Ammonium formate

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Guideline:

other: Study conducted prior to implementation of GLP and OECD guidelines

Principles of method if other than guideline:

Study conducted prior to implementation of GLP and OECD guidelines

GLP compliance:

no

Remarks:

data published prior to implementation of GLP

Test type:

standard acute method

Species:

mouse

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

oral application of doses up to the range of 2050- 2460mg/kg bw where LD50 values were determined.

Route of administration:

oral: gavage

Vehicle:

not specified

Doses:

up to 2050 - 2460 mg/ kg bw

No. of animals per sex per dose:

50

Control animals:

not specified

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

2 250 mg/kg bw

Based on:

test mat.

Mortality:

50 % Mortality was observed

Clinical signs:

other: Details of toxic effects not reported other than lethal dose value

Beside the determination of the LD50 of ammonium formate the LD50 of fomate ion was calculated to be 1610 mg/kg bw

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

According to the study of Malorny (1969) the LD50 of ammonium formate was determined in mice at a dose of 2250 mg/kg bw after oral administration. No other signs of toxicity were reported.
Based on the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) Ammonium formate has to be categorized as Category 5 "May be harmful if swalloed", according to Regulation (EC) No 1272/2008 Ammonium formate does not need to be classified for acute oral toxicity.

Executive summary:

In an acute oral toxicity study conducted prior to implementation of OECD and GLP Guidelines but comparable to OECD guideline 401, in sum 50 mice were given a single oral dose of Ammonium formate by gavage at doses up to 2050 - 2460mg/kg bw. No other adverse effects were described.

Oral LD50 (mice) =2250  mg/kg bw

Based on the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) Ammonium formate has to be categorized as Category 5 "May be harmful if swalloed", according to Regulation (EC) No 1272/2008 Ammonium formate does not need to be classified for acute oral toxicity.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

2 250 mg/kg bw

Quality of whole database:

Study conducted prior to implementation of OECD or GLP Guidelines, meets generally accepted scientific principles, acceptable for assessment

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

According to the study of Malorny (1969) the LD50 of ammonium formate was determined in mice at a dose of  2250 mg/kg bw after oral administration. No other signs of toxicity were reported.

Ammonium formate is registered as feed additive for animals and as food presevative. Similarly, sodium formate is also used as food preservative. According to GRAS notice 668, it was noted by SCOGS in 1976 that "Formic acid is a natural constituent of many foods  "is a metabolite in normal intermediary metabolism, and is a precursor in the biosynthesis of several body constituents. Formate is an intermediate in normal human metabolism and is normally present at low levels in the body. The tolerance of the body "to large amounts is relatively high " and "In men is reported 8 mg offormic acid/kg per day orally for a period offour weeks " (FDA Code of Federal Regulation, 1976 (SCOGS) 186.1756; FDA Code of Federal Regulation, 1976 (SCOGS) 186.1316; Jelleff Carr, 1976). Thus, it is assumed that classification into GHS Category 5 would overestimate the acute oral toxicity of formiates in general. Based on this information Ammonium formate is not classified accoding to the Globally Harmonized System for Classification and Labelling of Chemicals (GHS)and Regulation (EC) No 1272/2008 regarding acute oral toxicity.