Serine, 2-[(2,3,4-trihydroxyphenyl)methylene]hydrazide, hydrochloride (1:1)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Principles of method if other than guideline:

Corrositex® is an in vitro assay used to determine the skin corrosion potential of a test substance. The assay is based on the ability of a corrosive test substance to pass through a biobarrier membrane and to cause a colour change in the liquid Chemical Detection System (CDS).

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-amino-3-hydroxy-N'-[(E)-(2,3,4-trihydroxyphenyl)methylidene]propanehydrazide hydrochloride

EC Number:

940-411-0

Cas Number:

1353749-74-2

Molecular formula:

C10H14ClN3O5

IUPAC Name:

2-amino-3-hydroxy-N'-[(E)-(2,3,4-trihydroxyphenyl)methylidene]propanehydrazide hydrochloride

Details on test material:

- Purity: 100%

Test animals

Species:

other: Corrositex® biobarrier membrane

Details on test animals or test system and environmental conditions:

not applicable

Test system

Type of coverage:

other: not applicable

Preparation of test site:

other: not applicable

Vehicle:

unchanged (no vehicle)

Controls:

other: negative and positive substances were used with the biobarrier membrane

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: approximately 500 mg

Duration of treatment / exposure:

1 hour

Number of animals:

4 test substance treated membranes

Details on study design:

SCORING SYSTEM: Corrositex® Packing Group Category per UN and DOT regulations and classifications.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

other: other: UN and DOT Packing Group Classification

Remarks on result:

other:

Remarks:

Basis: mean. Time point: 1 hour. Remarks: mean breakthrough time > 1 hour; classified as non-corrosive. (migrated information)

Any other information on results incl. tables

The positive control, sulphuric acid, had a membrane breakthrough time of 1 minute. The negative control, citric acid, did not breakthrough in 1 hour. The positive control and negative control performed as anticipated. No breakthrough occurred in the 4 test substance membranes during the 1 hour treatment time indicating that the test substance was not corrosive.

Applicant's summary and conclusion

Interpretation of results:

other: non-corrosive

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

This study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
The test substance is non-corrosive.

Executive summary:

The test substance was evaluated for skin corrosion potential using the In Vitro International Corrositex® assay. Corrositex® is a standardized and quantitative in vitro corrosivity test. The model is based on the time required for the test substance to pass through a biobarrier membrane and produce a change in a chemical detection system. Approximately 500 mg of the test substance was applied to each of 4 membrane discs. The test substance did not pass through any of the membranes. Under the conditions of this test, the test substance is non-corrosive.