Poor Active Ingredient NOAEL Data GHS Classified

Sodium Hydroxide

INCI: SODIUM HYDROXIDE

CAS Number
1310-73-2
Function
alkali; cuticle-swelling agent; disulfide bond-breaking agent (lanthionization); pH modifier
Safety Rating
POOR

Regulatory Status

🇪🇺 EU Status restricted
EU Max Conc. Annex III entry 25: max 3.0% as hair straightener in professional products; max 2.0% in general consumer products; pH limits apply. Not for children.
🇺🇸 US Status restricted
US Notes Permitted in hair relaxer formulations as active at pH 12–14. NIEHS Sister Study (2022, EPH) found women using chemical straighteners ≥4x/year faced HR 2.55 for uterine cancer. JNCI 2026 follow-up linked frequent use to pancreatic cancer (HR 2.66), thyroid cancer (HR 1.71), and NHL (HR 1.62). FDA has not yet issued a formal ban but cancer findings have triggered significant regulatory and litigation scrutiny.

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

7 study endpoints found for Sodium Hydroxide. 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 147 mg/kg bw/day oral rabbit Special Toxicology Study COSMOS_DB
NOAEL 5000 mg/kg bw/day oral rabbit Special Toxicology Study COSMOS_DB
NOAEL 700 mg/kg bw/day oral rat Special Toxicology Study COSMOS_DB
NOAEL 200 mg/kg bw/day oral mouse Carcinogenicity COSMOS_DB
NOAEL 1 mg/kg bw/day oral rat Subchronic COSMOS_DB
dose_tested 200 mg/kg bw/day oral mouse Carcinogenicity COSMOS_DB
dose_tested 1 mg/kg bw/day oral rat Subchronic COSMOS_DB

GHS Hazard Classification

Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.

Signal Word
DANGER
Pictograms
corr; excl mark;warn
Hazard Statements
Harmful if swallowed Causes severe skin burns and eye damage May cause respiratory irritation
Short-term Exposure Effects
The substance is corrosive to the eyes, skin and respiratory tract. Corrosive on ingestion.
Long-term Exposure Effects
Repeated or prolonged contact with skin may cause dermatitis.
Routes of Exposure
Serious local effects by all routes of exposure.

Expert Verdict

Sodium hydroxide lye relaxers operate at pH 12–14, swelling the cuticle and allowing hydroxide ion to penetrate the cortex where it breaks disulfide bonds via lanthionization—a permanent, irreversible chemical change. Extreme alkalinity causes chemical burns and scalp lesions that significantly enhance percutaneous absorption of co-formulants. NIEHS Sister Study (2022) found HR 2.55 for uterine cancer in frequent users. JNCI 2026 follow-up found HR 2.66 for pancreatic cancer, HR 1.71 for thyroid cancer, and HR 1.62 for non-Hodgkin's lymphoma. Epidemiological signal is strong; causal pathway likely includes co-formulant absorption (formaldehyde-releasers, parabens, phthalates, BPA, metals) through burn-damaged scalp. Disproportionate risk burden on Black and African American women, many starting use in childhood/adolescence. EU Annex III restricts concentration and mandates professional use for higher-concentration products.

⚠️
Concern Level: High

Regulatory Flags

annex-iii restricted extreme-alkalinity scalp-burn-risk cancer-risk-signal niehs-sister-study-2022 jnci-2026 uterine-cancer-hr-2.55 pancreatic-cancer-hr-2.66 endocrine-disruptor-coformulant-pathway professional-only-eu childhood-exposure-concern enhanced-percutaneous-absorption eu_children_restricted epa_safer_alternative ifra_fragrance fda_food_additive jecfa_safe

Frequently Asked Questions

Is Sodium Hydroxide safe in cosmetics?

Sodium hydroxide lye relaxers operate at pH 12–14, swelling the cuticle and allowing hydroxide ion to penetrate the cortex where it breaks disulfide bonds via lanthionization—a permanent, irreversible chemical change. Extreme alkalinity causes chemical burns and scalp lesions that significantly enhance percutaneous absorption of co-formulants. NIEHS Sister Study (2022) found HR 2.55 for uterine cancer in frequent users. JNCI 2026 follow-up found HR 2.66 for pancreatic cancer, HR 1.71 for thyroid cancer, and HR 1.62 for non-Hodgkin's lymphoma. Epidemiological signal is strong; causal pathway likely includes co-formulant absorption (formaldehyde-releasers, parabens, phthalates, BPA, metals) through burn-damaged scalp. Disproportionate risk burden on Black and African American women, many starting use in childhood/adolescence. EU Annex III restricts concentration and mandates professional use for higher-concentration products. The EU classifies Sodium Hydroxide as "restricted". Safety rating: POOR. 7 toxicological study endpoint(s) are available in our database.

Is Sodium Hydroxide allowed in the EU?

Sodium Hydroxide EU regulatory status: restricted. Maximum allowed concentration: Annex III entry 25: max 3.0% as hair straightener in professional products; max 2.0% in general consumer products; pH limits apply. Not for children.. This is based on EU Regulation 1223/2009 and its amendments.

What does Sodium Hydroxide do in cosmetics?

Sodium Hydroxide functions as: alkali; cuticle-swelling agent; disulfide bond-breaking agent (lanthionization); pH modifier. It is classified as a Active Ingredient in our database. CAS number: 1310-73-2.

What is the Margin of Safety for Sodium Hydroxide?

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 Hydroxide?

The NOAEL (No Observed Adverse Effect Level) for Sodium Hydroxide is 147 mg/kg bw/day based on a Special Toxicology Study study via oral route in rabbit. A total of 7 study endpoints are available. Source: COSMOS_DB.

Is Sodium Hydroxide classified as hazardous under GHS?

Sodium Hydroxide carries a GHS signal word of "DANGER". Hazard statements: Harmful if swallowed Causes severe skin burns and eye damage May cause respiratory irritation. This classification is based on the ILO/WHO International Chemical Safety Card and ECHA C&L inventory data. Note: GHS classification applies to the pure substance — at cosmetic use concentrations, hazard thresholds may not be met.

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