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Toxicological information

Genetic toxicity: in vitro

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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:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
-reliability scoring based on 1997 guideline
Deviations:
yes
Remarks:
Salmonella typhimurium TA102 or Escherichia coli-WP2 uvrA strain not tested; 2-aminoanthracene was the only compound used to test the efficacy of the S9 fraction.
GLP compliance:
no
Remarks:
Study pre-dates GLP requirements.
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Lycasin® 80/55
- Physical state: Liquid (transparent syrup)
- Analytical purity: 74.60% (dry substances)
- Composition of test material, percentage of components: Sorbitol 7.6%; maltitol 53.6%; triitols 16.4%
- Lot/batch No.: Batch 720
- Expiration date of the lot/batch: Not reported
- Storage condition of test material: Not reported

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
Rat liver S9 (Aroclor 1254-induced)
Test concentrations with justification for top dose:
0.01, 0.05, 0.1, 0.5, and 1 mL per petri dish
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: None
Controls
Untreated negative controls:
yes
Remarks:
-without test substance
Negative solvent / vehicle controls:
no
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: see Table 1
Details on test system and experimental conditions:
METHOD OF APPLICATION: in medium; in agar (plate incorporation)


DURATION
- Exposure duration: 48 hours at 37°C


NUMBER OF REPLICATIONS: All the tests were carried out in triplicate.
Evaluation criteria:
Doubling of the spontaneous reversion rate accompanied by a dose-effect relationship are the criteria for mutagenicity.
Statistics:
No statistical analysis was performed.

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:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Additional information on results:
None
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