Registration Dossier

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:
OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
GLP compliance:
no
Type of assay:
other: Cytogenetic assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): FDA 71-45
- Chemical name: Zeolite, cuboidal, crystalline, synthetic, non-fibrous
- 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