Registration Dossier
Registration Dossier
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EC number: 225-898-3 | CAS number: 5138-18-1
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- (Q)SAR
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- no guideline required
- Version / remarks:
- (Q)SAR
- Principles of method if other than guideline:
- The following Prediction methods was sued:
Prediction and Applicability Domain analysis for models:
Mutagenicity (Ames test) CONSENSUS model 1.0.2
Mutagenicity (Ames test) model (CAESAR) 2.1.13
Mutagenicity (Ames test) model (SarPy/IRFMN) 1.0.7
Mutagenicity (Ames test) model (ISS) 1.0.2
Mutagenicity (Ames test) model (KNN/Read-Across) 1.0.0
reports are attached in justification
Test material
- Reference substance name:
- Sulphosuccinic acid
- EC Number:
- 225-898-3
- EC Name:
- Sulphosuccinic acid
- Cas Number:
- 5138-18-1
- Molecular formula:
- C4H6O7S
- IUPAC Name:
- sulphosuccinic acid
- Test material form:
- not specified
- Details on test material:
- theoretical substance for (Q)SAR
Constituent 1
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- other: (Q)SAR (Ames test) CONSENSUS model 1.0.2
- Metabolic activation:
- not applicable
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Key result
- Species / strain:
- other: (Q)SAR (Ames test) model (SarPy/IRFMN) 1.0.7
- Metabolic activation:
- not applicable
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Key result
- Species / strain:
- other: (Q)SAR (Ames test) model (CAESAR) 2.1.13
- Metabolic activation:
- not applicable
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Key result
- Species / strain:
- other: /Q)SAR (Ames test) model (ISS) 1.0.2
- Metabolic activation:
- not applicable
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Key result
- Species / strain:
- other: (Q)SAR (Ames test) model (KNN/Read-Across) 1.0.0
- Metabolic activation:
- not applicable
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Remarks on result:
- no mutagenic potential (based on QSAR/QSPR prediction)
Applicant's summary and conclusion
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.
