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Registration Dossier
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EC number: 201-186-8 | CAS number: 79-21-0
Direct observations: clinical cases, poisoning incidents and other
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:
- 1 987
- 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 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
Constituent 1
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.
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