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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
The experiment was performed between 21 February 2017 and 03 March 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
Version / remarks:
The experimental protocol was established in accordance with O.E.C.D. Test Guideline No. 435 adopted 28 July 2015.
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Certificate attached in the study report

Test material

Reference
Name:
Unnamed
Test material form:
liquid

In vitro test system

Test system:
artificial membrane barrier model
Source species:
other: CORROSITEX®
Cell type:
other: The test system is composed of two components, a synthetic macromolecular bio-barrier (MEMBRANE DISCS, batch No. CT060115) and a Chemical Detection System (CDS).
Cell source:
other: CORROSITEX® kit
Source strain:
other: The test system is composed of two components, a synthetic macromolecular bio-barrier (MEMBRANE DISCS, batch No. CT060115) and a Chemical Detection System (CDS).
Details on animal used as source of test system:
The in vitro membrane barrier test method was performed using a commercially available kit CORROSITEX® (InVitro International supplied by INT.E.G.RA. Srl, batch No. CT060115) received on 29 September 2016 and stored at 6°C ± 3°C.
Justification for test system used:
The test system is composed of two components, a synthetic macromolecular bio-barrier (MEMBRANE DISCS, batch No. CT060115) and a Chemical Detection System (CDS).
Prior to performing the membrane barrier test, a compatibility test was performed to insure that the test item and the CDS reagent were compatible. The CDS is a measurement system that must respond to the presence of the test item.
Vehicle:
other:
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
The test item Pine tar / Tar,Pinus sylvestris was applied as supplied, at the dose of 500 μL, onto 4 synthetic proteinaceous bio-barriers.
Duration of treatment / exposure:
Observation times points were in between 25 - 245 minutes.
Number of replicates:
4

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
penetration time (in minutes)
Run / experiment:
60 minutes
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In accordance with the Regulation EC No. 1272/2008, the results obtained under these experimental conditions enable to conclude that the test item Pine tar / Tar,Pinus sylvestris does not have to be classified in Category 1 “Corrosive”. The hazard statements “H314: causes severe skin bums and eye damage” with the signal word “Danger” are not required.
Executive summary:

The aim of the study was to evaluate the possible effects of the test item Pine tar / Tar, Pinus sylvestris after deposition on a synthetic proteinaceous bio-barrier and monitoring using a Chemical Detection System (CDS).

The test item Pine tar / Tar,Pinus sylvestris was applied as supplied, at the dose of 500 μL, onto 4 synthetic proteinaceous bio-barriers. Timescale Category Test showed that the test item belongs to Corrositex Category 2. The experimental protocol was established in accordance with O.E.C.D. Test Guideline No. 435 adopted 28 July 2015.

The test item did not disrupt the membrane after 60 minutes in the four replicates.

As expected, the negative control (propionic acid 6% (v/v)) did not disrupt the membrane and was not

corrosive. As expected, the positive control (sodium hydroxide) was found to be corrosive (GHS subcategory

1B) and disrupt the membrane after 16 minutes and 29 seconds. In accordance with the Regulation EC No. 1272/2008, the results obtained under these experimental conditions enable to conclude that the test item Pine tar / Tar,Pinus sylvestris does not have to be classified in Category 1 “Corrosive”. The hazard statements “H314: causes severe skin bums and eye damage” with the signal word “Danger” are not required.