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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:
2008
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
pentyl 6-deoxy-alpha-L-mannopyranoside
EC Number:
700-713-3
Cas Number:
83161-22-2
Molecular formula:
C11H22O5
IUPAC Name:
pentyl 6-deoxy-alpha-L-mannopyranoside
Details on test material:
For technical reason (solubility), APRC5 was diluted at 30% in a water/glycerol (1/5) mixture
This mixture corresponds to the industrial form.

Method

Target gene:
TA98 : target mutation His D 3052
TA100 : His G 46
TA102 : His G 428
TA1535 : His G46
TA1537 : His C 3076
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Test concentrations with justification for top dose:
tested concentrations : 1, 3, 10, 30 and 100% of APRC5 30% in water/glycerol
Vehicle / solvent:
water/glycerol
Controls
Untreated negative controls:
yes
Positive controls:
yes
Positive control substance:
2-nitrofluorene
Remarks:
TA98 : 2-nitrofluorene, TA100 and TA1535 : Sodium azide, TA102 : Mitomycin C, TA1537 : 9-Aminoacridine

Results and discussion

Test results
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:
no 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'. Remarks: non mutagenic and non pro-mutagenic

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

The Ames test is negative in presence of APRC5.