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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:
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:
1990
Report Date:
1990

Materials and methods

Test guideline
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

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Lot number : not identified

Method

Target gene:
Histidine
Species / strain
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
Controls
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

Results and discussion

Test resultsopen allclose all
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

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