Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 423-370-9 | CAS number: 10097-09-3
Endpoint summary
Administrative data
Description of key information
Guideline study shows that MDI-Urone is of very low toxicity
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- unknown
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 5000 mg MDI-Urone
- Amount of vehicle (if gavage): 10 ml/kg body weight
- Justification for choice of vehicle:The vehicle was chosen due to its non-toxic characteristics. - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 3 males and 3 females
- Control animals:
- no
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- As none of the animals died the LD0 is >5000 mg/kg body weight.
- Clinical signs:
- other: Signs of toxicity related to dose levels: Lethargy, ataxia, cool body, congestion, lacrimation, dried red material around snout, anorexia, emaciation, decreased defecation and scruffy coat
- Gross pathology:
- Effects on organs:
No treatment-related changes. - Other findings:
- no other findings
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of MDI-Urone was established to be > 5000 mg/kg body weight. As none of the animals died the corresponding LD0 is > 5000 mg/kg bw. Thus, MDI-Urone is practically nontoxic.
- Executive summary:
In an acute oral toxicity study according to OECD 423, groups of 3 male and 3 female rats were given a single oral dose of 5000 mg/kg body weight MDI-Urone and were observed for 14 days.
Considering the reported data of this toxicity test it can be stated that the test item MDI-Urone has no acute toxic characteristics.
According to the results obtained the LD50 was determined to be > 5000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Additional information
Justification for classification or non-classification
Guideline study shows that MDI-Urone is of very low toxicity
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.
