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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
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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