Registration Dossier
Registration Dossier
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EC number: 430-750-8 | CAS number: -
Endpoint summary
Administrative data
Description of key information
The test substance Urea 4 was tested for repeated oral toxicity in a 28-day study in rats, according to OECD Guideline 407. Based on the results of this study, a NOAEL of 1000 mg/kg bw/day was determined. The tests for repeated dose toxicity by the inhalation and the dermal routes were waived according to REACH Regulation No. 1907/2006, Annex VIII, 8.6.1.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- GLP and guideline conform study.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated dose toxicity: oral
The test substance Urea 4 was tested in a repeated dose 28 -day oral toxicity study in rats according to EU method B.7 and OECD Guideline 407. The test item was administered in doses of 150, 500 and 1000 mg/kg bw once a day, for a period of 28 days, to three groups of 5 male and 5 female Wistar rats by oral gavage. A control group of 5 male and 5 female rats was dosed with the vehicle, (CMC) 1% in aqua bidest.
Clinical and behaviour/ functional observations were carried daily and examination of body weight was performed throughout the study. Blood and urine samples, collected during necropsy, were used to perform a detailed haematology analysis and urinalysis. A detailed gross necropsy was performed as well as histopathological and organ weight examination. In comparison to the untreated control group, several borderline deviations were observed for few parameters examined in the treated groups. However, a clear dose dependency or toxicological compound related relevance could not be established. All rats treated with the test item Urea 4 survived the testing period without showing compound related toxic effects. Thus the NOAEL value determined was >= 1000 mg/kg bw/day.
Repeated dose toxicity: inhalation and dermal
The tests for repeated dose toxicity by the dermal and the inhalation routes were waived as a repeated dose oral toxicity study was performed. According to the REACH Regulation No. 1907/2006, Annex VIII, 8.6.1 only one repeated dose toxicity study is required, with test item administration via the most appropriate route.
Justification for selection of
repeated dose toxicity via oral route - systemic effects endpoint:
Only one reliable study available.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on repeated dose toxicity, the test item is not classified according to Regulation (EC) No 1272/2008 (CLP), as amended for the eighteenth time in Regulation (EU) 2022/692.
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.
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