Excellent Humectant NOAEL Data

Sodium Lactate

INCI: SODIUM LACTATE

CAS Number

72-17-3

Function

pH buffering agent; humectant; moisturizer

Safety Rating

EXCELLENT

Regulatory Status

🇪🇺 EU Status permitted

🇺🇸 US Status permitted

US Notes GRAS under 21 CFR 184.1768 for food use (emulsifier, flavor enhancer, humectant, pH control). Permitted in cosmetics under FDA general safety requirement. CIR Expert Panel (1998, re-reviewed 2017) concluded AHAs including sodium lactate are safe at <=10% concentration at final formulation pH >=3.5, when formulated to avoid increasing sun sensitivity or with daily sun protection labeling.

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)

adequate

Dermal Absorption

low

Sensitization

none

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

6 study endpoints found for Sodium Lactate. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.

Endpoint	Value	Route	Species	Study Type	Source
NOAEL	1330 mg/kg bw/day	oral	rat	oral	REACH
NOAEL	1330 mg/kg bw/day	oral	-	oral	REACH
LOEL	1913 mg/kg bw/day	oral	rat	oral	REACH
NOAEL	50000 mg/L drinking water	other	rat	oral	REACH
LOEL	1913 mg/kg bw/day	oral	-	oral	REACH
NOAEL	50000 mg/L drinking water	oral	-	oral	REACH

Expert Verdict

Sodium Lactate is permitted in the EU without specific concentration restrictions under Regulation (EC) No. 1223/2009, functioning as a humectant, buffering agent, and mild keratolytic. Toxicological profile is excellent: acutely non-toxic (LD50 >2,000 mg/kg), non-sensitizing, non-genotoxic, non-carcinogenic, with negligible dermal absorption in rinse-off use.

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Concern Level: None

Regulatory Flags

eu-unrestricted cir-approved gras-fda humectant non-sensitizing penetration-enhancer eu_children_restricted epa_safer_alternative fda_food_additive

Frequently Asked Questions

Is Sodium Lactate safe in cosmetics?

Is Sodium Lactate allowed in the EU?

Sodium Lactate EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Sodium Lactate do in cosmetics?

Sodium Lactate functions as: pH buffering agent; humectant; moisturizer. It is classified as a Humectant in our database. CAS number: 72-17-3.

What is the Margin of Safety for Sodium Lactate?

adequate The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

What is the NOAEL for Sodium Lactate?

The NOAEL (No Observed Adverse Effect Level) for Sodium Lactate is 1330 mg/kg bw/day based on a oral study via oral route in rat. A total of 6 study endpoints are available. Source: REACH.

Compliance Tools

Check Sodium Lactate compliance across multiple jurisdictions:

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Ingredient Decoder

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82 Allergen Checker

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Substance Compliance

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MoS Calculator

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Heavy Metal Limits

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