Registration Dossier
Registration Dossier
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EC number: 241-503-7 | CAS number: 17496-08-1
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:
- 2 017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- activation of keratinocytes
Test material
- Reference substance name:
- Ammonium propionate
- EC Number:
- 241-503-7
- EC Name:
- Ammonium propionate
- Cas Number:
- 17496-08-1
- Molecular formula:
- C3H6O2.H3N
- IUPAC Name:
- ammonium propionate
- Test material form:
- liquid
Constituent 1
In vitro test system
- Details on the study design:
- Study objective
The test consists in evaluating the activation of AKR1C2 in transformed keratinocytes (KeratinoSens™), by monitoring the induction of the luciferase gene fused to AKR1C2. The luciferase produced by the cells complexes with luciferin which, in the presence of ATP, produces light measured in relative light units (RLU).
After contact between a sensitizing potential element with a KeratinoSens™ monolayer, the induction of the luciferase is quantified. In parallel, the cytotoxicity is measured, in order to exclude a false positive generated by a skin irritation.
Test system
Cells: KeratinoSens™ (Givaudan) maintained according to the current working instruction IL 09.
Cells are cultured in maintenance medium (cf. § Media and reagents) at 37°C, 5% CO2.
Cells are exempt of mycoplasma. Assessment of mycoplasma was performed according to the current working instruction IL 07.
Cells were used at passage 22 in repetition 1 and passage 24 in repetition 2.
Results and discussion
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- other: 1
- Parameter:
- other: Induction
- Value:
- 1.05
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- other: 2
- Parameter:
- other: Induction
- Value:
- 0.91
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the retained experimental conditions AMMONIUM PROPIONATE (CAS: 17496-08-1;
EC: 241-503-7) IN AQUEOUS SOLUTION (50-55%) code ID-17/09215 may be classified as not sensitizer.
The test method KeratinoSensTM is considered scientifically valid to be used as part of an integrated approaches to testing and assessment, to support the identification of the sensitization potential of test item for hazard classification and labeling purposes.
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.
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