methyl (2Z)-2-(2-nitrobenzylidene)-3-oxobutanoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion

Remarks:

in vitro

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The method is approved by international regulatory agencies as a replacement for the identification of corrosives in the in vivo Rabbit skin assay (OECD 404) and is specifically approved as a replacement for the in vivo skin corrosivity test within OECD 431.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))

Version / remarks:

EPISKIN model

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

methyl (2Z)-2-(2-nitrobenzylidene)-3-oxobutanoate

EC Number:

810-021-4

Cas Number:

111304-31-5

Molecular formula:

C12H11NO5

IUPAC Name:

methyl (2Z)-2-(2-nitrobenzylidene)-3-oxobutanoate

Test material form:

solid: crystalline

Details on test material:

Name: Niliden
Cas no.: 111304-31-5
Batch no.: ND-78
Date of analysis: October 2014
Re-test date: October 2015
Storage: In well closed vial up to 25 °C
Description: white crystalline substance
Purity: 99,6%

Test system

Details on study design:

EpiSkin Small Model (EpiSkin SM) is a three-dimensional human skin model comprising a reconstructed epidermis with a functional stratum corneum. Cell viability determination is based on cellular mitochondrial dehydrogenase activity, measured by MTT reduction and conversion into a blue formazansalt that is quantitatively measured after extraction from tissues (Faller C. et al., 2002, Mosmann T., 1983) The reduction of cell viability in treated tissues is compared to negative controls and expressed as a %. The % reduction in viability is used to predict the irritation potential.
The negative control is Phosphate Buffered Saline, the positive control is Sodium Dodecyl Sulphate.

Results and discussion

In vivo

Results

Irritation parameter:

other: mean tissue viability %

Basis:

mean

Time point:

other: Cell viability measurements on day 2

Score:

93

Reversibility:

other: not applicable

Irritant / corrosive response data:

The test item Niliden did not show significantly reduced cell viability in comparison to the negative control (mean value: 93%)

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The results obtained from this in vitro skin irritation test, using the EpiSkin model indicated that the test item reveals no skin irritation potential under the utilised testing conditions. The test item Niliden is considered to be non irritant to skin and is therefore not classified (EU Non Irritant; UN GHS No category)