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EC number: -
CAS number: -
Oral (OECD 423), rat: LD50 cut-off value: unclassifiedDermal (OECD 402), rat: LD50: > 2000 mg/kg bw (limit test)
Acute toxicity: oral
The acute toxicity of the test substance was determined in a
recent GLP-Guideline study according to the acute toxic class method
(OECD 423) in which two groups of 3 female Wistar rats were exposed to
2000 mg/kg bw in a single oral application of 10 mL/kg bw via gavage
(Lütkenhaus, 2011a). According to OECD 423, morbidity and
mortality, clinical signs, alterations in body weight and cageside
observations were performed in addition to examination of the
respiratory, circulatory, autonomic and central nervous system. At the
end of the study, all animals were necropsied and examined
macroscopically. The test substance did not show any sign of acute
toxicity after a single application of 2000 mg/kg bw. In detail, no
alterations in clinical signs or on body weight gain were determined
until the end of the study period. Further, pathological examinations
did not reveal any specific gross pathological findings with the
exception of acute injection of blood vessels in the abdominal region
which is due to the euthanasia injection. Thus, a LD50 > 2000 mg/kg bw
was derived. Taken these data into consideration, the test substance is
not classified according to GHS.
Acute toxicity: dermal
Acute dermal toxicity was evaluated in a GLP-guideline study
according to OECD guideline 402 (Lütkenhaus, 2012). In detail, 2000
mg test substance/kg bw with a purity of 74.9% (main constituent: 54.3%)
were topically applied to the clipped dorsal area of the trunk of 5
Wistar Crl:WI (Han) rats per sex for 24 hours. Animals were observed for
clinical signs, mortality and skin reactions over a time period of 14
days. At the end of the observation period, no signs of acute toxicity
were observed. Body weight development of the test animals was within
the expected range. In contrast to males, all 5 females showed slight
dermal irritation on day 6 lasting for up to 48 hours visible as
erythema with a score of 1. 2 females revealed scratches on the skin
resulting in eschar formation in one female. Moreover, one female test
animal showed a slight nasal discharge on day 2 which was explained by
the administration procedure and the related stress induction.
Pathological examinations revealed dark spots in one female which are
not considered as treatment-related but incidental as the other test
animals did not show similar effects with the exception of acute
injection of blood vessels in the abdominal region due to euthanasia
injection. Thus, a LD50 > 2000 mg/kg bw was derived. Therefore, the test
substance is not considered to induce acute toxic effects after dermal
This information is not available.
In conclusion, the test substance does not meet the criteria for
classification according to GHS in regard to acute toxicity after oral
or dermal exposure.
The available data on oral and dermal 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.
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.
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