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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Experimental test run under GLP and according to OECD Guideline.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

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

Test material

Constituent 1
Details on test material:
Identity: FAT 40815/A TE
Batch No.: WP 8/03
Purity: Approx. 75 %
Stability in solvent: Stable in water, saline, PEG and CMC for 7 days at room temperature
Storage: Room temperature
Expiration Date: May 01,2010

Method

Species / strain
Species / strain / cell type:
bacteria, other: Salmonella typhimurium TA 1535, TA 1537, TA 98, TA 100 Escherichia coli WP2 uvrA
Metabolic activation:
with and without
Metabolic activation system:
Fraction S9 mix treated with phenobarbital and ß-Naphthoflavone induced in rat liver S9 and S9 liver mirosomal fraction
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 33; 100; 333; 1000; 2500; and 5000 µg/plate
Concentration range in the main test (without metabolic activation): 33; 100; 333; 1000; 2500; and 5000 µg/plate
Controls
Untreated negative controls:
yes
Remarks:
Concurrent untreated
Negative solvent / vehicle controls:
yes
Remarks:
deionised water
Positive controls:
yes
Positive control substance:
sodium azide
methylmethanesulfonate
other: 4-Nitro-o-phenylene-diamine, 2-aminoanthracene, DMSO
Remarks:
2-AA tested with metabolic activation (rat liver 59 mix and hamster liver 59 mix) and other positive control substance tested without metabolic activation
Details on test system and experimental conditions:
Salmonella typhimurium
Strains Genotype Type of mutations indicated
TA 1537 his C 3076; rfa-; uvrB-: frame shift mutations
TA98 his D 3052; rfa-; uvrB-; R-factor " "
TA 1535 his G 46; rfa-; uvrB-: base-pair substitutions
TA 100 his G 46; rfa-; uvrB-; R-factor " "

Escherichia coli
WP2 uvrA trp-; uvrA: base-pair substitutions and others

Results and discussion

Test resultsopen allclose all
Species / strain:
other: as specified above
Metabolic activation:
with
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 µg/plate)
Species / strain:
other: as specified above
Metabolic activation:
without
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(> 5000 µg/plate)
Remarks on result:
other: other: preliminary test
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.

Therefore, FAT 40'815/A is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.

Applicant's summary and conclusion

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