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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

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: Comparable to guideline study with acceptable restrictions (only male animals were tested; mitotic index is based on 500 cell counts instead of 1000).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
GLP compliance:
no
Type of assay:
other: Cytogenetic assay

Test material

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
IUPAC Name:
Automatically generated during migration to IUCLID 6, no data available
Details on test material:
- Name of test material (as cited in study report): FDA 71-45
- Framework: cuboidal
- Related CAS number: 1318-02-1
- Chemical name: Synthetic silica
- Analytical purity: no data
- Lot/batch No.: SR-1621

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
0.85 % saline
Details on exposure:
5 animals per dose group; observation 6, 24 and 48 hours after administration. Bone marrow cell preparations were made and 50 cells per animal were counted in metaphase for aberrations. For negative controls (0.85 % saline) 3 animals were doses and examined 6, 24, and 48 hours after administration, respectively; positive controls (0.3 mg/kg triethylene melamine) were also run in parallel (5 animals, which were killed 48 h after administration).
Testing of the highest dose of 5000 mg/kg was performed separately at a later date.
Duration of treatment / exposure:
single administration (acute)
Frequency of treatment:
single administration (acute)
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
acute: 4.25, 42.5, 425 mg/kg suspended in 0.85% Saline
Basis:
nominal conc.
Remarks:
Doses / Concentrations:
acute: 5000 mg/kg suspended as 18.9 % (w/v)) in 0.85 % saline
Basis:
nominal conc.
No. of animals per sex per dose:
5 males
Control animals:
yes, concurrent vehicle
Positive control(s):
0.3 mg/kg triethylene melamine

Examinations

Tissues and cell types examined:
Bone marrow cell preparations were made and 50 cells per animal were counted in metaphase for aberrations.

Results and discussion

Test results
Sex:
male
Genotoxicity:
negative
Toxicity:
no effects
Remarks:
425 mg/kg: LD5 (previous acute toxicity test, test compound suspended in 0.85% Saline)
Vehicle controls validity:
valid
Negative controls validity:
not examined
Positive controls validity:
valid

Any other information on results incl. tables

4.24 - 425 mg/kg: The negative controls and the 3 compound-treated groups were within the normal limits of breaks observed (0-3%). The mitotic indices were in good agreement except for the 425 mg/kg dose group at 24 h which was slightly but not significantly, depressed. In the positive control group 5% of the cells with severe damage (> 10% aberrations/cell) and 1% of the cells with pulverized chromosomes were observed.
The 5000 mg/kg dose group differed not significantly from control neither in variety nor in number of these aberrations.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative