chloride, carbonate and bicarbonate salts of ammonium and sodium

Endpoint summary

Description of key information

Based on reliable data with ammonium chloride the acute oral toxicity in rats was determined to have an LD50 of 1410 mg/kg bw, ammonium chloride is the main constituent of the raection mass. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Dose descriptor:

LD50

Value:

1 410 mg/kg bw

Quality of whole database:

This value is specific to ammonium chloride

Additional information

Oral

In an acute oral toxicity study in rats with ammonium chloride according to a well described method, the LD50 was determined to be 1410 mg/kg bw. Number of dead males (out of 10) at doses 2150/1780/1470/1000/681 mg/kg bw: (after 1h) 8/7/4/0/0, (after 1d) 8/7/4/0/0, (after 2-14d) 8/7/4/0/0. Number of dead females (out of 10) at doses 2150/1789/1470/1000/681 mg/kg bw: (after 1h) 10/9/7/0/0, (after 1 d) 10/9/7/3/0, (after 2-14d) 10/9/7/3/0. Clinical Signs and Symptoms observed were at a doses of 1000 mg/kg or higher, Dyspnea, apathy, abnormal position and staggering were observed in 15min to 2hr. No significant differences in weight were observed. Necropsy Findings: (Heart) dilatation bilaterally; sporadically dilatation on the left side, (Stomach) atonic several times; liquid contents; malacia of the mucosa in the glandular stomach, (Intestines) atonic, diarrheal and mucous contents; malacia of the mucosa in several cases. In necropsy findings, no abnormalities were detected in surviving animals.

Ammonium chloride is the main constituent of the reaction mass.

Justification for classification or non-classification

The registered substance has not been tested for the acute oral toxicity and, as a result, it is proposed to provide an assessment based on data read-acrossed from its main constituents.

 

The registered substance is an inorganic reaction mass consisting of water as well as chloride, carbonate and bicarbonate salts of ammonium and sodium. Those salts are well-known substances and relevant peer-reviewed published data are available to characterize their ecotoxicological/environmental fate/toxicological properties.

 

Six studies pertaining to acute oral toxicity endpoint are available for ammonium chloride. Based on the key study, this substance is classified Acute Tox. cat. 4, H302 (harmful if swallonwed). According to the available peer-reviewed published data, sodium chloride, diammonium carbonate, and sodium hydrogencarbonate are not classified for this endpoint. Ammonium hydrogencarbonate is also classified Acute Tox Cat. 4, H302 (harmful if swallowed) with the lower LD50 =1470 mg/kg b.w/day. However, the percentage of ammonium hydrogencarbonate present in the reaction mass is only 3.4%, this is not sufficient to have an impact on the classification of the reaction mass. As a result, it can be concluded that the reaction mass is not classified for acute oral toxicity.