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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 239-827-9 | CAS number: 15733-89-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in chemico
- Remarks:
- KeratinoSens method
- 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
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- Principles of method if other than guideline:
- KeratinoSens method
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- other: KeratinoSens method
- Justification for non-LLNA method:
- The test method described in this Test Guideline can be used to support the discrimination between skin sensitisers (i.e. UN GHS Category 1) and non-sensitisers in the context of IATA. The level of reproducibility in predictions that can be expected from the test method is in the order of 85% within and between laboratories. The accuracy (77% -155/201), sensitivity (78% -71/91) and specificity (76% -84/110) of the KeratinoSensTM for discriminating skin sensitisers (i.e. UN GHS Cat. 1) from non-sensitisers when compared to LLNA results were calculated by considering all of the data submitted to EURL ECVAM for evaluation and peer-review of the test method.
Test material
- Reference substance name:
- 1,2-dihydro-2-oxoquinoline-4-carboxylic acid
- EC Number:
- 239-827-9
- EC Name:
- 1,2-dihydro-2-oxoquinoline-4-carboxylic acid
- Cas Number:
- 15733-89-8
- Molecular formula:
- C10H7NO3
- IUPAC Name:
- 1,2-dihydro-2-oxoquinoline-4-carboxylic acid
- Test material form:
- solid: particulate/powder
Constituent 1
In chemico test system
- Details on the study design:
- human keratinocyte cell line
Results and discussion
- Positive control results:
- positive control substance : Cinnamic Aldehyde
Imax = 10.65
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- other: max concentration : 2000µM
- Parameter:
- other: mean viability %
- Value:
- 106
- Vehicle controls validity:
- valid
- Remarks:
- DMSO
- Negative controls validity:
- valid
- Remarks:
- DMSO
- Positive controls validity:
- valid
- Remarks:
- Cinnamic Aldehyde
- Key result
- Run / experiment:
- other: max concentration : 2000µM
- Parameter:
- other: Imax
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Other effects / acceptance of results:
- All acceptance criteria were fulfilled for the positive and negative controls in each run; all runs were
therefore considered as validated.
Both runs were performed using the following concentrations: 0.98, 1.95, 3.91, 7.81, 15.6, 31.3, 62.5, 125,
250, 500, 1000 and 2000 μM in culture medium containing 1% DMSO.
At these tested concentrations:
no precipitate/emulsion were observed in any test item treated-wells at the end of the 48-hour
treatment period, in either run,
no noteworthy decrease in cell viability was noted and no IC30 or IC50 was calculated (i.e. cell viability
> 70%) in both runs,
no statistically significant gene-fold induction above the threshold of 1.5 was noted in comparison to
the negative control, at any tested concentrations, in either run,
moreover, the Imax values were < 1.5 in both runs (i.e. 1.43 and 1.22 in the first and second runs,
respectively) and therefore no EC1.5 was calculated in either run.
The evaluation criteria for a negative response are met in both runs, the final outcome is therefore
negative. This negative result can be used to support the discrimination between skin sensitizers and
non-sensitizers in the context of an integrated approach to testing and assessment. It cannot be used on its
own to conclude on a lack of skin sensitization potential.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The sensitization potential was evaluated according to OECD442D. Under the experimental conditions of this study, the test item, ACIDE HYDROXY, was negative in the KeratinoSens assay and therefore was considered to have no potential to activate the Nrf2 transcription fact.
- Executive summary:
The sensitization potential was evaluated according to OECD442D. Under the experimental conditions of this study, the test item, ACIDE HYDROXY, was negative in the KeratinoSens assay and therefore was considered to have no potential to activate the Nrf2 transcription fact.
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.
