Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well reported GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Richtlinie 84/449/EWG, B.14
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Desoxynojirimycin, beige powder, 97.2% content

Method

Target gene:
histidin gene locus
Species / strain
Species / strain / cell type:
S. typhimurium, other: TA 1535, TA 100, TA 1537 and TA 98
Metabolic activation:
with and without
Metabolic activation system:
S9-mix
Test concentrations with justification for top dose:
Desoxynojirimycin: 20-12500 µg/plate
Sodium-azide: 10 µg/plate (TA 1535)
Nitrofurantoin: 0.2 µg/plate (TA 100)
4-Nitro-1,2-phenylene diamine: 10 µg/plate (TA 1537), 0.5 µg/plate (TA 98)
2-Aminoanthracene: 3 µg/plate
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
no
Remarks:
No solvent control was used since sufficient evidence was available in the literature and from testing laboratory experience, indicating that the solvents used had no influence on the spontaneous mutant counts of the used strains.
Positive controls:
yes
Positive control substance:
other: Sodium-azide, Nitrofurantoin, 4-Nitro-1,2-phenylene diamine, 2-Aminoanthracene

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA 1535, TA 100, TA 1537, TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
there was no indication of a bacteriotoxic effect up to and including 100 µg/plate; higher doses had a weak bacteriotoxic effect, specific to strain, and could therefore nevertheless be used for evaluation up to and including 12500 µg/plate
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

Executive summary:

Desoxynojirimycin was investigated using the Salmonella/microsome plate incorporation test for point-mutagenic effects in doses up to and including 12500 µg/plate on the four histidine-auxotrophic Salmonella typhimurium LT2 strains TA 1535, TA 100, TA 1537 and TA 98. Doses up to and including 100 µg/plate did not cause any bacteriotoxic effects. Higher doses had a weak bacteriotoxic effect, specific to strain, and could therefore nevertheless be used for evaluation up to and including 12500 µg/plate.

No evidence of mutagenic activity of Desoxynojirimycin was found without and with S9 mix.