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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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
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

Constituent 1
Chemical structure
Reference substance name:
Silicon dioxide
EC Number:
231-545-4
EC Name:
Silicon dioxide
Cas Number:
7631-86-9
Molecular formula:
O2Si
IUPAC Name:
dioxosilane
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: other: Salmonella typhimurium TA98, TA100, TA1535, TA1537,TA1538
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative