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Toxicological information

Developmental toxicity / teratogenicity

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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

Constituent 1
Chemical structure
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:

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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.

Applicant's summary and conclusion