Registration Dossier
Registration Dossier
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EC number: 202-996-4 | CAS number: 102-01-2
Endpoint summary
Administrative data
Description of key information
28-day oral toxicity (NONKEY_407_1991_Lonza_LZA 46/901159): symptoms of haematotoxicity
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 12 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
Acetoacetanilide when administered for 28 days to rats of both sexes at doses of 0 (control), 12 , 100 and 850 mg/kg bw. caused typical symptoms of haematotoxicity including changes of haematological parameters and morphological effects in liver, spleen and kidneys. The most prominent histopathological finding relevant for classification was hemosiderin deposition in the kidneys of male rats in the mid dose group. Continuing hemosiderin deposition in the kidney tubules will lead to tubular degeneration and finally to reduced renal function or even failure.
Repeated dose toxicity: via oral route - systemic effects (target organ) cardiovascular / hematological: other
Justification for classification or non-classification
As kidneys were already affected at a dose of 100 mg/kg bw in a 28 day study classification with STOT (re) Cat 2, H373 and R48/R22 is derived from the results of this study.
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