vinasses, residue of fermentation, depotassified

Endpoint summary

Description of key information

Oral: LD50 (rat) > 5000 mg/kg bw
Dermal: LD50 (rat) > 2000 mg/kg bw

Additional information

Vinasses, residue of fermentation and Vinasses, residue of fermentation, depotassified are by-products obtained after fermentation of molasses, or sugar, or other feedstock, using different microbial strains, in the production of alcohol, yeast and other organic substances. Boths are complex UVCB substances, composed of a mix of inorganic salts and organic molecules of different type, even macromolecular to some extent. For such a complex UVCB substance as Vinasses, residue of fermentation and Vinasses, residue of fermentation, depotassified, it is not possible to state a composition based on reference substances listed in the EC inventory. Then, macrocompositions of the two substances, based on dry matter content, has been established showing that boths substances have the same types of components with similar ranges. Therefore, an analogy can be done on toxicological properties between Vinasses, residue of fermentation and Vinasses, residue of fermentation, depotassified.

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.

Thwo 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). Since no mortalities occurred in any of the two 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).

Inhalation

This information is not available.

 

Dermal

The acute dermal toxicity of Vinasses, residue of fermentation was tested in accordance with OECD guideline 402 and in compliance with GLP (van Otterdijk, 2010a). The study was performed as a limit test in two groups of Wistar rats (5 males and 5 females) at a dose of 2000 mg/kg bw (1.05 mL/kg bw). The test substance was applied unchanged on the shaved skin of the test animals for 24 h under occlusive conditions. The test animals were observed for 14 days after application, and sacrificed thereafter for gross pathological examinations. No mortalities occurred. Slight clinical signs were observed in 9/10 animals on days 1 and/or 2 and included lethargy, hunched posture, shallow respiration, piloerection, ptosis and/or chromodacryorrhoea. No abnormal changes in body weight (gain) were observed. No abnormalities were found at macroscopic post mortem examination of the animals. According to the results of this study, the dermal LD50 value for male and female rats was greater than 2000 mg/kg bw.

Justification for classification or non-classification

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

Therefore, using the principle of read-across, Vinasses, residue of fermentation, depotassified is not classified according to DSD (67/548/EEC) and CLP (1272/2008/EC) criteria.