2,2',4,4',6,6'-hexanitrostilbene

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

2020

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)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2',4,4',6,6'-hexanitrostilbene

EC Number:

243-494-5

EC Name:

2,2',4,4',6,6'-hexanitrostilbene

Cas Number:

20062-22-0

Molecular formula:

C14H6N6O12

IUPAC Name:

1,3,5-trinitro-2-[(E)-2-(2,4,6-trinitrophenyl)ethenyl]benzene

Test material form:

solid: crystalline

Specific details on test material used for the study:

Batch no. 18909-1
Composition 100%
Expiry date 27/2/2028

In vitro test system

Test system:

human skin model

Vehicle:

unchanged (no vehicle)

Details on test system:

The EpiDermTM tissue consists of human-derived epidermal keratinocytes which have
been cultured to form a multi-layered, highly differentiated model of the human epidermis.
It consists of organized basal, spinous and granular layers, and a multi-layered stratum
corneum containing intercellular lamellar lipid layers representing main
lipid classes analogous to those found in vivo. The EpiDermTM tissues are cultured on spe-
cially prepared cell culture inserts

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Duration of treatment / exposure:

60 minutes

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Value:

97.3

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

After treatment with the negative control, the mean absorbance value was within the re-
quired acceptability criterion of 0.8 ≤ mean OD ≤ 2.8, OD was 1.8.
The positive control showed clear irritating effects. The mean value of relative tissue viabil-
ity was reduced to 2.2% (required:  20%).
The variation within the tissue replicates of negative control, positive control and test item
was acceptable (required: ≤ 18%).

Any other information on results incl. tables

After the treatment, the mean value of relative tissue viability was reduced to 97.3%. This value is above the threshold for skin irritation (50%). Test
items that induce values above the threshold of 50% are considered non-irritant to skin.
The optical density of the negative control was well within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8.
The positive control has met the acceptance criterion too, for thus ensuring the validity of the test system.
Variation within replicates was within the accepted range for negative control, positive control and test item (required: ≤ 18%).

The result of the test is considered valid.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item HEXANITROSTILBENE is considered as non-irritant to skin.