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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin corrosion: 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: guideline study according OECD 431 and B.40 skin corrosion (amending council directive 67/548/EEC)
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
Principles of method if other than guideline:
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 item 6-tert-Butyl-m-kresol.
A 100% concentration was tested on the skin/epidermal equivalents in triplicate. For the determination of time related cytotoxic effects the incubation periods were 3 min. and 60 min., respectively. Thus, the study was conducted in accordance with the OECD 431 guideline as well as with an EC 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 of this test procedure a blinded positive/negative control study is conducted at regular intervals in the lab. This reliability check is always performed by two technicians, in two laboratories in parallel using the same batches of the control test items.
The test item was applied at a 100% concentration, i.e. 50 µl per insert.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
content: 99.6%

Test animals

Species:
other: not applicable - in-vitro 3D skin corrosion test
Strain:
other: not applicable - in-vitro 3D skin corrosion test

Test system

Type of coverage:
other: not applicable - in-vitro 3D skin corrosion test
Preparation of test site:
other: not applicable - in-vitro 3D skin corrosion test
Vehicle:
other: not applicable - in-vitro 3D skin corrosion test
Controls:
other: not applicable - in-vitro 3D skin corrosion test
Duration of treatment / exposure:
not applicable - in-vitro 3D skin corrosion test
Observation period:
not applicable - in-vitro 3D skin corrosion test
Number of animals:
not applicable - in-vitro 3D skin corrosion test

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other:
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 3min and 60 min. Reversibility: other: not applicable - in-vitro 3D skin corrosion test. Remarks: corrosive. (migrated information)

In vivo

Other effects:
no data

Any other information on results incl. tables

cell viability after 3 min [%]: 25.16

cell viability after 60 min [%]: 13.77

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information in-vitro 3D skin corrosion test
Executive summary:

triethyl phosphate was corrosive in an artificial 3D-skin model according OECD 431 and and B.40 skin corrosion (amending council directive 67/548/EEC)