Registration Dossier
Registration Dossier
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EC number: 928-489-4 | CAS number: 194984-24-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 7 November 2012 to 12 November 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study according to international guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2013
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
Test material
- Reference substance name:
- 1-(pentanoylamino)cyclopentanenitrile
- IUPAC Name:
- 1-(pentanoylamino)cyclopentanenitrile
- Reference substance name:
- N-(1-cyanocyclopentyl)pentanamide
- EC Number:
- 928-489-4
- Cas Number:
- 194984-24-2
- Molecular formula:
- C11H18N2O
- IUPAC Name:
- N-(1-cyanocyclopentyl)pentanamide
- Test material form:
- other: liquid
- Details on test material:
- Test article identification: Valeroyl-aminonitrile oil
Test article description: liquid
Test article lot/batch number: 2U291
Storage conditions bulk material: between 2°C and 8°C
Purity: 92.4 %
Retest or expiry date: September 2013
Constituent 1
Constituent 2
Test animals
- Species:
- human
- Strain:
- other: Reconstructed human Epidermis (RhE)
Test system
- Amount / concentration applied:
- 10 µl
- Duration of treatment / exposure:
- 15 minutes
post-treatment incubation is approximately 42h, 37°C +/- 2°C, 5 +/- 1% CO2 - Observation period:
- The viability is assessed after approximately a 3-hour incubation with MTT solution in a 12-well plate
- Details on study design:
- Negative control: D-PBS (phosphate buffered saline)
Positive control: aqueous SDS (sodium dodecyl sulphate) 5%
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- <= 102
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- With Valeroil-aminonitrile, the mean viability was higher than 50% which indicated a non-irritant potential.
Any other information on results incl. tables
The experiment was validated as all the acceptance criteria were fulfilled.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under these experimental conditions, the test article Valeroyl-aminonitrile was considered as non-irritant to the skin.
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