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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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: guideline study with acceptable restrictions, i.e. no GLP conditions, missing tester strain for crosslinking/ oxidizing agents

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Naphthalenesulfonic acids
EC Number:
268-860-1
EC Name:
Naphthalenesulfonic acids
Cas Number:
68153-01-5
IUPAC Name:
naphthalene-1-sulfonic acid
Constituent 2
Chemical structure
Reference substance name:
Naphthalene-2-sulphonic acid
EC Number:
204-375-3
EC Name:
Naphthalene-2-sulphonic acid
Cas Number:
120-18-3
Molecular formula:
C10 H8 O3 S
IUPAC Name:
naphthalene-2-sulfonic acid
Details on test material:
- Name of test material (as cited in study report): Naphthalinsulfonsäure
- Analytical purity: ca. 86%
- Lot/batch No.: 46-9714
- Storage condition of test material: Room temperature

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:
0, 20, 100, 500, 2500, 5000 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: [DMSO]
- Justification for choice of solvent/vehicle: the test substance was completely soluble in DMSO.
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 TA 100, TA 98, TA 1537 and TA 1535
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 TA 100 and TA 1535
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 4-nitro-o-phenylendiamine
Remarks:
without S-9 mix for strain TA 98
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 9-aminoacridine chloride monohydrate
Remarks:
without S-9 mix for strain TA 1537
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation); preincubation

DURATION
- Preincubation period: 20 minutes (only preincubation test)
- Exposure duration: 48 hours at 37 °C in the dark

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:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
ADDITIONAL INFORMATION ON CYTOTOXICITY: No bacteriotoxic effect (reduced his- background growth) was observed.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Standard plate test (20 - 5000 µg/plate)
Strain Metabolic activation system mean revertants in Controls maximum revertant factor dose dependency Assessment
TA 98 no 22 1.0 no negative
  yes 33 1.2 no negative
TA 100 no 100 1.2 no negative
  yes 121 1.1 no negative
TA 1535 no 16 0.9 no negative
  yes 18 1.0 no negative
TA 1537 no 9 1.1 no negative
  yes 10 1.1 no negative
Preincubation test (20 - 5000 µg/plate)
Strain Metabolic activation system mean revertants in Controls maximum revertant factor dose dependency Assessment
TA 98 no 20 1.3 no negative
  yes 34 1.0 no negative
TA 100 no 110 1.1 no negative
  yes 117 0.9 no negative
TA 1535 no 14 1.2 no negative
  yes 16 1.1 no negative
TA 1537 no 8 1.3 no negative
  yes 12 0.9 no negative

Applicant's summary and conclusion