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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
28 march 2017 to 29 march 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
Deviations:
yes
Remarks:
It must be noted that the certificate of analysis supplied by the sponsor is not a GLP document.
GLP compliance:
yes
Remarks:
GLP certificate in annex 1 of the final report

Test material

Constituent 1
Reference substance name:
Thuya plicata, ext.
EC Number:
305-105-8
EC Name:
Thuya plicata, ext.
Cas Number:
94334-32-4
Molecular formula:
not relevant as a UVCB substance
IUPAC Name:
Water steam distillation of needles and twigs of Thuya plicata
Test material form:
liquid

In vitro test system

Test system:
human skin model
Source species:
other: Reconstructed human epidermis
Cell type:
other:
Control samples:
yes, concurrent negative control
Amount/concentration applied:
after a treatment of 3 min and 1 hour (see annexes 2 and 3 of the final report)
Duration of treatment / exposure:
3 minutes at room temperature and 1 hour at 37°C +/- 1°C

Test system

Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
dose of 50 µL
Duration of treatment / exposure:
3 minutes and 1 hour

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
skin 7
Value:
104.32
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
skin 8
Value:
99.14
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Test item does not have to be classified in category 1 as skin corrosive.