Registration Dossier
Registration Dossier
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EC number: 469-110-8 | CAS number: -
Endpoint summary
Administrative data
Description of key information
In a 28-day oral repeated dose toxicity study in rats, AD-1000 did not show any toxicologically relevant effects up to the highest dose, 1000 mg/kg bw/day, tested.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
In a 28 -day oral repeated dose toxicity study performed according to OECD 407, EC B.7 and EPA test guidelines, rats (5/sexe/dose) were exposed to 0, 50, 150 and 1000 mg/kg bw/day by oral gavage. All parameters evaluated, clinical signs, functional observation tests, body weight and food consumption, clinical pathology and macroscopy at termination, organ weight and histopathology on a selection of tissues, did not show any toxicologically relevant effect. Accuracy, homogeneity and stability over 5 hours of formulations of the substance were demonstrated by analyses. Therefore, the NOAEL is considered to be >= 1000 mg/kg bw/day.
Justification for classification or non-classification
Based on the available study, AD-1000 does not need to be classified for repeated dose toxicity according to Directive 67/548/EEC and the CLP Regulation 1272/2008.
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