Dipotassium bis[μ-[tartrato(4-)-O1,O2:O3,O4]]diantimonate(2-) , stereoisomer

Toxicity to reproduction

Administrative data

Endpoint:

one-generation reproductive toxicity

Remarks:

Prenatal Development Toxicity

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

substance similar to tartar emetic

Data source

Reference

Reference Type:

review article or handbook

Title:

Evaluation of the health aspects of potassium acid tartrate, sodium potassium tartrate, sodium tartrate and tartaric acid as food ingredients

Author:

Prepared for Bureau of Foods. Food and Drug Administration. Department of Health, Education, and Welfare, Washington, D.C.

Year:

1979

Bibliographic source:

FDA 223-75-2004. Life Sciences Research Office. Federation of American Societies for Experimental Biology, Bethesda, Maryland. USA.

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: OECD Guideline 414

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Sodium hydrogen tartrate

EC Number:

208-400-9

EC Name:

Sodium hydrogen tartrate

Cas Number:

526-94-3

Molecular formula:

C4H6O6.Na

Test animals

Species:

other: mose, rat and rabbit

Strain:

not specified

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Details on exposure:

Tartaric acid was given daily by oral intubation beginning on the sixth day of gestation.

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

The mice and rats received the treatment for 10 days, the hamsters for 5 days, and the rabbits for 15 days.

Frequency of treatment:

daily

Details on study design:

doses ranged from 2.7 to 274 mg/Kg in mice, 1.8 to 181 mg/Kg in rats, 2.3 to 225 mg/Kg in hamsters, and 2.2 to 215 mg/Kg in rabbits.

Examinations

Parental animals: Observations and examinations:

During the test period the animals were observed daily for appearance and behavior, and the animals were wighed periodically. On days 14, 17, 20 and 29, the hamsters, mice, rats and rabbits, respectively, were subjected to cesarean section and the number of implantation sites, resorption sites, and live and dead fetuses recorded.

Postmortem examinations (offspring):

All live pups were weighed and the urogenital tract of each of them was examined. All fetuses were examined grossly for the presence of external congenital defects. The surviving rabbit fetuses were placed in an incubator for 24 hours for evaluation of neonatal survival; one-third of each litter underwent detailed visceral examination and the remaining two-thirds were examined for the presence of skeletal abnormalities.

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:

no effects observed

Mortality:

not specified

Body weight and weight changes:

not specified

Behaviour (functional findings):

no effects observed

Effect levels (P0)

1

Dose descriptor:

NOAEL

Remarks:

in mice

Effect level:

ca. 274 mg/kg bw (total dose)

Based on:

test mat.

Sex:

female

Basis for effect level:

clinical signs

body weight and weight gain

Remarks on result:

not determinable due to absence of adverse toxic effects

2

Dose descriptor:

NOAEL

Remarks:

in rats

Effect level:

ca. 181 mg/kg bw (total dose)

Based on:

test mat.

Sex:

female

Basis for effect level:

clinical signs

body weight and weight gain

Remarks on result:

not determinable due to absence of adverse toxic effects

3

Dose descriptor:

NOAEL

Remarks:

in hamsters

Effect level:

ca. 225 mg/kg bw (total dose)

Based on:

test mat.

Sex:

female

Basis for effect level:

clinical signs

body weight and weight gain

Remarks on result:

not determinable due to absence of adverse toxic effects

4

Dose descriptor:

NOAEL

Remarks:

in rabbits

Effect level:

ca. 215 mg/kg bw (total dose)

Based on:

test mat.

Sex:

female

Basis for effect level:

clinical signs

body weight and weight gain

Remarks on result:

not determinable due to absence of adverse toxic effects

Results: F1 generation

General toxicity (F1)

Clinical signs:

no effects observed

Gross pathological findings:

no effects observed

Effect levels (F1)

1

Dose descriptor:

NOAEL

Remarks:

mouse fetus

Generation:

F1

Effect level:

ca. 274 mg/kg bw (total dose)

Based on:

test mat.

Sex:

not specified

Basis for effect level:

gross pathology

Remarks on result:

not determinable due to absence of adverse toxic effects

2

Dose descriptor:

NOAEL

Remarks:

rat fetus

Generation:

F1

Effect level:

ca. 181 mg/kg bw (total dose)

Based on:

test mat.

Sex:

not specified

Basis for effect level:

gross pathology

Remarks on result:

not determinable due to absence of adverse toxic effects

3

Dose descriptor:

NOAEL

Remarks:

hamster fetus

Generation:

F1

Effect level:

ca. 225 mg/kg bw (total dose)

Based on:

test mat.

Sex:

not specified

Basis for effect level:

gross pathology

Remarks on result:

not determinable due to absence of adverse toxic effects

4

Dose descriptor:

NOAEL

Remarks:

rabbit fetus

Generation:

F1

Effect level:

ca. 215 mg/kg bw (total dose)

Based on:

test mat.

Sex:

not specified

Basis for effect level:

gross pathology

Remarks on result:

not determinable due to absence of adverse toxic effects

Overall reproductive toxicity

Reproductive effects observed:

no

Treatment related:

yes

Applicant's summary and conclusion

Conclusions:

Under the conditions of the test, tartaric acid exhibited no teratogenic activity