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EC number: 212-133-3
CAS number: 764-99-8
Oral: The acute oral LD50 was determined to be > 2000 mg/kg bw in rats. Dermal: The acute dermal LD50 was determined to be > 2000 mg/kg bw in rabbits.Inhal.: The LD50 in the inhalation risk test was determined to be > 9 mg/l.
For the investigation of the acute oral toxicity of the test item, five males and five females Wistar rats received a single oral dose of the test material at a dose level of 2000 mg/kg bw (GLP guideline study; MB Research Laboratories, 2007). All ten animals survived the 2000 mg/kg oral dose. Instances of chromorhinorrhea, lethargy, ataxia, hunched posture, few feces, bloated abdomen, chromodacryorrhea, soiling of the anogenital area and/or emaciation ware noted in several rats during the study. The following abnormalities were noted in one or two rats at necropsy: slight or scattered red areas on the thymus, red areas on the intestines that ranged from slight or scattered to moderate or few; and/or slight or scattered soiling of the anogenital area. Bifurcated spleen was noted in two rats, although this abnormality should not be considered to be a result of treatment with the test article. Under the conditions of this study, the LD50 of the test item after oral application was found to be greater than 2000 mg/kg bw.
This value is confirmed by two supporting studies with less reliability showing LD50 values of 3.73 mL/kg bw (Smyth, 1962) and 2.57 mL/kg bw (Bingman, 2001).
For the determination of the acute dermal toxicity, the test material was applied undiluted at a dose level of 2000 mg/kg bw to the clipped epidermis (dorsal parts of the trunk) of five male and five female rats and covered by a occlusive dressing for 24 hours. Systemic signs of toxicity were not noted. Necropsy results were normal in 4/10 animals. Six animals were noted with scattered flaking of the treated skin area. No mortality occurred. Under the conditions of this study, the LD50 of the test item after dermal application was found to be greater than 2000 mg/kg bw.
This value is confirmed by a supporting study with less reliability showing an LD50 value of 14.1 mL/kg bw (Smyth, 1962).
In accordance with column 2 of REACH Annex VIII, the test acute toxicity after inhalation (required in section 8.5) does not need to be conducted as acute toxicity studies for oral and dermal application are available. In addition a supporting study with minor reliability shows, that the test substance is not acute toxic by inhalation as a saturated atmosphere generated at room temperature did not result in deaths of albino rats (Smyth, 1962).
Classification for acute toxicity is
not warranted according to the criteria of EU Directive 67/548/EEC and
EU Classification, Labelling and Packaging of Substances and Mixtures
(CLP) Regulation (EC) No 1272/2008.
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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