Registration Dossier
Registration Dossier
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EC number: 238-034-5 | CAS number: 14177-55-0
Endpoint summary
Administrative data
Description of key information
oral: LD50 (rat, female) > 300 - < 2000 mg/kg bw
Key value for chemical safety assessment
Additional information
Oral:
In a GLP-guideline study according to OECD guideline 423 and EU-Method B.1 tris (acute toxic class method) Molybdenum nickel tetraoxide was administered by gavage to a group of 6 female Sprague Dawley rats at the single dose of 2000 mg/kg bw (3 animals in a first and 3 animals in second step) and to a group of 6 female rats at the single dose of 300 mg/kg body weight (3 animals each in a third and fourth step) (Colas, 2010).
5 rats treated with 2000 mg/kg bw died within day 2 and day 4 post-exposure. Deaths were preceded by an absence or a decrease in spontaneous activity (5/5), in body temperature (1/5), in muscle tone (3/5), in Preyer’s reflex (1/5) and in righting reflex (1/5), dyspnea (1/5) and piloerection (4/5), which appeared only at 48 hours post-dose. Body weight was also decreased in the 5 animals on day 2 (4 -10% compared to control). Macroscopic examinations of the dead animals revealed a swelling of the stomach (5/5), a thickening of the corpus associated with white spots (2/5) or with a dark coloration (2/5), a thinning of the forestomach (5/5) and signs linked to rigor mortis.
The surviving animal dosed at 2000 mg/kg bw presented with decrease in spontaneous activity and in muscle tone and piloerection, which appeared only at 48 hours post-dose. The animal recovered a normal behaviour on day 5. A slight decrease in body weight (-4% compared to control) was noted on day 2; recovery was attained on day 7. The macroscopical examination of the animal did not reveal treatment related changes at the end of the study.
No mortality was observed in the 300 mg/kg bw dose group. In addition, no clinical signs were noted, body weight evolution remained normal throughout the study and no macroscopical changes were observed at the end of the study.
Thus, the LD50 of the test item Molybdenum nickel tetraoxide is higher than 300 mg/kg bw but lower than 2000 mg/kg bw by oral route in the rat. In accordance with the OECD guideline 423, the LD50 cut-off of the test item may be considered as 500 mg/kg bw by oral route in rats.
Justification for classification or non-classification
Based on the data on acute oral toxicity, Molybdenum nickel tetraoxide is classified as R22 "Harmful if swallowed" and as Acute Tox. 4 "Harmful if swallowed" according to the criteria of Directives 67/548/EEC (DSD) and 1272/2008/EC (CLP).
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