Trimethylacetic anhydride

Skin irritation / corrosion

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

Test material information

Constituent 1

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

Results

Results 1

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

Results 2

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.