Good Cosmetic Ingredient NOAEL Data

Strontium Chloride Hexahydrate

INCI: STRONTIUM CHLORIDE HEXAHYDRATE

CAS Number
10025-70-4
Function
Oral care, skin conditioning
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status restricted
EU Max Conc. 3.5%
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Previously an FDA-approved OTC active for tooth desensitizing (10%); FDA removed this active in 2014 monograph update; still permitted as cosmetic ingredient

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Strontium Chloride Hexahydrate. 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 12.4 mg/kg bw/day oral rat oral REACH
NOAEL 2.5 other dermal code:3484 dermal REACH
NOAEL 300 ppm oral rat oral REACH
NOAEL >=700 mg/kg bw/day oral rat oral REACH
NOAEL 300 mg/kg bw/day dermal - dermal REACH
NOAEL 553.7 mg/kg bw/day dermal - dermal REACH
NOAEL 100 mg/kg bw/day oral rat oral REACH
NOAEL 300 mg/kg bw/day oral - oral REACH
NOAEL 300 mg/kg bw/day oral - oral REACH
NOAEL 15 ppm oral mouse oral REACH

Expert Verdict

Same ECHA CMR review concern as all strontium salts ; FDA removed OTC drug status for tooth sensitivity claims

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Concern Level: Moderate

Regulatory Flags

eu_cosing_listed

Frequently Asked Questions

Is Strontium Chloride Hexahydrate safe in cosmetics?

Same ECHA CMR review concern as all strontium salts ; FDA removed OTC drug status for tooth sensitivity claims The EU classifies Strontium Chloride Hexahydrate as "restricted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.

Is Strontium Chloride Hexahydrate allowed in the EU?

Strontium Chloride Hexahydrate EU regulatory status: restricted. Maximum allowed concentration: 3.5%. This is based on EU Regulation 1223/2009 and its amendments.

What does Strontium Chloride Hexahydrate do in cosmetics?

Strontium Chloride Hexahydrate functions as: Oral care, skin conditioning. It is classified as a cosmetic ingredient in our database. CAS number: 10025-70-4.

What is the Margin of Safety for Strontium Chloride Hexahydrate?

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 Strontium Chloride Hexahydrate?

The NOAEL (No Observed Adverse Effect Level) for Strontium Chloride Hexahydrate is 12.4 mg/kg bw/day based on a oral study via oral route in rat. A total of 10 study endpoints are available. Source: REACH.

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