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: 814-283-0
CAS number: 42220-47-3
According to an OECD 423 and GLP
compliant study the median lethal dose of the test item waterfree after
oral administration was found to be greater than 2000 mg/kg bw in rats.
According to an OECD 402 and GLP
compliant study the median lethal dose (LD50) of the test item,
waterfree after dermal application was found to be greater than 2000
mg/kg bw in male and female rats.
Acute oral toxicity
In an acute oral toxicity study
performed according to the Acute Toxic Class Method, 2000 mg/kg of the
test item, waterfree (preparations in 0.5% CMC-solution) were
administered by gavage to two test groups of three fasted Wistar rats
each (6 females). The following test substance-related clinical
observations were recorded, clinical signs occurred within 10 days after
2000 mg/kg (first test group):
- No mortality occurred
general state in all animals
- Dyspnoea in all animals
- Piloerection in all animals
- Diarrhea in all animals
- Exsiccosis in all animals
- Cowering position in all animals
- Reduced defecation in all animals
- Non defecation in two animals
- Fur contaminated with feces in one
- Reduced body weight in all animals
- Chromodacryorrhea in one animal
2000 mg/kg (second test group):
- Mortality in one animal
- Impaired general state in all animals
- Poor general state in one animal
- Diarrhea in all animal
- Cowering position in one animal
- Twitching in one animal
- Tremor in one animal
- Macroscopic pathological findings in
the animal that died:
Due to the advanced putrefaction no
macroscopic pathological findings could be determined.
The body weight of the animals in the
first 2000 mg/kg bw test group decreased within the first 2 or 3 days
after administration. Thereafter, the body weight slightly increased
until the end of the first observation week. In the second week, the
body weight increased within the normal range in these animals. The body
weight of the surviving animals in the second 2000 mg/kg bw test group
increased within the normal range throughout the study period. There
were no macroscopic pathological findings in the surviving animals
sacrificed at the end of the observation period (5 females).
The acute oral LD50 was calculated to
be LD50, oral, rat > 2000 mg/kg bw.
Acute dermal toxicity
In an acute dermal toxicity study
(Limit Test), young adult Wistar rats (5 males and 5 females) were
dermally exposed to a single dose of 2000 mg/kg bw of the test item,
waterfree (as suspension in 0.5 % CMC-solution). The clipped application
site (dorsal and dorso-lateral parts of the trunk, comprising at least
10% of the total body surface) was covered by semi-occlusive dressing
during the 24-hour exposure period. The animals were observed for 14
signs of systemic toxicity nor skin effects were observed
body weight of all animals increased within the normal range throughout
the study period.
macroscopic pathologic abnormalities were noted in the animals examined
at the end of the study (5 males and 5 females).
Accordingly, the acute dermal median
lethal dose (LD50) was determined to beLD50, dermal, rat > 2000 mg/kg bw
Labelling, and Packaging Regulation (EC) No 1272/2008
available experimental test data are reliable and suitable for
classification purposes under Regulation (EC) No 1272/2008. The LD50 was
greater than 2000 mg/kg bw for the oral and dermal route, respectively.
As a result the substance is not considered to be classified for acute
oral and dermal toxicity under Regulation (EC) No 1272/2008, as amended
for the tenth time in Regulation (EU) No 2017/776.
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.
Questo sito web si avvale di cookie affinché possiate usufruire della migliore esperienza sui nostri siti web.
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