Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
other: Observation at workplace in India
Adequacy of study:
disregarded due to major methodological deficiencies
Study period:
1984
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: undefined, mixed exposure; unclear naming of testsubstance;

Data source

Reference
Reference Type:
publication
Title:
Contact dermatitis in tie and dye industry workers
Author:
Mathur N.K.; Mathur A.; Banerjee K.
Year:
1984
Bibliographic source:
Contact dermatitis 12; 38-41 (1985)

Materials and methods

Study type:
case report
Principles of method if other than guideline:
Patch test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
C.I 37125; 4-nitro-o-anisidin; no further detail

Method

Ethical approval:
not specified
Subjects:
26 Patients (workers in Indian textile dying industry) showing signs of contact dermatitis were patch tested
Clinical history:
positive signs of dermatitis
Controls:
25 healthy workers and 25 healthy volunteers
Route of administration:
dermal

Results and discussion

Results of examinations:
1 patient showed positive skin reactions to 3 chemical i.a. Red base (4-nitro-o-anisidine)

Applicant's summary and conclusion

Conclusions:
Study not valid