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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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-dimethylpropanoyl 2,2-dimethylpropanoate
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.