Tar, wood

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12.02.2014 - 14.02.2014

Reliability:

1 (reliable without restriction)

Cross-reference

Reason / purpose for cross-reference:

reference to other 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

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: EpiSkin™ SOP, Version 1.8 (February 2009),

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Tar, wood

EC Number:

294-436-0

EC Name:

Tar, wood

Cas Number:

91722-33-7

Molecular formula:

not applicable

IUPAC Name:

Tar, wood

Test material form:

liquid: viscous

Details on test material:

Test item: Tar wood CAS No.: 91722-33-7 Batch No.: 18092013 Appearance: viscous Colour: brown Purity: 100 % mixture Expiry date: December 31, 2015 Storage: room temperature Safety precautions: see SDB

In vitro test system

Test system:

human skin model

Test animals

Species:

other: not applicable (this is an invitro-test)

Strain:

other: not applicable (this is an invitro-test)

Test system

Type of coverage:

other: not applicable (this is an invitro-test)

Preparation of test site:

other: not applicable (this is an invitro-test)

Vehicle:

not specified

Remarks:

not applicable (this is an invitro-test)

Controls:

other: not applicable (this is an invitro-test)

Duration of treatment / exposure:

15 minutes exposure and 42 hours post incubation

Observation period:

42 hours

Number of animals:

not applicable (this is an invitro-test)

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

Episkin SM

Value:

< 50

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Any other information on results incl. tables

see study report for more information

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Remarks:

Migrated information

Conclusions:

In this in vitro skin irritation test in the EPISKIN model with test item Tar wood the results indicated that the test item is Irritant (I) [EU: R38; UN GHS: Category 2].

Executive summary:

EpiSkin^TMSM test of Tar wood has been performed to predict its irritation potential by measurement of its cytotoxic effect, as reflected in the MTT assay, according to the OECD Test Guideline No. 439, 26 July 2013.

Disks of EPISKIN (three units) were treated with test item and incubated for 15 minutes at room temperature. Exposure of test material was terminated by rinsing with PBS 1x solution. Epidermis units were then incubated at 37 °C for 42 hours in an incubator with 5% CO₂. The viability of each disk was assessed by incubating the tissues for 3 hours with MTT solution at 37°C in 5% CO₂protected from light. The precipitated formazan was then extracted using acidified isopropanol and quantified spectrophotometrically.

The test item has an intrinsic colour (brown), one additional chemical-treated tissue was used for the non-specific OD evaluation.SDS (5% aq.) and PBS treated epidermis were used as positive and negative controls respectively (three units / control). For each treated tissue viability was expressed as a percentage relative to negative control.

The test item is considered to be irritant to skin, if the mean relative viability after 15 minutes exposure and 42 hours post incubation is less or equal (≤) to 50% of the negative control.

The test item showed significantly reduced cell viability in comparison to the negative control (relative mean value: 13 %). All obtained test item viability results were below 50 % when compared to the viability values obtained from the negative control, therefore the test item was considered to be irritant to skin.