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: 204-101-2
CAS number: 115-70-8
Oral (OECD 423), rat: LD50 = 5000 mg/kg bw (cut-off value, limit test)Dermal, rat: LD50 > 2000 mg/kg bw
Acute toxicity: oral
In the study performed by Nishimura (2004) according to OECD 423 (limit
test), 3 females per group were administered 300 mg/kg bw
2-amino-2-ethyl-1,3-propanediol (AEPD) by gavage, in two consecutive
steps. As no mortality was observed at the 300 mg/kg bw dose level, 2
groups of 3 animals were administered 2000 mg/kg bw, in two consecutive
steps. Again, there was no mortality. No clinical signs and no effects
on body weight were observed during the 14-day observation period in any
of the animals. According to the acute toxic class method described in
the OECD guideline 423, if there is no mortality following
administration of 2000 mg/kg bw in two separate steps, the LD50 cut-off
limit is 5000 mg/kg bw. Therefore, the LD50 is considered to be 5000
mg/kg bw for female rats. In a study performed according to the 1979
version of 16 CFR 1500.3 (Parekh, 1982), male and female rats were
administered 1800, 2500, 3500 and 5000 mg/kg bw of the test substance
per oral. The mortality was 0, 1, 5 and 5 for the males and 0, 1, 2, and
9 for the females, respectively, listed by increasing dose. In the rats
that died, severe stomach- and intestinal haemorrhage was noted,
indicating a local irritating effect of the test substance due to the
alkaline pH value. The calculated LD50 for females was 3882 mg/kg bw and
for males the LD50 was 4571 mg/kg bw. A relatively old study
(Rubenkoenig, 1955) was also available, in which mice were administered
1000, 1500, 2000, 3000, 3600 and 4250 mg/kg bw AEPD, using 10 animals
per dose level. The mortality was 0, 1, 3, 7, 10 and 10, respectively,
by increasing dose. The estimated LD50 (oral) was 2470 mg/kg bw for the
Acute toxicity: dermal
A non-standard acute dermal toxicity study was performed in rabbits
(Parekh, 1982). The animals' abdomens were shaved free of hair, and the
test area was abraded. 2000 mg/kg bw AEPD was spread over the prepared
abdominal skin area, which was then covered with an occlusive dressing.
After 24 hours, the skin area was cleaned and the animals were observed
for 14 days following administration. No mortality was observed. There
were no signs of toxicity, no effects on body weight and no unusual
gross histopathological findings were noted. The exposed skin areas were
necrotic and oedemateous within 24 hours of the administration. The LD50
is considered to be > 2000 mg/kg bw.
Acute toxicity: other routes
The acute effects of an intraperitoneal dose of AEPD on mice was
assessed in a study performed by Rubenkoenig (1955). In the groups
administered 250, 500, 750, 1000, 1250 and 1750 mg/kg bw (10 per dose),
the mortality was 0, 1, 4, 8, 9 and 10, respectively. The calculated
intraperitoneal LD50 was 790 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 AEPD has a very low potential to cause acute
toxicity via these routes.
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
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