Registration Dossier
Registration Dossier
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EC number: 940-284-1 | CAS number: 1591782-62-5
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:
- 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- D-Glucitol, 1-deoxy-1-(methylamino)-, N-[C8-10(even numbered) acyl] derivs.
- EC Number:
- 940-284-1
- Cas Number:
- 1591782-62-5
- Molecular formula:
- C15H31NO6 C17H35NO6
- IUPAC Name:
- D-Glucitol, 1-deoxy-1-(methylamino)-, N-[C8-10(even numbered) acyl] derivs.
- Reference substance name:
- Glucamide 810
- IUPAC Name:
- Glucamide 810
- Details on test material:
- Chemical Name: D-Glucitol, 1-deoxy-1-(methylamino)-, N-C8-10 acyl derivs.
CAS No.: 85316-98-9 and 85261-20-7 (related to main C-chain lengths of the active material)
Physical State: solid, powder
Colour: colourless
Molecular Weight: 321.42 – 349.47 g/mol
Storage Conditions: room temperature
Constituent 1
Constituent 2
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Mammalian microsomal fraction S9-mix
- Test concentrations with justification for top dose:
- 3.16; 10.0; 31.6; 100; 316; 1000; 2500; 5000 microgram per plate
- Vehicle / solvent:
- Water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-NOPD, 2-AA
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The registration substance did not cause gene mutations in any of the tester strains and is therefore considered to be non-mutagenic in this bacterial reverse mutation assay. - Executive summary:
In order to investigate the potential of the registration substance to induce gene mutations, the plate incorporation test (experiment I) and the pre-incubation test (experiment II) were performed with the Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 102 according to OECD TG 471. In two independent experiments several concentrations of the registration substance up to 5000 microgram per plate were used and tested in triplicate. Each assay was conducted with and without metabolic activation. No precipitation of the test item was observed in any tester strain used in experiment I and II (with and without metabolic activation). In experiment I and II toxic effects of the test item were observed at concentrations of 1000 μg/plate and higher (without metabolic activation) and at concentrations of 2500 μg/plate and higher (with metabolic activation), depending on the particular tester strain. No biologically relevant increases in revertant colony numbers of any of the five tester strains were observed following treatment with the registration substance at any concentration level, neither in the presence nor absence of metabolic activation in experiment I and II. The reference mutagens induced a distinct increase of revertant colonies indicating the validity of the experiments.
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