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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:
weight of evidence
Study period:
June 22, 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test) (2004)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
other: Assessment of corrosive potential of the test substance by determination of its cytotoxic effect on an in vitro reconstructed human epidermis (exposure 3 min./room temperature and 60 min./37 °C, subsequently MTT assay).
Details on test animals and environmental conditions:
The experiment was carried out on a reconstructed human epidermis EST-1000 (CellSystems, St. Katharinen, 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)
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. 25 mg per insert (plus 50 µL 0.9 % NaCl-solution to moisten and ensure good contact to the skin), for 3 min. (room temperature) and 60 min. (37 +/- 2 °C, 5 % CO2, maximum huminity).
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:
3 min
Value:
105.54
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
not applicable
Remarks on result:
no indication of irritation
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
60 min
Value:
98.4
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
not applicable
Remarks on result:
no indication of irritation

Any other information on results incl. tables

Substances are classified as „corrosive (R34)“, if the cell viability of the EST 1000 is decreased by more than 50 % after 3 min. of incubation to the test item, or if the cell viability is less than 15 % after 60 min. of exposure to the test item.

 Sample No.

 Test item

 Time [min.]

 % Viability

 1-3

  control NaCl 0.9 %

 60

 100.00

 4-6

test item

 60

  98.4

 16-18

  control NaCl 0.9 %

 3

 100.00

 19-21

  test item

 3

 105.54

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: no corrosive property