Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 214-684-5
CAS number: 1185-53-1
Oral: OECD 425, rat: LD50 > 5000
mg/kg bw (result based on read across to source substance trometamol,
CAS 77-86-1, EC 201-064-4)
Dermal: OECD 402, rat: LD50 > 5000 mg/kg bw (result based on read across
to source substance trometamol, CAS 77-86-1, EC 201-064-4)
Inhalation: no data available
Mortality and clinical signs during the study period
Duration of clinical signs
Time of death
LD50 > 5000 mg/kg bw
number = number of dead animals
number = number of animals with clinical signs
number = number of animals used
There are no data available on
acute toxicity of the target substance
2-amino-2-(hydroxymethyl)propane-1,3-diol hydrochloride (TRIS HCl).
However, there are reliable data available from the source substance
Trometamol, considered suitable for read-across using the analogue
approach. A detailled justification for the applied analogue approach
can be found in Iuclid section 13.
acute oral toxicity of the chemical analogue, 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 (reference 7.2.1 -1). 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.
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.
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 (reference 7.2.3 -1). 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.
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 Trometamol has a very low potential to cause
acute toxicity via these routes.
available data on acute toxicity do not meet the criteria for
classification according to Regulation (EC) 1272/2008, and are therefore
conclusive but not sufficient for classification.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again