Registration Dossier
Registration Dossier
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EC number: 266-113-4 | CAS number: 66071-94-1 Substance obtained by the partial removal of water from the liquid resulting from steeping corn in a water and sulphur dioxide solution which is allowed to ferment by the action of naturally occurring lactic acid-producing microorganisms.
Endpoint summary
Administrative data
Description of key information
In accordance with section 1 of Annex IX, the acute toxicity studies by the oral route (section 8.5.1.), inhalation route (section 8.5.2.), and dermal route (section 8.5.3.), 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 acute toxicity of lactic acid - a major component of CSL.
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, five studies addressing acute toxicity of lactic acid, a major component of CSL, to mammals are presented in the dossier.
Acute oral toxicity to rats was assessed by Smyth et al. (1941). Male rats were exposed to 5% lactic acid by oral gavage administration. The LD50 was determined to be 3.73 g/kg bw.
Acute oral toxicity to guinea pigs was assessed by Smyth et al. (1941). Male and female guinea pigs were exposed to 5% lactic acid by oral gavage administration. The LD50 was determined to be 1.81 g/kg bw.
Acute oral toxicity to rats was assessed according to EPA OPP 81-1 (Acute Oral Toxicity) under Good Laboratory Practices (GLP) in 1984 at Toxigenics, Inc. Male and female rats were exposed to lactic acid by oral administration. The LD50 was determined to be between 3543 and 4936 mg/kg bw.
Acute oral toxicity to rats was assessed according to EPA OPP 81-1 (Acute Oral Toxicity) under Good Laboratory Practices (GLP) in 1983 at Toxigenics, Inc. Male and female rats were exposed to a single dose of lactic acid by oral administration. The LD50 was determined to be greater than 5 mg/kg bw.
Acute inhalation toxicity to rats was assessed according to EPA OPP 81-3 (Acute inhalation Toxicity) under Good Laboratory Practices (GLP) in 1987 at Microbiological Associates Inc. Male and female rats were exposed to lactic acid by inhalation of aerosol. The LD50 determined to be >7.94 mg/L air.
Acute dermal toxicity to rabbits was assessed according EPA OPP 81-2 (Acute Dermal Toxicity) under Good Laboratory Practices (GLP) in 1983 at Toxigenics, Inc. Male and female rats were exposed to lactic acid by occlusive dermal administration. The LD50 determined to be greater than 2000 mg/kg bw.
Justification for classification or non-classification
not classified as dangerous
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