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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Data source

Reference
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Safepharm Laboratories Limited
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
C8-C16 branched and linear hydrocarbons (full range) – Kerosine
Cas Number:
848301-66-6
Molecular formula:
main general molecular formula: CnH(2n+2)
IUPAC Name:
C8-C16 branched and linear hydrocarbons (full range) – Kerosine

Method

Species / strain
Species / strain / cell type:
bacteria, other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. Coli WP2 uvr A
Details on mammalian cell type (if applicable):
S9 cells from livers of Spraque-Dawley rats
Additional strain / cell type characteristics:
DNA polymerase A deficient
Metabolic activation:
with and without
Metabolic activation system:
Phenobarbitone / beta-naphtoflavone induced, rat liver S9
Test concentrations with justification for top dose:
0, 15, 50, 150, 500, 1500 and 5000 µg/plate
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
4-nitroquinoline-N-oxide
Remarks:
Migrated to IUCLID6: further control substances: 9AA, ENNG

Results and discussion

Test results
Species / strain:
bacteria, other: S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. Coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity, but tested up to precipitating concentrations
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:
All positive control chemicals gave increases in revertants, either with or without the metabolising system as appropriate, within expected ranges. No statistically significant increase in the numbers of revertant colonies was recorded for any of the bacterial strains with any dose of the substance,
either with or without metabolic activation. The substance 'Kerosine (Fischer-Tropsch), full range, C8-16 - branched and linear' was found to be non-mutagenic under the conditions of this test.