Registration Dossier
Registration Dossier
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EC number: 464-520-3 | CAS number: 189813-45-4
Endpoint summary
Administrative data
Description of key information
The test substance does not require any classification
Key value for chemical safety assessment
Additional information
Oral route:
In the key study (BASF AG, 2009) performed according to OECD guideline 408 (Repeated Dose 90-Day Toxicity in Rodents) and GLP, the test substance was administered to groups of 10 male and 10 female Wistar rats at concentrations in the diet of 0 (vehicle control), 250 and 1250 ppm in animals of either sex as well as at concentrations of 5000 ppm in males and 2500 ppm in females over a period of 3 months. Signs of general systemic toxicity were observed only in male animals of the 5000 ppm group as indicated by a reduced body weight and body weight change as well as increased hemoglobin and hematocrit values. No other substance-related adverse findings were observed, neither in mid and low dose males nor in females throughout all concentrations tested. Therefore, the no observed adverse effect level (NOAEL) under the conditions of this study was 1250 ppm in male (about 77.6 mg/kg bw/day) and 2500 ppm in female (about 191.3 mg/kg bw/day) Wistar rats.
In supporting study (BASF AG, 2006) performed according to OECD guideline 407 (Repeated Dose 28-Day Toxicity in Rodents), the test substance was administered to groups of 5-10 male/female Wistar rats at concentrations in the diet of 0 (vehicle control), 1000, 3000 and 10000 ppm for 28 days, followed by recovery period of 14 days in the control and high dose groups. Signs of general systemic toxicity and liver injury were recorded in the mid and high dose group. Pancreas was identified as a target Organ. Moreover, body weight data and apoptotic cell death of acinar cells of the exocrine pancreas in both sexes persisted throughout the recovery period performed in top dose animals only. Therefore, the no observed adverse effect level (NOAEL) was found to be 1000 ppm in males (88.3 mg/kg bw/d) and females (91.5 mg/kg bw/d). Combining results of both subacute and subchronic studies, the test substance does not require any classification according to EU and GHS standards.
Dermal and inhalation route: no data
Justification for classification or non-classification
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