N-phenylprop-2-enamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

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)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

N-phenylprop-2-enamide

EC Number:

606-936-1

Cas Number:

2210-24-4

Molecular formula:

C9 H9 N O

IUPAC Name:

N-phenylprop-2-enamide

In vitro test system

Test system:

human skin model

Remarks:

EpiSkin

Source species:

human

Cell type:

non-transformed keratinocytes

Details on test system:

Negative control: DPBS
Positive control: 5% SLS

RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE )
- Model used: Epiderm Skin Tissue (Epi-200-SIT Kit)
- Tissue batch number(s): Lot No. 18334
- Production date: 05/06/2013
- Shipping date: 04/06/2013
- Delivery date: 04/06/2013
- Date of initiation of testing: 04/06/2013

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C
- Temperature of post-treatment incubation (if applicable): 37°C

REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: at least 15 times, with DPBS. After rinsing, the inserts were submerged at least 3 times in DPBS.
- Observable damage in the tissue due to washing: no
- Modifications to validated SOP: no

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 300 µl (
- Incubation time: 42 hours
- Spectrophotometer: microplate reader (Versamax Molecular Devices, 85737 Ismaning, Germany)
- Wavelength:
- Filter: yes
- Filter bandwidth: 570 +- 1 nm
- Linear OD range of spectrophotometer: not specified

FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: passed the test
- Barrier function: passed the test
- Morphology: passed the test
- Contamination: no contamination detected
- Reproducibility: not specified

NUMBER OF REPLICATE TISSUES: 3

CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
not applicable

NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1

PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be irritant to skin if the viability is less than 50%,
- The test substance is considered to be non-irrtant to skin if the viability is greater than or equal to 50% and the viability

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

25mg (+/- 41.7mg/cm2) to each tissue

Duration of treatment / exposure:

60 minutes

Duration of post-treatment incubation (if applicable):

42

Number of replicates:

3

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Value:

4.5

Vehicle controls validity:

not examined

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other:

Remarks:

11.7% standard deviation (within the standard deviation of OECD439)

Other effects / acceptance of results:

Test item is irritating to skin since relative cell viability after 60 minutes is <50%

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The OECD 439 test was performed to determine the skin irritation potential of CH03859. Mean tissue viability after 60 minutes was <50%, indicating skin irritation. Following these results, the following classification and labelling applies:
- (EC) 1272/2008: cat.2, label H315: causes skin irritation
- 67/548/EEC: labelXi, R38: irritating to skin