Sodium hydrogencarbonate

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

Taken from OECD SIDS on Sodium bicarbonate (2002), where a similar reliability was assigned.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Materials and methods

Principles of method if other than guideline:

Aqueous solutions of sodium bicarbonate were administered daily via oral intubation to pregnant rats at doses ranging from 3.4-340 mg/kg bw mg/kg bw during days 6-15 of gestation. The fetuses were examined for the presence of external congenital abnormalities, detailed visceral abnormalities and for skeletal defects.

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium hydrogencarbonate

EC Number:

205-633-8

EC Name:

Sodium hydrogencarbonate

Cas Number:

144-55-8

Molecular formula:

CH2O3.Na

IUPAC Name:

sodium hydrogen carbonate

Test animals

Species:

rat

Strain:

Wistar

Details on test animals or test system and environmental conditions:

- Strain: Albino Wistar derived rats.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Duration of treatment / exposure:

Day 6 - day 15 of gestation

Frequency of treatment:

Once daily

Control animals:

yes

Details on study design:

Sex: female

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Dose descriptor:

NOAEL

Effect level:

>= 340 mg/kg bw/day (actual dose received)

Based on:

test mat.

Basis for effect level:

other: No effects observed at the highest dose tested.

Remarks on result:

not determinable due to absence of adverse toxic effects

Results (fetuses)

Details on embryotoxic / teratogenic effects:

Embryotoxic / teratogenic effects:no effects

Effect levels (fetuses)

Remarks on result:

not determinable due to absence of adverse toxic effects

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified

Any other information on results incl. tables

NOAEL (NOEL): 340 mg/kg
ACTUAL DOSE RECEIVED BY DOSE LEVEL BY SEX: Not reported. 
TOXIC RESPONSE/EFFECTS BY DOSE LEVEL: 
-----------------------------------------------------------
Dose (mg/kg): Sham   Aspirin  3.4  15.8  73.3  340
-----------------------------------------------------------
Pregnancies       20      24      20     21     21     22
Died or aborted    1       0       0      0      0      0
Live litters      19      19      20     21     21     22
Implant sites    226     277     239    268    238    254
Resorptions        5      93       3      0      0      1
Live fetuses     221     183     236    268    237    251
Dead fetuses       0       1       0      0      1      2
Fetus weight (g) 3.57   2.53    3.66   3.80   3.85 3.72
-----------------------------------------------------------
- Effects on offspring: The number of abnormalities seen in either soft or skeletal tissues of the test groups did  not differ from the number occurring spontaneously in the sham-treated controls.