1,3,5-trichlorobenzene

Skin irritation / corrosion

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

Test material information

Constituent 1

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.