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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from collection of data.

Data source

Reference
Reference Type:
review article or handbook
Title:
Genetic toxicity study in vitro for sorbitol
Author:
U. S. National Library of Medicine
Year:
2018
Bibliographic source:
- Chemical Carcinogenesis Research Information System, US national Library of Medicine reviewed by SRC, 2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: As mention below
Principles of method if other than guideline:
To evaluate the mutagenic potential of test substance in Salmonella typhimurium TA97A and TA102 by AMES test.
GLP compliance:
not specified
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): sorbitol
-Molecular formula;C6H14O6
-Molecular weight ; 182.1g/mol

Method

Target gene:
Histidine
Species / strain
Species / strain / cell type:
S. typhimurium, other: TA97A and TA102
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
not specified
Cytokinesis block (if used):
not specified
Metabolic activation:
with and without
Metabolic activation system:
Rat liver, induced with AROCLOR 1254
Test concentrations with justification for top dose:
0, 0.5-50 mg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: Distilled water
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
not specified
Details on test system and experimental conditions:
METHOD OF APPLICATION: Preincubation method
Rationale for test conditions:
Not specified
Evaluation criteria:
Histidine revertants colonies were observed
Statistics:
Not specified.

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA97A and TA102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: No mutagenic effect were observed

Applicant's summary and conclusion

Conclusions:
Test chemical was evaluated for its mutagenic potential in Salmonella typhimurium TA97A and TA102 by AMES test. The test result was considered to be negative in both strain in the presence and absence of metabolic activation S9.
Executive summary:

Genetic toxicity in vitro study was assessed for test chemical. The test material was exposed to Salmonella typhimurium TA97A and TA102 in the presence and absence of metabolic activation S9. The concentration of test material used in the presence and absence of metabolic activation were0, 0.5-50 mg/plate. No mutagenic effects were observed in both strains, in the presence and absence of metabolic activation. Therefore test chemical was considered to be non mutagenic in Salmonella typhimurium TA97A and TA102 by AMES test. Hence the substance cannot be classified as gene mutant in vitro.