Registration Dossier
Registration Dossier
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EC number: 207-838-8 | CAS number: 497-19-8
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:
- In the OECD SIDS on sodium carbonate (2002) a similar reliability was assigned.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
- Principles of method if other than guideline:
- Method: other: no data
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium carbonate
- EC Number:
- 207-838-8
- EC Name:
- Sodium carbonate
- Cas Number:
- 497-19-8
- Molecular formula:
- CH2O3.2Na
- IUPAC Name:
- disodium carbonate
- Details on test material:
-
SOURCE: Not reported.
PURITY: Not reported.
IMPURITY/ADDITIVE/ETC.: Not reported.
ANY OTHER INFORMATION: Not reported.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- d 6-15
- Frequency of treatment:
- daily
- Control animals:
- other: yes, sham-treated
- Details on study design:
- Not reported, well described.
Examinations
- Statistics:
- Not reported.
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 245 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 245 mg/kg bw/day
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
TOXIC RESPONSE/EFFECTS BY DOSE
LEVEL:
- Parental data and F1: No effects.
- Body weight: No effects.
- Mortality: No effects.
- Number of implantations: No effects.
- Litter size and weights: No effects.
- Other observations: No effects on resorptions, live fetuses, visceral
and skeletal effects.
STATISTICAL RESULTS: Not
reported.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
