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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-compliant guideline study, fully adequate for assessment. In the OECD SIDS on sodium bicarbonate (2002) a similar reliability was assigned.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: EPA-FIFRA 40 CFR 160
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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 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