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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14 Mar - 14 Apr 2006
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Version / remarks:
adopted in 2004 (Draft Version)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Version / remarks:
adopted in 2019
Deviations:
yes
Remarks:
no positive control, no details on RhE model used (batch no., supporting infromation on barrier function, morphology, quality control), no check for MTT reduction of test item, acceptance and evaluation criteria not specified, no historical control data
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

In vitro test system

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
other: CellSystems Biotechnologie Vertrieb GmbH, St. Katharinen, Germany
Source strain:
other: Epidermal Skin Test EST-1000
Vehicle:
unchanged (no vehicle)
Control samples:
yes, concurrent negative control
Amount/concentration applied:
TEST MATERIAL
- Amount applied: 50 µL

NEGATIVE CONTROL
- Amount applied: 50 μL
Duration of treatment / exposure:
3 min and 60 min
Duration of post-treatment incubation (if applicable):
not applicable
Number of replicates:
triplicates for each treatment and control group

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Remarks:
mean value of 3 tissues
Run / experiment:
3 min exposure
Value:
98.25
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
not examined
Irritation / corrosion parameter:
% tissue viability
Remarks:
mean value of 3 tissues
Run / experiment:
60 min exposure
Value:
96.89
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
not examined

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Conclusions:
In this in vitro skin corrosion test in EST-1000 tissue, the mean cell viability compared to the negative control was 98.25% after 3 min exposure and 96.89% after 60 min exposure with the test substance. The negative controls were within acceptable limits. The reliability of the test was confirmed before by interlaboratory validation. In conclusion, the test substance was not corrosive to human epidermis tissue and does not have to be classified according to EU classification criteria.