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EC number: 289-214-5
CAS number: 86261-90-7
oralrat: LD50 > 5000 mg/kg bw; transient clinical signs (OECD 401; BASF AG 1986)rat: LD50 > 5000 mg/kg bw; reduced bw in females (GLP, OECD 401; Rohm & Haas 2002)rat: LD50 > 2000 mg/kg bw; no clinical signs (GLP, OECD 423; BSL 2000)inhalationno data availabledermalrat: LD50 > 5000 mg/kg bw (GLP, OECD 402; Rohm & Haas 2002) rabbit: LD > 5000 mg/kg bw (Rohm & Haas 1977, 1976)
There are reliable data available to assess
the acute oral and dermal toxicity of ureido methacrylate.
Results of a few studies indicate a very low
acute toxic potential of ureido methacrylate for rats after oral
application. In the most reliable studies performed according to OECD
test guideline 401, the LD50 values were > 5000 mg/kg bw after 14 days
of observation. No substance related mortality was observed in the study
performed by BASF AG (1986); clinical signs (dyspnoea, apathy, poor
general state, staggering and imbalance) were observed directly after
administration of the test substance (purity > 99%). In a GLP conform
limit test, no mortality was observed and reduced body weight gain in
female rats (-26%) was observed as sign of toxicity after administration
of the test substance (purity unknown; Rohm & Haas 2002).
In a study according to OECD guideline 423,
the test item ureido methacrylate was given in a dose of 2000 mg active
ingredient/kg body weight to two groups of 3 male and 3 female rats
(Wistar) in a single exposure via oral gavage. A careful clinical
examination was made once a day. At the end of the observation period
the animals were sacrificed and necropsy was carried out to record gross
pathological changes. A maximum dosage of 2000 mg/kg bw according to the
acute toxic class method regime, caused no compound related mortality
within 14 days post application.. No clinical signs of toxicity were
observed throughout the observation period. The LD50 was determined to
be > 2000 mg/kg BW.(BSL, 2000)
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. Inhalation exposure is regarded
negligible as the vapour pressure of the substance is very low. In
addition, inhalation is a unlikely route of human exposure for this
Ureido methacrylate showed a very low acute
toxic potential in rats and rabbits after dermal application in a few
studies performed by Rohm & Haas. In the most reliable study performed
according to GLP requirements and OECD test guideline 402, the acute
dermal toxicity of ureido methacylate (containing approximately 50%
active ingredient) was assessed in Crl: CD®BR rats. The test substance
was applied to the shaved intact skin of five male and five female rats
at 5000 mg/kg body weight. The application sites were occluded for 24
hrs. After the 24-hr exposure, the application sites were wiped with
paper towels saturated with tap water and blotted dry with paper towels.
There were no mortalities or body weight effects. Scant feces were
observed in 2 females on a single day during the observation period.
Signs of skin irritation including edema, erythema and desiccation were
observed beginning day 1 of the observation period and continuing
through day 11. Necropsy revealed no gross changes. The acute dermal
LD50 for ureido methacrylate was greater than 5000 mg/kg in male and
Comparable results were provided by two
rabbit studies with limited documentation (Rohm & Haas 1977, 1976). In
rabbits no local irritant effects were observed if the test substance
did not adhered to the skin; then well-defined erythema were identified
(edema could not properly estimated; Rohm & Haas 1977).
Ureido methacrylate showed a very low toxic
potential after single oral or dermal application. A classification is
therefore not warranted accoding to Directive 67/548/EEC (DSD) and Regulation
(EC) No 1272/2008 (GHS, CLP).
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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