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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:
Dec 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Trimethylacetic anhydride
EC Number:
216-263-1
EC Name:
Trimethylacetic anhydride
Cas Number:
1538-75-6
Molecular formula:
C10H18O3
IUPAC Name:
2,2-dimethylpropanoic anhydride
Test material form:
liquid

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
other: no data available
Source strain:
other: not applicable
Justification for test system used:
according to guideline
Vehicle:
unchanged (no vehicle)
Details on test system:
RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: epiCS (CellSystems, Troisdorf, Germany)
- Tissue Lot number: 100-AE2014-1
- Date of initiation of testing: 01 Dec 2015

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 3 min (room temperature), 60 min (37°C)
- Temperatur used during post-treatment: after washing, incubation with MTT solution for 3 hours at 37°C

REMOVAL OF TEST MATERIAL AND CONTROLS
- Washing: after the incubation period inserts were washed carefully in PBS
- Observable damage in the tissue due to washing: not applicable
- Modifications to validated SOP: not applicable

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 mg/ml
- Incubation time: 3 hours
- Spectrophotometer: EL808, Bio-Tek
- Wavelength: 570 nm


FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
Reliability of the test was previously confirmed by interlaboratory validation

NUMBER OF REPLICATE TISSUES:
All tests were performed in triplicates for each concentration and each time point

PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be corrosive to skin if [complete, e.g. the viability after 3 minutes exposure is less than 50%, or if the viability after 3 minutes exposure is greater than or equal to 50 % and the viability after 1 hour exposure is less than 15%.]
- The test substance is considered to be non-corrosive to skin if [complete, e.g. the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%.]
Control samples:
yes, concurrent negative control
Amount/concentration applied:
TEST MATERIAL
- Amount(s) applied: 50 µl
- Concentration (if solution): undiluted


NEGATIVE CONTROL
- Amount(s) applied: 50 µl
- Concentration (if solution): 0.9% NaCl

Duration of treatment / exposure:
3 min (room temperature), 60 min (37°C)
Duration of post-treatment incubation (if applicable):
after washing, incubation with MTT solution for 3 hours at 37°C
Number of replicates:
three

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Cell viability after 3 min [%]
Value:
100.79
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
not applicable
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Cell viability after 60 min [%]
Value:
112.37
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
not applicable

Applicant's summary and conclusion

Interpretation of results:
other: not corrosive to skin
Executive summary:

The test substance was evaluated of corrosive properties by using an artificial 3D-Skin model according to OECD guideline 431. The test substance was characterized by no significant impact on cell viability after 3 min. or after the 60 min. period. Thus, the test substance is not to be labeled as corrosive to skin.