The first set of data has details for workers exposed to both manufacture and production but did not provide details of pulmonary function. This test is not performed during medical checks as no risk is assumed from exposure.

No evidence of other inhalation issues were noted during the medical examinations (39 subjects, exposure times of between <1 year and 25 years). The measured concentration in the workplace is detailed as 3.5 mg.m-3(equivalent to 1.8 mg.m-3over a 12 hr average) and 8.8 mg.m-3(equivalent to 3.9 mg.m-3over a 12 hr average) for manufacture and production respectively. No data on measurement techniques were provided.

 

The second set of data also lacks detailed pulmonary function data (74 subjects, exposure times between 1 and 31 years) and is covered by a separate report from the medical doctor responsible for the production site. This report concludes that there are no chronic adverse health effects following exposure to STPP. 

This set of data did not provide information on the type of exposure (manufacturing or packaging).

Of the 74 subjects examined, one was identified as having emphysema and chronic bronchitis (subject exposed to STPP for two years) but should be excluded as the subject had previously been exposed to fluorides for a period of 23 years.

Of the remaining 73 subjects, 15 were identified that did not meet the normal criteria for auscultation. Of these 15 only 1 subject did not have an underlying cause, this subject suffers epistaxis (nosebleeds) which increases with increased contact with dust (STPP).

 

The remaining two sets of data both gave pulmonary function results. One data set  indicated normal (FEV1 greater than 80%) and gave percentage figures for those that deviated from this and the other data set gave full results, including actual measurements and percentage for both FEV1 and FVC. Both data sets differentiated between workers exposed during manufacturing and workers exposed during packaging activities.

 

The first of these data sets covers twenty three subjects exposed during packaging activities with STPP (exposure time between 2 and 39 years) and 60 subjects exposed during production of STPP (exposure time between 2 and 36 years).

Of the 23 exposed during packaging activities, 8 showed below normal FEV1 values at the first measurement[1]. Of these 8, three showed normal FEV1 values at the most recent examination, 1 showed slight improvement (73.60% initially and 77.5% at the final measurement) and the remaining 4 showed some decrease in FEV1 values with the highest level of decreasing being from 79.5% to 70.7% (8.8% decrease). The lowest level of decrease was from 71.60% to 71.5%. In this data set an additional 5 subjects exhibited reduced FEV1 values at the last measurement point who had shown normal valued in the initial evaluation (lowest FEV1 value 71.7%). Of the 13 subjects with reduced pulmonary function, 7 are smokers, 7 are considered medically to be overweight and 4 are both smokers and overweight. Only 2 subjects with reduced pulmonary function are neither smokers nor overweight.

 

The remaining set of data covers 8 subjects exposed during packaging activities (exposure for between 3 and 15 years) and 18 subjects exposed during manufacturing of STPP (exposure for between 11 and 44 years).

Of the 8 exposed during packaging activities, all showed normal FVC function with percentage FVC values of between 91% and 127%. FEV1 values for the same group were also within the normal range with one exception where the value of 77% was slightly below the normal range of > 80%. Of this group 2 were smokers, including the subject with a reduced FEV1 value and 3 were considered to be medically overweight. 6 of this group are reported as habitually wearing a dust mask during exposure periods, including the subject with the reduced FEV1 value.

The subjects exposed during manufacturing activities all showed normal results for both FVC and FEV1 (between 89% and 150% for FVC and between 83% and 142% for FEV1) except one. The one subject with below normal values had an FVC figure of 66% and an FEV1 of 69%. This subject is a smoker and is considered medically to be grossly overweight. The subject has a restrictive lung pattern which is most likely to be due to lung compression caused by being overweight.


[1]From the dates of measurements it can be concluded that this measurement does not always relate to the start of exposure

Applicant's summary and conclusion

Conclusions:
The available medical data indicates that there are no chronic adverse effects on health following exposure to sodium tri polyphosphate during manufacture and packaging activities.