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Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12-Jul-2010 to 19-Jul-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: EU method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: OECD Guidelines for Testing of Chemicals, Guideline no. 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Diisodecyl adipate
EC Number:
248-299-9
EC Name:
Diisodecyl adipate
Cas Number:
27178-16-1
Molecular formula:
C26H50O4 (C24H46O4 - C28H54O4)
IUPAC Name:
bis(8-methylnonyl) adipate
Details on test material:
- Name of test material (as cited in study report): Diisodecyl adipate- Substance type: Clear colourless oily liquid- Physical state: Liquid- Purity: >99.7% (based on GC-FID area %)- Lot/batch No.: D30204- Expiration date of the lot/batch: 25 January 2013- 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): 10 µl

NEGATIVE CONTOL:
- Amount(s) applied (volume or weight with unit): 10 µl Phosphate buffered saline

POSITIVE CONTROL
- Amount(s) applied (volume or weight with unit): 10 µl
- Concentration (if solution): 5% (aq) Sodium dodecyl sulphate
Duration of treatment / exposure:
Exposure:15 minutes
Post incubation period: 42 hours
Details on study design:
TEST SITE
- Area of exposure: human epidermis model
- % coverage: 0.38 cm2

REMOVAL OF TEST SUBSTANCE
- Washing (if done): phosphate buffered saline
- Time after start of exposure: 15 minutes

POST INCUBATION PERIOD
- 42 hours

SCORING SYSTEM:
- After a 42 hour incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment. Cell viability was calculated for each tissue as a percentage of the mean of the negative control tissues.

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Value:
103
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The positive and negative controls were within the historical control data.

Skin irritation is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 15 minutes treatment with Diisodecyl adipate compared to the negative control tissues was 103%. Since the mean relative tissue viability for Diisodecyl adipate was above 50% after 15 minutes treatment Diisodecyl adipate is considered to be non-irritant.

Finally, it is concluded that this test is valid and that Diisodecyl adipate is non-irritant in the in vitro skin irritation test under the experimental conditions described in the report.