Registration Dossier

Diss Factsheets

Toxicological information

Genetic toxicity: in vivo

Currently viewing:

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

Constituent 1
Chemical structure
Reference substance name:
Tetrahydroxysilane
EC Number:
233-477-0
EC Name:
Tetrahydroxysilane
Cas Number:
10193-36-9
Molecular formula:
H4O4Si
IUPAC Name:
tetrahydroxysilane
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

Applicant's summary and conclusion