Filter cake from enzyme fermentation, consisting of fungal biomass and inorganic filtration aid

Endpoint summary

Description of key information

Oral: LD50 (rat) > 5000 mg/kg bw

Additional information

There are no data available for filter cake from enzyme fermentation, consisting of fungal biomass and inorganic filtration aid. However, data on acute toxicity are available for vinasses, residue of fermentation. Since all types of vinasses share a common origin and are therefore constituted of the same components determining their toxicological properties, read-across is performed (a detailed justification is attached in IUCLID section 13).

Oral

The acute toxicity of vinasses, residue of fermentation after oral administration to Wistar rats was investigated in a limit test according to OECD guideline 401 under GLP conditions (Daamen, 1992). A group of 10 Wistar rats (5 per sex) were given the undiluted test material by gavage at 5000 mg/kg bw (3.817 mL/kg bw) and observed for a period of 14 days post-administration. The dose level was selected based on the results of a pilot study with pairs of male and female animals given the test material at 1000, 2000 and 5000 mg/bw, in which no abnormalities had been noted during the 7-day observation period.

No mortalities occurred during the study period. Signs of ill health or behavioural changes included piloerection, observed in 3 males and 3 females approximately 2 h after dosing. The body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain. Macroscopic post-mortem examination of the surviving animals at termination did not reveal any abnormalities. Therefore, the oral LD50 for male and female rats was considered to be greater than 5000 mg/kg bw.

Three further reliable studies are available, in which the acute oral toxicity of vinasses, residue of fermentation was studied in rats administered the test material by gavage at 5000 mg/kg bw (Clouzeau, 1992; Lheritier, 1990; van Eeken and Aboulwafa-van Velthoven, 1983). Since no mortalities occurred in any of the three studies. the oral LD50 for male and female rats was determined to be greater than 5000 mg/kg bw. Moreover, no clinical signs and no abnormalities in body weight (gain) were observed during the 14-day observation period and macroscopic examinations at termination revealed no treatment-related changes (Clouzeau, 1992; Lheritier, 1990).

In an earlier study, the oral LD50 was reported to be greater than 40000 mg/kg bw in rats administered three different types of vinasses, residue of fermentation (van Eeken, 1974).

Justification for classification or non-classification

The available data on the acute toxicity of the substance are conclusive but not sufficient for classification according to the DSD (67/548/EEC) and CLP (1272/2008/EC) criteria.