Regulatory Status
For full compliance data across 55 jurisdictions, use the Substance Compliance tool.
Safety Data
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.
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.
Regulatory Flags
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.
Compliance Tools
Check Sodium Hydroxide compliance across multiple jurisdictions:
Related Ingredients
Is Sodium Hydroxide in Your Products?
Scan any product label with Piro — our free ingredient scanner. Point your camera at the ingredients list and get instant safety scores for every ingredient.
Try Piro Free →Analyze Your Full Ingredient List
Paste any INCI list into the Decoder for instant safety analysis, or calculate the Margin of Safety for Sodium Hydroxide in your formulation.