1-(2-hydroxy-5-nonyl(branched)-phenyl)ethanone oxime

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02.2009 - 04.2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)

Version / remarks:

April 2004

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-(2-Hydroxy-5-nonyl(branched)-phenyl)ethanone oxime

EC Number:

627-083-1

Cas Number:

244235-47-0

IUPAC Name:

1-(2-Hydroxy-5-nonyl(branched)-phenyl)ethanone oxime

Details on test material:

- Name of test material (as cited in study report): C-SAT 080104
- Physical state: liquid
- Analytical purity: 54.5%
- dissolved in petroleum
- Composition of test material, percentage of components:
Nonyl phenol: 5-10%
Kerosene: 30-50%

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

other: EpiDerm tissue

Vehicle:

unchanged (no vehicle)

Details on test system:

RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm TM tissues
- Tissue batch number(s):
9640 Kit N
- Delivery date:
02/17/09
- Date of initiation of testing:
02/18/09

REMOVAL OF TEST MATERIAL AND CONTROLS
- tissue was rinsed with phosphate buffered saline

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration:
1mg/ml MTT diluted in Dulbecco´s Modified Eagle Medium (DMEM)
- Incubation time: 3h
- Spectrophotometer:
microplate reader
- Wavelength:
540 nm

NUMBER OF REPLICATE TISSUES:
duplicate

CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Frozen tissues
- Method of calculation used:
% viability = 100 X (OD sample / OD negative control)

PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%.
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

TEST MATERIAL
- Amount applied: 50µl
- Concentration: undiluted

NEGATIVE CONTROL
- Amount applied: 50µl
- Concentration: not applicable

POSITIVE CONTROL
- Amount applied: 50µl
- Concentration: 8.0 N

Duration of treatment / exposure:

3min, 60min

Number of replicates:

2

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Basis: mean in %. Time point: 3 minutes

Value:

105.5

Results 2

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Basis: mean in %. Time point: 60 minutes

Value:

102.5

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance with a purity of 54.5% and in the presence of other chemicals originating from the production process (petroleum and nonylphenol) was not corrosive in the in vitro test according to OECD 431.

Executive summary:

The skin corrosion potential of the test substance with a purity of 54.5% and in the presence of other chemicals originating from the production process was evaluated in a study according to OECD Test Guideline 431 under GLP. The substance was applied unchanged for 60 minutes to in vitro skin tissue. After 60 minutes cell viability was not reduced. Interpreting these results by applying the evaluation system of the EU regulation 1272/2008, the test substance is considered as not corrosive to the skin.