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Registration Dossier
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EC number: 213-911-5 | CAS number: 1066-33-7
Toxicological information
Developmental toxicity / teratogenicity
Currently viewing:
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study which meets basic scientific principles.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 974
- Reference Type:
- publication
- Title:
- SIDS Initial Assessment Report For SIAM 15
- Author:
- OECD
- Year:
- 2 002
- Bibliographic source:
- OECD SIDS SODIUM BICARBONATE
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Female Wistar rats were treated with sodium bicarbonate by oral intubation at doses of 3.4, 15.8, 73.3 and 340 mg/kg from day 6-15 of gestation. On day 20 all dams were subjected to Caesarean section and the number of implantation sites, resorption sites and live and dead fetuses were recorded. One-third of the fetuses of each litter underwent detailed visceral examinationswhile the remainings examined for skeletal defects.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Sodium hydrogencarbonate
- EC Number:
- 205-633-8
- EC Name:
- Sodium hydrogencarbonate
- Cas Number:
- 144-55-8
- IUPAC Name:
- sodium hydrogen carbonate
- Details on test material:
- - Name of test material (as cited in study report): sodium bicarbonate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- VOLUME
At a dosage level of < 250 mg/kg the test material was dosed at 1 mI/kg. At a dosage of 340 mg/kg the test material was dosed at 2 ml/kg. - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: data not given
- Length of cohabitation: data not given
- Further matings after two unsuccessful attempts: data not given
- Verification of same strain and source of both sexes: data not given
- Proof of pregnancy: vaginal plug referred to as day 0 of pregnancy - Duration of treatment / exposure:
- day 6 - 15 of gestation
- Frequency of treatment:
- once daily
- Duration of test:
- 20 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
3.4, 15.8, 73.3, 340 mg/kg
Basis:
nominal conc.
- No. of animals per sex per dose:
- 25
- Control animals:
- yes, sham-exposed
- other: Aspirin: 250 mg/kg bw
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: on days 0, 6,11, 15 and 20 of gestation
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day # 17
- Organs examined: urogenital tract - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: No data
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes: 1/3rd per litter
- Soft tissue examinations: Yes: 1/3rd per litter
- Skeletal examinations: Yes: 1/3rd per litter
- Head examinations: Yes: No data
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 340 mg/kg bw/day (nominal)
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
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
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Results:
| Sham | Aspirin (250 mg/kg bw) | Sodium bicarbonate (mg/kg bw) | ||||
| 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 | 3.8 | 3.85 | 3.72 |
Applicant's summary and conclusion
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