What is the NOAEL for Hydroxylapatite (Ca5(OH)(PO4)3)?
Hydroxylapatite (Ca5(OH)(PO4)3) has 4 NOAEL studies in the database. The lowest reported value is 91D9GV0Z28 UNII. Source: openFDA substances.
NOAEL Data
REACH Registered
Cosmetic Ingredient
Hydroxylapatite (Ca5(OH)(PO4)3)
Also known as: Apatite hydroxide (Ca10(PO4)6(OH)2), Calcium hydroxyapatite, Hydroxypol, EINECS No.: 215-145-7, Hydroxylapatite (+8 more)
CAS 1306-06-5
Hydroxylapatite (Ca5(OH)(PO4)3) (CAS 1306-06-5) is a chemical substance. Key regulatory status: REACH registered, 1 regulatory/inventory list, cosmetic ingredient cross-reference; source data from EPA ToxValDB, EPA CPDat, AICIS, SCCS, ECHA REACH.
SOURCE
noael studies public
NOAEL studies
4
SOURCE
chemical inventory jurisdictions
Regulatory lists
1
SOURCE
eu clp annex vi
GHS signal
Not classified
Chemical Identity
CAS, identifiers, formula, and alternate names for the matched substance record.
SOURCE
DSSTox identifiers
16 fields
Name
Hydroxylapatite (Ca5(OH)(PO4)3)
CAS Number
1306-06-5
DTXSID
DTXSID10872538
Synonyms
Apatite hydroxide (Ca10(PO4)6(OH)2)Calcium hydroxyapatiteHydroxypolEINECS No.: 215-145-7HydroxylapatiteCellyard-AXCoralina HAP 200Boneceram P-G 1Bone jectCaptal 60-1HAP 100 (mineral)Micro-SHAp IHM 100P000
Functional Uses
Industrial and product-use categories associated with this substance.
SOURCE
EPA CPDat
5 records
AbrasiveSoftener and conditionerFiller
Regulatory Lists
Inventory, screening, and regulatory list matches from public chemical databases.
SOURCE
EPA CPDat
1 records
| List | Keyword | Source |
|---|---|---|
| Canada; consumer_product; Substances in Products - Canada (4/2014) | Government of Canada | CPCat |
NOAEL Studies
Toxicology endpoints rendered from public NOAEL study rows.
SOURCE
NOAEL studies
Showing 4 of 4 studies
| Value | Unit | Endpoint | Route | Species | Source |
|---|---|---|---|---|---|
| 91D9GV0Z28 | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 91D9GV0Z28 | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 91D9GV0Z28 | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 91D9GV0Z28 | UNII | FDA UNII substance identifier | - | - | openFDA substances |
Showing 4 of 4 studies
REACH Registration
Registration status from the ECHA REACH registered substances database.
SOURCE
ECHA (EU)
1 records
| Status | Name | EC Number | Link |
|---|---|---|---|
| Registered | Hydroxylapatite (Ca5(OH)(PO4)3) | 215-145-7 | ECHA overview → |
Australian Status (AICIS)
Australian industrial chemicals inventory status and applicable conditions.
SOURCE
AICIS inventory
1 records
Inventory Status
listed
SCCS Opinions
EU Scientific Committee opinions tied to the matched substance.
SOURCE
EU SCCS
4 opinions
| Opinion | Date | Conclusion | Max Conc. | Concerns |
|---|---|---|---|---|
| SCCS/1677/25 | 26 June 2025 | safe with restrictions | 29.5% toothpaste; 10% mouthwash | Rod-shaped particles only (≥87% with aspect ratio ≤3; remainder ≤9); max particle length 122 ± 43 nm; uncoated/unmodified particles only; needle-shaped HAP must not be used |
| SCCS/1648/22 | 21-22 March 2023 | safe with restrictions | 10% toothpaste; 0.465% mouthwash | Rod-shaped particles only (≥95.8% with aspect ratio <3; remaining ≤4.9); previous concern over genotoxicity resolved; needle-shaped HAP excluded |
| SCCS/1624/20 | 30-31 March 2021 | insufficient data | Not determined | Cannot exclude genotoxic potential; insufficient data on mammalian gene mutation and chromosomal aberration/clastogenicity; needle-shaped HAP should not be used |
| SCCS/1566/15 | 16 March 2016 | insufficient data | Not determined (assessed up to 10% oral) | Insufficient data submitted; evidence insufficient to draw safety conclusion; needle-shaped nano-hydroxyapatite should not be used |
Cosmetic Safety Profile
Same-CAS cosmetic ingredient record for cross-vertical context.
SOURCE
CosIng / Ingredients DB
EU Status
restricted
Max
Non-nano conventional hydroxyapatite permitted in cosmetics (e.g., oral care). Nano-form prohibited in cosmetics effective February 2025 per Commission Regulation (EU) 2024/858
Category
Other
Pharmaceutical Data
Same-CAS pharmaceutical records from drug and bioactivity sources.
SOURCE
EMBL-EBI ChEMBL
DURAPATITE
ChEMBL Phase
2
Adverse Events
1
Bioactivity
0
Frequently Asked Questions
What regulatory lists include Hydroxylapatite (Ca5(OH)(PO4)3)?
Hydroxylapatite (Ca5(OH)(PO4)3) appears on 1 regulatory/inventory list including Canada; consumer_product; Substances in Products - Canada (4/2014). Source: EPA CPDat.
Is Hydroxylapatite (Ca5(OH)(PO4)3) used in cosmetics?
Yes, Hydroxylapatite (Ca5(OH)(PO4)3) is also indexed as a cosmetic ingredient under the name Hydroxyapatite. View the full cosmetic safety profile on the ingredient page for detailed safety data, SCCS opinions, and regulatory status.
Where does the safety data for Hydroxylapatite (Ca5(OH)(PO4)3) come from?
Safety data is sourced from EPA ToxValDB, EPA CPDat, AICIS (Australian Industrial Chemicals Introduction Scheme), EPA DSSTox, ECHA REACH, CosIng / Ingredients DB, ChEMBL / DailyMed. All data traces to primary regulatory sources and is updated from official government databases.
Is Hydroxylapatite (Ca5(OH)(PO4)3) used outside industrial chemicals?
Hydroxylapatite (Ca5(OH)(PO4)3) also appears in cosmetics, pharmaceutical databases.