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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study, however only 4 strains tested

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
4 strains only
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): chloroformic acid methyl ester
- Physical state: colorless liquid
- Analytical purity: 99.2 %
- Lot/batch No.: 2/i v Mai 87
- Storage condition of test material: 4°C

Method

Target gene:
his +/-
Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA 98, 100, 1535, 1537
Metabolic activation:
with and without
Metabolic activation system:
S9 -mix
Test concentrations with justification for top dose:
0.0005 µl - 5.0 µl/Platte (TA 1535); 0.0005 - 1.0 µl/Platte (TA 100, 1537, 98), respectively 0.5-5000 µg/Platte (TA 1535); 0.5 - 1000µg/Platte (TA 100, 1537, 98)
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: stability and soloubility
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: 2- amino anthracene
Remarks:
all strains with s9 mix
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: TA 100; TA 1535: N-methyl-N'-nitro-N-nitrosoguanidine; TA 98 : 4-nitro-o-phenylendiamine; TA 1357 : 9-aminoacridine
Remarks:
with out S-9 mix
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation); preincubation

DURATION
- Preincubation period: 20 min
- Exposure duration: 48-72 h

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
Evaluation criteria:
The test chemical is considered positive in this assay if the following criteria are met:

In general, the test is considered as positive if the following requirements are fulfilled:
 
Doubling of the spontaneous mutation rate (control)
Dose response relationship
Reproducibility of the results
Statistics:
mean + sd

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Raw data see attached file.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative