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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: simillar to guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Principles of method if other than guideline:
10 male Wistar rats/ group received single doses of the test item by gavage and were observed for clinical signs and mortality for 14 days
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Aminoguanidinium hydrogen carbonate
EC Number:
219-956-7
EC Name:
Aminoguanidinium hydrogen carbonate
Cas Number:
2582-30-1
Molecular formula:
CH6N4.CH2O3
IUPAC Name:
N-aminoguanidine; carbonic acid
Test material form:
other: solid
Details on test material:
content: ca. 99 %

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 180-200 g
- Housing: 5 per cage

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
10 male Wistar rats/ group received single doses of aminoguanidinium hydrogen carbonate by gavage and were observed for clinical signs and mortality for 14 days.
Doses:
3100, 5000 mg/kg bw
No. of animals per sex per dose:
10 males/group
Control animals:
no
Details on study design:
10 male Wistar rats/ group received single doses of aminoguanidinium hydrogen carbonate by gavage and were observed for clinical signs and mortality for 14 days.
Statistics:
no data

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: In the 5000 mg group 4/10 animals died: sedation and poor general condition
Mortality:
No animal died in the 3100 mg/kg bw group.
4/10 animals died within 2 to 6 days in the 5000 mg/kg bw group.
Clinical signs:
other: 3100 mg/kg bw animals tolerated treatment without impairment 5000 mg/kg bw 10 /10: sedation, poor general condition
Gross pathology:
no details given

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Executive summary:

Groups of 10 male Wistar rats received single oral doses (3100 or 5000 mg/kg bw) of aminoguanidinium hydrogen carbonate dissolved in water and were observed for 14 days. Rats dosed with 3100 mg/kg bw tolerated the treatment without clinical signs or mortality. All 10 rats dosed with 5000 mg/kg bw showed sedation and poor general condition within 2 to 6 days after application of aminoguanidinium hydrogen carbonate, 4/10 died. Thus the LD50(oral) is >5000 mg/kg bw.

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