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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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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: GLP study according EU/OECD guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
N1-[4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl)-2-methylphenyl]-N2-(1-methanesulfinyl-2-methylpropan-2-yl)benzene-1,2-dicarboxamide
EC Number:
609-338-9
Cas Number:
371771-07-2
Molecular formula:
C23H23F7N2O3S
IUPAC Name:
N1-[4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl)-2-methylphenyl]-N2-(1-methanesulfinyl-2-methylpropan-2-yl)benzene-1,2-dicarboxamide

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: viability
Time point:
other: 3 Min.
Remarks on result:
other: 103.23%
Irritation parameter:
other: viability
Time point:
other: 60 min.
Remarks on result:
other: 114.07%

Applicant's summary and conclusion

Executive summary:

This study for predicting non-specific, corrosive potentials of compounds by using reconstructed human skin (RHS) was performed in 2006. The experiment was carried out on a reconstructed human epidermis EST-1000 (CellSystems, St. Katharinen, Germany) for detection of topically applied skin corrosives with the test substance.

Corrosive skin effects of substances are defined as irreversible damage of the skin; namely, visible necrosis through the epidermis and into the dermis, following the application of a test substance for up to four hours. In vivo corrosive reactions are typified by ulcers, bleeding, and bloody scabs.

A 100% concentration was tested on the skin/epidermal equivalents in triplets. For the determination of time related cytotoxic effects the incubation periods were 3 min and 60 min, respectively. By this the study was conducted in accordance with the OECD 431 guideline draft as well as with an EC draft guideline (amending Council Directive 67/548/EEC, B.40 Skin corrosion) using the test item concentrations and incubation periods recommended there. These tests are also related to the revised OECD 404 guideline "Acute Dermal Irritation/Corrosion".

To check the reliability a blinded positive/negative control study is conducted at regular intervals in the lab. This reliability check is always performed by two technicians, two laboratories in parallel using the same batches of the control test items.

The test item was applied at a 100% concentration, i.e. 25 mg per insert, (plus 50ul 0.9% NaCI to moisten and ensure good contact with the skin)

The MTT (Methylthiazoletetrazolium) method has determined the following values of viability after 3 min. or after 60 min. of incubation: 103.23% and 114.07%, respectively.

Thus, the results show that no corrosive property of the test item was determined by the assay used.