Hexachloroethane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 29 MARCH 2021 to 12 MAY 2021

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Report date:

2021

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

no

Test material

Test material information

impurity 1

Reference substance name:

Tetrachloroethylene

EC Number:

204-825-9

EC Name:

Tetrachloroethylene

Cas Number:

127-18-4

IUPAC Name:

tetrachloroethene

Constituent 1

Reference substance name:

Hexachloroethane

EC Number:

200-666-4

EC Name:

Hexachloroethane

Cas Number:

67-72-1

Molecular formula:

C2Cl6

IUPAC Name:

hexachloroethane

In vitro test system

Test system:

human skin model

Details on test system:

RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiDerm(TM) Part EPI-212
- Tissue batch number(s): 34144 kit B
- Production date, shipping date, delivery date: not specified
- Date of initiation of testing: 2021-04-13

REMOVAL OF TEST MATERIAL AND CONTROLS
After exposure, the tissue samples are removed by washing them with phosphate buffered saline (PBS).

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- Wavelength: 570 nm

PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be irritant to skin if the average viability after 60 minutes exposure is less than 50%.

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

TEST MATERIAL
- Amount(s) applied: 25 mg

NEGATIVE CONTROL
- Amount(s) applied: 30 µl PBS

POSITIVE CONTROL
- Amount(s) applied: 30 µl sodium dodecyl sulfate (SDS)
- Concentration: 5%

Duration of treatment / exposure:

60 minutes

Number of replicates:

Triplicate

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Value:

149.39

Negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

Absorbance and mean cell viability of samples and controls after contact with EpiDerm

	Absorbance	Cell Viability (%)
Negative control (PBS)	1.26 ± 0.37	100 ± 29.4
Positive control (5% SDS)	0.10 ± 0.02	7.55 ± 1.53
Hexachloroethane	1.89 ± 0.13	149.39 ± 9.97

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions applied, and according to the results obtained and the defined evaluation criteria, the test material is not irritating to the skin.

Executive summary:

The skin irritation potential of hexachloroethane was assessed by performing an in vitro skin irritation study according to the OECD test guideline No. 439, using a reconstructed human epidermis model (EpiDermTM). The irritant potential of the test material is based on the cytotoxicity produced after exposure and measured by MTT assay. 

 

The test material (25 mg), negative control (30 µl PBS) and positive control (30 µl 5% SDS) were applied to epiderm skin tissue, in triplicate, for 60 minutes. At the end of exposure period, the tissue samples were removed by washing them with PBS and the cell viability of the tissue was measured. 

The cell viability of skin tissues exposed with PBS was of 100 ± 29.4%. No significant change in cell viability was observed for tissues exposed with the test material (149.39 ± 9.97%), while a significant reduction was measured for tissues in contact with 5% SDS (viability of 7.55 ± 1.53%).   

 

Under the test conditions applied, and according to the results obtained and the defined evaluation criteria, the test material is not irritating to the skin.