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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
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:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

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 EpiDermTMwere 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