Registration Dossier
Registration Dossier
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EC number: 227-290-3 | CAS number: 5766-67-6
Endpoint summary
Administrative data
Description of key information
See for data at section 7.8.1 toxicity to reproduction where an OECD 421 study has been summarized.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 250 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
Administration of EDTN for 6 weeks in females at 500 mg/kg bw and for 5 weeks in males at 750 mg/kg bw resulted in overt signs of parental toxicity in the high dose group as indicated by reduced food consumption, body weights, and body weight gains and one treatment-related death in the high dose group females. Based on these findings, the no-observed-adverse-effect level (NOAEL) for parental toxicity is 250 mg/kg.
Justification for classification or non-classification
Based on a NO(A)EL of 250 mg/kg bw in a 6 -week study (which would correspond to an approximate level of 125 mg/kg bw in a 13 -week study based on a calculated total dose) no classification is needed for STOT repeated exposure.
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