Registration Dossier

Administrative data

Description of key information

Oral (TSCA, 40 CFR, 798.1175), rat: LD50 = 5000 mg/kg bw 
Dermal (TSCA, 40 CFR, 798.1100) , rat: LD50 > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Additional information

Acute toxicity: oral

In an acute oral toxicity limit test (Lister, 1995a), performed according to 40 CFR, Part 798, Subpart A, General Toxicity Testing, Acute Oral Toxicity, 798.1175, Toxic Substances Control Act, July 1989, 10 rats were administered 5000 mg/kg bw 2 -amino-1,3 -propanediol (APD) by gavage. 4/10 animals died, while piloerection and lethargy was observed in 10/10 animals. Gross pathology examination indicated that all the animals that died had discoloration in the liver, spleen, kidneys and small intestine, and hemorrhaging in the stomach. The local effects in the stomach were probably caused by the alkaline pH of the test substance. The LD50 is considered to be = 5000 mg/kg bw.

Acute toxicity: dermal

An acute dermal toxicity limit test (Lister, 1995b) was performed with 2 -amino-1,3 -propanediol (APD) according to 40 CFR, Part 798, Subpart B Section 798.1100, Toxic Substances Control Act, 1985. Rabbits were exposed to 2000 mg/kg bw APD under semiocclusive conditions for 24 hours. There was no mortality. Nine of ten animals showed slight to defined erythema at the test site after 24 hours, while 1 rabbit had edema at the 24 -hour reading time point. The LD50 is therefore considered to be > 2000 mg/kg bw.

The test substance-related findings were comparable for oral and dermal routes of application in the acute toxicity studies, with the high LD50-values indicating that APD has a very low potential to cause acute toxicity via these routes.

Justification for classification or non-classification

The available data on acute toxicity of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.