Moderate Preservative NOAEL Data Sensitization Data Dermal Penetration

Sodium Hydroxymethylglycinate

INCI: SODIUM HYDROXYMETHYLGLYCINATE

CAS Number
70161-44-3
Function
Preservative
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 0.5%
๐Ÿ‡บ๐Ÿ‡ธ US Status restricted
US Notes Washington State: banned effective January 1, 2027 (Aug 2025 rule, WAC 246-930). Often marketed as a natural or gentle preservative, but mechanism of action is formaldehyde release. CIR: safe at current use concentrations. No federal limit.

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
moderate
Sensitization
moderate

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

2 study endpoints found for Sodium Hydroxymethylglycinate. 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 >=160 mg/kg bw/day oral rat oral REACH
LOAEL 640 mg/kg bw/day oral rat oral REACH

Sensitization Profile

Contact sensitization data for Sodium Hydroxymethylglycinate based on clinical patch test studies and IFRA standards.

Sensitization Rate
moderate
Allergen Class
preservative
EU Allergen Listed
no
Patch Test Positive Rate
1.0%
Cross-reactivity Group
formaldehyde-releaser-group
Reaction Type
contact-dermatitis

Source: ESSCA 2019/20; IVDK; FDA

Dermal Penetration Profile

Skin absorption and penetration characteristics of Sodium Hydroxymethylglycinate, relevant to systemic exposure and MoS calculations.

Absorption %
2-5%
Penetration Level
surface
Penetration Depth
stratum corneum
Molecular Weight
127.1 Da
Log P
-2.5
Systemic Absorption
minimal
Topical Bioavailability
1-3%
Safety Margin Factor
low
Vehicle Dependent
Yes โ€” absorption varies by formulation

Source: SCCS Opinion

Expert Verdict

Formaldehyde releaser often positioned as a natural preservative due to amino acid structure. EU Annex V restricted at 0.5%. Washington State ban effective January 1, 2027. Released formaldehyde is an IARC Group 1 carcinogen. Moderate sensitization risk. Marketing as gentle or natural does not eliminate formaldehyde release mechanism.

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Concern Level: Moderate

Regulatory Flags

formaldehyde-releaser iarc-group-1-related contact-allergen preservative washington-state-ban-2027 eu-restricted annex-v federal-ban-pending misleading-natural-label eu_cosing_listed

Frequently Asked Questions

Is Sodium Hydroxymethylglycinate safe in cosmetics?

Formaldehyde releaser often positioned as a natural preservative due to amino acid structure. EU Annex V restricted at 0.5%. Washington State ban effective January 1, 2027. Released formaldehyde is an IARC Group 1 carcinogen. Moderate sensitization risk. Marketing as gentle or natural does not eliminate formaldehyde release mechanism. The EU classifies Sodium Hydroxymethylglycinate as "restricted". Safety rating: MODERATE. 2 toxicological study endpoint(s) are available in our database.

Is Sodium Hydroxymethylglycinate allowed in the EU?

Sodium Hydroxymethylglycinate EU regulatory status: restricted. Maximum allowed concentration: 0.5%. This is based on EU Regulation 1223/2009 and its amendments.

What does Sodium Hydroxymethylglycinate do in cosmetics?

Sodium Hydroxymethylglycinate functions as: Preservative. It is classified as a Preservative in our database. CAS number: 70161-44-3.

What is the Margin of Safety for Sodium Hydroxymethylglycinate?

not established 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 Hydroxymethylglycinate?

The NOAEL (No Observed Adverse Effect Level) for Sodium Hydroxymethylglycinate is >=160 mg/kg bw/day based on a oral study via oral route in rat. A total of 2 study endpoints are available. Source: REACH.

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