2-chloroacetamide

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:

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

Test material information

Constituent 1

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

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).