Poor Cosmetic Ingredient NOAEL Data GHS Classified

Hydroxylamine HCl

INCI: HYDROXYLAMINE HCL

CAS Number
5470-11-1
Function
Antioxidant / Reducing agent
Safety Rating
POOR

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status prohibited
๐Ÿ‡บ๐Ÿ‡ธ US Status restricted
US Notes Not specifically prohibited under 21 CFR for cosmetics; no FDA monograph. Permitted by default but flagged by GHS classification.

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

3 study endpoints found for Hydroxylamine HCl. 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
LOAEL 233 mg/kg bw/day oral rat oral REACH
NOAEL 3.29 mg/kg bw/day oral rat oral REACH
NOAEL 7.77 mg/kg bw/day oral - oral REACH

GHS Hazard Classification

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

Signal Word
DANGER
Pictograms
corr; skull;toxic; cancer;health haz; enviro;aqua
Hazard Statements
May be osive to metals Toxic if swallowed Harmful in contact with skin Causes skin and eye irritation May cause an allergic skin reaction Suspected of causing cancer May cause damage to blood May cause damage to blood through prolonged or repeated exposure Very toxic to aquatic life
Short-term Exposure Effects
The substance is irritating to the eyes, skin and respiratory tract. The substance may cause effects on the blood. This may result in the formation of methaemoglobin. Medical observation is indicated.
Long-term Exposure Effects
Repeated or prolonged contact may cause skin sensitization. The substance may have effects on the blood. This may result in the formation of methaemoglobin. Tumours have been detected in experimental animals but may not be relevant to humans.
Routes of Exposure
The substance can be absorbed into the body by inhalation of its aerosol, through the skin and by ingestion.

Expert Verdict

Suspected carcinogen with skin sensitization hazard; harmful via oral and dermal routes with organ damage upon prolonged exposure; mutagenic in mouse lymphoma assay and highly toxic to aquatic organisms.

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Concern Level: High

Regulatory Flags

potential-allergen

Frequently Asked Questions

Is Hydroxylamine HCl safe in cosmetics?

Suspected carcinogen with skin sensitization hazard; harmful via oral and dermal routes with organ damage upon prolonged exposure; mutagenic in mouse lymphoma assay and highly toxic to aquatic organisms. The EU classifies Hydroxylamine HCl as "prohibited". Safety rating: POOR. 3 toxicological study endpoint(s) are available in our database.

Is Hydroxylamine HCl allowed in the EU?

Hydroxylamine HCl EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.

What does Hydroxylamine HCl do in cosmetics?

Hydroxylamine HCl functions as: Antioxidant / Reducing agent. It is classified as a cosmetic ingredient in our database. CAS number: 5470-11-1.

What is the Margin of Safety for Hydroxylamine HCl?

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 Hydroxylamine HCl?

The NOAEL (No Observed Adverse Effect Level) for Hydroxylamine HCl is 233 mg/kg bw/day based on a oral study via oral route in rat. A total of 3 study endpoints are available. Source: REACH.

Is Hydroxylamine HCl classified as hazardous under GHS?

Hydroxylamine HCl carries a GHS signal word of "DANGER". Hazard statements: May be osive to metals Toxic if swallowed Harmful in contact with skin Causes skin and eye irritation May cause an allergic skin reaction Suspected of causing cancer May cause damage to blood May cause damage to blood through prolonged or repeated exposure Very toxic to aquatic life. 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 โ€” at cosmetic use concentrations, hazard thresholds may not be met.

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