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
10 study endpoints found for Heliotropine. 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 | 250 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
| NOAEL | 1000 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| NOAEL | 100 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
| dose_tested | 250 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
| dose_tested | 1000 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| dose_tested | 100 mg/kg bw/day | oral | rat | Chronic | COSMOS_DB |
| NOAEL | 300 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | 17 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | 1000 ppm | oral | rat | oral | REACH |
| NOAEL | 1000 ppm | oral | rat | oral | REACH |
Expert Verdict
Reprotoxic substance (H360Fd) with fertility and developmental effects; EU regulatory status uncertain pending SCCS Article 15(2) review; industry dossier submitted for fine fragrances at maximum 1.8% for adult use only; formulation in new EU products not recommended until final SCCS opinion issued.
Regulatory Flags
Frequently Asked Questions
Is Heliotropine safe in cosmetics?
Reprotoxic substance (H360Fd) with fertility and developmental effects; EU regulatory status uncertain pending SCCS Article 15(2) review; industry dossier submitted for fine fragrances at maximum 1.8% for adult use only; formulation in new EU products not recommended until final SCCS opinion issued. The EU classifies Heliotropine as "restricted". Safety rating: POOR. 10 toxicological study endpoint(s) are available in our database.
Is Heliotropine allowed in the EU?
Heliotropine EU regulatory status: restricted. This is based on EU Regulation 1223/2009 and its amendments.
What does Heliotropine do in cosmetics?
Heliotropine functions as: Fragrance ingredient with vanilla/almond aroma; fixative; masking agent. It is classified as a cosmetic ingredient in our database. CAS number: 120-57-0.
What is the Margin of Safety for Heliotropine?
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 Heliotropine?
The NOAEL (No Observed Adverse Effect Level) for Heliotropine is 250 mg/kg bw/day based on a Chronic study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.
Compliance Tools
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Related Ingredients
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