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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
fertility, other
Remarks:
based on test type (migrated information)
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:
other: OECD 414: Pre-Natal Developmental toxicity screening test.
Principles of method if other than guideline:
The above experiment was performed to assess and evaluate the effects of the test chemical on Long-Evans rats.
GLP compliance:
not specified
Limit test:
no
Justification for study design:
No Data Available

Test material

Constituent 1
Chemical structure
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:
Details on test material
- Name of test material (as cited in study report):Sodium iodide
- Molecular formula (if other than submission substance):INa
- Molecular weight (if other than submission substance):149.89427
- Substance type:Inorganic
- Physical state:Solid
- Impurities (identity and concentrations):N/A
Specific details on test material used for the study:
- Molecular weight (if other than submission substance): 149.89427 g/mol
- Substance type: Inorganic
- Physical state: Solid
- Impurities (identity and concentrations): N/A

Test animals

Species:
rat
Strain:
Long-Evans
Details on species / strain selection:
No Data Available
Sex:
female
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:
Details on exposure
PREPARATION OF DOSING SOLUTIONS: The test chemical was administered through diet.

DIET PREPARATION
- Rate of preparation of diet (frequency): Daily
- Mixing appropriate amounts with (Type of food): No Data Available
- Storage temperature of food: No Data Available

VEHICLE
- Justification for use and choice of vehicle (if other than water): The test chemical was best miscible in corn oil.
- Concentration in vehicle: 0, 2500 ppm (150 mg/kg bw)
- Amount of vehicle (if gavage): No Data Available
- Lot/batch no. (if required): No Data Available
- Purity: 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 the test chemical and had produced but lost all young in one or more litters were subsequently re-bred after removal from dietary iodine.

- After successful mating each pregnant female was caged (how): Individually
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
No Data Available
Duration of treatment / exposure:
12 days
Frequency of treatment:
Daily
Details on study schedule:
No Data Available
Doses / concentrations
Remarks:
Doses / Concentrations:
0 and 150 mg/kg bw (2500 ppm)
Basis:
Nominal in diet
No. of animals per sex per dose:
27 female rats were used
Control animals:
yes, concurrent vehicle
Details on study design:
- F1 parental animals not mated until weeks after selected from the F1 litters: No Data Available
- Selection of parents from F1 generation when pups were [...] days of age: No Data Available
- Age at mating of the mated animals in the study: No Data Available
Positive control:
No Data Available

Examinations

Parental animals: Observations and 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 .
Oestrous cyclicity (parental animals):
No Data Available
Sperm parameters (parental animals):
No Data Available
Litter observations:
Survival of young animals was observed.
Postmortem examinations (parental animals):
No Data Available
Postmortem examinations (offspring):
No Data Available
Statistics:
The data was subjected to statistical analysis. The analytical methods included Analysis of Variance (ANOVA).
Reproductive indices:
No Data Available
Offspring viability indices:
Pups Viability Index.

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

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
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Other effects:
not specified

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:
not specified
Reproductive function: sperm measures:
not specified
Reproductive performance:
effects observed, treatment-related
Description (incidence and severity):
REPRODUCTIVE PERFORMANCE: Gestation time for rats was not affected by the test chemical; however, prolonged parturition was observed in rats.No signs of the beginning of lactation were observed.

Effect levels (P0)

Dose descriptor:
LOAEL
Effect level:
150 other: mg/kg bw
Based on:
test mat.
Sex:
female
Basis for effect level:
other: Effects observed on the following parameters : Gestation time, Parturition and No signs of the beginning of lactation were observed.

Results: F1 generation

General toxicity (F1)

Clinical signs:
not specified
Dermal irritation (if dermal study):
not specified
Mortality / viability:
mortality observed, treatment-related
Description (incidence and severity):
Average mortality was slightly greater of young from those fed with the test chemical.
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
Weaning weight was significantly less than that of controls.
Food consumption and compound intake (if feeding study):
not specified
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
Sexual maturation:
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
not specified
Histopathological findings:
not specified
Other effects:
not specified

Developmental neurotoxicity (F1)

Behaviour (functional findings):
not specified

Effect levels (F1)

Dose descriptor:
LOAEL
Generation:
F1
Effect level:
150 mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
viability
mortality
body weight and weight gain
Remarks on result:
other: Not Specified

Target system / organ toxicity (F1)

Critical effects observed:
not specified
System:
other: Not Specified

Overall reproductive toxicity

Reproductive effects observed:
not specified
Treatment related:
not specified

Applicant's summary and conclusion

Conclusions:
The LOAEL value of orally administered test chemical in Long-Evans rats was determined to be 150mg/kg bw.
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 oabove observations, LOAEL was found to be 150 mg/kg bw and it is likely to be regarded that there is no reproductive toxicity at concentrations lower than 150 mg/kg bw when administered orally.