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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

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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:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EPA-FIFRA 40 CFR 160
GLP compliance:
yes
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
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.

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