Potassium perchlorate

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

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)

Data source

Reference

Reference Type:

publication

Title:

A 90-day drinking water toxicity study in rats of the environmental contaminant ammonium perchlorate

Author:

Siglin JC, Mattie, DR, Dodd RD, Hildebrandt PK & Baker WH

Year:

2000

Bibliographic source:

Toxicol Sci. 2000, Sep; 57(1):61-74

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The induction of micronuclei was assessed in bone marrow PCEs taks from rats administered ammonium perchlorate in the drinking water for up to 90 days.

GLP compliance:

yes

Type of assay:

micronucleus assay

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

IUPAC Name:

ammonium perchlorate

Test material form:

not specified

Details on test material:

Ammonium perchlorate (Aldrich); 99.8% purity

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Springborn Ohio
- Age at study initiation: 7 weeks
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 2 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 50 +/- 15
- Air changes (per hr): 12-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: drinking water

Vehicle:

Drinking water

Details on exposure:

Groups of 20 -30 rats per sex were administered ammonium perchlorate in the drinking water at target dose levels of 0, 0.1, 0.05, 0.2, 1.0 or 10.0 mg/kg bw/d. Animals were sacrificed at Day 14 (10/sex: all groups), Day 90 (10/sex: all groups) or following a 30 -day recovery period (Day 120; 0, 0.05, 1 and 10 mg/kg bw/d).

Duration of treatment / exposure:

Up to 90 days

Frequency of treatment:

Daily/continuous

Post exposure period:

Not applicable

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 0.1, 0.5, 0.2, 1, 10 mg/kg bw/d
Basis:
other: target dose level

No. of animals per sex per dose:

20-30

Control animals:

yes

Positive control(s):

Positive control animals were administered a single intraperitoneal injection of cyclophosphamide at 20 mg/kg bw/d.

Examinations

Tissues and cell types examined:

Bone marrow polychromatic erythrocytes (PCEs)

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

valid

Negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

No increase in the incidence of micronucleated cells was observed. PCE:NCE ratio was unaffected by treatment. Toxicity was limited to effects on throid (increased weight, histopathology) at the highest dose level; effects on TSH and thyroid hormones were apparent in all treated groups.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative
Administration of ammonium perchlorate in the drinking water at dose levels of up to 10 mg/kg bw/d for up to 90 days did not result in an increased incidence of micronucleated bone marrow polychromatic erythrocytes.

Executive summary:

The incidence of micronuclei in rat bone marrow polychromatic erythrocytes was investigated as part of a 90 -day toxicity study in which ammonium perchlorate was administered to rats in the drinking water at dose levels of up to 10 mg/kg bw/d for up to 90 days. No increase in the incidence of micronucleated cells was observed. PCE:NCE ratio was unaffected by treatment. Toxicity was limited to effects on throid (increased weight, histopathology) at the highest dose level; effects on TSH and thyroid hormones were apparent in all treated groups.