2,6,10-trimethylundec-9-enal

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 June 2014 to 9 Decembre 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Deviations:

yes

Remarks:

43 hour incubation period was used instead of 42 hours specified in the protocol.

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

43 hour incubation period was used instead of 42 hours as specified in the protocol.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,6,10-trimethylundec-9-enal

EC Number:

205-460-8

EC Name:

2,6,10-trimethylundec-9-enal

Cas Number:

141-13-9

Molecular formula:

C14H26O

IUPAC Name:

2,6,10-trimethylundec-9-enal

Test material form:

liquid

Specific details on test material used for the study:

Batch : SC00010875
Expiration Date: 09 April 2015

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

other: EpiSkinTM three-dimensional human skin model

Cell source:

other: A reconstructed epidermis with a functional stratum corneum, supplied by SkinEthic Laboratories, Lyon, France.

Vehicle:

unchanged (no vehicle)

Remarks:

The test article was used as supplied.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

A volume of 40 μL of the undiluted test article was added topically to the tissues. A volume of 40 μL of the positive and negative control solutions was used.

Duration of treatment / exposure:

15 minutes

Duration of post-treatment incubation (if applicable):

At the end of the treatment period, the tissues were washed with PBS and cell viability was assessed using the 3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT) assay.The tissues were then incubated at 37°C for 43 hours

Number of replicates:

The test was performed on a total of three tissues per test article, negative and positive control.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Value:

57.7

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

The group mean viability for the negative control was 100.0 %
The group mean viability for the positive controls was 11.8 %

Any other information on results incl. tables

Table 1: Results

Substance	Tissue replicate	OD570		Corrected mean	Standard deviation	Coefficient of variance	% Relative survival
		Aliquot 1	Aliquot 2				Tissue	Mean
Negative control	A	1.022	1.041	1.031	9.6940	9.694	93.3	100.0
	B	1.068	1.046	1.057			95.6
	C	14.221	1.236	1.228			111.1
Test material	A	0.805	0.775	0.790	11.9747	20.766	7.5	57.7
	B	0.556	0.563	0.560			50.6
	C	0.562	0.563	0.563			50.9
Positive control	A	0.136	0.141	0.139	2.0100	16.984	12.5	11.8
	B	0.106	0.105	0.106			9.6
	C	0.152	0.145	0.148			13.4
Blank		0.001	-0.001

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Not sufficient to be classified under the GHS criteria

Conclusions:

The test article, Adoxal, was considered to be non-irritant in the in vitro skin model EpiSkin.

Executive summary:

In the in vitro study (Dreher, 2014), the potential for the test material to cause skin irritation was investigated in a study conducted in accordance with standardised guideline OECD 439 and EU Method B.46 under GLP conditions using the EpiSkin in vitro model.

EpiSkinTM inserts were treated with the test material, negative control and positive control for 15 minutes. At the end of the exposure period, the tissues were washed and assessed for viability using MTT (3 -(4,5 -Dimethylthiazol-2 -yl)-2,5 -diphenyl tetrazolium bromide).

The group mean viability for the test material was 57.7 %. The group mean viability for the negative control was 100.0 % and 11.8 % for the positive control.

The test material was determined to be non-irritant under the conditions of the test in the in vitro skin model EpiSkin.