D-Tryptophan, methyl ester, hydrochloride (1:1)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

methyl (2R)-2-amino-3-(1H-indol-3-yl)propanoate hydrochloride

EC Number:

639-469-7

Cas Number:

14907-27-8

Molecular formula:

C12H15ClN2O2

IUPAC Name:

methyl (2R)-2-amino-3-(1H-indol-3-yl)propanoate hydrochloride

Test animals

Details on test animals or test system and environmental conditions:

This in vitro study was performed to assess the irritation potential of D-Tryptophan Methyl Ester HCl by means of the Human Skin Model Test.

Test system

Amount / concentration applied:

Approximately 25 mg of the test item (powder) were applied to each tissue, wetted with 40 μL DPBS, and spread to match the tissue size.
30 μL of either the negative control (DPBS) or the positive control (5% Sodium lauryl sulfate) were applied to each tissue.

Duration of treatment / exposure:

60 minutes

Details on study design:

Three tissues of the human skin model EpiDerm™ were treated with the test item, the negative or the positive control for 60 minutes.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

other: other: relative viability

Value:

83.7

Remarks on result:

other:

Remarks:

Basis: mean. Time point: 60 min. (migrated information)

Any other information on results incl. tables

The mean OD of the three negative control tissues was calculated. This value corresponds to 100% tissue viability in the current test. For each individual tissue treated with the test item or the positive control the individual relative tissue viability was calculated.

For the test item and the positive control the mean relative viability +/- standard deviation of the three individual tissues were calculated and used for classification according to the following prediction model:

For the current test, an irritation potential of a test item according to EU classification R38 (according to directive 67/548/EEC), H315 (according to regulation (EC) 1272/2008) is recommended if the mean relative tissue viability of three individual tissues is reduced

below 50% of the negative control. If the mean tissue viability is above 50 % the substance is non-irritant.

The test item showed a mean tissue viability of 83.7 %

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item D-Tryptophan Methyl Ester HCl
(applied as powder) is not irritant to skin.