Registration Dossier

Administrative data

Endpoint:
health surveillance data
Type of information:
other: Health surveillance data for workers in perborate production
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Data from peer-reviewed publication

Data source

Reference
Reference Type:
publication
Title:
EU Risk Assessment Report Perboric acid, sodium salt. 3rd Priority List, Volume 71
Author:
ECB
Year:
2007
Bibliographic source:
European Commission, Joint Research Centre

Materials and methods

Study type:
health record from industry
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Health surveillance data for workers in perborate production
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Perboric acid, sodium salt
EC Number:
234-390-0
EC Name:
Perboric acid, sodium salt
Cas Number:
11138-47-9
Molecular formula:
For detailed information on substance identity, molecular and structural formula see attached file AD_PBS_Substance_Identification (taken from ECB (2007) EU RAR Perboric acid)
IUPAC Name:
sodium hydroxy hydrogen borate
Details on test material:
not further specified

Method

Type of population:
occupational
Ethical approval:
not applicable
Details on study design:
Health surveillance data for workers in perborate production

Results and discussion

Results:
This information was taken from the EU RAR.

Routine examinations have been performed with 67 workers of two production sites exposed to 0.2-0.8 mg/m3 sodium perborate mono and/or tetrahydrate during 3-36 years. These included lung function measurements by spirometry determining forced vital capacity (FVC) and peak expiratory flow (PEF). According to a questionnaire (questions relating to health effects were rather general) filled in by the physicians, no alterations related to exposure to sodium perborate were observed.
Data on individual workers were provided for 26 workers in one plant including yearly measurements of forced vital capacity (FVC), forced expiratory volume 1 (FEV1), vital capacity (VC) and peak expiratory flow (PEF). Smoking habits and confounding diseases or medication were also reported. 15 workers have been exposed for > 20 years, 4 workers have been exposed 11-20 years and 8 workers 6-8 years. No trend for decreasing lung function compared to standard values was found, which could be attributed to exposure to sodium perborate.
Similarly according to questionnaires in 4 other production plants, no effects on FVC and FEV1 have been found in general medical examinations performed every 3 years. Also no effects were found in one plant, where spirometry was performed before and after filter change work. 1 case of eye irritation which was reversible within one day has been reported for a filter change worker. Slight reversible irritative effects on the mucosa of the nose have been reported in another plant. The duration of exposure, number of workers examined and timeframe covered by the questionnaire was not given.
From one production plant more detailed data are available. For 16 operators the FVC and FEV1 have been analysed from 1992-2001 and no differences compared to the standard predicted values were found. The exposure concentrations in this time ranged from 0.1-2.8 mg/m3 of total inhalable dust (medians: 0.4-1.8 mg/m3). In addition information on individual workers was provided and none of the workers showed values, which were clearly below the standard predicted values. Furthermore, for none of the workers a trend towards lower values with increasing exposure duration could be detected.
In another production plant FVC and FEV 1 were measured in 15 workers from 2000-2002 and FEV1/FVC (ITF) was calculated. No significant deviations from a non smoking reference population of 443 non smokers (age 20-70 years) were found. The average value for FVC was 89 +/- 13% of the control, the average FEV1 92 +/- 13% and ITF was 105 +/- 8%. No information on exposure concentrations was given in this study.

Individual data are summarised in the attached file.

Applicant's summary and conclusion

Conclusions:
Health surveillance data for workers in perborate production are not indicating obstructive lung effects such as asthma or chronic bronchitis.
Executive summary:

No effects in the lungs have been reported in spirometric examinations of about 100 workers in production plants, even at workplaces with presumed high exposure (filter change). Furthermore, follow-up of the workers for several years to more than 20 years did not show deterioration of the lung function measured as FVC, FEV1, VC and PEF. Although, these parameters are not very sensitive, especially for small airways disease, the absence of effects in a great number of workers and even in workers exposed for more than 20 years leads to the conclusion that there is no concern for obstructive lung effects such as asthma or chronic bronchitis in production workers.