1,3-difluorobenzene

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

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

Year:

2018

Report date:

2018

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-difluorobenzene

EC Number:

206-746-5

EC Name:

1,3-difluorobenzene

Cas Number:

372-18-9

Molecular formula:

C6H4F2

IUPAC Name:

1,3-difluorobenzene

In vitro test system

Test system:

human skin model

Source species:

other: human reconstructed epidermis model

Control samples:

yes, concurrent negative control

Duration of treatment / exposure:

1 h

Duration of post-treatment incubation (if applicable):

1h

Test animals

Species:

other: human reconstructed epidermis model

Test system

Type of coverage:

not specified

Preparation of test site:

abraded

Controls:

yes, concurrent positive control

yes, concurrent negative control

Duration of treatment / exposure:

1h

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Value:

ca. 17.4

Any other information on results incl. tables

One valid experiment was performed.

Three tissues of the human skin model EpiDerm^TMwere treated with1,3-DIFLUOROBENZENEfor 60 minutes.

The test item was applied directly to each tissue and spread to match the tissue size (0.63 cm²; as indicated by the supplier).

DPBS-buffer was used as negative control and 5% SDS solution was used as positive control.

After treatment with the negative control, the mean absorbance value was within the required acceptability criterion of 0.8 ≤ mean OD ≤ 2.8, OD was 1.3. The positive control showed clear irritating effects. The mean value of relative tissue viability was reduced to 2.9% (required:£20%).

The variation within the tissue replicates of negative control, positive control and test item was acceptable (required: ≤ 18%).

 

After the treatment with the test item, the mean value of relative tissue viability was reduced to 17.4%. This value is below the threshold for skin irritation potential (50%). Test items that induce values below the threshold of 50% are considered at least irritant to skin.

 

 

Therefore,1,3-DIFLUOROBENZENEis considered at least irritant to skin in the Reconstructed human Epidermis (RhE) Test Method.

 

The OECD guideline 439 addresses the human health endpoint skin irritation. Therefore, further testing on skin corrosion potential with another suitablein vitrostudy (e.g. OECD 431) may be required.

Applicant's summary and conclusion

Conclusions:

irritant