1,3,5-trichloro-2,4-dinitrobenzene

Skin irritation / corrosion

Administrative data

Endpoint:

skin corrosion: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Study conducted according to the OECD Guideline 431 and under GLP conditions

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 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)

Deviations:

no

Remarks:

No deviation to the study plan was registered during the study.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1,3,5-trichloro-2,6-dinitrobenzene

Cas Number:

6284-83-9

IUPAC Name:

1,3,5-trichloro-2,6-dinitrobenzene

Constituent 2

Reference substance name:

1,3,5-trichloro-2,4-dinitrobenzene

EC Number:

228-510-0

EC Name:

1,3,5-trichloro-2,4-dinitrobenzene

Cas Number:

6284-83-9

Molecular formula:

C6HCl3N2O4

IUPAC Name:

1,3,5-trichloro-2,4-dinitrobenzene

Test material form:

solid: particulate/powder

Details on test material:

• Date received: 17 September 2021
• CAS No.: 6284-83-9
• EINECS No.: 228-510-0
• Container: plastic flask (n=1)
• Category: Chemical Substance
• Quantity: 111.70 g (container + content + label)
• Storage: room temperature
• Homogeneity: yes
• Form: solid (powder)
• Stability: not specified
• Colour: yellowish
• Production date: not specified
• Expiry date: February 2024
• Composition: 1,3,5-trichloro-2,6-dinitrobenzene • Purity: 99.24%
It was identified under the code number: PH-21/0912.

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

other: reconstituted epidermis (epiCS®, Phenion®– Batch No. epiCS, 21-42)

Duration of treatment / exposure:

at the dose of 25 mg to the epidermal surface of the 2 living
human skin models previously moistened with 25 μL of distilled water, during 3 minutes at room
temperature and during 1 hour at 37°C ± 1°C, 5% ± 1% CO2.

Results and discussion

In vitro

Results

Results 1

Irritation / corrosion parameter:

other: the mean percent viability of the epidermis treated

Value:

100

Positive controls validity:

valid

Remarks:

0.5% and 0.3%, respectively, with the positive control item (potassium hydroxide 8N).

Results 2

Irritation / corrosion parameter:

other: the mean percent viability of the epidermis treated

Value:

89

Positive controls validity:

valid

Remarks:

0.5% and 0.3%, respectively, with the positive control item (potassium hydroxide 8N).

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In accordance with the Regulation (EC) No. 1272/2008, the results obtained under these experimental
conditions enable to conclude that the test item DNTCB (1,3,5-trichloro-2,6-dinitrobenzene) does
not have to be classified in Category 1 “Corrosive”.
The hazard statement “H314: Causes severe skin burns and eye damage” with the signal word
“Danger” are not required.

Executive summary:

The aim of the study was to evaluate the possible corrosive effects of the test item after topical administration on in vitro human reconstituted epidermis (epiCS®, supplied by Phenion®).
The test item DNTCB (1,3,5-trichloro-2,6-dinitrobenzene) was applied, as supplied, at the dose of 25 mg to 2 living Human skin model surfaces (epiCS®, supplied by Phenion®) during 3 minutes and 1 hour, followed by a rinse with 20 mL of DPBS. 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 the O.E.C.D. Test Guideline No. 431 dated 14 June 2019.

3 minutes and 1 hour after the test item application, the mean percent viability of the epidermis treated with the test item were 89.0% and 108.5% (considered as 100%), versus 0.5% and 0.3%, respectively, with the positive control item (potassium hydroxide 8N).

In accordance with the Regulation (EC) No. 1272/2008, the results obtained under these experimental conditions enable to conclude that the test item DNTCB (1,3,5-trichloro-2,6-dinitrobenzene) does
not have to be classified in Category 1 “Corrosive”. The hazard statement “H314: Causes severe skin burns and eye damage” with the signal word “Danger” are not required.