Registration Dossier
Registration Dossier
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EC number: 220-860-2 | CAS number: 2920-38-9
Eye irritation
Administrative data
- Endpoint:
- eye 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 study, protocol internally validated for distinguishing non-irritants from irritants
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
- Principles of method if other than guideline:
- In Vitro Eye Irritation Test in Reconstructed Human Cornea (EPIOCULAR)
- 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 / tissue source
- Species:
- human
- Strain:
- other: not applicable
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: yes (tissue incubations for positive and negative controls included)
- Amount / concentration applied:
- 50 μL bulk volume (about 17 mg)
- Duration of treatment / exposure:
- 90 minutes
- Observation period (in vivo):
- 18h
- Number of animals or in vitro replicates:
- Two tissue samples were used per group.
- Details on study design:
- 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 the values indicates the relative tissue viability.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: Viability
- Basis:
- mean
- Time point:
- other: 18h
- Score:
- 98
- Max. score:
- 100
- Remarks on result:
- other: The substance is not able to reduce MTT directly.
Any other information on results incl. tables
Methyl acetate was used as positive control and deionised water as negative control and both gave the results to satisfy acceptance criteria.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
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