(2S)-2-amino-3-(3,4-dimethoxyphenyl)-2-methylpropanoic acid;hydrochloride

Skin irritation / corrosion

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-amino-3-(3,4-dimethoxyphenyl)-2-methylpropanoic acid hydrochloride hydrate

Cas Number:

5486-79-3

Molecular formula:

C12H20ClNO5

IUPAC Name:

2-amino-3-(3,4-dimethoxyphenyl)-2-methylpropanoic acid hydrochloride hydrate

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Vehicle:

unchanged (no vehicle)

Details on test system:

SKIN DISC PREPARATION
- Procedure used: EpiSkin SM kit
- Quality control for skin discs: certified ISO 9001

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment/ exposure: room temperature

DYE BBINDING METHOD
- Dye used in the dye-inding assay: MTT
- Spectrophotometer: 96-well plate spectrophotometer
-Wavelength: 570 nm

Amount/concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 20 mg

NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 mikroliter
- Concentration (if solution): 100%

POSITIVE CONTROL
- Amount(s) applied (volume or weight): 50 mikroliter
- Concentration (if solution): 100%

Duration of treatment / exposure:

4 hours

Number of replicates:

2

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

mean

Value:

103

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

The test item did not show significantly reduced cell viability in comparison to the negative control after 4 hours of exposure. The average test item treated tissue viability was 103 % at 4 hours of exposure. The test item treated tissue viability was above 35 % of the mean negative control value after 4 hours of exposure.
Positive and negative controls showed the expected cell viability values within acceptable limits.
All assay acceptance criteria were met, the experiment was considered to be valid.

Applicant's summary and conclusion

Interpretation of results:

other: no skin corrosion potential

Conclusions:

The results obtained from this in vitro skin corrosion test, using the EPISKIN model, indicated that the test item reveals no skin corrosion potential under the utilised testing conditions. In conclusion, the test item 3,4-O-dimethyl methyldopa monohydrochloride monohydrate (DMAKS) can be classified as Non-corrosive.