Registration Dossier
Registration Dossier
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EC number: 610-199-1 | CAS number: 446292-04-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well reported GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 431
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- The experiment was carried out on a reconstructed human epidermis EST-1000.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-(4-nitrophenyl)morpholin-3-one
- EC Number:
- 610-199-1
- Cas Number:
- 446292-04-2
- Molecular formula:
- C10 H10 N2 O4
- IUPAC Name:
- 4-(4-nitrophenyl)morpholin-3-one
- Details on test material:
- 4-(4-Nitrophenyl)-3-morpholinon, batch number BXR2LPC, content 97.5%
Constituent 1
Results and discussion
Any other information on results incl. tables
The MTT method has determined the following values of viability:
after 3 min of incubation: 99.74%
after 60 min of incubation: 104 .83%
Applicant's summary and conclusion
- Executive summary:
The study on a reconstructed human epidermis EST-1000 was carried out for detection of topically applied skin corrosives with the test item 4 -(4 -Nitrophenyl)-3 -morpholinon.
A 100% concentration was tested on the skin/epidermal equivalents in triplets. For the determination of time related cytotoxic effects the incubation periods were 3 minutes (room temperature) and 60 minutes (incubator), respectively. Using the MTT (methylthiazoletetrazolium) method the cell viability after 3 minutes or after 60 minutes of incubation was determined to be 99.74% and 104.83%, respectively. Thus, 4 -(4 -Nitrophenyl)-3 -morpholinon was not characterised by a significant impact on cell viability and it therefore showed no corrosive properties.
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