2-({1-[(2-methoxyphenyl)amino]-1,3-dioxobutan-2-yl}diazenyl)benzoic acid

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)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: OECD Guidelines for Testing of Chemicals, Section 4, No. 431

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-(2-{1-[(2-methoxyphenyl)carbamoyl]-2-oxopropyl}diazen-1-yl)benzoic acid

EC Number:

683-287-0

Cas Number:

877670-90-1

Molecular formula:

C18H17N3O5

IUPAC Name:

2-(2-{1-[(2-methoxyphenyl)carbamoyl]-2-oxopropyl}diazen-1-yl)benzoic acid

Details on test material:

Batch 939-76

Test animals

Species:

human

Details on test animals or test system and environmental conditions:

The EPISKIN Standard Model™ is a three-dimensional human skin model comprising a reconstructed epidermis with a functional stratum corneum.
Each reconstructed epidermis unit consists of a plastic well and a human collagen (Types III and I) matrix, representing the dermis, covered with a film of Type IV human collagen, upon which stratified differentiated epidermis derived from human keratinocytes has been laid.
Supplier : Skinethic, Nice, France.
Batch No. : 11-EKIN-008
Expiry date : 28 February 2011

Test system

Vehicle:

water

Remarks:

9g/L NaCl saline

Amount / concentration applied:

20 mg

Duration of treatment / exposure:

4 Hours

Observation period:

3 hours

Results and discussion

In vivo

Results

Irritation parameter:

other: cytotoxic effect

Basis:

mean

Time point:

other: 4 hours

Score:

ca. 98

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In conclusion, in this in vitro EPISKIN model test with AA-AAOA, the results indicate that the test item is not a skin corrosive.

Executive summary:

Disks of EPISKIN (three units / chemical) were treated with test item AA-AAOA and incubated for 4 hours at room temperature. Exposure of test material was terminated by rinsing with PBS 1x solution (0.9 %). The viability of each disk was assessed by incubating the tissues for 3 hours with MTT solution. The formazan precipitated was then extracted using acidified isopropanol and quantified spectrophotometrically.

NaCI (9 g/l saline) and glacial acetic acid treated epidermis were used as negative and positive controls respectively. For each treated tissue viability was expressed as a % relative to negative control.

The test substance is considered to be corrosive to skin, if the mean relative viability after 4 hours of exposure is below 35% of the negative control.

The test item did not show significantly reduced cell viability in comparison to the negative control. All test item results were far above 35% of the mean negative control value.

All validity criteria were within acceptable limits and therefore the study can be considered as valid.