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Toxicological information

Developmental toxicity / teratogenicity

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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

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Details on test animals 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 / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
0
Basis:
no data
Remarks:
Doses / Concentrations:
3.4 mg/kg
Basis:
no data
Remarks:
Doses / Concentrations:
15.8 mg/kg
Basis:
no data
Remarks:
Doses / Concentrations:
73.3 mg/kg
Basis:
no data
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.

Applicant's summary and conclusion