Registration Dossier
Registration Dossier
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EC number: 201-174-2 | CAS number: 79-07-2
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted to state-of-the-art methods and was considered reliable, adequate and relevant for classfication.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- epicutaneous, occlusive test
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-chloroacetamide
- EC Number:
- 201-174-2
- EC Name:
- 2-chloroacetamide
- Cas Number:
- 79-07-2
- Molecular formula:
- C2H4ClNO
- IUPAC Name:
- 2-chloroacetamide
- Details on test material:
- Technical substance , Hoechst, purity acc. to specification
Constituent 1
Method
- Type of population:
- other: patients
- Subjects:
- 296 persons, 162 women, 134 men
- Clinical history:
- presumed contact allergy
- Route of administration:
- dermal
- Details on study design:
- 0.2 % aqueous solution of chloroacetamide, 0.1 mL per patient on a test swab,
positioned on the healthy back skin of the volunteers & covered by a test-plaster (manufacturer: Beiersdorf, Hamburg, Germany).
Examination of the test areas: 24 h, 2 & 3 days after application.
Results and discussion
- Results of examinations:
- 4 of 162 women, 3 of 134 men reacted positive.
All 7 patients had a history of eczema.
Applicant's summary and conclusion
- Conclusions:
- The author concluded that positive skin reactions in 7/296 patients were due to previously obtained contact allergies against
chloroacetamide. - Executive summary:
In a clinical study, 296 patients with presumed contact allergy were treated with 0.1 mL of a 0.2 % aqueous chloroacetamide solution on the back skin under occlusion for 24h. Examination of the test areas at 24 h, 2 & 3 days after application showed positive skin reactions in 7 patients due to previous contact wiht Chloroacetamide. This complies with a frequency of 0.3 -2.8% individuals with acquired contact allergies to Chloroacetamide in the patients groups treated at dermatology departments (BG Chemie, Germany, Toxicological Evaluations no. 8 chloroacetamide (2000-06).
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