Erythritol

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Link to relevant study records

Reference

Reference 1

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Specific details on test material used for the study:

Lot number : not identified

Target gene:

Histidine

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

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

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

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

Reference 2

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)

GLP compliance:

not specified

Type of assay:

in vitro mammalian chromosome aberration test

Species / strain / cell type:

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 / solvent:

water

Untreated negative controls:

yes

Remarks:

saline

Negative solvent / vehicle 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 experimental 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 / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

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)