Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well documented and scientifically acceptable publication

Data source

Reference
Reference Type:
publication
Title:
Isocyanate asthma: respiratory symptoms due to 1,5-naphthylene diisocyanate
Author:
Harries MG et al.
Year:
1979
Bibliographic source:
Thorax 34: 762-766

Materials and methods

Type of sensitisation studied:
respiratory
Study type:
study with volunteers
Principles of method if other than guideline:
Bronchial provocation testing with MDI, TDI, NDI, histamine and exercise according to the method described by O'Brien et al. (Clinical Allergy 9: 1-6, 1979).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no further information

Method

Type of population:
occupational
Controls:
no data
Route of administration:
inhalation

Results and discussion

Any other information on results incl. tables

2/3 patients with occupationally related asthma had non-immediate reactions by exposure to NDI only; 1/3 of the same patients had a

dual reaction provoked by NDI (no reaction to MDI, TDI and exercise).

Applicant's summary and conclusion