Registration Dossier
Registration Dossier
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EC number: 473-780-7 | CAS number: -
Endpoint summary
Administrative data
Description of key information
In a sub-chronic oral toxicity study with NX 8000J no adverse effects were noted. Therefore the NOAEL is set at 1682 mg/kg bw/day
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 1 682 mg/kg bw/day
Additional information
The oral administration of NX 8000J to rats by dietary admixture for a period of ninety consecutive days at a maximum dose level of 1682 mg/kg bw/day resulted in treatment-related histopathological changes at 20000 ppm. The changes however, were considered not to represent an adverse health effect and as such, the ‘No Observed Adverse Effect Level’ (NOAEL) was considered as 1682 mg/kg bw/day.
Dietary administration of the substance to rats for a period of fourteen consecutive days at dietary concentrations of up to 2544 mg/kg bw/day, produced no toxicologically significant changes in the parameters measured. The “No Observed Effect Level” (NOEL) was, therefore, considered to be 2544 mg/kg bw/day.
Justification for classification or non-classification
Based on the results of the oral repeated dose toxicity studies, NX 8000J does not need to be classified for repeated dose toxicity according to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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