Trisodium hydrogendicarbonate

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented study which meets basic scientific principles. 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 bicarbonate

IUPAC Name:

sodium bicarbonate

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

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
0
Basis:
no data

Doses / concentrations 2

Remarks:

Doses / Concentrations:
3.4 mg/kg
Basis:
no data

Doses / concentrations 3

Remarks:

Doses / Concentrations:
15.8 mg/kg
Basis:
no data

Doses / concentrations 4

Remarks:

Doses / Concentrations:
73.3 mg/kg
Basis:
no data

Doses / concentrations 5

Remarks:

Doses / Concentrations:
340 mg/kg
Basis:
no data

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:

no data

Basis for effect level:

other: developmental toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:

Embryotoxic / teratogenic effects:no effects

Fetal abnormalities

Abnormalities:

not specified

Overall developmental toxicity

Developmental effects observed:

not specified

Any other information on results incl. tables

NOAEL: 340 mg/kg

ACTUAL DOSE RECEIVED BY DOSE LEVEL BY SEX:

Not reported. TOXIC RESPONSE/EFFECTS BY DOSE LEVEL:

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Dose (mg/kg): Sham Aspirin 3.4 15.8 73.3 340

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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

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- Effects on offspring: The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differfrom the number occurring spontaneously in the sham-treated controls.