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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
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:
publication
Title:
Occupational asthma in professional cleaning work: a clinical study
Author:
Mäkelä R., Kaupp P., Suuronen K., Tuppurainen M., HannuT.
Year:
2011
Bibliographic source:
Occupational Medicine 2011;61:121–126

Materials and methods

Type of sensitisation studied:
respiratory
Study type:
case report
Principles of method if other than guideline:
Twenty cases of occupational asthma (OA) diagnosed at the Finnish Institute of Occupational Health (FIOH) during the period 1994–2004 in workers employed in professional cleaning work were described. OA was diagnosed according to patient history, lung function examinations and specific challenge tests with measurements of the forced expiratory volume in 1 second and peak expiratory flow values.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Method

Type of population:
occupational
Ethical approval:
confirmed, but no further information available
Subjects:
This study consists of the cases (a subject with Occupational Asthma [OA] with positive challenge test) diagnosed at the Finnish Institute of Occupational Health (FIOH) during the period 1994–2004.
- Number of subjects exposed: 20
- Sex: Female
- Age: Mean age of 48.8 years (range 27–60 years).
Clinical history:
The mean duration of cleaning work before the onset of the respiratory symptoms was 14.3 years (range 1–36 years), and the mean duration of cleaning work before the FIOH examinations was 18.6 years (range 3–38 years).
Route of administration:
inhalation
Details on study design:
Skin-prick tests (SPT) for common environmental allergens as well as for work-related allergens were performed.
Histamine hydrochloride (10 mg/mL) was used as the positive control. The environmental allergens were as follows: pollens of birch, alder, timothy hay, meadow foxtail, mugwortand dandelion; epithelia of horse, dog, cat and cow; dust mites and moulds.
The work-related allergens were as follows: ethanolamine [monoethanolamine (MEA), diethanolamine (DEA) and triethanolamine (TEA)], chloramine-T, formaldehyde, storage mites, latex, Ficus benjamina, metal salts, isocyanates, diphenylmethane, diisocyanate (MDI) and toluene diisocyanate (TDI)] and moulds.
A positive reaction was defined as a wheal diameter ≥3 mm in the absence of a reaction to the diluent and in the presence of a positive reaction to histamine hydrochloride. Atopy was defined as either positive results to common environmental allergens (one or more allergens) in SPTs or positive atopic history (earlier infantile eczema, atopic dermatitis, hay fever or other allergic rhinitis).

Flow-volume spirometry was performed in accordance with the recommendations of European Respiratory Society, and forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1) and the FEV1/FVC ratio (FEV%) were measured. A histamine challenge test was performed according to Sovijärvi’s method. Inhalation challenge tests (ICT) were perfomed in a 6 m3 test chamber (except for those of nickel sulphate and moulds)

Wax removing detergents containing ethanolamines:
The patient’s own wax-removing detergent (WRD) (5–100 mL) was mixed with 1–5 L of 40 °C water in the test chamber at the beginning of the ICT, and the mixture was left to evaporate in the chamber over the duration of the test (from 30 to 45 min). One ICT was carried out as a workplace challenge using wax- and TEA-containing WRD according to the normal working procedure.

Results and discussion

Results of examinations:
None of the SPTs to ethanolamines were positive.
Of the 20 patients diagnosed with OA. 5 were attributed to WRDs containing ethanolamines. 1 case of OA was confirmed to be caused by TEA, in the single patient who was challenged with pure TEA. Exposure to pure MEA was not conducted. The author concluded that ethanolamines in the tested products were the likely cause of the reaction in all cases.

Any other information on results incl. tables

Significant lack of clarity regarding the formulation of the WRDs tested (defined solely as containing either MEA or TEA). Only 1 patient was challenged with pure TEA. No patients were challenged with pure MEA. Limited evidence of OA triggered by exposure to MEA. Inconclusive as reaction to pure MEA was not examined.

Applicant's summary and conclusion