Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 January 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
OECD 471

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
Test in accordance with OECD guidelines 471, as explicitely mentioned in test report conclusion page 18 of enclosed study report
GLP compliance:
yes (incl. certificate)
Remarks:
See quality assurance statement in report page 4
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
solid

Method

Target gene:
His locus
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Additional strain / cell type characteristics:
DNA polymerase A deficient
Remarks:
except TA102 (rfa/uvrB+)
Metabolic activation:
with and without
Metabolic activation system:
rat microsomal liver fraction (S9 mix)
Test concentrations with justification for top dose:
Test concentrations: 0, 50, 150, 500, 1500, 5000 µg/plate.
Justification for top dose: due to its solubility in aqueous medium, the test compound was dissolved in distilled water at a maximum concentraion of 50 mg/mL. After that, this solution was used at 100 µL/plate giving a final concentration of 5000 µL/plate (maximum dose recommended by OECD guideline).
Vehicle / solvent:
Distilled water
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
benzo(a)pyrene
mitomycin C
other: 2-anthramine(a)
Details on test system and experimental conditions:
0.1 ml of the test product + 0.1 ml of a bacterial suspension from a culture agitated overnight at 37°C added to 2 mL of top agar to which 10% of 0.5 mM biotin histidine solution, maintained in a state of superfusion at 45 °C, has been added. Content agitated and spread out in a Petri plate containing 20 mL of minimum agar. A triplicate test for each experimental point is made and the plates are then kept at 37°C for 48 hours after which the number of revertant colonies is determined for each plate.
In case of metabolic activation, same mecanism but 0.5 mL of the S9 mix is added before spreading in the plates.
Rationale for test conditions:
in accordance with OECD guideline 471
Evaluation criteria:
Developpement of prototrophic mutant colonies which are then counted.
Statistics:
Results may be analysed by means of Dunnett's method allowing the comparison of several treatment means to a solvent control.

Results and discussion

Test results
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Additional information on results:
The validity criteria for the test were fulfilled.
Remarks on result:
other: no mutagenic activity

Applicant's summary and conclusion

Conclusions:
Chondroitine sulfate sodium salt was non mutagenic (nor cytotoxic) on the 5 Salmonella typhimurium strains tested. The results do not allow to classify the substance.
Executive summary:

Non mutagenic in an OECD 471 Ames test in vitro, up to 5000 ug/plate on the 5 Salmonella typhimurium strains tested.