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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:
2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

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

Test material

Reference
Name:
Unnamed
Test material form:
liquid

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
The test item was applied undiluted. 50 µL of the test item was dispensed directly atop the tissue.
Duration of treatment / exposure:
3 min and 60 min exposure time.
Number of replicates:
The test was performed on a total of 4 tissues per dose group, 2 replicates for each treatment period (3 min and 60 min exposure time).

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
3 min Experiment
Value:
118.6
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
60 min Experiment
Value:
101
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In this study under the given conditions the test item showed no corrosive effects. The test item is classified as “non-corrosive“.
Executive summary:

The potential of the test item to induce skin corrosion was analysed by using the three-dimensional human skin model EpiDermä, comprising a reconstructed epidermis with a functional stratum corneum.

In the present study TEA Trioleate was applied topically to the EpiDermä tissue for 3 min and 60 min followed by immediate determination of cytotoxic effects via MTT reduction assay.

Corrosivity potential of the test item was predicted from the relative mean tissue viabilities obtained after both treatment periods compared to the corresponding negative control tissues.

The test item showed no non-specific MTT-reducing and no colouring potential in the relevant wavelength range, therefore no additional controls were necessary.

The test item showed no corrosive effects. The mean relative tissue viability (% negative control) was > 50% (118.6%) after 3 min treatment and >15% (101.0%) after 60 min treatment.

The controls confirmed the validity of the study. The mean OD570of the two negative control tissues was > 0.8 and≤ 2.8 for each exposure period. The mean relative tissue viability (% negative control) of the positive control was < 15% (5.4%) after 60 min treatment. The coefficient of variation (CV) (in the range of 20 – 100% viability) of replicate tissues of all dose groups was < 30% (4.1% - 7.2%).