Excellent Cosmetic Ingredient NOAEL Data GHS Classified

Calcium Sulfate Hydrate

INCI: CALCIUM SULFATE HYDRATE

CAS Number
10101-41-4
Function
Abrasive, Astringent, Anticaking, Binding, Bleaching, Opacifying, Skin Conditioning
Safety Rating
EXCELLENT

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes Adequate — No systemic exposure concern

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
negligible
Sensitization
none

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Calcium Sulfate Hydrate. 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 3.17 mg/kg bw/day dermal code:3543 dermal REACH
NOAEL 100 mg/kg bw/day oral rat oral REACH
NOAEL 342 mg/kg bw/day oral rat oral REACH
NOAEL 2.45 2104 1991 rat inhalation REACH
LOAEL 10 mg/kg bw/day other code:1959 other REACH
NOAEL 300 mg/kg bw/day oral rat oral REACH
NOAEL 0.65 2104 1992 code:3544 inhalation REACH
NOAEL 1.3 2104 1991 rat inhalation REACH
LOAEL 108 mg/kg bw/day oral rat oral REACH
NOAEL 79 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.

Hazard Statements
No hazard classification according to GHS criteria
Short-term Exposure Effects
May cause mechanical irritation.
Long-term Exposure Effects
Lungs may be affected by repeated or prolongated exposure to dust particles.

Expert Verdict

Inert mineral salt (gypsum) with mechanical abrasion risk only at very coarse particle sizes.

⚠️
Concern Level: None

Frequently Asked Questions

Is Calcium Sulfate Hydrate safe in cosmetics?

Inert mineral salt (gypsum) with mechanical abrasion risk only at very coarse particle sizes. The EU classifies Calcium Sulfate Hydrate as "permitted". Safety rating: EXCELLENT. 10 toxicological study endpoint(s) are available in our database.

Is Calcium Sulfate Hydrate allowed in the EU?

Calcium Sulfate Hydrate EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Calcium Sulfate Hydrate do in cosmetics?

Calcium Sulfate Hydrate functions as: Abrasive, Astringent, Anticaking, Binding, Bleaching, Opacifying, Skin Conditioning. It is classified as a cosmetic ingredient in our database. CAS number: 10101-41-4.

What is the Margin of Safety for Calcium Sulfate Hydrate?

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 Calcium Sulfate Hydrate?

The NOAEL (No Observed Adverse Effect Level) for Calcium Sulfate Hydrate is 3.17 mg/kg bw/day based on a dermal study via dermal route in code:3543. A total of 10 study endpoints are available. Source: REACH.

Compliance Tools

Check Calcium Sulfate Hydrate compliance across multiple jurisdictions:

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Ingredient Decoder
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82 Allergen Checker
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Substance Compliance
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MoS Calculator
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Heavy Metal Limits
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