Zeolite, silica and titanium based, crystalline, synthetic, non fibrous

Genetic toxicity: in vivo

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

Test material information

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
- 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 / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
acute: 4.25, 42.5, 425 mg/kg suspended in 0.85% Saline
Basis:
nominal conc.

Doses / concentrations 2

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