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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 939-579-8 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 43 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- GLP-compliant study with Klimish 1.
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
In a GLP 13 -week repeated dose oral toxicity study conducted according to the OECD Guideline 408, CHIMEXANE HB was administered in the diet to groups of Sprague-Dawley, Rj Han: SD, rats (10/sex/dose) at the target doses of 50, 150 and 450 mg active content/kg bw/day.
CHIMEXANE HB did not induced any deaths nor clinical signs. However, some signs of nephrotoxicity were observed at 150 (7/10 females and 1/10 males) and 450 (all animals) mg active content/kg bw/day.They consisted in urinalysis of lower urine pH, differences in urine turbidity and color, and of trace levels of bilirubin and proteins in urine. At necropsy, higher relative kidney weights were noted, associated with microscopic changes (vacuolar degeneration in the tubules of the inner cortex, inflammatory mononuclear cell infiltration and/or increased tubular basophilia).
Under these test conditions, the No Observed Adverse Effect Level (NOAEL) of CHIMEXANE HB was considered to be 43 and 47 mg active content/kg bw/day for males and females, respectively (target dose-level: 50 mg active content/kg bw/day).
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
The study with the longest duration (90-days) and the lowest NOAEL was chosen (key study).
Repeated dose toxicity: via oral route - systemic effects (target organ) urogenital: kidneys
Justification for classification or non-classification
As the submission substance (i.e., the active content of Chimexane HB) is associated with adverse nephotoxic effects at 150 mg/kg bw/day and that it cannot be ruled out that these effects still occur below 100 mg/kg bw/day, it is classified STOT-RE Category 2 according to the CLP Regulation (EC) N°1272/2008. However, as no nephrotoxicity was observed at doses <50 mg/kg bw/day, it is not classified according to the Annex VI to the Directive 67/548/EEC.
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.
