Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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:
2002
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

Constituent 1
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

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.