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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:
other: GLP 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: viscous
Details on test material:
- Name of test material (as cited in study report): Reaction mass of 2,2'-iminodiethanol and 2-{[bis(2-hydroxyethyl)amino]methyl}-4-[2-(4-hydroxyphenyl)propan-2-yl]phenol and 2,2-bis(4-hydroxyphenyl)propane and 2-{[bis(2-hydroxyethyl)amino]methyl}-4-[2-(3-{[bis(2-hydroxyethyl)amino]methyl}-4-hydroxyphenyl)propan-2-yl]phenol
- Appearance: viscous, clear, yellowish liquid

Test animals

Species:
other: Assessment of the 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 triplets 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
Run / experiment:
exposure period: 3 min.
Value:
ca. 77
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
not specified
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
exposure period: 60 min.
Value:
ca. 69
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
not specified

Any other information on results incl. tables

A chemical is classified "corrosive" (sub-category 1A) if the cell viability after 3 min treatment with a test item is decreased by more than 50 %. If cell viability after 3 min exposure is ≥ 50 %, while it is below 15 % after 60 min exposure the substance is also classified as corrosive, but sub-category 1B/1C. If cell viability after 3 min exposure is ≥ 50 % and after 60 min exposure ≥ 15 %, the substance is classified as non-corrosive.

 Sample No.

 Test item

 Time [min.]

 % Viability

 1 -3

  control NaCl 0.9 %

 60

 100.00

 4 -6

test item

 60

  68.52

 13 -15

  control NaCl 0.9 %

 3

 100.00

 16 -18

  test item

 3

 76.85

Based on the result the test item was characterized by no significant impact on cell viability after 3 min. or after the 60 min. period.

Applicant's summary and conclusion

Interpretation of results:
other: non-corrosive
Executive summary:

An in vitro study according to OECD TG 431 for predicting non specific, corrosive potential of substances was conducted. 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 or 60 minutes in an incubator (37 °C, 5 % CO2, maximum humidity), the cell viability was 77 % and 69 %, respectively, as measured by a MTT conversion assay. It was therefore concluded that the test substance is not corrosive to the skin.