Tetrahydroxysilane

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Justification for type of information:

See attached justification

Cross-reference

Reason / purpose for cross-reference:

read-across source

Reference

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration

Type of information:

other: Read Across Source

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 475 (Mammalian Bone Marrow Chromosomal Aberration Test)

Principles of method if other than guideline:

METHOD FOLLOWED: cytogenetic assay using bone marrow cells
of mice
DEVIATIONS FROM GUIDELINE: not reported
GLP: no
STATISTICAL METHODS: not reported
METHOD OF CALCULATION: not reported
ANALYTICAL METHODS: not reported

GLP compliance:

no

Type of assay:

mammalian bone marrow chromosome aberration test

Species:

mouse

Strain:

DBF1

Sex:

male

Route of administration:

oral: feed

Vehicle:

Not reported

Details on exposure:

BDF1 mouse, lowest dose was 740 mg/kg bw.
Highest dose is not given, but exceeded 940 mg/kg bw, the
concentration, where fatalities occurred in a range-finding
test.

Duration of treatment / exposure:

24h

Frequency of treatment:

once, on day 0. 4 mg/kg bw
colchicine was administered intraperitoneally 2 hours before
necropsy.

Dose / conc.:

940 mg/kg bw/day

Remarks:

Highest dose is not given, but exceeded 940 mg/kg bw, the concentration, where fatalities occurred in a range-finding test.

Dose / conc.:

740 mg/kg bw/day

Remarks:

Lowest dose

No. of animals per sex per dose:

4-6

Control animals:

yes

Positive control(s):

No

Key result

Sex:

male

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

not specified

Negative controls validity:

not specified

Positive controls validity:

not examined

Conclusions:

MORTALITY: not reported
CLINICAL SIGNS: not reported
NECROPSY FINDINGS: not reported
BODY WEIGHT CHANGES: not reported
FOOD AND WATER CONSUMPTION CHANGES: not reported
EFFECT ON MITOTIC INDEX OR PCE/NCE RATIO: not reported
GENOTOXIC EFFECTS: negative
NOAEL (NOEL) (C) / LOAEL (LOEL) (C): not reported
MUTANT/ABERRATION/mPCE/ POLYPLOIDY FREQUENCY: no significant
increase of chromosomal aberrations compared to negative
control even at dosage levels exceeding the M.T.D. of 940
mg/kg bw.

Executive summary:

EXAMINATIONS:
- Clinical observations: not reported
- Organs examined at necropsy: not reported
- Criteria for evaluating results: not reported
- Criteria for selection of M.T.D.: not reported.
The chromosomes were examined blind by three persons. Slides from femur bone marrow cells were prepared according to standard methods, and 100 metaphases per animal analyzed for chromosomal aberrations (including gaps, breaks, deletions and exchanges).

Data source

Reference

Reference Type:

review article or handbook

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test material

Test material information

Constituent 1

Reference substance name:

Tetrahydroxysilane

EC Number:

233-477-0

EC Name:

Tetrahydroxysilane

Cas Number:

10193-36-9

Molecular formula:

H4O4Si

IUPAC Name:

silicic acid

Test material form:

solid

Results and discussion

Test results

Key result

Sex:

male

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

not specified

Negative controls validity:

not specified

Positive controls validity:

not examined