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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:
21st February 2013 - 28th March 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

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

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
foreskin from a single donor
Vehicle:
unchanged (no vehicle)
Details on test system:
MatTek’s patented EpiDerm tissue samples were used:
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
50 µl of the test article were applied to the top of each EpiDerm tissue. The nylon mesh was then placed on top to facilitate even distribution of the test material. The test article remained in contact with the EpiDerm tissue for 3 and 60 minutes.
Duration of treatment / exposure:
The test article remained in contact with the EpiDerm tissue for 3 and 60 minutes.
Duration of post-treatment incubation (if applicable):
At the end of the exposure period, each EpiDerm™ tissue was rinsed with phosphate buffered saline (PBS) and transferred to a 24-well plate containing 300 µI of MIT solution (1 mg/ml MIT in OMEM). The tissues were then returned to the incubator for a three-hour MTT incubation period. Following the MIT incubation period, each EpiDerm tissue was rinsed with PBS and then treated overnight with 2.0 ml of extractant solution (isopropanol) per well. The absorbency of an aliquot of the extracted MIT formazan was measured in triplicate at 540 nm using a microplate reader (µQuant Plate Reader, BioTek Instruments, Winooski, VT).

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3 Min - 1st experiment
Value:
85.2
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3 Min - 2nd Experiment
Value:
85.7
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
60 minm - 1st experiment
Value:
98.3
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
60 minm - 2nd experiment
Value:
99.3
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
Quality Controls:
The mean OD of the Negative Control tissues was 2.212 at 3 minutes and 2.065 at 60 minutes, which met the acceptance criterion.

The mean relative tissue viability of the 60-minute Positive Control was 3.8%, which met the acceptance criterion.

Viability differences between the two identically treated tissues in all samples and controls at 3 minutes were 0.5% to 4.5%. Viability differences between the two identically treated tissues at 60 minutes were 0.3% to 9.3%. Inter-tissue viability differences at both time points met the acceptance criterion.

Any other information on results incl. tables

 Test Article Identity  viability (3 min)  viability (60 min)  Predicted corrosivity
 CAS# 1365345-64-7 (SE7B Batch 2137-0)  85.5 %  98.8 %  Non - corrosive
 Tissue culture water (Negative Control)  100.0 %  100.0%  Non - corrosive
 Potassium Hydroxide, 8.0 N (Positive Control)  22.2 %  3.8%  Corrosive

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of this study, the test material is not corrosive to the skin.
Executive summary:

OBJECTIVE: To predict and classify the skin corrosivity potential of a chemical by using a three dimensional human epidermis model. This protocol follows the procedures outlined in OECD Test Guideline 431, effective April 2004. METHOD SYNOPSIS: MatTek EpiDerm™ tissue samples were treated in duplicate with the test article, Negative Control and Positive Control for 3 minutes and 60 minutes. Following treatment, the viability of the tissues was determined using Methyl thiazole tetrazolium (MTT) uptake and conversion, and the absorbance of each sample was measured at 540 nm. The viability was then expressed as a percent of control values. The percent viability was used to determine corrosivity potential.

SUMMARY/CONCLUSION:

The results of the study can be seen below:

Test Article Identity  viability (3 min)  viability (60 min)  Predicted corrosivity
 CAS# 1365345-64-7 (SE7B Batch 2137-0)  85.5 %  98.8 %  Non - corrosive
 Tissue culture water (Negative Control)  100.0 %  100.0%  Non - corrosive
 Potassium Hydroxide, 8.0 N (Positive Control)  22.2 %  3.8%  Corrosive

Based on the results of the study the test material is not corrosive. The test material will not be classified as corrosive, according to CLP.