3,7-dimethylnona-1,6-dien-3-ol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09/06/2010 - 26/08/2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD: Draft Proposal for a New Guideline on In Vitro Skin Irritation: Human Skin Model Test of 06-Jun-2008 and OECD Guideline for Testing of Chemicals No. 404, April 24, 2002 (Acute Dermal Irritation/Corrosion)

Cross-reference

Reason / purpose for cross-reference:

reference to same study

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: OECD: Draft Proposal for a New Guideline on In Vitro Skin Irritation: Human Skin Model Test of 06-Jun-2008; therefore OECD 439, In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: BfR: EpiDermTM Skin Irritation Test: Standard Operating Procedure. SOP Version 7.0 of October 2007

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Spielmann et al 2007, ATLA 35: 559-601

Principles of method if other than guideline:

In addition the study follows the test strategy for determination of a corrosive/irritation property as given in the following guideline: OECD Guideline for Testing of Chemicals No. 404, April 24, 2002 (Acute Dermal Irritation/Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

3,7-dimethylnona-1,6-dien-3-ol

EC Number:

233-732-6

EC Name:

3,7-dimethylnona-1,6-dien-3-ol

Cas Number:

10339-55-6

Molecular formula:

C11H20O

IUPAC Name:

3,7-dimethylnona-1,6-dien-3-ol

Details on test material:

- Name of test material (as cited in study report): Ethyllinalool
- Stability under test conditions: The stability under storage conditions over the study period was guaranteed by the sponsor.
- Other: The test substance was homogeneous by visual inspection.
- Physical state: liquid

Test animals

Species:

human

Strain:

other: Epi-200, MatTek Corporation, Ashland MA, USA

Details on test animals or test system and environmental conditions:

No remarks

Test system

Type of coverage:

other: nylon meshto spread the liquid material on the tissue.

Preparation of test site:

other: Three dimensional human epidermis model, EpiDerm TM

Vehicle:

unchanged (no vehicle)

Controls:

other: control tissues have been used with: PBS, sterile (negative control) or 5% (w/v) sodium dodecyl sulfate in highly de-ionized water, sterile (positive control)

Amount / concentration applied:

Test substance was applied undiluted

Duration of treatment / exposure:

1 hour

Observation period:

42 hours post incubation

Number of animals:

not applicable

Details on study design:

The potential of Ethyllinalool to cause dermal irritation was assessed by a single topical application of 30 µL of the test substance to a reconstructed three dimensional human epidermis model (EpiDerm TM). The tissues were purchased from MatTek Corporation, Ashland MA, USA. The test substance was spread onto 3 EpiDerm TM tissue samples (0.6 cm2 surface). Control tissues (#3 per control) were concurrently exposed to the negative control PBS and the positive control 5% SDS. For both, 30 µL were spread on the tissues. The tissues were incubated with the test substance and the controls for 1 hour followed by a 42-hours post-incubation period. After the postincubation period, the assay medium was replaced by 0.3 mL MTT solution and the tissues were incubated in the incubator for 3 hours. After incubation, the tissues were washed with PBS to stop the MTT-incubation. The formazan that was metabolically produced by the tissues was extracted by incubation of the tissues in isopropanol for at least 2 hours at room temperature on a plate shaker. The optical density at a wavelength of 570 nm (OD570) of the extracts was determined spectrophotometrically. Blank values were established of 6 microtiter wells filled with isopropanol for each microtiter plate.

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

other: other: Viability (% of negative control)

Value:

100

Remarks on result:

other:

Remarks:

Basis: mean. Remarks: Negative control. (migrated information)

Results 2

Irritation / corrosion parameter:

other: other: Viability (% of negative control)

Value:

7

Remarks on result:

other:

Remarks:

Basis: mean. Remarks: Test substance. (migrated information)

Results 3

Irritation / corrosion parameter:

other: other: Viability (% of negative control)

Value:

7

Remarks on result:

other:

Remarks:

Basis: mean. Remarks: Positive control. (migrated information)

In vivo

Irritant / corrosive response data:

No remarks

Other effects:

No remarks

Any other information on results incl. tables

Irritant potential of the test materials is predicted from the mean relative tissue viabilities compared to the negative control tissues concurrently treated with sterile PBS. A chemical is considered as "irritant", if the mean relative tissue viability with a test material is less than or equal to 50%.

Mean tissue viability (% of negative control) ---> Prediction

= 50 ---> irritant

= 50 ---> non-irritant

Historical control values of negative and positive controls have been gathered over an appropriate time period.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant)

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

It was concluded, that Ethyllinalool shows a skin irritation potential in the EpiDerm skin irritation test under the test conditions chosen. Based on the criteria laid down in Regulation 1272/2008/EC, undiluted Ethyllinalool is considered a skin irritant (category 2).

Executive summary:

It was concluded, that Ethyllinalool shows a skin irritation potential in the EpiDerm skin irritation test under the test conditions chosen. Based on the criteria laid down in Regulation 1272/2008/EC, undiluted Ethyllinalool is considered a skin irritant (category 2).