Fatty acids, tall-oil, reaction products 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:

From Jan 21 to Jan 24, 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, tall-oil, reaction products with acrylic acid

EC Number:

939-424-4

Cas Number:

1469983-44-5

Molecular formula:

Not applicable for UVCB

IUPAC Name:

Fatty acids, tall-oil, reaction products with acrylic acid

Test material form:

liquid: viscous

Details on test material:

Appearance amber viscous liquid
Composition UVCB
CAS No. Unknown
EINECS-No. 939-424-4
Molecular formula not applicable for UVCB
Molecular weight not applicable UVCB
Purity Not applicable (UVCB)
Homogeneity Not stated
Vapour pressure 0.000045 Pa at 25 °C
Stability H2O; EtOH; acetone; CH3CN; DMSO: unknown
Solubility H2O: < 0.1 g/l; EtOH; acetone; CH3CN; DMSO: unknown
Production date Jun 2013
Expiry date Jun 2015
Storage Room temperature

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Vehicle:

unchanged (no vehicle)

Details on test system:

Commercially available Epi-200-SIT-Kit.
Epi-200 tissues were procured from MatTek In Vitro Life Science Laboratories, Bratislava.

Control samples:

yes, concurrent negative control

Amount/concentration applied:

30 μL of liquid test item

Duration of treatment / exposure:

1 hour

Duration of post-treatment incubation (if applicable):

18 hours

Number of replicates:

2 replicates for each of the three tissues.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

other: % formazan production compared to negative control

Run / experiment:

Mean of 3 tissues

Value:

3.8

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks:

2.9%

Other effects / acceptance of results:

The variation within replicates (RSD) of test item was 35%. This high value is due to mathematical reasons. The absorption values of the test itme are vary small; therefore the variation within the replicates leads to a high RSD. This can eb seen as uncritical because the test item showed very clearly irritating results and the value is well below the threshold for irritation (50%). Values for negative and positive controls were within the range of historical data of the test facility. Therefore, the experiment is considered valid.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The test item is considered irritant

Executive summary:

Three tissues of the human skin model EpiDerm ^TM were treated with test item for 60 minutes. 30 μL 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 of the negative and positive controls was acceptable (<18%). after the treatment with test item, the relative absorbance values were reduced to 3.8%. This value is well below the threshold for irritation potential (50%). Therefore, test item was considered as irritant in the Human Skin Model Test. According to the UN GHS system for skin irritation, the substance is considered classified as "Skin Irritant Cat. 2".