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Toxicological information

Sensitisation data (human)

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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:
1984
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
Name:
Unnamed
Type:
Constituent
Details on test material:
Technical substance , Hoechst, purity acc. to specification

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).