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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.
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 58.43 mg/m³
- Most sensitive endpoint:
- carcinogenicity
DNEL related information
- Overall assessment factor (AF):
- 38
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.29 mg/kg bw/day
- Most sensitive endpoint:
- carcinogenicity
DNEL related information
- Overall assessment factor (AF):
- 150
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
Acute DNELs:
Worker: Production of Corn Steep Liquor is in excess of 10 t/y. According to the REACh "Guidance on information requirements and chemical safety assessment, Part B: Hazard Assessment", above 10 t/y, the establishment of acute toxicity DNEL is unnecessary in most cases, as the DNEL based on long-term exposure is normally sufficient to ensure that adverse effects do not occur. Thus, as long term DNELs are available for Corn Steep Liquor and this substance is not classified for acute toxicity via any route of exposure, separate acute DNELs were not derived.
Long-term DNELs:
DNELs are based on a 2 -year oral toxicity and carcinogenicity rat study (key study selected) entitled "Long-term toxicity/carcinogenicity study of calcium lactate in F344 rats” (Maekawa et al., 1991). This study allowed for an estimation of chronic exposure the read -across substance lactic acid. The most sensitive endpoint was selected as carcinogenicity.
Starting Dose for DNEL calculation:
1243 mg/kg bw/day (identified by registrant as the NOAEL for high-dose male rats; this represents the calculated intake of lactic acid in high-dose male rats).
Modified dose for DNEL Calculation
Worker – Inhalation = 1243 mg/kg bw/day x 1/0.38 x 6.7/10 = 2191 mg/m3(no adjustment for absorption)
Worker – Dermal = 1243 mg/kg bw/day (no adjustment for absorption).
Assessment Factors (AF)
Worker – Inhalation = 2.5 (for non-metabolic species differences) x 5 for (intraspecies difference); no scaling factor required (as per REACh guidance) x 3 (quality of whole database)
Worker – Dermal = 4 x 2.5 (species differences) x 5 for (intraspecies difference); no scaling factor required (as per REACh guidance) x 3 (quality of whole database)
Absorption
Absorption by all routes was conservatively estimated to be 100%.
Final DNELs
Worker – Inhalation = 58.43 mg/m3
Worker – Dermal = 8.29 mg/kg bw/day
References
Maekawa et al., Fd Chem Toxic 1991;29:589 -594
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 14.4 mg/m³
- Most sensitive endpoint:
- carcinogenicity
DNEL related information
- Overall assessment factor (AF):
- 75
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.14 mg/kg bw/day
- Most sensitive endpoint:
- carcinogenicity
DNEL related information
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.14 mg/kg bw/day
- Most sensitive endpoint:
- carcinogenicity
DNEL related information
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
DNEL calculation is performed on the read-across substance lactic acid
Acute DNEL:
General population: Production of Corn Steep Liquor is in excess of 10 t/y. According to the REACh "Guidance on information requirements and chemical safety assessment, Part B: Hazard Assessment", above 10 t/y, the establishment of acute toxicity DNEL is unnecessary in most cases, as the DNEL based on long-term exposure is normally sufficient to ensure that adverse effects do not occur. Thus, as long term DNELs are available for Corn Steep Liquor and this substance is not classified for acute toxicity via any route of exposure, separate acute DNELs were not derived.
Long-term DNELs:
DNELs are based on a 2 -year oral toxicity and carcinogenicity rat study (key study selected) entitled "Long-term toxicity/carcinogenicity study of calcium lactate in F344 rats” (Maekawa et al., 1991). This study allowed for an estimation of chronic exposure the read -across substance lactic acid. The most sensitive endpoint was selected as carcinogenicity.
Starting Dose for DNEL calculation:
1243 mg/kg bw/day (identified by registrant as the NOAEL for high-dose male rats; this represents the calculated intake of lactic acid in high-dose male rats).
Modified dose for DNEL Calculation
General Population – Inhalation = 1243 mg/kg bw/day x 1/1.15 = 1080 mg/m3 (no adjustment for absorption)
General Population – Oral = 1243 mg/kg bw/day (no adjustment for absorption)
General Population - Dermal - 1243 mg/kg bw/day (no adjustment for absorption)
Assessment Factors (AF)
General Population – Inhalation = 2.5 (for non-metabolic species differences) x 10 (for intraspecies difference); no scaling factor required (as per REACh guidance) x 3 (quality of whole database)
General Population – Oral = 4 x 2.5 (species differences) x 10 for (intraspecies difference); no scaling factor required (as per REACh guidance) x 3 (quality of whole database)
General Population - Dermal = 4 x 2.5 (species differences) x 10 for (intraspecies difference); no scaling factor required (as per REACh guidance) x 3 (quality of whole database)
Absorption
Absorption by all routes was conservatively estimated to be 100%.
Final DNELs
General Population - Inhalation = 14.4 mg/m3
General Population - Oral = 4.14 mg/kg bw/day
General Population - Dermal = 4.14 mg/kg bw/day
References
Maekawa et al., Fd Chem Toxic 1991;29:589 -594
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