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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OCDE 442E
GLP compliance:
yes (incl. QA statement)
Type of study:
other: In vitro skin sensitisation

Test material

Constituent 1
Chemical structure
Reference substance name:
Haematoxylin
EC Number:
208-237-3
EC Name:
Haematoxylin
Cas Number:
517-28-2
Molecular formula:
C16H14O6
IUPAC Name:
haematoxylin
Specific details on test material used for the study:
Identification: Hematoxylin HPL
Batch: 007766
Purity: 81.6%
Partition coefficient (n-octanol/water): log Pow: <0.3
Water solubility: App. 19 g/L
Appearance: Light reddish-brown, solid (powder)
Expiry Date: January 2019
Storage Conditions: At room temperature, light protected
Stability in Solvent: Unstable in water
Purpose of Use: Biological stain

Results and discussion

In vitro / in chemico

Resultsopen allclose all
Key result
Run / experiment:
other: first and second runs
Parameter:
other: RFI of CD86 (%)
Remarks:
in at least one concentration
Value:
150
Vehicle controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: Due to strong cytotoxicity observed at the three highest test item concentrations of the first and second h-CLAT run, a confirmatory third run was conducted with adjusted test item concentrations.
Key result
Run / experiment:
other: First and second runs
Parameter:
other: RFI of CD54(%)
Remarks:
in at least one concentration
Value:
200
Vehicle controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: Due to strong cytotoxicity observed at the three highest test item concentrations of the first and second h-CLAT run, a confirmatory third run was conducted with adjusted test item concentrations.
Key result
Run / experiment:
other: Third run
Parameter:
other: RFI of CD86 (%)
Remarks:
in at lest one concentration
Value:
150
Vehicle controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of skin sensitisation
Key result
Run / experiment:
other: Third run
Parameter:
other: RFI of CD54 (%)
Remarks:
in at least one concentration
Value:
200
Vehicle controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of skin sensitisation

Applicant's summary and conclusion

Conclusions:
The test item Hematoxylin HPL with a log Pow of < 0.3 activated THP-1 cells under the test conditions of this study. Therefore the test item is considered positive for the third key event of the skin sensitisation Adverse Outcome Pathway (AOP).