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Toxicological information

Skin irritation / corrosion

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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

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

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Basis: mean in %. Time point: 3 minutes
Value:
105.5
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.