Moderate Cosmetic Ingredient NOAEL Data GHS Classified Sensitization Data

Sodium Sulfite

INCI: SODIUM SULFITE

CAS Number
7757-83-7
Function
Preservative; antioxidant; reducing agent (in hair dye/perm formulations)
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 0.2%
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Permitted in cosmetics; CIR reviewed; sulfite sensitivity labeling may be recommended

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
moderate
Sensitization
moderate

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

9 study endpoints found for Sodium Sulfite. 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 Developmental COSMOS_DB
NOAEL 3070 mg/kg bw/day oral rat Subchronic COSMOS_DB
dose_tested 3070 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 108 mg/kg bw/day oral rat oral REACH
NOAEL 0.05 other oral rat oral REACH
NOAEL 0.35 other oral pig oral REACH
NOAEL 70 mg/kg bw/day oral rat oral REACH
NOAEL 108 mg/kg bw/day oral rat oral REACH
NOAEL >53 mg/kg bw/day oral rat 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
excl mark;warn; cancer;health haz
Hazard Statements
Harmful if swallowed May cause allergy or asthma symptoms or breathing difficulties if inhaled May cause an allergic skin reaction Harmful to aquatic life
Short-term Exposure Effects
The aerosol is irritating to the respiratory tract.
Long-term Exposure Effects
Repeated or prolonged contact may cause skin sensitization. Repeated or prolonged inhalation may cause asthma. See Notes.
Routes of Exposure
The substance can be absorbed into the body by inhalation and by ingestion.

Sensitization Profile

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

Sensitization Rate
low
Allergen Class
preservative
EU Allergen Listed
no
Patch Test Positive Rate
0.2%
Cross-reactivity Group
none
Reaction Type
contact-dermatitis

Source: IVDK; SCCS

Expert Verdict

Sulfite sensitivity affects ~1% of general population and ~5% of asthmatics; can cause bronchospasm, urticaria, and anaphylactoid reactions in sensitive individuals; mandatory concentration limits in EU; oxidizes to sulfate on storage โ€” formulation stability must be monitored

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Concern Level: Moderate

Regulatory Flags

preservative epa_safer_alternative ifra_fragrance fda_food_additive

Frequently Asked Questions

Is Sodium Sulfite safe in cosmetics?

Sulfite sensitivity affects ~1% of general population and ~5% of asthmatics; can cause bronchospasm, urticaria, and anaphylactoid reactions in sensitive individuals; mandatory concentration limits in EU; oxidizes to sulfate on storage โ€” formulation stability must be monitored The EU classifies Sodium Sulfite as "restricted". Safety rating: MODERATE. 9 toxicological study endpoint(s) are available in our database.

Is Sodium Sulfite allowed in the EU?

Sodium Sulfite EU regulatory status: restricted. Maximum allowed concentration: 0.2%. This is based on EU Regulation 1223/2009 and its amendments.

What does Sodium Sulfite do in cosmetics?

Sodium Sulfite functions as: Preservative; antioxidant; reducing agent (in hair dye/perm formulations). It is classified as a cosmetic ingredient in our database. CAS number: 7757-83-7.

What is the Margin of Safety for Sodium Sulfite?

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 Sulfite?

The NOAEL (No Observed Adverse Effect Level) for Sodium Sulfite is 160 mg/kg bw/day based on a Developmental study via oral route in rat. A total of 9 study endpoints are available. Source: COSMOS_DB.

Is Sodium Sulfite classified as hazardous under GHS?

Sodium Sulfite carries a GHS signal word of "DANGER". Hazard statements: Harmful if swallowed May cause allergy or asthma symptoms or breathing difficulties if inhaled May cause an allergic skin reaction Harmful 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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