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EC number: 201-064-4 | CAS number: 77-86-1
Oral (OECD 425), rat: LD50 > 5000 mg/kg bwDermal (OECD 402), rat: LD50 > 5000 mg/kg bw
Table 1: Mortality and clinical signs during the study period
Duration of clinical signs
Time of death
LD50 > 5000 mg/kg bw
* first number = number of dead animals
second number = number of animals with clinical signs
third number = number of animals used
The acute oral toxicity of 2 -amino-2 -(hydroxymethyl)-1,3 -propanediol (trometamol) was assessed in a study performed according to the up-and-down procedure (OECD 425) in rats administered 5000 mg/kg bw (Mohan Kumar, 2011). Single animals were administered the limit dose stepwise, up to a total of 3 rats. There was no mortality, no clinical signs were observed during the 14-day observation period and no effects on the body weight were noted. There were no substance-related findings of the histopathological examination. The LD50 is considered to be > 5000 mg/kg bw.
In addition, several pre-guideline studies with rats (Giroux and Beaulaton, 1961), mice (Giroux and Beaulaton, 1961 and Rubenkoenig, 1955) and rabbits (Machle, 1940) are available confirming the low systemic acute oral toxicity of trometamol.
Acute toxicity: dermal
In a study performed according to OECD 402, 5000 mg/kg bw trometamol was applied to the shaved skin of rats and held under a semi-occlusive dressing for 24 hours (mohan Kumar, 2011). There was no mortality, and no signs of toxicity or effects on body weight were observed during the study period. No substance-related findings were noted during the gross pathological examination and the test substance did not cause skin irritation effects on the application site. The LD50 is considered to be > 5000 mg/kg bw.
Acute toxicity: other routes
A number of studies were performed to determine the acute LD50 in several species and via several routes.
The LD50 (intravenous) of trometamol for rats varied from > 500 to 2300 and 3500-3600 mg/kg bw, (Darby and Anderson, 1966; Giroux and Beaulaton, 1961; Thompson, 1965). Severe dose-related damage to the kidneys was observed at the highest value (Giroux and Beaulaton, 1961). In mice, the LD50 (i.v.) ranged from 1044 – 1980 mg/kg bw, decreasinh inversely with the pH (Darby and Anderson, 1966; Giroux and Beaulaton, 1961;Thompson, 1965) The LD50 (i.v.) for rabbits was reported to be > 500 mg/kg bw; while for dogs the LD50 > 125 mg/kg bw, following a single dose (Giroux and Beaulaton, 1961), and approximately 500 mg/kg bw with a slow perfusion (Darby and Anderson, 1966). Lower blood glucose levels were observed following i.v. perfusions of non-lethal doses of trometamol in dogs and in humans; the latter also reporting transient discomfort. Temporary changes in respiration rate and depth were the only effects observed in dogs perfused with up to 10 mg/kg bw (Giroux and Beaulaton, 1961). The LD50 (intraperitoneal) values of trometamol reported for mice were 790 and 3350 mg/kg bw, respectively (Giroux and Beaulaton, 1961; Rubenkoenig, 1955). For dogs, the LD50 (i.p.) was > 2160 mg/kg bw (Darby and Anderson, 1966). Subcutaneous injections of 1000 mg/kg bw trometamol in rats and did not cause mortality (Giroux and Beaulaton, 1961).
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.
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