Pentapotassium bis(peroxymonosulphate) bis(sulphate)

Epidemiological data

Administrative data

Endpoint:

epidemiological data

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2013-2016

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Study type:

cross sectional study

Endpoint addressed:

respiratory sensitisation

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

- Principle of test:
Active employees (as of January 1st, 2016) at the Oxone™ facility, Memphis site, were identified from the Chemours Epidemiology Registry. The most recent responses to Interval Health History and Wellness Appraisal (IHWA) questionnaire from these employees were obtained from Medgate (an internal health electronic recording system). The IHWA questionnaire was administered by the Chemours Global Health Services (GHS) staff every three years to assess the current physical health status of the employees (Attachment 1 in "attached background material"). For those employees who are participated in the fire brigades, the same questionnaire is administered annually. Of the 28 yes/no questions of the IHWA questionnaire, 3 questions are designed to assess the current respiratory health: (1) frequent cough, chest congestion or wheezing; (2) a chronic respiratory condition such as bronchitis or emphysema; and (3) recurring nasal and/or sinus congestion.
Recently hired employees do not fill out the IHWA questionnaire, but instead they fill out the OSHA Respirator Medical Evaluation Questionnaire (OSHA questionnaire, Attachment 2 in "attached background material"). Questions 3 (a to l), 4 (a to n), and 7a of Part A and Section 2 of the OSHA questionnaire are designed to assess the current respiratory health. Health information obtained from the OSHA questionnaire also served as the health baseline of the employee. This applies to a small number of these employees.
In addition to respiratory health questionnaires, pulmonary function test (PFT) results were also evaluated for potential airway obstruction. As part of the medical surveillance program, GHS staff who have completed a NIOSH-approved pulmonary function testing course or equivalent administer the test to all required employees every three years at the minimum. The spirometric criterion from the Global Initiative for Chronic Obstructive Lung Disease (GOLD) was used for the diagnosis of chronic obstructive pulmonary disease (COPD) (GOLD 2016). COPD is defined as the ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) less than 0.7 (or <70%).
A summary of responses for the current respiratory health from both the IHWA and OSHA questionnaires, and PFT results are compiled to evaluate for any potential pulmonary symptoms among these employees.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Pentapotassium bis(peroxymonosulphate) bis(sulphate)

EC Number:

274-778-7

EC Name:

Pentapotassium bis(peroxymonosulphate) bis(sulphate)

Cas Number:

70693-62-8

Molecular formula:

H3K5O18S4

IUPAC Name:

pentapotassium bis((hydroperoxysulfonyl)oxidanide) hydrogen sulfate sulfate

Test material form:

solid

Method

Type of population:

occupational

Ethical approval:

not applicable

Details on study design:

METHOD OF DATA COLLECTION
- Type: Questionnaire, pulmonary function test (PFT)

STUDY PERIOD: 2013-2016
SETTING: Oxone™ facility, Memphis site

STUDY POPULATION
- Selection criteria: active employees
- Total number of subjects participating in study: 33, 6 of them were newly hired
- Sex/age/race: 6 females, 27 males, mean 44 years (min: 25, max: 68)
- 30 of the employees worked in production and maintenance, 1 in supply chain management, 2 in training

HEALTH EFFECTS STUDIED
- IHWA-questionnaire: frequent cough, chest congestion or wheezing chronic respiratory condition such as bronchitis or emphysema, recurring nasal and/or sinus congestion
- OSHA-questionnaire: pulmonary or lung problems/illnesses, medication
- Diagnostic procedure: Questionnaire and pulmonary function test (PFT) results

Exposure assessment:

not specified

Results and discussion

Results:

FINDINGS
Among those employees who filled out an IHWA questionnaire, none had reported frequent cough, chest congestion or wheezing, as well as a chronic respiratory condition such as bronchitis or emphysema. Of these, 6 employees reported of having recurring nasal and/or sinus congestion but five of them attributed the symptoms to seasonal and year-round allergies, and one employee attributed the sneezing to dust in the area. The individual employee who reported of having sneezing was part of the fire brigades, and had been filling out the IHWA questionnaire annually. For the 2014 calendar year, this same individual employee did not report having any recurring nasal and/or sinus congestion. Among those 6 newly hired employees who filled out the OSHA questionnaire, which consisted of 27 health factors describing the conditions or symptoms of pulmonary or lung illness, only one employee reported of having mild asthma which flares up with colds. This individual employee with mild asthma at baseline health passed the pulmonary function test, and is medically able to use any respirator.
The results of the pulmonary function test showed that no COPD was observed among the employees from 2013 to 2016 calendar year.

Any other information on results incl. tables

 Table 1: Pulmonary function test (PFT) results

Spirometric indices	N	Mean	Max	75th	Median	25th	Min
FEV1 (% predicted)	33	91	121	98	91	85	70
FVC (% predicted)	33	93	113	102	92	85	74
FEV1/FVC (%)	33	97	109	104	99	93	79

 

Applicant's summary and conclusion

Conclusions:

Results obtained from both the IHWA and OSHA questionnaires, and PFT among current active employees who are associated with the Oxone™ manufacturing facility at Memphis site indicated that there were no pulmonary symptoms reported among the employees for the 2013-2016 calendar year.

Executive summary:

33 active employees (as of January 1st, 2016) at the Oxone™ facility, Memphis site, filled out a questionnaire to assess their current physical health status. Of the 28 yes/no questions of the IHWA (Interval Health History and Wellness Appraisal ) questionnaire, 3 questions were designed to assess the current respiratory health. Recently hired employees did not fill out the IHWA questionnaire, but instead they filled out the OSHA Respirator Medical Evaluation Questionnaire. In addition to the respiratory health questionnaires, pulmonary function test (PFT) results were also evaluated for potential airway obstruction.

Among those employees who filled out an IHWA questionnaire, none had reported frequent cough, chest congestion or wheezing, as well as a chronic respiratory condition such as bronchitis or emphysema. Of these, 6 employees reported of having recurring nasal and/or sinus congestion but five of them attributed the symptoms to seasonal and year-round allergies, and one employee attributed the sneezing to dust in the area. The individual employee who reported of having sneezing was part of the fire brigades, and had been filling out the IHWA questionnaire annually. For the 2014 calendar year, this same individual employee did not report having any recurring nasal and/or sinus congestion.

Among those 6 newly hired employees who filled out the OSHA questionnaire, which consisted of 27 health factors describing the conditions or symptoms of pulmonary or lung illness, only one employee reported of having mild asthma which flares up with colds. This individual employee with mild asthma at baseline health passed the pulmonary function test, and is medically able to use any respirator.

The PFT results indicated that there were no pulmonary symptoms reported among the employees for the 2013-2016 calendar year.