Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 208-779-0 | CAS number: 541-42-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Remarks:
- h-CLAT
- 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:
- 2 018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 442E (h-Clat: HUMAN CELL LINE ACTIVATION TEST)
- Deviations:
- yes
- Remarks:
- without impact on the study conclusion
- Qualifier:
- according to guideline
- Guideline:
- other: h-CLAT DB-ALM protocol N°158
- Deviations:
- yes
- Remarks:
- without impact on the study conclusion
- GLP compliance:
- not specified
- Type of study:
- activation of dendritic cells
Test material
- Reference substance name:
- Isopropyl nitrite
- EC Number:
- 208-779-0
- EC Name:
- Isopropyl nitrite
- Cas Number:
- 541-42-4
- Molecular formula:
- C3H7NO2
- IUPAC Name:
- propan-2-yl nitrite
Constituent 1
In vitro test system
- Details on the study design:
- THP-1 (monocytic leukeamia cell line) cells were cultured, at 37°C under 5% CO2 and humidified atmosphere, in RPMI-1640 medium supplemented with 10% Fœtal Calf Serum, 100 units/mL penicillin and 100 µg/mL streptomycin. THP-1 were routinely seeded every 3-4 days at the density of 0.15 to 0.2 x 106 cells/mL. For testing, THP-1 cells were seeded at a density of either 0.2 x 106 and pre-cultured in culture flasks for 72 hours.
Results and discussion
- Positive control results:
- Positive references (DNCB and NiSO4) showed an increase of CD54/86 expression (RFI ≥ 200/150 respectively) compared to the negative control:
DNCB: RFI CD54 of 891 and RFI CD86 of 466
NiSO4: RFI CD54 of 3388 and RFI CD86 of 304
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- other: Dose levels: 164, 190, 221, 256 ug/mL (experiment 1)
- Parameter:
- other: RFI CD54
- Value:
- 200
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- other: Dose level: 105, 122, 142, 164, 190, 221, 256 ug/mL (experiment 2)
- Parameter:
- other: RFI CD54
- Value:
- 200
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The test item “ISOPROPYL NITRITE” was tested in medium containing 0.2% DMSO.
Based on the solubility and cell toxicity assays, the maximum dose level selected for the main study (Activation test) was 400 µg/mL.
On the two activation experiments, five to seven concentrations could be analysed.
Under the assay conditions, a reproducible "increase" of the CD54 expression compared with the negative control at least for four dose-levels of ISOPROPYL NITRITE was noticed. No increase was observed for CD86 expression.
For both experiments, none of the tested doses induced a 1.5 increase of CD86 expression compared to the negative control. A dose-response relationship was noticed for CD54 marker with an increase of 2.20 to 7.09 fold of expression compared to the negative control.
Applicant's summary and conclusion
- Interpretation of results:
- other: the test item “ISOPROPYL NITRITE” demonstrated an in vitro sensitizing potential
- Conclusions:
- Based on these results, the test item “ISOPROPYL NITRITE” demonstrated an in vitro sensitizing potential with a Minimum Induction Threshold (MIT) of 155 µg/mL under the conditions used during this study.
- Executive summary:
Cytotoxicity was induced on THP-1 cells by ISOPROPYL NITRITE.
According to this cytotoxic profile, CV75 value of 257 µg/mL could be determined.In the activation tests, therefore, the doses-range was chosen between 90.7 and 400 µg/mL to cover a cytotoxic profile until 50% of dead cells.
Under the assay conditions,a reproducible "increase" of the CD54 expression compared with the negative control at least for four dose-levels of ISOPROPYL NITRITE was noticed. No increase was observed for CD86 expression.
For both experiments,none of the tested doses induced a 1.5 increase of CD86 expression compared to the negative control. A dose-response relationship was noticed for CD54 marker with an increase of 2.20 to 7.09 fold of expression compared to the negative control.
Based on these results, the test item “ISOPROPYL NITRITE” demonstrated an in vitro sensitizing potential with a Minimum Induction Threshold (MIT) of 155 µg/mL under the conditions used during this study
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
