(octahydro-4,7-methano-1H-indenediyl)bis(methylene) diacrylate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 December 2013 -- 03 February 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2009

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2010

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

(octahydro-4,7-methano-1H-indenediyl)bis(methylene) diacrylate

EC Number:

255-901-3

EC Name:

(octahydro-4,7-methano-1H-indenediyl)bis(methylene) diacrylate

Cas Number:

42594-17-2

Molecular formula:

C18H24O4

IUPAC Name:

octahydro-1H-4,7-methanoindene-1,1-diylbis(methylene) bisacrylate

Test material form:

liquid

In vitro test system

Test system:

human skin model

Source species:

other: not applicable

Cell type:

other: reconstructed human epidermis

Cell source:

other: EpiskinTM Model Kit (0.38 cm2 tissues) supplied by SkinEthic Laboratories, Lyon, France.

Source strain:

other: not applicable

Vehicle:

unchanged (no vehicle)

Control samples:

yes, concurrent vehicle

yes, concurrent positive control

Amount/concentration applied:

Amount applied per tissue: 10 ± 2 µL.

Duration of treatment / exposure:

Exposure period of 15 minutes, followed by rinsing.
MTT-loading after a 42h-incubation period following rinsing. Observation of MTT-> formazan transformation by viable cells.

Number of replicates:

3

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

test

Value:

109

Vehicle controls validity:

valid

Negative controls validity:

not examined

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

Following a 15 minutes exposure and a 42 hours recovery periods, the relative mean viability of the tissues treated with the test item was 109% with a standard deviation of 17% as assessed by the MTT assay. As the mean viability was > 50% after the MTT reduction, the results met the criteria for a non-irritant response.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Not skin irritating

Conclusions:

Under the experimental conditions of this study, the test item is considered to be non-irritant to skin.

Executive summary:

The objective of this study was to evaluate the skin irritation potential of the test item using the EpiskinTM reconstructed human epidermis model.

The study design was based upon international guidelines (OECD Guideline No. 439 and Commission Regulation (EC) No. 761/2009, B.46). The study was conducted in compliance with CiToxLAB’s standard operating procedures and the principles of Good Laboratory Practice.

 

Methods

 

Preliminary tests were performed to detect the ability of the test item to directly reduce MTT as well as its colouring potential.

Following the preliminary tests, the skin irritation potential of the test item was tested in the main test. The test item and both the negative and positive controls were applied topically on triplicate tissues and incubated at room temperature for 15 minutes. At the end of the treatment period, each tissue was rinsed with D-PBS and incubated for 42 hours at, 5% CO2 in a humidified incubator. The cell viability was then assessed by means of the colourimetric MTT reduction assay.

Relative viability values were calculated for each tissue and expressed as a percentage of the mean viability of the negative control tissues which was set at 100% (reference viability).

 

Results

Preliminary tests

In the preliminary tests, the test item was found not to have direct MTT reducing properties or colouring potential.

 

Main test

All acceptance criteria for the negative and positive controls were fulfilled. The study was therefore considered to be valid.

Following a 15 minutes exposure and a 42 hours recovery periods, the relative mean viability of the tissues treated with the test item was 109% with a standard deviation of 17% as assessed by the MTT assay. As the mean viability was > 50% after the MTT reduction, the results met the criteria for a non-irritant response.

Conclusion

 

Under the experimental conditions of this study, the test item is considered to be non-irritant to skin.

 

According to the results of this study, the classification of the test item should be:

- not classified (Directive 67/548/EEC) and no category (Regulation (EC) No. 1272/2008).