Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

Corn steep liquor (CSL) consists of all-natural, water soluble components (crude proteins, amino acids, minerals, vitamins, reducing sugars, organic acids, enzymes and other elemental nutrients), that have been extracted by soaking corn in water, along with a very small amount of sulfurous acid (<0.01%). CSL has a long history of safe use as an added source of nutrition in animal feed, in fermentation processes, and in antibiotic production. On this basis, CSL is not expected to cause adverse toxic effects to humans.

 

While no studies are available on CSL, three studies addressing genetic toxicity of lactic acid, a major component of CSL, are presented in the dossier.

 

Ishidate Jr. et. al. (1984) investigated lactic acid by the bacterial reverse mutation assay according to OECD Guideline 471 (Bacterial Reverse Mutation Assay). S. typhimurium TA 97, TA 98, TA 100, and TA 104 were exposed to lactic acid with and without metabolic activation.  No evidence of mutagenic activity was found.

 

Ishidate Jr. et. al. (1984) investigated lactic acid by in vitro mammalian chromosome aberration in a manner similar to OECD Guideline 473 (In vitro Mammalian Chromosome Aberration Test). Chinese hamster lung fibroblasts (V79) were exposed to lactic acid with and without metabolic activation.  No evidence of clastogenic activity was found.

 

Morita et. al. (1990) investigated lactic acid by in vitro mammalian chromosome aberration in a manner similar to OECD Guideline 473 (In vitro Mammalian Chromosome Aberration Test). Chinese hamster ovary (CHO) were exposed to lactic acid with and without metabolic activation.  No evidence of clastogenic activity was found.


Short description of key information:
In accordance with section 1 of Annex IX, the in vitro gene mutation study in bacteria (section 8.4.1.), the in vitro cytogenicity study in mammalian cells (section 8.4.2.), and the in vitro gene mutation study in mammalian cells (section 8.4.3.), do not need to be conducted as corn steep liquor (CSL) consists of all-natural, water soluble components (crude proteins, amino acids, minerals, vitamins, reducing sugars, organic acids, enzymes and other elemental nutrients), that have been extracted by soaking corn in water, along with a very small amount of sulfurous acid (<0.01%). CSL has a long history of safe use as an added source of nutrition in animal feed, in fermentation processes, and in antibiotic production. On this basis, CSL is not expected to cause adverse toxic effects to humans. This expectation is supported by the demonstrated lack of genetic toxicity of lactic acid - a major component of CSL.

Endpoint Conclusion:

Justification for classification or non-classification