Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Currently viewing:

Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Toxische Risiken bei der Anwendung von Desinfektionsmitteln auf der Haut
Author:
Kramer, A. et al.
Year:
1987
Bibliographic source:
Hyg. + Med. 12, 134-142

Materials and methods

Study type:
clinical case study
Endpoint addressed:
skin irritation / corrosion
Principles of method if other than guideline:
The material tested was a product containing 0.5 % of peracetic acid and was applied to the intact or soaped and brushed skin of humans for a period of 5 min. each prior to each operation. Surgeons were assumed to perform 5 surgeries per day.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Peracetic acid
EC Number:
201-186-8
EC Name:
Peracetic acid
Cas Number:
79-21-0
Molecular formula:
C2H4O3
IUPAC Name:
Peracetic acid generated by perhydrolysis of N-acetylcaprolactam by hydrogen peroxide in alkaline conditions
Test material form:
other: solution
Details on test material:
- Name of test material (as cited in study report): Wofasteril 0.5%
- Composition of test material, percentage of components: 0.5% peracetic acid

Method

Type of population:
occupational
Subjects:
- Number of subjects exposed: 15
- Race: Caucasians
- Demographic information: surgeons
Route of exposure:
dermal
Reason of exposure:
intentional, occupational
Exposure assessment:
estimated
Details on exposure:
The aim of the study was to investigate the cytotoxic and irritating potential of peracetic acid in humans with a view to its local tolerance when used as a disinfectant for hand washind procedures applied by surgeons. The material tested was a product containing 0.5 % of peracetic acid. In detail, test material was applied to the intact or soaped and brushed skin of humans for a period of 5 min. each prior to each operation. Surgeons were assumed to perform 5 surgeries per day.
Examinations:
- Treated skin of was examined

Results and discussion

Clinical signs:
3 out of 15 surgeons developed immediately erythema and 6 of 15 surgeons developed dermatosis of the hands after 7 days following daily soaping, brushing and disinfection of skin with peracetic acid at a concentration of 0.5 %.

Applicant's summary and conclusion

Conclusions:
The investigations performed demonstrated that peracetic acid applied caused dermal irritation reactions in a third of health care workers.