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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06-10-2012 to 09-10-2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: study performed according to the guideline and under GLP

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 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Qualifier:
according to
Guideline:
other: EU B40bis (EC440/2008)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): Fatty acids, C12-18 , reaction products with ethanol, 2-amino, reaction products with ammonia, by products from"
- Substance type: UVCB
- Physical state: extremely viscous liquid
- Storage condition of test material: room temperature in dark

Test system

Details on study design:
The EpiSKIN assay uses reconstructed human epidermis to assess skin corrosion. For the viability test enzymatic conversion of MTT to formazan is used.

In a pre-test direct interaction of the test substance with the detection chemical MTT is assessed. As the substance showed interference additional controls were added (water killed EPISKIN tissues).

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3 min
Value:
94.2
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
60 min
Value:
74.7
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
240 min
Value:
84.4
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
The test substance interfered with the reduction of MTT to blue formazan salt. Direct reduction compared to negative controls was 6.1 to 29.1% (validity criterion < 30%).

Any other information on results incl. tables

 

Exposure time

Mean corrected OD540

Correction applied

Relative mean viability

Negative control:

240 min

0.772

 

100 %

Positive controls:

240 min

0.029

 

3.8%

Test substance

3 min

60 min

240 min

0.727*

0.577*

0.655*

0.046#

0.197#

0.225#

94.2%

74.7%

84.8%

* TODTT = [ODTV – (ODkt - ODku)]

# correction value: ODkt - ODku

 

ODTV : chemical treated viable tissues

TODTT : true MTT metabolic conversion for treated tissue.

ODku : untreated killed tissues

ODkt: chemical treated killed tissues

 

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is non-corrosivein the EPISKIN reconstructed human epidermal model.
Executive summary:

In the EpiSKIN test, tissues of reconstructed human skin were treated with 50 uL of the test substance in duplicate during 3, 60 and 240 minutes. After treatment tissues were rinsed and incubated with MTT for 3 hours (at room temeprature). Thereafter tissues were allowed to dry, epidermis and collagen were separated, suspended (after vortexing) in isopropanol and kept overnight (all procedures in dark). Optical density of homogene solutions of MTT treated tissues was measured at 540 nm. As the test substance was shown to interfere with the MTT reduction, additional controls were included (non-viable tissue). Viability was expressed as the corrected percentage MTT conversion versus negative control. The true viability was 74.7 -94.2% for the different exposure times, which is indicative for non-corrosive substances.