Registration Dossier
Registration Dossier
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EC number: 406-176-9 | CAS number: 79072-96-1 NC-4
Endpoint summary
Administrative data
Description of key information
NOEL 90 days, mice = 7280 mg/kg bw/day (males), 10710 mg/kg bw/day (females).
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 7 280 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- mouse
Additional information
A 13 -week repeat dose toxicity study (Gotemba Laboratory, Bozo Research Center, 1981) was conducted to determine the effect of repeated dietary administration of NC-4 to mice (Crj:CD-1 (ICR)). The study methodology was essentially equivalent to the modern OECD Test Guideline 408. Test groups of 20 male and 20 female mice were administered test material in diet at the following concentrations; 0 (untreated diet control group), 5000, 15000, and 50000 ppm.
No mice died during the study, and there were no treatment-related changes observed in body weight, food consumption, clinical signs, haematology, clinical chemistry and urinalysis, gross pathology, organ weights, or histopathology. On this basis, it was concluded that the NOEL for NC-4 following 90 -day (13 -week) administration to mice was 50000 ppm, which was equivalent to 7280 mg/kg bw/day in males and 10710 mg/kg bw/day in females.
Justification for classification or non-classification
In the repeat oral toxicity study noted above, no deaths were seen following 90 -day administration of NC-4, and no toxic signs in any examined organs were noted. This result is considered to have conclusively demonstrated that classification for STOT (repeat dose) is not required for NC-4 by the oral route.
No information is available for repeated dose administration by either dermal or inhaled routes, and so it is not possible to reach a definitive conclusion regarding STOT (repeat dose) overall (all routes of exposure).
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