Tricyclo[8.2.2.24,7]hexadeca-1(12),4,6,10,13,15-hexaene

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

1

Reference substance name:

Dichlorotricyclo[8.2.2.24,7]hexadeca-1(12),4,6,10,13,15-hexaene, mixed isomers

EC Number:

249-236-8

EC Name:

Dichlorotricyclo[8.2.2.24,7]hexadeca-1(12),4,6,10,13,15-hexaene, mixed isomers

Cas Number:

28804-46-8

Molecular formula:

C16H14Cl2

IUPAC Name:

Unknown constituents

Test material form:

solid: granular

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Control samples:

yes, concurrent no treatment

yes, concurrent positive control

Amount/concentration applied:

20 mg of test item/0.5 cm2

Duration of treatment / exposure:

3 minutes and 60 minutes

Number of replicates:

Three replicates were used for both the exposure times

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

% tissue viability

Value:

106

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation / corrosion parameter:

% tissue viability

Value:

90

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

other: non-corrosive

Conclusions:

From the results of this study, under the specified experimental conditions, DPX-C (Di-Cloro-Di-p-Xililene) is concluded to be non-corrosive in in vitro skin corrosion test using reconstructed human epidermis (RHE) tissues.

Executive summary:

This study was performed to evaluate the non-corrosive and corrosive potential of DPX-C (Di-Cloro-Di-p-Xililene) using reconstructed human epidermis (RHE) tissue in accordance with the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (UN GHS).

The tissues were exposed to DPX-C (Di-Cloro-Di-p-Xililene) for 3 minutes and 60 minutes at room temperature using three replicates/time point and positive control tissues were exposed for 60 minutes. Two tissue replicates were used for adapted negative control and positive controls (8N KOH) was exposed for 60 minutes, for the treatment of freeze killed tissues (to correct nonspecific MTT reduction). All the treated tissues were incubated at room temperature.

Percent relative viability in the tissues treated with the test item was 106% at 3 minute exposure period and 90% at 60 minute exposure period. Significant reduction in percent cell viability was not observed at any of the exposure period in the treated tissues when compared with the concurrent negative control. Differences between the viability of treated tissues was around 2% i.e. %CV.

All the OD values for the negative control replicates were between 2.292 to 2.591, against guideline requirement of ≥ 0.8 and ≤ 3.0 (the acceptance criteria for SkinEthicTM RHE model). Positive control showed 0.54% cell viability, against guideline requirement of <15%, compared to concurrent negative control, which demonstrate the efficiency of the test system, SkinEthicTM RHE model.

All criteria for a valid study were met as described in the study plan. From the results of this study, under the specified experimental conditions, DPX-C (Di-Cloro-Di-p-Xililene) is concluded to be non-corrosive in in vitro skin corrosion test using reconstructed human epidermis (RHE) tissues.