Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 228-055-8 | CAS number: 6104-30-9
Table 1: Absolute organ weights
Test group (mg/kg bw/d)
Table 2: Relative organ weights
Table 3: Histopathology
No. of animals
- Grade 1
- Grade 2
Tubules, basophilic, multifocal
- Grade 3
N,N'-(isobutylidene)diurea was administered by gavage to groups of 10 male and 10 female Wistar rats at dose levels of 0 (test group 0), 100 (test group 1), 300 (test group 2) and
1000 mg/kg bw/d (test group 3) over a period of 3 months.
With regard to clinical examinations, no signs of general systemic toxicity were observed even at a dose level of 1000 mg/kg bw/d. In addition, no test substance-related effects on
estrous cycle length and the number of cycles were obtained.
Concerning clinical pathology, no treatment-related, adverse effects were observed up to a dose of the compound of 1000 mg/kg bw/d.
Regarding pathology, treatment-related findings were observed in the kidneys of male animals consisting of increased protein storage in tubules (eosinophilic droplets, positive CAB staining), an increasing incidence of basophilic tubules of minimal severity with dose, and in test group 3, tubular casts. In a previous study with this test item, the tubular protein was identified as alpha 2 urinary protein (BASF study No 99P0113/00132).
Findings were regarded as treatment-related and adverse in test group 3. Findings in test groups 1 and 2 were regarded as treatment-related but in absence of degenerative findings (tubular casts) as non-adverse.
Although the increase of eosinophilic droplets was considered treatment-related and adverse in test group 3 due to tubular damage, this finding does not represent a risk for humans since they do not synthesize this protein (Durham and Swenberg, 2013).
All other findings occurred either individually or were biologically equally distributed over control and treatment groups. They were considered to be incidental or spontaneous in origin and without any relation to treatment.
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.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Close Do not show this message again