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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

Currently viewing:

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP, near guideline study, some restrictions in reporting but adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
E. coli not included
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Naphtha, thermal cracked, residues, naphthalene cut
EC Number:
285-562-7
EC Name:
Naphtha, thermal cracked, residues, naphthalene cut
Cas Number:
85117-10-8
IUPAC Name:
85117-10-8
Constituent 2
Reference substance name:
rohnaphthalin-gemisch
IUPAC Name:
rohnaphthalin-gemisch
Details on test material:
- BASF test substance number: 83/142
- Storage +4°C
- No further details

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
other: TA 98 and TA 100 have a modified post replication DNA repair system
Metabolic activation:
with and without
Metabolic activation system:
Aroclor induced rat liver S9
Test concentrations with justification for top dose:
0, 20, 100, 200, 300, 400, 500, 2500 and 5000 µg/plate
Vehicle / solvent:
- DMSO
Controlsopen allclose all
Untreated negative controls:
yes
Remarks:
sterility control
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other:
Remarks:
all strains, with S9
Positive controls:
yes
Positive control substance:
other:
Remarks:
TA 100 and TA 1535, without S9
Positive controls:
yes
Positive control substance:
other:
Remarks:
TA 98, without S9
Positive controls:
yes
Positive control substance:
other: 100 μg 9-aminoacridine chloride monohydrate
Remarks:
TA 1537, without S9
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)
- Standard plate test: Test tubes containing 2 mL of soft agar (100 ml agar (0.6% agar + 0.6% NaCl) and 10 mL amino-acid solution: 0.5 mM histidine + 0.5 mM biotin) kept in a water bath at 45°C, and the remaining components are added in the following order: 0.1 mL test solution; 0.1 mL bacterial suspension; 0.5 mL S-9 mix (in tests with metabolic activation) or 0.5 mL phosphate buffer (in tests without metabolic activation).
- After mixing, the samples are poured onto the Vogel-Bonner agar plates (minimal glucose agar plates) within approx. 30 seconds.
- Preincubation test: 0.1 mL test solution, 0.1 mL bacterial suspension and 0.5 mL S-9 mix incubated at 37°C for the duration of 20 minutes. Subsequently, 2 mL of soft agar is added, and, after mixing, the samples are poured onto the Vogel-Bonner agar plates within approx. 30 seconds
- After incubation for 48 hours at 37°C in the dark, the bacterial colonies (his+ revertants) are counted.

NUMBER OF REPLICATIONS:
- For each test, 3 plates per dose or per control.

DETERMINATION OF CYTOTOXICITY
- Yes

CHECKING OF TESTER STRAINS
- The Salmonella strains are checked for the following characteristics at regular intervals: deep rough character (rfa); UV sensitivity (∆ uvrB); ampicillin resistance (R factor plasmid) .
- Histidine auxotrophy is automatically checked in each experiment via the spontaneous rate.

Evaluation criteria:
A substance is characterised as positive if it fulfils the following requirements: doubling of the spontaneous mutation rate (control); dose-response relationship; reproducibility of the results.
Statistics:
None specified.

Results and discussion

Test resultsopen allclose all
Species / strain:
other: S. typhimurium TA 1535 and TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Remarks:
No increase in the number of his+ revertants
Vehicle controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
ambiguous
Remarks:
Only in 2 standard plate tests was a slight increase in the number of revertant colonies at 100 - 200µg by a factor 1.5-1.9 detected after metabolic activation.
Vehicle controls validity:
valid
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
other: In all 4 standard plate tests with S-9 mix a slight increase in the number of his+ revertants by a factor of 1.4-1.7 was observed at 100-200 µg/plate
Vehicle controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

Clear bacteriotoxic effect (reduced his- background growth, decrease in the number of his+ revertants) at doses ≥200 µg/plate.

Applicant's summary and conclusion

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

Rohnaphthalin-gemisch (CAS 85117-10-8) was negative with and without metabolic activation when tested in a bacterial reverse mutation assay.

Executive summary:

Rohnaphthalin-gemisch (CAS 85117-10-8) was tested in a bacterial reverse mutation test using Salmonella typhimurium tester strains TA98, TA100, TA1535 and TA1537 in the presence and absence or Aroclor-induced rat liver S9.

Toxicity was observed with some conditions at > 200 µg/plate. Small increases in revertant colonies seen in strains TA98 and 100, in only some of the experiments, were not seen on changing the test conditions (pre-incubation test to try to optimise any activity that may be present).  The increases in revertant colonies seen do not meet the criteria for a positive response and are considered not to indicate a mutagenic effect of the test material.

Rohnaphthalin-gemisch (CAS 85117-10-8) did not induce a significant increase in revertant colonies in Salmonella strains with or without rat liver metabolic activation at any dose level and is considered not to be a mutagen in this test system.