Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From october 2017 to November 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 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
Deviations:
no
GLP compliance:
yes
Type of study:
activation of keratinocytes

Test material

Constituent 1
Reference substance name:
Reference substance 001
Cas Number:
28300-74-5
Molecular formula:
C8H4K2O12Sb2 ∙ 3H2O
Test material form:
solid

Results and discussion

In vitro / in chemico

Results
Parameter:
other:
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
Category 1 (skin sensitising) based on GHS criteria
Conclusions:
The test item is considered positive because the following conditions are met:
Imax is >1.5 fold increased and stadistically significant (p<0.05) compared to the negative contro..
Cell viability is >70% at the lowest concentration with an induction of luciferase activity >1.5 fold.
EC1.5 value is < 1000 µM
Executive summary:

Tartar Emetic is considered skin sensitizer (category 1).