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Genetic toxicity in vitro

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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
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay
Test material information:
Composition 1
Specific details on test material used for the study:
Lot number : not identified
Target gene:
Histidine
Species / strain:
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:
water
Negative controls:
yes
Remarks:
untreated controls
Solvent 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 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
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
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

Endpoint:
in vitro gene mutation study in mammalian cells
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
GLP compliance:
not specified
Type of assay:
in vitro mammalian chromosome aberration test
Test material information:
Composition 1
Species / strain:
Chinese hamster lung fibroblasts (V79)
Test concentrations with justification for top dose:
Nonactivated assay : 1.25, 2.5, 5.0, or 10.0 mM. (10mM = concentration as the maximum in cases when cell proliferation is not repressed)
Metabolic activation assay : 1.25, 2.5, 5.0, or 10.0 mM.
Vehicle:
water
Negative controls:
yes
Remarks:
saline
Solvent controls:
yes
Remarks:
vehicule control
True negative controls:
not specified
Positive controls:
yes
Remarks:
DMSO
Positive control substance:
N-dimethylnitrosamine
mitomycin C
Details on test system and conditions:
Direct nonactivated assays : Positive control = mitomycin C
Metabolic activated assays : Positive control = N-nitrosodimethylamine
Non activated Assays : CHL/IU cells cultured at 37°C for 3 days, after which time erythritol or MMC was added and the culture continued for 24 or 48 hr. Two plates were used for each erythritol concentration
Metabolic activation assay : erythritol or DMN was added to the cell culture, followed by S-9 mix, and the cells were incubated for 6 hr. After the culture medium was changed, the cells were further incubated for 18 hr.
Statistics:
reverse mutation assay: positive response judged by the appearance of a 2-fold or greater increase in the number of revertants per plate in the treated culture compared to the vehicule control treated culture
chromosome aberration test: positive response judged by X2-analysis of the difference in the incidence of abnormal and polyploid cells between the erythritol treated and the negative control groups
Key result
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
Conclusions:
Erythritol exhibited no mutagenicity in the chromosome aberration tests using cultured cells
Executive summary:

In an assay similar to OECD 473, Erythritol exhibited no mutagenicity in the chromosome aberration tests using cultured cells

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Justification for classification or non-classification