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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
Study period:
20 Nov. - 12 Dec. 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

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)
Principles of method if other than guideline:
Plate incorporation assay
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Cab-O-Sil EH-5:
CAS-Name: Silica, amorphous, fumed, cryst.-free;
CAS-No.: 112945-52-5
- Analytical purity: >99%
- Lot/batch No.: 1H049
- Stability under test conditions: stable

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 1538
Metabolic activation:
with and without
Metabolic activation system:
Aroclor induced rat liver S9 (adult male SD rats)
Test concentrations with justification for top dose:
667, 1000, 3333, 6667, and 10000 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: no data
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: Nitrofluorene (TA98, TA1538, -S9); 2-aminoanthracene (all strains, +S9); sodium azide (TA100, TA1535, -S9); ICR-191 (TA1537, -S9)
Details on test system and experimental conditions:
Ames test
METHOD OF APPLICATION: in medium; in agar (plate incorporation)

DURATION
- Exposure duration: no data

NUMBER OF REPLICATIONS: 3/concentration

NUMBER OF CELLS EVALUATED: seeded cells 10^8/plate

DETERMINATION OF CYTOTOXICITY
- Background lawn evaluated in pre-tests using TA 100

OTHER EXAMINATIONS:
- Other: Reversion rate

Evaluation criteria:
no data
Statistics:
Arithmetic averages with standard deviations

Results and discussion

Test results
Species / strain:
other: Nitrofluorene (TA98, TA1538, -S9); 2-aminoanthracene (all strains, +S9); sodium azide (TA100, TA1535, -S9); ICR-191 (TA1537, -S9)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: none
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative