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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:
2003
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: MatTek Corporation EpiDermTM skin model in vitro toxicity testing system
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
Deviations:
not applicable
GLP compliance:
yes

Test material

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

In vitro test system

Test system:
human skin model
Remarks:
artificial three-dimensional model of human skin
Source species:
human
Cell type:
non-transformed keratinocytes
Justification for test system used:
Validated, accurate and reliable method for the prediction skin irritationg and no-label (no-skin irritating) test substances.
Vehicle:
unchanged (no vehicle)
Details on test system:
Three tissues were used for each treatment and concurrent control groups. The optical density (OD) was determined by using the MTT (3-(4,5-Dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide, Thiazolyl blue) reduction assay and expressed as relative percentage of viability of the negative control-treated tissues.
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
- 25 mg neat test substance
- 50 µL of water
- 8N potassium hydroxide
Duration of treatment / exposure:
3 minutes or 1 h
Number of replicates:
3

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Remarks:
compared to negative control
Run / experiment:
3 min exposure
Value:
ca. 101
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks:
28% viability
Remarks on result:
other: no prediction of irritation
Irritation / corrosion parameter:
% tissue viability
Remarks:
compared to negative control
Run / experiment:
1 h exposure
Value:
ca. 99
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks:
6% viability
Remarks on result:
no indication of irritation
Other effects / acceptance of results:
The test substance did not reduce the viability to 50% or below and should be considered as non-corrosive to the skin.

Applicant's summary and conclusion

Interpretation of results:
other: not classified based on EU CLP criteria
Conclusions:
Under the study conditions, the test substance tested was determined to be non-corrosive to the skin.
Executive summary:

A study was conducted to determine the in vitro skin corrosion potential of the test substance, 'mono- and di- C16 -18 PSE and C16-18 AE20 PSE' using reconstructed human epidermis (RHE), according to a method similar to OECD Guideline 431, in compliance with GLP. Three replicates of 25 µg of the test substance (with 25 µL of distilled water), 50 µL of the negative control (water) and 8N positive control substance (8N Potassium hydroxide) were added to millicells MatTek Epiderm tissue samples for 3 minutes and 1 h time period. After exposure periods, the tissues were rinsed with phosphate buffered saline (PBS) to remove any residual material. After all tisses had been rinsed and dosed, they were placed for MTT assay. The MTT plates were then incubated for 3 h (at 37 ºC, 5% C02). After incubation period, the optical density (OD) was determined by using the MTT reduction assay and expressed as relative percentage of viability of the negative control-treated tissues. The mean viability of cells exposed to the test substance were 101% and 99% of the negative control after 3 min and 1 h, respectively. The test substance did not reduce the viability to 50% or below and should be considered as non-corrosive to the skin. Under the study conditions, the test substance tested was determined to be non-corrosive to the skin (CPT, 2003).