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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guidline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Method

Target gene:
Salmonella typhimurium TA98, TA100, TA1535 and TA1537: GC
Escherichia coli WP2 uvrA: AT
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 (rat)
Test concentrations with justification for top dose:
1.581, 5, 15.81, 50, 158.1, 500, 1581, 5000 μg/plate
Vehicle / solvent:
Dimethyl sulfoxide (DMSO):
Supplier: Sigma-Aldrich Co.
Batch No.: SZBD1830V
Expiry date: 16 June 2016
Grade: puriss, p.a., ACS reagent
Purity: 100.0%

Distilled water:
Manufacturer: TEVA Hungary Ltd.
Batch No.: 0790713 / 0271113
Expiry date: 31 July 2016 / 30 November 2016

Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
DMSO, Distilled Water
Positive controls:
yes
Remarks:
2µg
Positive control substance:
sodium azide
Remarks:
TA 100, TA 1535, without metabolic activation
Positive controls:
yes
Remarks:
50µg
Positive control substance:
9-aminoacridine
Remarks:
TA 1537, without metabolic activation
Positive controls:
yes
Remarks:
2µL
Positive control substance:
methylmethanesulfonate
Remarks:
WP2 uvrA, without metabolic activation
Positive controls:
yes
Remarks:
4µg
Positive control substance:
other: 4-nitro-1,2-phenylene-diamine (NPD)
Remarks:
TA 98, without metabolic activation
Positive controls:
yes
Remarks:
2µg
Positive control substance:
other: 2-aminoanthracene (2AA)
Remarks:
TA 98, TA 100, TA 1535, TA 1537, with metabolic activation
Positive controls:
yes
Remarks:
50µg
Positive control substance:
other: 2-aminoanthracene (2AA)
Remarks:
WP2 uvr2, with metabolic activation
Details on test system and experimental conditions:
METHOD OF APPLICATION: 1st main experiment: in agar (Plate Incorporation Method); 2nd main experiment: Plate Incorporation Method instead of
Pre-Incubation Method due to the limited solubility of the test item.

DURATION
- 1st main experiment: 48±1 hours incubation (37°C)
- 2nd main experiment: 48±1 hours incubation (37°C)

NUMBER OF REPLICATIONS: 3

DETERMINATION OF CYTOTOXICITY
The colony numbers on the untreated / negative (vehicle/solvent) / positive control and test item treated plates were determined by manual
counting. Visual examination of the plates was also performed; precipitation or signs of growth inhibition (if any) were recorded and reported.
Evaluation criteria:
The study was considered valid if:
-the number of revertant colonies of the negative (vehicle/solvent) and positive controls were in the historical control range in all strains of the main tests;
-at least five analyzable concentrations were presented in all strains of the main tests.

Criteria for a Positive Response:
A test item was considered mutagenic if:
- a dose–related increase in the number of revertants occurred and/or;
- a reproducible biologically relevant positive response for at least one of the dose groups occurred in at least one strain with or without metabolic activation.

An increase was considered biologically relevant if:
- the number of reversions was more than two times higher than the reversion rate of the negative (vehicle/solvent) control in Salmonella typhimurium TA98,
TA100 and Escherichia coli WP2 uvrA bacterial strains;
- the number of reversions was more than three times higher than the reversion rate of the negative (vehicle/solvent) control in Salmonella typhimurium
TA1535 and TA1537 bacterial strains.

Criteria for a Negative Response:
A test item was considered non-mutagenic if it produced neither a dose-related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups, with or without metabolic activation.

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no 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'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with and without metabolic activation

In conclusion, the test item Oxophos 64i had no mutagenic activity in the examined bacterial strains under the test conditions of this study.