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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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Administrative data

Endpoint:
skin sensitisation: in vitro
Remarks:
In vitro skin sensitization test: KeratinoSens on TCB
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Final Report 16 DEC 2021
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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 442D (In Vitro Skin Sensitisation: ARE-Nrf2 luciferase KeratinoSens™ test method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
ARE-Nrf2 luciferase KeratinoSens™ test method

Test material

Constituent 1
Chemical structure
Reference substance name:
1,3,5-trichlorobenzene
EC Number:
203-608-6
EC Name:
1,3,5-trichlorobenzene
Cas Number:
108-70-3
Molecular formula:
C6H3Cl3
IUPAC Name:
1,3,5-trichlorobenzene
Test material form:
solid
Details on test material:
• Sponsor’s identification: TCB (1,3,5-trichlorobenzène)
• Batch No.: 171882
• Category: Chemical Substance
• Date received: 17 September 2021
• EINECS No.: 203-608-6
• Container: plastic flask (n=1)
• CAS No : 108-70-3
• Quantity: 101.00 g (container + content + label)
• Form: solid
• Homogeneity: yes • Colour: white
• Production date: not provided
• Expiry date: February 2024
• Storage: room temperature
• Purity: 99,85 %
• Stability: stable under storage conditions
• Composition : 99.85 % 1,3,5-trichlorobenzène

In vitro test system

Details of test system:
Keratinoses transgenic cell line [442D]
Details on the study design:
Cells: KeratinoSens™ (Givaudan) maintained according to the current working instruction IL 09.
Cells are cultured in maintenance medium at 37°C, 5% CO2.
Vehicle / solvent control:
DMSO
Negative control:
other: Negative control: each culture plate contains 6 wells of solvent control (treatment medium with 1% DMSO final).
Positive control:
other: for each culture plate, the cinnamaldehyde was tested at 5 concentrations from 4 to 64 µM according to a geometric progression of ratio 2.

Results and discussion

In vitro / in chemico

Resultsopen allclose all
Group:
test chemical
Run / experiment:
mean
Parameter:
IC30 [442D]
Value:
73.13 µM
Cell viability:
30%
Vehicle controls validity:
not specified
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: cf IC50
Key result
Group:
test chemical
Run / experiment:
other: geometric mean of
Parameter:
IC50 [442D]
Value:
87.84 µM
Cell viability:
50%
Vehicle controls validity:
not specified
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: In the both repetitions: the gene induction is statistically significant above the threshold of 1.5, the EC1.5 value is between IDEA Lab historical data, the cinnamaldehyde at 64 µM is between 2 and 8, the coefficient of variation of the solvent control

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the retained experimental conditions TCB (1, 3, 5 - TRICHLOROBENZENE) may be classified as not skin sensitizer

The test method KeratinoSensTM is considered scientifically valid to be used as part of an integrated approaches to testing and assessment, to support the identification of the sensitization potential of test item for hazard classification and labeling purposes.