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Diss Factsheets

Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Data is from peer reviewed poublication

Data source

Reference
Reference Type:
publication
Title:
Repeated dose oral toxicity study of the test chemical
Author:
Webster et al
Year:
1959
Bibliographic source:
Toxicology and Applied Pharmacology

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Refer below principle
Principles of method if other than guideline:
The subacute (28 days) study was conducted to evaluate the toxic effects of repeated administration of the test chemical to guinea pigs by the oral route.
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Potassium iodate
EC Number:
231-831-9
EC Name:
Potassium iodate
Cas Number:
7758-05-6
Molecular formula:
HIO3.K
IUPAC Name:
potassium iodate
Details on test material:
- Name of test material: Potassium iodate
- Molecular formula: IO3K
- Molecular weight: 213.995 g/mol
- Substance type: Inorganic
- Physical state: Solid

Test animals

Species:
guinea pig
Strain:
other: Beltsville
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: N/A
- Housing:Each animal was housed in a separate cage
- Diet (e.g. ad libitum):dry Purina Rabbit Chow ad libitum
- Water (e.g. ad libitum):ad libitum


Administration / exposure

Route of administration:
oral: drinking water
Vehicle:
water
Details on oral exposure:
1st group : 12.5 mg/kg bw/day KIO3 in the drinking water.
2nd group : 125 mg/kg bw/day KIO3
3rd group (Control group):Control group was given distilled water.
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
28 days
Frequency of treatment:
Daily
Doses / concentrations
Remarks:
Doses / Concentrations:
0,12.5, 62.5,125 mg/kg bw/day
Basis:

No. of animals per sex per dose:
Control: 6 males and 6 females
12.5 mg/kg bw/day: 6 males and 6 females
125 mg/kg bw/day:6 males and 6 females
Control animals:
yes, concurrent vehicle
Details on study design:
Because the 125 mg/kg bw/day KI03 group drank so little, the iodate concentration was reduced to 62.5 mg/kg bw/day after the fourteenth day.

Examinations

Observations and examinations performed and frequency:
BODY WEIGHT: Yes
- Average body weight examined.
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
Total water consumption observed.

OPHTHALMOSCOPIC EXAMINATION: Yes
The eyes of each one were examined microscopically.

HAEMATOLOGY: Yes
Blood samples were taken from two males and females in each group 5-6 days before the end of the 4-week experimental period.
Following parameters were examined:
red cell count, hematocrit, hemoglobin, white cell count, and differential counts
Sacrifice and pathology:
GROSS PATHOLOGY: Yes
Sacrifice : yes
The animals were killed with ether and given a postmortem examination.
HISTOPATHOLOGY: Yes
Microscopically organs were studied in only a few animals in each group.
Statistics:
No data

Results and discussion

Results of examinations

Clinical signs:
not specified
Mortality:
not specified
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
smaller gain in body weight
Food consumption and compound intake (if feeding study):
effects observed, treatment-related
Description (incidence and severity):
consumed less iodate
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
effects observed, treatment-related
Description (incidence and severity):
Water consumption increased
Ophthalmological findings:
no effects observed
Description (incidence and severity):
No retinal degeneration was observed.
Haematological findings:
no effects observed
Description (incidence and severity):
Blood examinations failed to show any striking changes
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
no effects observed
Description (incidence and severity):
No adverse effects observed
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
no effects observed
Description (incidence and severity):
No gross changes were observed on postmortem examination.
Histopathological findings: neoplastic:
not specified
Other effects:
not specified
Details on results:
All animals remained in good physical condition during the 4-week study period.

Effect levels

Dose descriptor:
NOAEL
Effect level:
125 other: mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: Basis for effects : Haematology, Histopathology, Opthalmoscopic examination, Gross pathology

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
In a sub acute repeated dose toxicity study of the test chemical, it showed no effect on male and female guinea pigs when present in the diet at a level upto 125 mg/kg bw/day (0.50 % concentration) for a 28 days study period. Thus the NOAEL (no observed adverse effect level) for repeated dose oral toxicity was considered to be 125 mg/kg bw/day.
Executive summary:

The study was designed to investigate the subacute repeated dose toxicity effects of the test chemical to Beltsville guinea pigs(male/female) by oral route in an overall estimation period of 28 days. First group (6 animals per sex in each dose group) was fed a dry Purina Rabbit Chow in the drinking water equivalent to 12.5 mg/kg bw/day (0.05 % concentration) test chemical in the diet. The second group received only the test chemical equivalent to125 mg/kg bw/day (0.50 % concentration), and the third group as control received distilled water. During the study period body weight, haematology, histopathology, opthalmoscopic examination, gross pathology, water consumption, total body weight and compound intake were examined. The blood examinations failed to show any striking changes related to the target compound. All animals remained in good physical condition during the 4-week study period. No gross changes were observed on postmortem examination and no retinal degeneration or other significant histologic changes were noted. Thus from overall dissussion of the study, the NOAEL (no observed adverse effect level) for repeated dose oral toxicity was considered to be 125 mg/kg bw/day.