Potassium perchlorate

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OPPTS 870.3100 combined with micronucleus formation study

Deviations:

not specified

GLP compliance:

yes

Type of assay:

mammalian erythrocyte micronucleus test

Test material

Test material information

Constituent 1

Reference substance name:

Ammonium perchlorate

EC Number:

232-235-1

EC Name:

Ammonium perchlorate

Cas Number:

7790-98-9

Molecular formula:

ClHO4.H3N

IUPAC Name:

ammonium perchlorate

Test material form:

solid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

12 h light/ 12 h darc cycle; 22 +- 2 °C, 50 +- 15% relative humidity, 12 - 15 air changes/h; 2 weeks of acclimation time

Administration / exposure

Route of administration:

oral: drinking water

Duration of treatment / exposure:

14 and 90 days, respectively

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

0 mg/kg bw/day (nominal)

Remarks:

control group

Doses / concentrations 2

Dose / conc.:

0.01 mg/kg bw/day (nominal)

Doses / concentrations 3

Dose / conc.:

0.05 mg/kg bw/day (nominal)

Doses / concentrations 4

Dose / conc.:

0.2 mg/kg bw/day (nominal)

Doses / concentrations 5

Dose / conc.:

1 mg/kg bw/day (nominal)

Doses / concentrations 6

Dose / conc.:

10 mg/kg bw/day (nominal)

No. of animals per sex per dose:

20 or 30, respectively

Control animals:

yes, concurrent no treatment

Positive control(s):

As a positive control material cyclophosphamide was used, administered by a single intraperitoneal injection (20 mg/kg bw).

Examinations

Tissues and cell types examined:

For all animals a complete gross necropsy examination after death or scheduled euthanasia was conducted. For each animal, a complete set of tissues and organs was preserved by immersion in 10% neutral buffered formalin. From the control-group and the high-dose-groupe animals euthanized after 14 or 90 days all tissues were examined microscopically. From all groups the livers, kidneys, lungs, thyroids and gross lesions were examined for histopathological changes.

Results and discussion

Test results

Key result

Sex:

male/female

Genotoxicity:

negative

Toxicity:

yes

Remarks:

test-material related effects on thyroid observed at a dose of 10 mg/kg/day

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

The positive control material (cyclophosphamide) induced a marked increase in micronucleated polychromatic erythrocyte.

Applicant's summary and conclusion

Conclusions:

No test-material-related changes in bone marrow micronucleus formation or polychromatic erythrocyte/normochromatic erythrocyte ratio were observed in both sex groups after 90 days of treatment at a dose of 10 mg/kg/day. The perchlorat moiety of ammonium perchlorate can be stated as non-genotoxic. As potassium perchlorate dissociated rapidly and potassium in known to be non-genotoxic, an eqivalent dose of 11.8 mg/kg/day potassium perchlorate can be stated as non-genotoxic.