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Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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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:
other: Acceptable, well documented publication which meets basic scientific principles

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

Reference
Name:
Unnamed
Type:
Constituent
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.