Registration Dossier
Registration Dossier
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EC number: 234-282-3 | CAS number: 11065-74-0
Endpoint summary
Administrative data
Description of key information
In an extended oral OECD 422 study male animals were exposed for at least 13 weeks and females for almost 14 weeks. At the high dose level the following effects were observed: soft faeces (both sexes), decreased body weight gain (males), prolonged prothrombin time (males), increased haemoglobin concentration (males), decreased ALAT activity and chloride concentration (males) and decreased ALP activity and increased relative weights of kidneys and liver (both sexes). No toxicologically relevant changes were observed at the lower levels of 500 and 150 mg/kg bw.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 500 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- The results of this study are in compliance with the results obtained in studies with other chelates and metal chelates (see read across document in section 13).
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
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Well performed and reported GLP study
Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: liver; urogenital: kidneys
Justification for classification or non-classification
Based on a NOAEL of 500 mg/kg bw in a study in which male rats were treated for at least 13 weeks and females for almost 14 weeks, no classification is needed for STOT repeated exposure.
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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