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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2022
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2022
Report date:
2022

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
GLP compliance:
yes (incl. QA statement)

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

Test system:
human skin model
Source species:
human
Cell type:
other: human epidermis

Test animals

Species:
other: Reconstructed Human Epidermis

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Controls:
yes, concurrent positive control
Amount / concentration applied:
16 mg
Duration of treatment / exposure:
42 min
Details on study design:
dose of 16 mg to 3 living Reconstructed Human Epidermis for 42 min. The application was followed by a rinse with 25mL of DPBS and a 42 hours 13 min incubation period at 37°C, 5% CO2. Cell viability was then measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that was quantitatively measured after extraction from tissues.

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Mean percent viability of the treated tissues
Value:
91.7
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
valid
Remarks:
1.4% in the positive control of 5% Sodium Dodecyl Sulfate

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In accordance with the Regulation EC No. 1272/2008, the test item TCB (1,3,5-trichlorobenzene) has to be considered as Non-irritant to skin. It corresponds to UN GHS No Category. No hazard statement or signal word is required.
Executive summary:

The aim was to evaluate the possible irritating effects of the test item TCB (1,3,5-trichlorobenzène) after topical application on in vitro human reconstructed epidermis (SkinEthic RHE® model). The test item TCB (1,3,5-trichlorobenzène) was applied after being reduced in fine powder, at the dose of 16 mg, to 3 living Reconstructed Human epidermis (SkinEthic RHE® model) for 42 minutes.
The application was followed by a rinse with 25 mL of DPBS and a 41 hours 06 minutes incubation period at 37°C, 5% CO2. Cell viability was then measured by enzymatic conversion of the vital dye MTT into a blue formazan salt that was quantitatively measured after extraction from tissues.
The experimental protocol was established in accordance with O.E.C.D. Test Guideline No. 439 adopted 14 June 2021.


The mean percent viability of the treated tissues was 91.7%, versus 1.4% in the positive control (5% Sodium Dodecyl Sulfate).


In accordance with the Regulation EC No. 1272/2008, the test item TCB (1,3,5-trichlorobenzène) has to be considered as Non-irritant to skin. It corresponds to UN GHS No Category. No hazard statement or signal word is required.