Registration Dossier
Registration Dossier
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EC number: 220-860-2 | CAS number: 2920-38-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and OECD guideline compliant study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- p-phenylbenzonitrile
- EC Number:
- 220-860-2
- EC Name:
- p-phenylbenzonitrile
- Cas Number:
- 2920-38-9
- Molecular formula:
- C13H9N
- IUPAC Name:
- biphenyl-4-carbonitrile
- Details on test material:
- - Name of test material (as cited in study report): p-Phenylbenzonitrile
- Physical state: Solid / white
- Analytical purity: 96.0 G%/G%
- Lot/batch No.: 0005797001
- Expiration date of the lot/batch: March 18, 2017
- Stability under test conditions: stable
- Storage condition of test material: Room temperature
pH-value: Ca. 4 (undiluted test substance, moistened with water)
Constituent 1
Test animals
- Species:
- human
- Strain:
- other: not applicable
Test system
- Details on study design:
- The potential to cause dermal irritation was assessed by a single topical application of 25 μL bulk volume (about 15 mg) of the undiluted test substance to a reconstructed three dimensional human epidermis model (EpiDerm™). Three EpiDerm™ tissue samples were incubated with the test substance for 1 hour followed by a 42-hours post-incubation period. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure/ post-incubation using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as endpoint. The formazan production of the testsubstance treated epidermal tissues is compared to that of negative control tissues. The quotient of both values indicates the relative tissue viability.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: viability
- Value:
- 112
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 42h. Max. score: 100.0. Remarks: The substance is not able to reduce MTT directly.. (migrated information)
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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