Registration Dossier

Administrative data

Description of key information

With the test material CC-5-V one oral acute toxicity study was conducted. The results show no mortality, no body weight change and no other signs of toxicity. No further acute toxicity studies for inhalative or dermal administration are available.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
2 000 mg/kg bw

Additional information

In an acute oral toxicity study (key - CC-5 -V - T14191), one group of fasted, young adult Wistar rats (5/sex) were given a single oral dose of CC-5 -V prepared with liquid paraffin solution (100 g/L) as vehicle at a dose of 2000 mg/kg bw and observed for 14 days. The following results were obtained:

Oral LD50:

Males > 2000 mg/kg bw

Females > 2000 mg/kg bw

Combined > 2000 mg/kg bw

No mortality occurred in this limit test.

CC-5 -V is of low toxicity based on the LD50 in male and female rats.

Besides wet anal region observed on day one after treatment, there were no treatment related clinical signs, necropsy findings or changes in body weight.

Justification for classification or non-classification

Based on the results for acute oral and dermal toxicity in rats, CC-5 -V is considered to have no acute toxic potential. The expected LC50 values are higher than 2000 mg/kg bw after oral administration to rats.Therefore, CC-5 -V is not classified according to EU Directive 67/548/EC amended and repealed by EU Regulation No.1272/2008 and CLP.