reaction products of diglycidyl ether bisphenol F (DGEBF) and oligomeric phenol diglycidyl ethers with acrylic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2010-10-05 - 2010-10-12

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study, GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: EU B.46

Deviations:

yes

Remarks:

The test item was brought onto a nylon mesh on a microscope slide. Instead of incubating it for 30 minutes at 37 °C, the test item was incubated for 60 minutes at 37 °C. This deviation can be seen as uncritical.

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EU B.46

Deviations:

yes

Remarks:

The plate was not left to stand over night at room temperature. The plate was shaken for two hours and then the tissues were pierced with an injection needle.

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: EU B.46

Deviations:

yes

Remarks:

Within the pre-tests and the main study 25±6 mg of the test item were used instead of 25mg. This deviation can be seen as uncritical since it was very difficult to weigh an exact amount of test item because of its resin appearance.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

reaction products of diglycidyl ether bisphenol F (DGEBF) and oligomeric phenol diglycidyl ethers with acrylic acid

EC Number:

700-487-6

Molecular formula:

Not applicable.

IUPAC Name:

reaction products of diglycidyl ether bisphenol F (DGEBF) and oligomeric phenol diglycidyl ethers with acrylic acid

Details on test material:

Name: Epoxy half acrylate

Test animals

Species:

other: Human Skin Model

Test system

Type of coverage:

open

Vehicle:

unchanged (no vehicle)

Controls:

not required

Duration of treatment / exposure:

60 min

Observation period:

60 min

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

other: other: % Formazan Production

Value:

12.2

Remarks on result:

other:

Remarks:

Basis: mean. Time point: 60 min. Max. score: 50.0. Reversibility: no data. (migrated information)

Any other information on results incl. tables

For the test item and the positive control, the following percentage values of formazan production were calculated in comparison to the negative control:

 % Formazan Production

Designation	Test item	Positive Control
% Formazan production (Tissue 1)	12.6%	7.0%
% Formazan production (Tissue 2)	12.9%	7.3%
% Formazan production (Tissue 3)	11.0%	7.7%
% Formazan production Mean	12.2%	7.3%

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)

Conclusions:

The test item is considered irritant.
After the treatment, the relative absorbance values were decreased to 12.2%. This value is well below the threshold for irritation (50%).
The optical density of the negative control was well within the required acceptability crite-rion of 1.0 < mean OD < 2.5. The positive control induced a decrease in the relative absorbance as compared to the negative control to 7.3% (required: For these reasons, the result of the test is considered valid.

Executive summary:

One valid experiment was performed. Three tissues of the human skin model EpiDerm^TM were treated with Epoxy half acrylate for 60 minutes.

25 mg of the liquid test item (using a nylon mesh) were applied to each tissue and spread to match the tissue size.

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

After treatment with the negative control, the absorbance values were within the required acceptability criterion of 1.0 < mean OD < 2.5. The positive control showed clear irritating effects. Variation within tissues was acceptable (< 18%).

After the treatment with the test item, the relative absorbance values were reduced to 12.2 %. This value is well below the threshold for irritation potential (50%). Therefore, Epoxy half acrylate is considered as irritant in the Human Skin Model Test.