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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
4 strains and standard plate test only.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Naphthyl-ethylhexylamin (ohne Lösemittel)
- Physical state: solid
- Storage condition of test material: at 4-6 °C

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
S-9 mix
Test concentrations with justification for top dose:
20-5000 µg/plate (TA98, TA1537); 20-7500 µg/plate (TA100, TA1535)
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: [DMSO;]
- Justification for choice of solvent/vehicle: none given, the test substance was not completely soluble in DMSO from about 2500 µg/plate onward
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
with S-9 mix for strains TA100, TA98, TA1537 and TA1535
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: N-methyl-N'-nitro-N-nitroso-guanidine (MNNG)
Remarks:
without S-9 mix for strains TA100 and TA1535
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 4-nitro-o-phenylenediamine
Remarks:
without S-9 mic for strain TA98
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 9-aminoacridine chloride
Remarks:
without S-9 mix for strain TA1537
Details on test system and experimental conditions:
METHOD OF APPLICATION: standard plate test

DURATION
- Exposure duration: 48 hours at 37°C in the dark

SELECTION AGENT (mutation assays): his+ revertants

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Evaluation criteria:
In general, a substance to be characterized as positive in the Ames test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results.
Statistics:
no data

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
positive
Remarks:
only with S-9 mix in strains TA100 and TA1535
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'.

Any other information on results incl. tables

No increase in the number of his+ revertants was observed without S-9 mix in all strains tested.

No increase in the number of his+ revertants was observed with S-9 mix in the strains TA1537 and TA98.

TA1535: Positive reaction from about 500 µg/ plate (factor 2.1 - 2.8) onward with an increase in the number of mutant colonies by a factor of 5.4 - 5.5 at 5000 µg - 7500 µg/plate.

TA100: Slight increase in the number of his+ revertants in a dose range of 2500 µg - 7500 µg/plate (factor 1.6 - 2.2).

Applicant's summary and conclusion