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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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP compliant guideline study, adequate for assessment. However, no data on analytical purity was reported. Study is included as a read across to a similar substance to provide data on a 5th bacterial strain (TA102).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
according to
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The report states 'not provided'

Method

Target gene:
his
Species / strain
Species / strain:
other: T98, TA100, TA102, TA1535, TA1537
Metabolic activation:
with and without
Metabolic activation system:
liver S9 fraction (induced with Aroclor 1254) from male SD rats
Test concentrations with justification for top dose:
50, 150, 500, 1500 and 5000 µg/plate
Vehicle:
water
Controls
Negative controls:
yes
Solvent controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: hydrazine sulphate (TA1535), 9-aminoacridine HCl monohydrate (TA1537), doxorubicine HCl (TA98 and TA100), mitomycin C (TA102), 2-aminoanthracene (TA1535 and TA1537), 2-aminofluorene (TA98, TA100 and TA102)
Details on test system and conditions:
Two independent experiments were performed, setting up triplicates plates for each experimental point.

The first trial was performed using the plate incorporation assay with and without metabolic activation (incubation: 37 degrees Celsius, 72 hours), while the second one was carried out using the plate incorporation assay without metabolic activation (incubation: 37 degrees Celsius, 72 hours) and the pre-incubation method with metabolic activation (pre-incubation at 37 degrees Celsius for 2 hours, followed by incubation at 37 degrees Celsius for 72 hours).

As the test article is a volatile liquid the plates were placed inside a sealed glass jar as soon as they were prepared.
Evaluation criteria:
A positive response is considered:
the number of revertant colonies is significantly higher when compared with the number of rervertants in the solvent controls
and
either a dose-response can be verified, that is, a positive correlation between the number of revertants and the dose in an interval of a least 3 doses
or a statistically significant increase is recorded at one dose only, when confirmed in independent assays.
Statistics:
After completion of scoring, mean of revertant colonies and standard deviation for each dose are determined, comparison was performed by Student's "t" test.

Results and discussion

Test results
Species / strain:
other: TA98, TA100, TA102, TA1535, TA1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
no
Vehicle controls valid:
yes
Negative controls valid:
not examined
Positive controls valid:
yes
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion