Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
other: case report
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Peer reviewed publication, only very brief desciption of methods

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2009

Materials and methods

Study type:
case report
Principles of method if other than guideline:
Peak expiratory flow measurement with specific inhalation challenges
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
solder flux containing unspecified concentration of dodecanedioic acid ("predominant")

Method

Ethical approval:
not applicable
Subjects:
One male person
Clinical history:
worker using gel flux for soldering in electronis.
5 year before the patient developed work-related stuffy-nose and dyspnoea; blocked nose, sputum and wheeze for 2h after waking;
conditions worsened after soldering activity with palmitic acid based solder flux.
No history of childhood asthma, hayfever or eczema
Smoking history: 7-10 per day until 6 weeks before seeing the clinic
Negative skin tests to all common environmental allergens
Route of administration:
inhalation
Details on study design:
serial peak expiratory flow measurements every 2 h for a total of 4 weeks
specific inhalation challenge testing to solder wires and fluxes;
solder iron (370°C) was dipped every 10 s into fluxwith the resulting fumeinto the challenge chamber

Results and discussion

Results of examinations:
The forced expiratory volume fell by a maximum of 23% when exposed to fumes from dodecanedioic acid flux, no effect was induced by fluxes containing colophony or palmitinic acid.
Two years later after removal from solder flux exposure asthma continues but is no longer work related.

Applicant's summary and conclusion

Conclusions:
A single case of occupational asthma was reported that was associated with exposure to dodecanedioic acid containing solder flux. The temperature of the soldering iron (360°C) resultes in decomposition of dodecanedioic acid. Exposure history is unclear patient smoked cigarettes.
Executive summary:

A single case of occupational asthma was reported that was associated with exposure to dodecanedioic acid containing solder flux. The temperature of the soldering iron (360°C) resultes in decomposition of dodecanedioic acid. Exposure history of the patient is unclear, patient smoked cigarettes. In a inhalatory challenge test forced expiratory volume was reduced by a maximum of 23% upon exposure to fumes from dodecanedioic acid flux generated by dipping a solder iron into the flux.