Sodium iodide

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

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 a publication.

Data source

Reference

Reference Type:

publication

Title:

Effects of Excess Dietary Iodine upon Rabbits, Hamsters, Rats and Swine.

Author:

R. Arrington, R. N. Taylor, Jr., C. H. Ammerman AndR. L. Shirley

Year:

1965

Bibliographic source:

Journal of Nutrition; vol. 87, no. 4, pg. 394-398; December 1, 1965

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Principles of method if other than guideline:

The above experiment was conducted to evaluate and assess the effects of the test chemical on the developmental parameters of the Long-Evans Rats.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Sodium iodide

EC Number:

231-679-3

EC Name:

Sodium iodide

Cas Number:

7681-82-5

Molecular formula:

INa

IUPAC Name:

sodium iodide

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report):Sodium iodide
- Molecular formula (if other than submission substance): NaI
- Molecular weight (if other than submission substance):149.89427
- Substance type:Inorganic
- Physical state:Solid

Specific details on test material used for the study:

- Molecular weight (if other than submission substance):149.89427
- Substance type:Inorganic
- Physical state:Solid

Test animals

Species:

rat

Strain:

Long-Evans

Details on test animals or test system and environmental conditions:

Details on test animal
TEST ANIMALS
- Housing:Animals were housed individually in wire cages. Prior to littering, rats were transferred to 3 X 3 mesh wire cages.
- Diet (e.g. ad libitum):Purina Laboratory Chow were provided ad libitum
- Water (e.g. ad libitum):Tap water was supplied ad libitum

Administration / exposure

Route of administration:

oral: feed

Vehicle:

other: Diet as Purina Laboratory Chow

Details on exposure:

No Data Available

Analytical verification of doses or concentrations:

not specified

Details on analytical verification of doses or concentrations:

No Data Available

Details on mating procedure:

- The sexually mature females were bred to normal males of the breed or strain.

- Monogamous pairs of rats were mated. When breeding occurred, the time of first copulation was recorded and gestation subsequently calculated from this time to birth of the first young of the litter. Fourteen female rats which had been fed with the test chemical and had produced but lost all young in one or more litters were subsequently re-bred after removal of the test chemical

- After successful mating each pregnant female was caged (how): Individually

Duration of treatment / exposure:

12 days

Frequency of treatment:

Daily

Duration of test:

From breeding to day 21 of suckling

Doses / concentrations

Remarks:

Doses / Concentrations:
0,150 mg/kg bw (2500 ppm)
Basis:

No. of animals per sex per dose:

27 females

Control animals:

yes, concurrent vehicle

Details on study design:

No Data Available

Examinations

Maternal examinations:

Observations were made for length of parturition time and number of young born dead and those born live. Periodic observations were made through the lactation period for mothering instinct, evidence of lactation and survival of young.

Ovaries and uterine content:

No Data Available

Fetal examinations:

All surviving young from each female in the control and experimental groups were permitted to nurse through the normal suckling period.

Statistics:

The statistical data was analyzed by using Analysis of Variance (ANOVA).

Indices:

Pups Viability Index.

Historical control data:

No Data Available

Results and discussion

Results: maternal animals

General toxicity (maternal animals)

Clinical signs:

not specified

Dermal irritation (if dermal study):

not specified

Mortality:

not specified

Body weight and weight changes:

effects observed, treatment-related

Food consumption and compound intake (if feeding study):

effects observed, treatment-related

Description (incidence and severity):

Voluntary feed intake of rats fed with the test chemical was about 6 to 7% less than that of control rats and this reduced feed intake

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not specified

Haematological findings:

not specified

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:

not specified

Neuropathological findings:

not specified

Histopathological findings: non-neoplastic:

not specified

Histopathological findings: neoplastic:

not specified

Other effects:

not specified

Maternal developmental toxicity

Number of abortions:

not specified

Pre- and post-implantation loss:

not specified

Total litter losses by resorption:

not specified

Early or late resorptions:

not specified

Dead fetuses:

effects observed, treatment-related

Description (incidence and severity):

An increased incidence of death in the neonates, with <10% of the young surviving for 3 days.

Changes in pregnancy duration:

no effects observed

Description (incidence and severity):

Gestation time for rats was not affected by the test chemical.
Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): no effects observed
Field "Description (incidence and severity)" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.DescriptionIncidenceAndSeverityEffectsOnPregnancyDuration): Gestation time for rats was not affected by the test chemical.

Changes in number of pregnant:

not specified

Other effects:

not specified

Details on maternal toxic effects:

Prolonged parturition was observed in rats.No signs of the beginning of lactation were observed.

Effect levels (maternal animals)

Dose descriptor:

LOAEL

Effect level:

150 other: mg/kg bw

Based on:

test mat.

Basis for effect level:

other: developmental toxicity

Maternal abnormalities

Abnormalities:

not specified

Results (fetuses)

Fetal body weight changes:

effects observed, treatment-related

Description (incidence and severity):

Weaning weight was significantly less than that of controls.
Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed
Field "Description (incidence and severity)" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.DescriptionIncidenceAndSeverityFetalPupBodyWeightChanges): Survival of the young and body weights at weaning were equal to those of controls.

Reduction in number of live offspring:

not specified

Changes in sex ratio:

not specified

Changes in litter size and weights:

not specified

Changes in postnatal survival:

not specified

External malformations:

not specified

Skeletal malformations:

not specified

Visceral malformations:

not specified

Other effects:

not specified

Effect levels (fetuses)

Dose descriptor:

LOAEL

Effect level:

150 mg/kg bw/day

Based on:

test mat.

Sex:

male/female

Basis for effect level:

fetal/pup body weight changes

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

Based on all the observations, it was concluded that the LOAEL for the test chemical was found to be 150 mg/kg bw after analyzing the effects on developmental parameters of the Long-Evans Rats.

Executive summary:

A study was conducted with rats to determine the effects of intake of the test chemical. A total of 27 animals were used in this study. Females were bred to normal males, wherein the test chemical was added to the diet during the latter portion of gestation and the females were permitted to litter normally. The effect of the treatment on gestation period, lactation and survival of the young was observed.It was observed that, gestation time for rats was not affected ; however, prolonged parturition was observed in rats. In fetal parameters, average mortality was slightly greater of young from those fed with the test chemical, while the weaning weight was significantly less than that of controls.In other experiment, the female rats were re-bred after removal of dietary intake of the test chemical. It was observed that the females gave birth and nursed litters normally. Thus, from all the above observations,LOAEL was found to be150 mg/kg bw and it is likely to be regarded that there is no reproductive and developmental toxicity at concentrations lower than150 mg/kg bw when administered orally.