Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02-Mar-2010 to 05-Mar-2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study has been performed according to OECD and/or EC guidelines and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Rape oil, oxidized
EC Number:
305-871-3
EC Name:
Rape oil, oxidized
Cas Number:
95193-59-2
Molecular formula:
Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance).
IUPAC Name:
Rape oil, oxidized
Details on test material:
- Name of test material (as cited in study report): Blown rapeseed oil
- Substance type: Yellow to brown viscous liquid
- Physical state: liquid
- Analytical purity: treated as 100% pure
- Expiration date of the lot/batch: 16 December 2010
- Stability under test conditions: stable
- Storage condition of test material: At room temperature in the dark

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
other: The model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis.
Cell source:
other: not specified
Source strain:
other: not applicable
Justification for test system used:
According to OECD 431
Vehicle:
unchanged (no vehicle)
Details on test system:
RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm Skin Model (EPI-200,no.: 12935 kit H).
The model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those foundin vivo. The EpiDerm tissues (surface 0.6 cm²) were cultured on polycarbonate membranes of 10 mm cell culture inserts.

TEST SITE
- % coverage: 0.6 cm2

REMOVAL OF TEST MATERIAL AND CONTROLS
- Washing: physiological saline
- Time after start of exposure: 3 minutes and 1 hour

SCORING SYSTEM:
- Percentage viability

PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be corrosive to skin if [complete, e.g. the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.]
- The test substance is considered to be non-corrosive to skin if [complete, e.g. 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(s) applied (volume or weight with unit): 50 µl of the undiluted test substance

NEGATIVE CONTROL
- Amount(s) applied (volume or weight with unit): 50 µl water

POSITIVE CONTROL
- Amount(s) applied (volume or weight with unit): 50 µl KOH
- Concentration (if solution): 8N
Duration of treatment / exposure:
- 3 minutes and 1 hour exposure times

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3 minutes
Value:
97
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
1 hour
Value:
97
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
other:
Remarks:
not corrosive according to CLP criteria
Conclusions:
The positive and negative controls were within the historical control data. Skin corrosion is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 3-minute and 1-hour treatments with Blown rapeseed oil compared to the negative control tissues was 97%. Because the mean relative tissue viability for Blown rapeseed oil was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment Blown rapeseed oil is considered to be not corrosive.

Finally, it is concluded that this test is valid and that Blown rapeseed oil is not corrosive in the in vitro skin corrosion test under the experimental conditions described in the report.