Diisodecyl sebacate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion

Remarks:

other: in vitro

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

12-Jul-2010 to 19-Jul-2010

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study on a structurally-related read-across compound has been performed according to OECD and/or EC guidelines and to GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: EU method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

Deviations:

no

Test guideline 2

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

Test material information

Constituent 1

Reference substance name:

Diisodecyl adipate

EC Number:

248-299-9

EC Name:

Diisodecyl adipate

Cas Number:

27178-16-1

Molecular formula:

C26H50O4

IUPAC Name:

bis(8-methylnonyl) adipate

Test material form:

other: clear colourless oily liquid

Details on test material:

- Name of test material (as cited in study report): Diisodecyl adipate
- Molecular formula (if other than submission substance): C26-H50-O4
- Molecular weight (if other than submission substance): 426.677
- Smiles notation (if other than submission substance): C(CCCCC(OCCCCCCCC(C)C)=O)(OCCCCCCCC(C)C)=O
- InChl (if other than submission substance): InChI=1S/C26H50O4/c1-23(2)17-11-7-5-9-15-21-29-25(27)19-13-14-20-26(28)30-22-16-10-6-8-12-18-24(3)4/h23-24H,5-22H2,1-4H3
- Structural formula attached as image file (if other than submission substance): see Fig. 1
- 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 animals

Species:

human

Test system

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 µl [presumably undiluted]

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 vivo

Results

Irritation parameter:

other: percentage viability

Basis:

other: percentage of control

Time point:

other: 15 minutes

Score:

103

Remarks on result:

other: The score relates to the relative mean tissue viability, compared to the negative controls. As such, the maximum score is not applicable and no reversibility assessed.

Any other information on results incl. tables

The positive and negative controls were within the historical control data.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a GLP study, conducted according to OECD Guideline 439, DIDA was not irritating in an in vitro human epidermis (EPISKIN) model

Executive summary:

In a GLP study, conducted according to OECD Guideline 439, the potential of DIDA, a compound that is structurally-related to DIDS, was investigated in vitro in human epidermal keratinocytes (EPISKIN Standard Model^TM).

 

The EPISKIN Standard Model^TM, a three-dimensional human epidermis model, was exposed to 10 μl of [presumably undiluted] DIDA for 15 minutes.

 

After treatment, relative mean tissue viability was 103% of that seen in the negative control. Positive and negative controls performed as expected.

Since the mean relative tissue viability for DIDA was above 50% of that seen for the negative control after 15 minutes treatment, DIDA was not considered to be irritating under the conditions of this test.