Registration Dossier

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Publication in peer reviewed journal. However, limited information is given on exposure situation (no direct measurements of the test substance). Only 18 workers were investigated.

Data source

Reference
Reference Type:
publication
Title:
Formation of new blood vessels in the nose after exposure to dicumylperoxide at a chemical plant.
Author:
Petruson B, Järvholm B
Year:
1983
Bibliographic source:
Acta Otolaryngol 95, 333-339

Materials and methods

Study type:
other: Investigation of worker at a chemical plant
Endpoint addressed:
respiratory irritation
Principles of method if other than guideline:
No guideline available

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No further information given, only named as dicumylperoxide

Method

Type of population:
occupational
Subjects:
18 workers, mean age 43, smokers 7, mean exposure time 3.3
Ethical approval:
not specified
Route of exposure:
inhalation
Reason of exposure:
unintentional, occupational
Exposure assessment:
not specified
Details on exposure:
only dust was measured: 0.9 mg/m3 during routine work, 2 samples when cleaning a sieve were reported to be 49 and 5.5 mg/m3
Examinations:
Questionaire, rhinoscopy, mucociliary function, Rhinomanometry

Results and discussion

Clinical signs:
The mucociliary function and nasal airflow were the same in exposed and unexposed subjects. 9 workers exposed to the test substance had visible blood vessels in the muscosa of the anterior part of nasal septum, while only 2 persons in the control group had such effects. Both subjects had a cold at the time of teh examination.

Applicant's summary and conclusion

Conclusions:
The study revealed visible blood vessels in the nasal mucosa. The authors discussed that DCP may have contributed to the formation of blood vessels. Given the fact that only a limited number of worker were investigated and the exposure was not measured, the reliability was rated as not assignable.