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Diss Factsheets

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
Study period:
20 November to 1 December 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD Guidelines for Testing of Chemicals Method 442E
Version / remarks:
09 October 2017
Deviations:
no
Principles of method if other than guideline:
In Vitro Skin Sensitisation (human Cell Line Activation Test)
GLP compliance:
yes (incl. QA statement)
Type of study:
other: Potential to activate monocytes and dendritic cells in the human monocytic leukemia cell line

Test material

Constituent 1
Chemical structure
Reference substance name:
Isopropyl 2-ethylhexanoate
EC Number:
266-549-5
EC Name:
Isopropyl 2-ethylhexanoate
Cas Number:
67024-46-8
Molecular formula:
C11H22O2
IUPAC Name:
isopropyl 2-ethylhexanoate
Test material form:
liquid

In vitro test system

Details on the study design:
The study was conducted to investigate the potential of Isopropyl 2-ethylhexanoate to activate monocytes and dendritic cells in the human monocytic leukemia cell line THP-1, by quantifying changes in the expression of cell surface markers (CD86 and CD54).
An h-CLAT prediction is considered POSITIVE if at least one of the following conditions is met in 2 of 2 or in at least 2 of 3 independent runs, otherwise the h-CLAT prediction is considered NEGATIVE:
• The relative fluorescence intensity of CD86 is ≥150% at any tested concentration (with cell viability ≥50%)
• The relative fluorescence intensity of CD54 is ≥200% at any tested concentration (with cell viability ≥50%)

Results and discussion

Positive control results:
For the positive control, RFI values were ≥150% for CD86 and ≥200% for CD54 in each independent run. Cell viability was >50% in each independent run.

In vitro / in chemico

Resultsopen allclose all
Run / experiment:
other: CD86
Parameter:
other: The relative fluorescence intensity (RFI) values
Value:
150
Vehicle controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of skin sensitisation
Run / experiment:
other: RFI (CD54)
Parameter:
other: relative fluorescence intensity (RFI)
Value:
200
Vehicle controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
All assay acceptance criteria were met.
The cell viabilities of medium and solvent control were greater than 90% in each independent run.
In the solvent control, RFI values of both CD86 and CD54 did not exceed the positive criteria (CD86 RFI ≥150% and CD54 RFI ≥200%).
For both medium and solvent controls, the MFI ratio of both CD86 and CD54 to isotype control was >105% on all occasions.
For the positive control, RFI values were ≥150% for CD86 and ≥200% for CD54 in each independent run. Cell viability was >50% in each independent run.
For the test article, the cell viability was more than 50% in all tested concentrations in
each independent run.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test article did not induce the expression of CD86 or CD54 cell surface markers and was considered to be negative in the human Cell Line Activation Test.