Registration Dossier
Registration Dossier
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EC number: 915-741-3 | CAS number: 25618-55-7
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:
- 02.05.2002-02.06.2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was performed according to OECD and EC guidelines and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Polyglycerol
- IUPAC Name:
- Polyglycerol
- Details on test material:
- - Name of test material (as cited in study report): R-PG
- Substance type: organic
- Physical state: colourless extremely viscous liquid
- Analytical purity:
Diglycerin 270 g/kg
Triglycerin 487 g/kg
Tetraglycerin 152 g/kg
Pentaglycerin and higher oligomers 47 g/kg
Water 1.8 g/kg
- Purity test date: 26.03.2002
- Lot/batch No.: 20207-1
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: room temperature in the dark
Constituent 1
Method
- Target gene:
- Histidine gene in S. typhimurium
Tryptophan gene in E. coli
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- induced rat liver S9-mix
- Test concentrations with justification for top dose:
- Preliminary study: 0; 0.15; 0.5; 1.5; 5; 15; 50; 150; 500; 1500; 5000 microg/plate
First test: 50; 150; 500; 1500; 5000 microg/plate
Second test: 50; 150; 500; 1500; 5000 microg/plate
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- without S9-mix
Migrated to IUCLID6: 3 microg/plate for TA 100; 5 microg/plate for TA1535; 2 microg/plate for WP2uvrA
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9-mix
Migrated to IUCLID6: 80 microg/plate for TA1537
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without S9-mix
Migrated to IUCLID6: 0.2 microg/plate for TA98
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene 1microg/plate for TA100; 2 microg/plate for TA1535 and TA1537; 10 microg/plate for WP2uvrA
- Remarks:
- with S9-mix
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with S9-mix
Migrated to IUCLID6: 5 microg/plate for TA98
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: 48h
NUMBER OF REPLICATIONS: doses of the test substance were tested in triplicate in each strain. Two independent experiments were conducted.
DETERMINATION OF CYTOTOXICITY
- reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies
Results and discussion
Test results
- Species / strain:
- other: all tested
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The test material caused no visible reduction in the growth of the bacterial background lawn at any dose level.
No test material precipitate was observed on the plates at any of the doses tested in either presence or absence of S9-mix.
No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains. - 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 test substance polyglycerol is considered to be non-mutagenic under the conditions of this test.
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