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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:
04-01-2017 to 02-02-2017
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 guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
Version / remarks:
EC Directive 2000/33/EC, OJ L136200, dated June 08, 2000, adopting the 27th time to technical progress the Dangerous Substances Directive 67/548/EEC, Annex V, part B40 and EC regulation No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation No 1907/2006 of the European Parliament and of the Council on REACH, 1st ATP, section B40.
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Version / remarks:
adopted July 29, 2016
Qualifier:
according to
Guideline:
other: MatTek test protocol “In vitro EpiDermTM Skin Corrosion Test (EPI-200-SCT)”
Version / remarks:
07 November 2014
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

In vitro test system

Test system:
human skin model
Remarks:
EpiDerm™ tissues models
Source species:
human
Cell type:
non-transformed keratinocytes
Vehicle:
unchanged (no vehicle)
Details on test system:
RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: Human Skin Model Test with EpiDerm™ tissues models
- Tissue batch number(s): EpiDerm™ Kit Lot No.: 23390
- Delivery date: 31 Jan 2017

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure:
for the 3 ± 0.5 minutes exposure periods: room temperature
for the 60 ± 5 minutes exposure period plates were placed into an incubator (37 ± 1.5 °C, 5 ± 0.5% CO2)

REMOVAL OF TEST MATERIAL AND CONTROLS
At the end of the exposure period the tissues were gently rinsed using a wash bottle or multipipette containing DPBS (20 times). Excess DPBS was removed by gently shaking the tissue insert and blotting the lower surface with blotting paper.

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: MTT solution (300 µL) was added to each well
- Incubation time: 3 hours
The OD was determined in a microplate reader (Versamax®, Molecular Devices, SoftMax Pro Enterprise (version 4.7.1) at 570 nm (OD570) without reference filter.

PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be corrosive to skin if the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.]
- The test substance is considered to be non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%.
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
50 µL (79.4 µL/cm2 according to guideline) of the test item were dispensed directly onto duplicate EpiDermTM tissue surface.
Duration of treatment / exposure:
3 minutes and 60 minutes
Number of replicates:
2 Duplicates per Exposure Interval:
2 Duplicates / 3 min
2 Duplicates / 60 min

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3 min exposure
Value:
56
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: non-corrosive
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
60 min exposure
Value:
66.6
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: non-corrosive

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Both values 56.0% (3 min exposure) and 66.6% (60 min exposure) did not exceed the threshold for corrosivity which is defined to be 50% after the 3 minutes exposure and 15% after the 1 hour exposure. Therefore, the test item is not considered to be corrosive.
Under the experimental conditions according to OECD guideline 431, the test item is non corrosive to skin according to EU CLP and UN GHS.
Executive summary:

Both values 56.0% (3 min exposure) and 66.6% (60 min exposure) did not exceed the threshold for corrosivity which is defined to be 50% after the 3 minutes exposure and 15% after the 1 hour exposure. Therefore, the test item is not considered to be corrosive.

Under the experimental conditions, the test item is non corrosive to skin according to EU CLP and UN GHS.