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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion
Remarks:
other: in vitro
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:
other: 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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: OECD Guideline 431: In Vitro Skin Corrosion: Human Skin Model Test
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EU method B.40 BIS: "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
IUPAC Name:
95193-59-2
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

Test system

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
Details on study design:
TEST SITE
- Area of exposure: human skin model
- % coverage: 0.6 cm2

REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline
- Time after start of exposure: 3 minutes and 1 hour

SCORING SYSTEM:
- Percentage viability

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: Percentage viability
Basis:
other: Percentage of control
Time point:
other: 3 minutes
Score:
97
Irritation parameter:
other: Percentage viability
Basis:
other: Percentage of control
Time point:
other: 1 hour
Score:
97

Applicant's summary and conclusion

Interpretation of results:
other: not corrosive
Remarks:
Criteria used for interpretation of results: EU
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.