Registration Dossier
Registration Dossier
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EC number: 270-337-8 | CAS number: 68425-17-2
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without detailed documentation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- -reliability scoring based on 1997 guideline
- Deviations:
- yes
- Remarks:
- Salmonella typhimurium TA102 or Escherichia coli-WP2 uvrA strain not tested; 2-aminoanthracene was the only compound used to test the efficacy of the S9 fraction.
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP requirements.
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Syrups, corn, hydrogenated
- EC Number:
- 270-337-8
- EC Name:
- Syrups, corn, hydrogenated
- Cas Number:
- 68425-17-2
- Molecular formula:
- UVCB substance: not applicable
- IUPAC Name:
- Syrups, hydrolyzed starch, hydrogenated
- Details on test material:
- - Name of test material (as cited in study report): Lycasin® 80/55
- Physical state: Liquid (transparent syrup)
- Analytical purity: 74.60% (dry substances)
- Composition of test material, percentage of components: Sorbitol 7.6%; maltitol 53.6%; triitols 16.4%
- Lot/batch No.: Batch 720
- Expiration date of the lot/batch: Not reported
- Storage condition of test material: Not reported
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9 (Aroclor 1254-induced)
- Test concentrations with justification for top dose:
- 0.01, 0.05, 0.1, 0.5, and 1 mL per petri dish
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: None
Controls
- Untreated negative controls:
- yes
- Remarks:
- -without test substance
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: see Table 1
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation)
DURATION
- Exposure duration: 48 hours at 37°C
NUMBER OF REPLICATIONS: All the tests were carried out in triplicate. - Evaluation criteria:
- Doubling of the spontaneous reversion rate accompanied by a dose-effect relationship are the criteria for mutagenicity.
- Statistics:
- No statistical analysis was performed.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- not applicable
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- not examined
- Positive controls validity:
- not examined
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- None
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- The substance was found negative with and without metabolic activation for all strains tested (s. typhimurium TA98, TA100, TA1535, TA1537).
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