Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 205-633-8 | CAS number: 144-55-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EPA-FIFRA 40 CFR 160
- GLP compliance:
- yes
- Limit test:
- no
Test material
- 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
- Details on test material:
- SOURCE: Church & Dwight Co., Inc., Old Fort, OH, USA.
PURITY: 99.9%.
IMPURITY/ADDITIVE/ETC.: Arsenic < 2 ppm. Heavy metals < 5
ppm. Loss on drying < 0.25%. Chloride < 0.015%. Sulfate <
0.015%.
ANY OTHER INFORMATION: Lot No. 063095F.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: Charles River Laboratories, Inc.
- Age: Young adult, no further detalis were given.
- Weight at study initiation: 234-299 g.
- Controls: Not reported.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- Females: 3000, 3500, 4000 mg/kg bw. Males: 3000, 3500, 4500 mg/kg bw.
- No. of animals per sex per dose:
- 5
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 4 000 mg/kg bw
Any other information on results incl. tables
MORTALITY:
- One female dosed with 4000 mg/kg died.
- Time of death: The animal died within 24 hours of administration.
- Number of deaths at each dose: 1/5 females dosed with 4000 mg/kg died.
CLINICAL SIGNS:
All the surviving animals gained weight during the postexposure observation period. The clinical signs of toxicity included soft stool, hypoactivity, dark-stained urogenital area. The surviving animals returned to a normal appearance by day 2. Of the females dosed with 3500mg/kg, 4/5 had soft stool, 1/5 had a dark-stained urogenital area and 1/5 exhibited hypoactivity, within the first day.
Among the females dosed with 4000 mg/kg, 1/5 had soft stool and 1/5 was hypoactive during the first day.
Among the males dosed with 4500 mg/kg, 1/5 had soft stool and 1/5 was hypoactive during the first day.
NECROPSY FINDINGS:
In the female that died on day 0, a single erosion was found in the glandular mucosa of the stomach near the pylorus. An enlarged pelvis was present in the right kidney of a male given 3000 mg/kg, both mandibular lymph nodes were enlarged in a male given 4000 mg/kg, and multiple opaque areas were on the parietal surface of the spleen in a male and a female given 4000 mg/kg.
POTENTIAL TARGET ORGANS: Not reported.
SEX-SPECIFIC DIFFERENCES: Not reported.
The no observable adverse effects level (NOAEL) is 4,000 mg/kg in males and 3,000 mg/kg in females.
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.
