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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
other information
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Annex V, Method B13/B14
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
Chemical structure
Reference substance name:
-
EC Number:
454-140-6
EC Name:
-
Cas Number:
376608-71-8
Molecular formula:
C9H9F2N*C8H8O3
IUPAC Name:
(1R)-2-(3,4-difluorophenyl)cyclopropan-1-aminium (2R)-2-hydroxy-2-phenylacetate

Method

Species / strain
Species / strain / cell type:
bacteria, other: Salmonella typhimurium TA1535, TA1537, TA98, TA100 Escherichia coli WP2 (pKM101), WP2 uvrA (pKM101)
Metabolic activation system:
Liver S9 derived from phenobarbital/ß-naphthoflavone-induced Sprague Dawley rats
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 100 - 5000 µg/plate
Concentration range in the main test (without metabolic activation): 100 - 5000 µg/plate
Vehicle / solvent:
Solvent: DMSO
Details on test system and experimental conditions:
Concentration of the test substance resulting in precipitation: 0 µg/plate

Results and discussion

Test results
Species / strain:
other: as specified above
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
( 5000 µg/plate)
Additional information on results:
Observations:
none
Remarks on result:
other: other: main test
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

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

Under the condition of this assay C3RO gave a negtive, i.e. non -mutagenic, response in Salmonella typhimurium TA1537, TA98, TA100 Escherichia coli WP2 (pKM101), WP2 uvrA (pKM101), in both the presence and absence of S9-mix.