Ammonium propionate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Ammonium propionate

EC Number:

241-503-7

EC Name:

Ammonium propionate

Cas Number:

17496-08-1

Molecular formula:

C3H6O2.H3N

IUPAC Name:

ammonium propionate

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Doses:

STARTING DOSE: 2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

MORTALITY AND CLINICAL SIGNS
On the day of dosing, all animals were observed for signs of toxicity and death, periodically during the first 24 hours with special attention given during the first 4 hours (i.e. at 10 minutes, 30 minutes, 1 hour, 2 and 4 hours following dosing) and thereafter they were observed once a day for 14 days.
The appearance, progress and disappearance of these signs were recorded
BODY WEIGHTS
The body weights of rats were individually recorded at one day prior to dosing (day 0), on the day of dosing (day 1, for fasting body weight), on day 7 and at termination on day 15. Weight changes and group mean values were computed over day 0 body weights.
NECROPSY AND HISTOPATHOLOGY
At end of the study all animals were weighed and humanely sacrificed by carbon dioxide asphyxiation. All animals in the study including those found dead during study, were subjected to a complete necropsy and the gross pathological changes were recorded. Histopathological evaluations were not conducted in absence of any remarkable gross pathology.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 5 000 mg/kg bw

Based on:

test mat.

Mortality:

When tested on three female rats at the dose level of 2000 mg/kg body weight, Ammonium propionate (CAS: 17496-08-1; EC: 241-503-7) in aqueous solution (50-55%) did not induce any abnormal clinical signs in the treated rats during the 14 days observation period following application

Gross pathology:

No gross pathological alterations were encountered in any of the female rats when sacrificed at termination of the study.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

In this study, single oral administration of undiluted Ammonium propionate (CAS: 17496-08-1; EC: 241-503-7) in aqueous solution (50-55%) was made to groups of three female rats in step-wise manner to assess its acute toxicity.
Following the starting dose of 2000 mg/kg body weight, which was also repeated in the second step of the test, Ammonium propionate (CAS: 17496-08-1; EC: 241-503-7) in aqueous solution (50-55%) did not induce any abnormal clinical signs in the treated rats during the 14 days observation period following application. Body weight change by treated rats was not adversely affected during the 14 day observation period post dosing. As evident at terminal necropsy Ammonium propionate (CAS: 17496-08-1; EC: 241-503-7) in aqueous solution (50-55%) did not induce any gross pathological alterations in their organs / tissues.
Based on these results, and according to the criteria for classification (described under section 3.5 of this report) viz. Globally Harmonised System (GHS) for classification of chemicals which cause acute toxicity, OECD series on testing and assessment, Number 33, and the European Commission’s Dangerous Substances Directive (Directive 2001/59/EC) and also the Classification, Labelling and Packaging of Substances Regulation (Regulation 1272/2008/EC), the test item, Ammonium propionate (CAS: 17496-08-1; EC: 241-503-7) in aqueous solution (50-55%), is classified in GHS Category 5 or unclassified for the obligatory labelling requirement for oral toxicity. This category corresponds to an LD50 cut of value being 5000 mg/kg body weight.