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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Version / remarks:
(2014)
GLP compliance:
yes (incl. certificate)

Test material

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

Test animals

Species:
other: Assessment of corrosive potential of the test item by determination of its cytotoxic effect on an in vitro reconstructed human epidermis (exposure 3 min./rt and 60 min./37 °C, subsequently MTT).
Details on test animals and environmental conditions:
The experiment was carried out on a reconstructed human epidermis epiCS (CellSystems, Troisdorf, Germany). Inserts were of 0.6 cm² size. The model has a functional stratum corneum with an underlying layer of living cells. The barrier function of the stratum corneum is adequate, as has been shown by the supplier.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: as negative control: physiological saline solution (0.9 % NaCl, 50 µL)
Amount / concentration applied:
50 µL per insert
Duration of treatment / exposure:
3 min./room temperature or 60 min. in an incubator (37 °C, 5 % CO2, maximum humidity)
Observation period:
post-exposure incubation: none
Details on study design:
The corrosive potential of the test item is assessed by determination of its cytotoxic effect on an in vitro reconstructed human epidermis. The test principle is based on the MTT assay reflecting the cell viability after exposure of the epidermal equivalent to topically applied test item.
All tests were performed in triplicates for each time point. The test item was applied at a 100 % concentration, i.e. 50 µL for 3 min. (room temperature) or 60 min. (37 +/- 2 °C, 5 % CO2, maximum humidity). Cell viability was measured by the amount of MTT reduction, i.e. an OD value following exposure to the negative control substance or the test item.

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Remarks:
3 min., rt
Value:
12.8
Vehicle controls valid:
not applicable
Negative controls valid:
yes
Positive controls valid:
not applicable
Remarks on result:
positive indication of irritation
Irritation / corrosion parameter:
% tissue viability
Remarks:
60 min., 37 °C
Value:
1.82
Vehicle controls valid:
not applicable
Negative controls valid:
yes
Positive controls valid:
not applicable
Remarks on result:
positive indication of irritation

Any other information on results incl. tables

According to OECD TG 431 a chemical should be classified as "corrosive" if the cell viability after a 3-min. treatment with a test item is decreased by more than 50 %.

 Sample No.

 Test item

 Time [min.]

 % Viability

 1 -3

  control NaCl 0.9 %

 60

 100.00

 4 -6

test item

 60

 1.82

 10 -12

  control NaCl 0.9 %

 3

 100.00

 13 -15

  test item

 3

 12.77

In this case the test item was characterized by having a significant impact on cell viability after the 3 -min. or the 60-min. period.

Applicant's summary and conclusion

Interpretation of results:
other: corrosive potential
Executive summary:

An in vitro study according to OECD TG 431 for predicting a non specific, corrosive potential of a substance was conducted. In that study undiluted test item was applied topically on a reconstructed human skin (50 µL; epiCS, CellSystems, Germany). After an exposure period of 3 minutes at room temperature and 60 minutes in an incubator (37 °C, 5 % CO2, maximum humidity), the cell viability was 13 % and 2 %, respectively, as measured by a MTT conversion assay. Based on OECD TG 431 the test substance should be therefore classified as corrosive.