Registration Dossier

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
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: Study was performed similar to OECD TG 475, with the restriction that no positive controls were used.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Safety of anticorrosives in building water-pipe metal inhibitors sodium polyphosphate and sodium metasilicate.
Author:
Ito, R. et al.
Year:
1986
Bibliographic source:
Toxicol. Lett. 31 (Suppl. P1-28), 44
Reference Type:
publication
Title:
Safety of the metal scavengers sodium metasilicate and sodium polyphosphate.
Author:
Saiwai, K. et al.
Year:
1980
Bibliographic source:
Internal Report Toho University
Reference Type:
secondary source
Title:
Soluble Silicates. CAS No. 1344-09-8, 6834-92-0, 10213-79-3, 13517-24-3 and 1312-76-1.
Author:
OECD SIDS
Year:
2004
Bibliographic source:
SIDS Initial Assessment Report for SIAM 18 Paris, France 20-23 April, 2004

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
Deviations:
not specified
GLP compliance:
no
Type of assay:
chromosome aberration assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
SOURCE: not reported
PURITY: not reported
IMPURITY/ADDITIVE/ETC.: not reported
ANY OTHER INFORMATION: the test substance was sodium metasilicate with an unknown concentration.

Test animals

Species:
mouse
Strain:
other: BDF1
Sex:
male
Details on test animals and environmental conditions:
- Age: 9 weeks

Administration / exposure

Route of administration:
oral: feed
Duration of treatment / exposure:
24 hours
Frequency of treatment:
once, 4 mg/kg bw  colchicine was  administered intraperitoneally 2 hours before necropsy.
Post exposure period:
sampling time was 24 h after administration of an acute dose
Doses / concentrations
Remarks:
Doses / Concentrations:
740-1340 mg/kg bw (7 graduated  levels)
Basis:
nominal conc.
No. of animals per sex per dose:
4 - 6
Control animals:
yes, concurrent vehicle

Examinations

Tissues and cell types examined:
femur bone marrow cells
Evaluation criteria:
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 were analyzed for chromosomal aberrations (including  gaps, breaks, deletions, and exchanges).

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified

Any other information on results incl. tables

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.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative