Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
The read across justification is detailed in section 13.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2000

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Similar Substance 01
IUPAC Name:
Similar Substance 01

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Metabolic activation system:
S9-mix from livers of 7 week old male Sprague-Dawleey rats, enzyme induction by intraperitoneal injection of sodium phenobarbital and 5,6-benzoflavone prior to sacrifice
Test concentrations with justification for top dose:
first trial: 0 (DMSO), 1.22, 4.88, 19.5, 78.1, 313, 1250, 5000 µg/plate
second trial: 0 (DMSO), 313, 625, 1250, 2500, 5000 µg/plate
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
2-acetylaminofluorene
9-aminoacridine
sodium azide
other: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide
Details on test system and experimental conditions:
preincubation methodology
Evaluation criteria:
Chemicals were consitered to be mutagenic when a dose related increase in revertant colony count was observed and the number of revertant colonies per plate with the test substance was nore than twice that of the negative control and when a reproducibility of the test result was observed.

Results and discussion

Test results
Species / strain:
other: Salmonella Typhimurium TA98, TA100, TA1535, TA1537, e. coli WP2uvrA/pKM101
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
The substance does not show a mutagenic activity and it is thus negative under test conditions
Executive summary:
The substance was tested in the Ames test according to the OECD TG 471 and GLP using Salmonella typhimurium TA98, TA100, TA1535, TA1537, E. coli WP2uvrA/pKM101 in the presence and absence of S9-mix and preincubation methodology. The concentrations used ranged from 0 (solvent control) up to 5000 µg/plate according to the requirement of the guideline.

It did not show mutagenic activity in any of the strains used. The positive controls were valid.


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