Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

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:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD Guideline 442E
GLP compliance:
yes (incl. certificate)
Type of study:
other: HCLAT
Justification for non-LLNA method:
In vitro study.

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vitro test system

Details on study design:
THP-1 cell cultures are exposed to the test item for 24 hours. After exposure, the expression of two cell surface antigens, CD86 and CD54, is measured by flow cytometry method. THP-1 cells show up-regulation of CD86 or CD54 expression, known as dendritic cell activation, following treatment with various sensitizers, but not non-sensitizers.

Results and discussion

In vitro / in chemico

Results
Key result
Parameter:
other: Minimum Induction Threshold (MIT) - µg/mL
Value:
85
Negative controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Based on these results, the test item “ ISOAMYL NITRITE ” demonstrated an in vitro sensitizing potential with a Minimum Induction Threshold (MIT) of 85 µg/mL under the conditions used during this study.
Executive summary:

Cytotoxicity was induced on THP-1 cells byISOAMYL NITRITE. According to this cytotoxic profile, CV75 value of 160 µg/mL could be determined.However, no cytotoxicity was observed for the two highest concentrations tested.In the activation tests, therefore, the doses-range was chosen between 7.81 and 1000 µg/mLto cover a cytotoxic profile until 50% of dead cells.

Under the assay conditions,a reproducible "increase" of the CD54/CD86 expression compared with the negative control for at least three and two dose-levels respectively of ISOAMYL NITRITEwas noticed.

In all three experiments, a dose-response relationship was noticed for CD54/CD86 markers with an increase of 2.37 to 12.15 and 1.68 to 2.69 fold of expression compared to the negative control, respectively.

Based on these results, the test item ISOAMYL NITRITEdemonstrated anin vitrosensitizing potential with a Minimum Induction Threshold (MIT) of 85 µg/mL under the conditions used during this study.