Registration Dossier

Diss Factsheets

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
other: clinical cases
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was not conducted according to regulatory guidelines and only contained limited information, therefore it is considered relevant but less reliable and adequate for classification.
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Contact allergy to chloracetamide
Author:
Klaschka F
Year:
1975
Bibliographic source:
Contact Dermatitis (1975) 1, 265-266

Materials and methods

Study type:
clinical case study
Endpoint addressed:
skin sensitisation
Principles of method if other than guideline:
Patch tests for contact allergens

Test material

Constituent 1
Chemical structure
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:
Chloroacetamide was provided by the manufacturer

Method

Type of population:
general
occupational
Subjects:
1) 57-year-old female pensioner
2) 43-year-old female worker
Route of exposure:
dermal
Reason of exposure:
other: unintentional, 1) non-occupat. 2) occupational
Exposure assessment:
not specified
Details on exposure:
1) pensioner: cosmetic skin cleanser used, which contained chloroacetamide
2) worker in contact with wet cork, treated with 0.5 % chloroacetamide as disinfectant
Examinations:
Dermal clinical examination

Results and discussion

Clinical signs:
1) pensioner using skin cleanser: inflammatory reddening and swelling of the skin of the face, neck, nape and neck-line, on the back of her hands and forearms ascending to the middle of the upper arms.
2) worker in contact with wet cork: the first two fingers of her right hand showed an eczematous reaction, which improved during periods of time off and deteriorated after returning to work. Dermatitis spread to other fingers and to the back of her right hand causing deeper rhagades.
Results of examinations:
Only on 1) pensioner using skin cleanser:
Patch tests performed with contact allergens chosen on the basis of the case history were negative, except
a) for a facial cleanser presently used b) for another cosmetic skin cleanser used previously for more than one year.
Effectivity of medical treatment:
1) resistent

Any other information on results incl. tables

Two case studies were described in which Chloroacetamide was determined to be a skin sensitizer: 1) a pensioner using skin cleanser developed inflammatory reddening and swelling of the skin of the face, neck, nape and neck-line, on the back of hands and forearms ascending to the middle of the upper arms: a patch test containing facial cleanser was positive; 2) a worker in contact with wet cork developed an eczematous reaction on the fingers of the right hand, which improved during periods of time off and deteriorated after returning to work.

Applicant's summary and conclusion

Conclusions:
In both cases, chloroacetamide was a contact sensitizer.