Bishydroxyethyl Biscetyl Malonamide
INCI: BISHYDROXYETHYL BISCETYL MALONAMIDE
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
2 study endpoints found for Bishydroxyethyl Biscetyl Malonamide. 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 | 15 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| LOAEL | 150 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
Expert Verdict
Reproductive Toxicity Category 3 (R62) with ovarian corpora lutea apoptosis and granulomata observed at 150-1000 mg/kg/day oral. Foetal narrow/flattened heads at 1000 mg/kg/day (13% of foetuses, 7/9 litters). Liver hepatocyte necrosis at high dose. Accumulates in liver, spleen, adrenals, and ovaries with very slow tissue clearance. Despite negligible dermal absorption providing a wide safety margin, the R62 classification mandates disclosure and risk assessment in any CPSR.
Regulatory Flags
Frequently Asked Questions
Is Bishydroxyethyl Biscetyl Malonamide safe in cosmetics?
Reproductive Toxicity Category 3 (R62) with ovarian corpora lutea apoptosis and granulomata observed at 150-1000 mg/kg/day oral. Foetal narrow/flattened heads at 1000 mg/kg/day (13% of foetuses, 7/9 litters). Liver hepatocyte necrosis at high dose. Accumulates in liver, spleen, adrenals, and ovaries with very slow tissue clearance. Despite negligible dermal absorption providing a wide safety margin, the R62 classification mandates disclosure and risk assessment in any CPSR. The EU classifies Bishydroxyethyl Biscetyl Malonamide as "prohibited". Safety rating: MODERATE. 2 toxicological study endpoint(s) are available in our database.
Is Bishydroxyethyl Biscetyl Malonamide allowed in the EU?
Bishydroxyethyl Biscetyl Malonamide EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.
What does Bishydroxyethyl Biscetyl Malonamide do in cosmetics?
Bishydroxyethyl Biscetyl Malonamide functions as: Skin conditioning agent (ceramide mimic / pseudo-ceramide); used in skin creams, shampoos, conditioners, makeup, sun care. It is classified as a cosmetic ingredient in our database. CAS number: 149591-38-8.
What is the Margin of Safety for Bishydroxyethyl Biscetyl Malonamide?
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 Bishydroxyethyl Biscetyl Malonamide?
The NOAEL (No Observed Adverse Effect Level) for Bishydroxyethyl Biscetyl Malonamide is 15 mg/kg bw/day based on a Short Term Toxicity study via oral route in rat. A total of 2 study endpoints are available. Source: COSMOS_DB.
Compliance Tools
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