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EC number: 289-214-5
CAS number: 86261-90-7
Combined repeated dose study in rats (OECD TG 422), gavage: NOEL parental toxicity: 100 mg/kg bw/day in males and 300 mg/kg bw/day in females (due to increased organ weights); NOAEL neurotoxicity >= 1000 mg/kg bw/day (no effects observed; GLP, Rohm & Haas 2002)
The neurotoxicity of ureido methacrylate was
assessed regarding results of a FOB and motor activity evaluation during
a subacute oral study in rats.
The neurotoxic potential of the test
substance, ureido methacrylate (purity unknown), was evaluated in a GLP
conform combined repeated dose study in rats following OECD test
guideline 407 including a functional observation battery and a motor
activity evaluation (Rohm & Haas 2002). The test substance was
administered orally by gavage to four groups of 12 male and 12 female
Crl:CD BR rats once daily for eight weeks. Dose levels were 0, 100, 300,
and 1000 mg a.i./kg/day, administered at a dosage volume of 5 ml/kg. The
control group received the vehicle, double-distilled water, on a
comparable regimen at a dosage volume of 5 ml/kg. Males and females of
the same treatment group were mated 1:1 two weeks after the beginning of
During the treatment period, each rat was
observed twice daily for morbidity or mortality. General clinical
observations were made at least once daily. Body weight was determined
at least weekly throughout this study. Functional Observational Battery
(FOB) and motor activity evaluations were performed on week 5 (males)
and week 7 (females). After eight weeks, overnight
fasted animals were euthanized and necropsied. Hematology and clinical
chemistry measurements were performed on all animals at terminal
necropsy. Animals were fasted overnight and blood samples were collected
just prior to terminal necropsy. Microscopic examinations of the studied
organs were performed for 5 (randomly selected) parental animals/sex in
the high dose group and control group. All tissues exhibiting gross
pathological changes were examined microscopically.
Treatment-related decreases in hemoglobin
(6%), hematocrit (7%), and mean cell volume (4%) were noted in males at
1000 mg a.i./kg bw/day. In addition, platelet counts were increased
(14%) at this level. Treatment-related increases in absolute and
relative kidney weights (10-11%) and in absolute and relative liver
weights (20%) were noted in both sexes at 1000 mg a.i./kg. Absolute and
relative liver weights were also increased (12-16%) in males at 300 mg
a.i./kg. Other effects were considered as incidental and not
treatment-related. Microscopic examinations in the relevant organs
revealed no complementary effects seen in liver and kidney weights,
these observations are considered as not adverse.
No treatment related effects were observed
in both the functional Observational Battery (FOB) and motor activity
Based on the results of this study, the NOEL
(no-observed-effect level) for systemic toxicity of ureido methacrylate
administered orally is 100 mg a.i./ kg bw/day in males and 300 mg a.i./
kg bw/day in females. The NOAEL for neurotoxicity is assessed to be >=
1000 mg a.i. /kg bw/ day.
There is no indication given for a relevant
neurotoxic potential of ureido methacrylate and in conlusion the
substance has not to be classified according to 67/548/EEC and
Regulation (EC) No 1272/2008 (GHS, CLP), respectively.
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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