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EC number: 205-737-3 | CAS number: 149-32-6
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03/1990-07/1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Erythritol
- EC Number:
- 205-737-3
- EC Name:
- Erythritol
- Cas Number:
- 149-32-6
- Molecular formula:
- C4H10O4
- IUPAC Name:
- butane-1,2,3,4-tetrol
Constituent 1
- Specific details on test material used for the study:
- Lot number : not identified
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 activation system derived from male Wistar (Crl:W1 (WU)BR) rats (Charles River Wiga GmbH, Sulzfeld, Germany)
- Test concentrations with justification for top dose:
- Toxicity test: 0, 0.003, 0.03, 0.3, 3,0 and 30.0 mg/plate with and without S9 for all strains
First Mytagenicity Test : 0, 0.37, 1.11, 3.33, 10.0 and 30 mg/plate with and without S9 for all strains (in triplicate)
Repeat Mutagenicity Test : 0, 0.37, 1.11, 3.33, 10.0 and 30 mg/plate with and without S9 for all strains (in triplicate) - Vehicle / solvent:
- water
Controls
- Untreated negative controls:
- yes
- Remarks:
- untreated controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- vehicule control
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- Details on test system and experimental conditions:
- Method : plate incorporation method
Positives controls :
- sodium azide : TA1535 and TA100 in the absence of S9 mix
- 2-nitrofluorene : TA1538 and TA98 in th absence of S9 mix
- 9-aminoacridine TA 1537 in the absence of S9 mix - Evaluation criteria:
- - determination of spontaneous revertant numbers and viable cells/mL for untreated controls
- dertermination of revertants/plate and background lawn for treated cultures - Statistics:
- - number of revertants per plate determined by an Artek Electronic Counter
- positive response judged by the appearance of a 2-fold or greater increase in the mean number of revertants per plate in the treated cultures compared to the vehicle control treated cultures
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Erythritol, both in absence or presence of an exogenous source of metabolic activation, showed no evidence of mutagenic activity in the ames test at concentrations up to 30 mg/plate
- Executive summary:
In an assay comparable to OECD 471 Ames test, Erythritol, both in absence or presence of an exogenous source of metabolic activation, showed no evidence of mutagenic activity in the ames test at concentrations up to 30 mg/plate
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