vinasses, residue of fermentation, depotassified

Endpoint summary

Description of key information

The substance is not considered as a skin or eye irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Vinasses, residue of fermentation (Vinasses) 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 and Vinasses, residue of fermentation, depotassified.

Skin irritation

Vinasses, residue of fermentation were tested for acute dermal irritation/corrosion in two studies according to OECD guideline 404 and complying with GLP (Beerens-Heijnen, 2005; Pels Rijcken, 1992). In each study, 3 albino rabbits were exposed to 0.5 mL of the undiluted test material, applied onto the clipped or shaved skin for 4 h using a semi-occlusive dressing. The treated skin was observed for reactions after patch removal and evaluations were made at 1, 24, 48 and 72 h post-application.

In one study, very slight erythema was observed at the treated skin areas of all 3 animals at 1 h post-application. This effect was fully reversible within 24 hours post-application in all animals. No oedema was observed (Beerens-Heijnen, 2005).

In the second study, the observed skin reaction consisted of very slight oedema in 2 animals and very slight erythema in all 3 animals at 1 h post-application. These effects were fully reversible within 24 h post-application in 2 animals and within 48 h in the third animal (Pels Rijcken, 1992).

There was no evidence of an irritating/corrosive effect of the test materials on the skin and no other signs of intoxication were seen. The mean erythema and edema scores over 24, 48 and 72 h were equal to 0 for all 3 animals in both studies.

 

Eye irritation

Vinasses, residue of fermentation were tested for eye irritation/corrosion in albino rabbits in a study performed according to the OECD guideline 405 and complying with GLP (van Otterdijk, 2010). The test material (0.1 mL) was applied into the conjunctival sac of one eye, the other eye serving as control. The eyes were examined and scored 1, 24, 48 and 72 h after application. Initially, one animal was tested only, in which no corrosive effects were observed. The negative response was confirmed using two additional animals. Irritation of the conjunctivae, which consisted of redness, chemosis and discharge, was observed at 1 h post-application. The latter two findings were only present in two animals. These effects were fully reversible within 48 h post-instillation in all animals. No iridial irritation or corneal opacity was observed, and treatment of the eyes with 2% fluorescein 24 h post-instillation revealed no corneal epithelial damage. The average cornea, iris, and chemosis scores over 24, 48, and 72 h were all 0 for all animals. The mean conjunctivae score over 24, 48 and 72 h was 0.3 for each of the 3 animals.

 

Respiratory tract

This information is not available.

Justification for classification or non-classification

The available data on the skin and eye irritating potential 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.