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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
Study period:
12.02.2014 - 14.02.2014
Reliability:
1 (reliable without restriction)
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
Deviations:
no
Qualifier:
according to
Guideline:
other: EpiSkin™ SOP, Version 1.8 (February 2009),
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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:

EpiSkinTMSM 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.