Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vitro
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:
2021

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 442E (In Vitro Skin Sensitisation: human Cell Line Activation Test (h-CLAT))
GLP compliance:
yes
Type of study:
human Cell Line Activation Test (h-CLAT)

Test material

Constituent 1
Chemical structure
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

Details of test system:
THP-1 cell line [442E]
Details on the study design:
In total a pre-test and one valid experiment (2 runs) with a treatment period of 24 hours were
performed.
For the experiment the highest nominal applied concentration (10 µg/mL) was chosen based
on the results obtained in the pre-test. A geometric series (factor 1.2) of 7 dilutions was
prepared. Precipitation of the test item was not visible in none of the runs.
As solvent control for the test item, DMSO was used in a final concentration of 0.2 % in
culture medium.
As positive control, 2,4-dinitrochlorobenzene (DNCB, CAS n. 97-00-7, ≥ 99% purity) was
used.
Vehicle / solvent control:
DMSO
Positive control:
dinitrochlorobenzene (DNCB) [442E]

Results and discussion

In vitro / in chemico

Resultsopen allclose all
Run / experiment:
run/experiment 1
Parameter:
RFI CD86>200 [442E]
Cell viability:
≥ 50 %
Remarks on result:
no indication of skin sensitisation
Run / experiment:
run/experiment 2
Parameter:
RFI CD86>200 [442E]
Cell viability:
≥ 50 %
Remarks on result:
no indication of skin sensitisation
Run / experiment:
run/experiment 2
Parameter:
RFI CD54>150 [442E]
Cell viability:
≥ 50 %
Remarks on result:
no indication of skin sensitisation
Run / experiment:
run/experiment 1
Parameter:
RFI CD54>150 [442E]
Cell viability:
≥ 50 %
Remarks on result:
no indication of skin sensitisation
Other effects / acceptance of results:
In both runs the RFI of CD86 was not ≥ 150 % as well as the RFI of CD54 was not ≥ 200 % at
any tested concentration with cell viability ≥ 50 %.
Since the result of the two individual runs is negative, the test item is considered as “nega-
tive”.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the experimental conditions of this study, the test item, HEXANITROSTILBENE, was
negative in the h-CLAT and is therefore considered not having the potential to activate den-
dritic cells and therefore not to up-regulate the cell surface marker (CD86 and CD54) ex-
pression of THP-1 cells.