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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:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Refer to remarks.
Remarks:
Summary with tables and figures of a pre-guideline study. Meets generally accepted scientific standards, well documented and acceptable for assessment. This report was submitted to the MAK commission of the Deutsche Forschungsgemeinschaft (DFG) assessing hazardous materials.

Data source

Reference
Reference Type:
publication
Title:
Die akute und chronische Toxizität der Ameisensäure und ihrer Formiate.
Author:
Malorny G
Year:
1969
Bibliographic source:
Zeitschrift Ernährungswissenschaft 9, 332-339.

Materials and methods

Principles of method if other than guideline:
Pre-guideline study. LD50 determination was presumably conducted similar to the method used in OECD guideline 401.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Potassium formate
EC Number:
209-677-9
EC Name:
Potassium formate
Cas Number:
590-29-4
Molecular formula:
CH2O2.K
IUPAC Name:
Alcohols, C16-18
Details on test material:
- Name of test material (as cited in study report): Kaliumformiat, or K-Formiat
Specific details on test material used for the study:
- Name of test material (as cited in study report): Kaliumformiat, or K-Formiat

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
no data
Doses:
Applied doses not specified
No. of animals per sex per dose:
Total number of animals: 50
Control animals:
not specified

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
5 500 mg/kg bw
95% CL:
5 000 - 6 000

Any other information on results incl. tables

Table: oral LD50 of formic acid and its salts in the mouse:

 

 

Substance

LD50

(mg/kg bw)

LD50range

(mg/kg bw)

LD50,formate

(mg/kg bw)#

No of animals

Formic acid

1100

1000-1200

1076

55

Na-formate

11200

9600-12800

7410

45

K-formate

5500

5000-6000

2950

50

NH4-formate

2250

2050-2460

1610

50

Ca-formate

1920

1280 -2560

1330

45

 

# = calculated proportion of formate anion of the LD50dose.

Thus, the order of oral toxicity in mice was  formic acid  >  Ca, NH4, K salts  >  sodium formate.

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The oral LD50 of potassium formate was 5500 mg/kg bw in mice. The oral toxicity of formic acid and its salts depended largely on the presence of H-ions, not on the presence of formate. Therefore formic acid was more toxic than the salts.

Executive summary:

The acute oral toxicity of formic acid and several of its salts was examined in male and female mice in a pre-guideline study. The aim was to establish LD50 values and elucidate the mode of action. Potassium formate was tested in a total of 50 mice. The oral LD50was 5500 (range 5000 to 6000) mg/kg bw in mice. The acute oral toxicity was therefore low (Malorny, 1969).

 

This pre-guideline publication reviews the results of a variety of studies including metabolism and excretion, acute and repeated toxicity, and toxicity to reproduction. These results were used in the course of an early MAK-assessment. Though formal requirements for modern studies are not met, the published results are valuable for the assessment of formic acid and its salts. The study is considered to be valid (low reliability of 4 is assigned for formal reasons) and is used in a Weight of Evidence approach.