Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication which meets basic scientific principles

Data source

Reference
Reference Type:
publication
Title:
Asthma caused by peracetic acid-hydrogen peroxide mixture.
Author:
Cristofari-Marquand, E. et al.
Year:
2007
Bibliographic source:
J. Occup. Health 2007, 49, 155-158

Materials and methods

Type of sensitisation studied:
respiratory
Study type:
case report
Principles of method if other than guideline:
Case report of of two subjects are reported who developed cough, wheezing and shortness of breath after being exposed to PA-HP vapors.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
occupational
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 2
- Sex: male and female
- Age: Subject 1: 48 years (male); Subject 2: 47 years (female)
Clinical history:
Subject 1:
- Symptoms, onset and progress of the disease: Symptoms as rhinorrhea, conjunctivitis, continuous cough, breathlessness and chest thightness occurred from 5 months of PAA-HP employment onwards whilst present at the work place. The symptoms completely improved when the subject was off work
- Exposure history: employed as a hospital anaesthetist nurse in an endoscopy unit of a gastroenterology department. In his job he sterilized flexible endoscopic immersion in detergent-disinfectants containing quaternary ammonium compounds for 15 min before rinsing and brushing. Every day he performed 2 disinfection cycles, manual and automatic, in a communicating enclosed room. For manual disinfection he prepared bathes of PAA-HP, for the automatic disinfection he used PAA only. He was exposed to PAA-HP vapours 5 d a week. In the sterilizing room a ventilation system with a chemical filter was present but no data on area PAA-HP concentrations were available. He also used protective clothing and gloves and additionally a mask (without vapour filter) and goggles when adding disinfectant product to the washer every 2 d.
- Aggravating factors both in home and workplace: never exposed to cats
- Smoking history: non-smoker

Subject 2:
- Symptoms, onset and progress of the disease: symptoms as rhinorrhea, conjunctivitis and chest thightness occurred. Symptoms started 1-4 h after the end of exposure and persisted for several hours. Additionally contact dermatitis, epistaxis and dysphonia occurred at the end of a working week. Symptoms improved during weekends and completely disappeared on holidays.
- Exposure history: employed as auxiliary nurse in an otorhinolaryngology department. Every day her work consisted of sterilizing endoscopic equipment. Therefore she was exposed to PAA-HP mix vapours 8 h/d for 5 d/week. The ventilation system of the area was considered to be poor. During sterilization the subject used protective gloves, mask and goggles.
- Smoking history: a smoker (1 pack of cigarettes daily) for 30 years
Route of administration:
inhalation
Details on study design:
TYPE AND DETAILS OF TEST(S) USED
- Chest radiography
- Skin prick tests to common allergens
- Specific inhalation challenge (SIC)
- Baseline spirometric measurements
- Methacholine challenge (PC20)

Results and discussion

Results of examinations:
Chest radiograph was normal for both subjects. Results for skin prick tests were negative for both subjects with the exception of a positive result for cat fur in subject 1.
Subject 2 showed a positive result in the specific inhalation challenge test with methacholine. She developed an early asthmatic reaction (20% drop in FEV1) with dysphonia 50 minutes after challenge.
It is known that PAA can cause a “reactive airways dysfunction syndrome” (RADS) after exposure to high PAA concentrations. Possible asthma effects or potential for induction allergic reactions due PAA-HP exposure have not been reported before.
In the present cases the diagnosis of RADS can be excluded because of the observed latency period and the absence of a single high exposure. The presence of an irritant or allergic mechanism is difficult to define. The allergic mechanism is supported by the existence of a latency period necessary for acquiring sensitization and the complete disappearance of symptoms after removal from exposure.
Many arguments support the irritant induced asthma thesis: presence of wheezing (major sign of asthma), association of irritant syndrome, repeated prolonged exposures containing irritant agents, difficulty in breathing, absence of asthma signs before occupational exposure, absence of activity to inhalant common prick tests for subject 2.

Any other information on results incl. tables

Medical treatment:

Subject 2: Albuterol reversed FEV1 reduction as a consequence of bronchial obstruction.

Applicant's summary and conclusion

Conclusions:
It can be concluded that occupational prolonged exposure to vapours of PAA-HP mixtures was observed to cause symptoms which were the consequence of a sustained irritation process rather than a real asthmatic reaction. Disinfectants belonging to the oxidant class, such as mixtures of PAA-HP, seem to act as occupational irritants on subjects free of any apparent pathology.
Executive summary:

In this publication the cases of two subjects (subject 1: 48-years-old male, subject 2: 47-years-old female) who developed cough wheezing and shortness of breath after being exposed to PAA-HP vapours are reported. Chest radiography, skin prick tests to common allergens, baseline spirometric measurements and methacholine challenge tests (PC20) were conducted. Results for chest radiography and skin prick tests were normal for both subjects with one exception in subject 1. Subject 2 showed a positive result in the specific inhalation challenge test. She developed an early asthmatic reaction (20% drop in FEV1) after challenge. Both allergic and irritant mechanism were discussed. Many arguments support the irritant mechanism thesis: presence of wheezing (major sign of asthma), association of irritant syndrome, repeated prolonged exposures containing irritant agents, difficulty in breathing, absence of asthma signs before occupational exposure, absence of activity to inhalant common prick tests for subject 2. It was therefore concluded that symptoms in these subjects were generated by an irritant mechanism.