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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-770-8 | CAS number: 110-46-3
Skin sensitisation
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:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 442E
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- other: HCLAT
- Justification for non-LLNA method:
- In vitro study.
Test material
- Reference substance name:
- ''amyl nitrite'', mixed isomers
- EC Number:
- 203-770-8
- EC Name:
- ''amyl nitrite'', mixed isomers
- Cas Number:
- 110-46-3
- Molecular formula:
- C5H11NO2
- IUPAC Name:
- pentyl nitrite
Constituent 1
In vitro test system
- Details on the 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 NITRITE” demonstrated anin vitrosensitizing potential with a Minimum Induction Threshold (MIT) of 85 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.
