Registration Dossier
Registration Dossier
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EC number: 202-588-6 | CAS number: 97-52-9
Sensitisation data (human)
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:
- 1 984
- 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 substance name:
- 4-nitro-o-anisidine
- EC Number:
- 202-588-6
- EC Name:
- 4-nitro-o-anisidine
- Cas Number:
- 97-52-9
- Molecular formula:
- C7H8N2O3
- IUPAC Name:
- 2-methoxy-4-nitroaniline
- Reference substance name:
- PNOA
- IUPAC Name:
- PNOA
- Details on test material:
- C.I 37125; 4-nitro-o-anisidin; no further detail
Constituent 1
Constituent 2
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
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