Castor oil, ester with sorbitol

Genetic toxicity: in vitro

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

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

Test material information

Constituent 1

Reference substance name:

D-glucitol

EC Number:

200-061-5

EC Name:

D-glucitol

Cas Number:

50-70-4

Molecular formula:

C6H14O6

IUPAC Name:

(2R,3R,4R,5S)-hexane-1,2,3,4,5,6-hexol

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.