What is the NOAEL for Annatto?
Annatto has 13 NOAEL studies in the database. The lowest reported value is 0.6 mg/kg via oral in Human. Source: WHO/JECFA.
NOAEL Data
Cosmetic Ingredient
Annatto
Also known as: C.I. Natural Orange 4, San Annatto 2380, C.I. 75120, Annatto coloring dye, Annatto extract (Bixa orellana L.) (+7 more)
CAS 1393-63-1
Annatto (CAS 1393-63-1) is a chemical substance. Key regulatory status: 13 regulatory/inventory lists, cosmetic ingredient cross-reference; source data from EPA ToxValDB, EPA CPDat, AICIS.
SOURCE
NOAEL studies
NOAEL studies
13
SOURCE
Chemical inventory jurisdictions
Regulatory lists
13
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
14 fields
Name
Annatto
CAS Number
1393-63-1
Synonyms
C.I. Natural Orange 4San Annatto 2380C.I. 75120Annatto coloring dyeAnnatto extract (Bixa orellana L.)Annatto seed (Bixa orellana L.)Annotta extractBixa orellana extractEINECS 215-735-4FEMA No. 2103FEMA No. 2104UNII-6PQP1V1B6O
Functional Uses
Industrial and product-use categories associated with this substance.
SOURCE
EPA CPDat
20 records
DyeFragranceDeodorizerSoftener and conditionerNo specific technical functionFlavouring and nutrientProcessing aids not otherwise specifiedSurface modifier
Regulatory Lists
Inventory, screening, and regulatory list matches from public chemical databases.
SOURCE
EPA CPDat
13 records
| List | Keyword | Source |
|---|---|---|
| Personal care | FDA | United States Food and Drug Administration (FDA) |
| Europe; Personal care | European Commission | CosIng |
| consumer_product | P&G | Proctor & Gamble |
| general_foods | FDA | United States Food and Drug Administration (FDA) |
| pharmaceutical | FDA | United States Food and Drug Administration (FDA) |
| food_additive; Substances Added to Food (formerly EAFUS) (2/2019) | FDA | United States Food and Drug Administration (FDA) |
| IFRA Transparency | IFRA | IFRA |
| children; Europe; Personal care | Danish Environmental Protection Agency | Danish EPA |
| children; Europe; Personal care - specialized bath products - bubble bath | Danish Environmental Protection Agency | Danish EPA |
| children; Europe; Personal care - dental care - toothpaste | Danish Environmental Protection Agency | Danish EPA |
| children; Europe; Personal care | Danish Environmental Protection Agency | Danish EPA |
| children; Europe; Personal care | Danish Environmental Protection Agency | Danish EPA |
| IFRA Transparency | IFRA | IFRA |
NOAEL Studies
Toxicology endpoints rendered from public NOAEL study rows.
SOURCE
NOAEL studies
Showing 13 of 13 studies
| Value | Unit | Endpoint | Route | Species | Source |
|---|---|---|---|---|---|
| <=0.6 | mg/kg | ADI | oral | Human | WHO/JECFA |
| <=12 | mg/kg | ADI | oral | Human | WHO/JECFA |
| 6PQP1V1B6O | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| concept | identifier | FDA UNII substance identifier | - | - | openFDA substances |
| 0.8 | mg/kg bw/day | NOAEL | oral | rat | COSMOS DB |
| 56 | mg/kg bw/day | NOAEL | oral | mouse | COSMOS DB |
| 204 | mg/kg bw/day | NOAEL | oral | rat | COSMOS DB |
| 500 | mg/kg bw/day | NOAEL | oral | swine | COSMOS DB |
| 750 | mg/kg bw/day | NOAEL | oral | mouse | COSMOS DB |
| 1000 | mg/kg bw/day | NOAEL | oral | rat | COSMOS DB |
| 1012 | mg/kg bw/day | NOAEL | oral | dog | COSMOS DB |
| 2000 | mg/kg bw/day | NOAEL | oral | rat | COSMOS DB |
| 5000 | mg/kg bw/day | NOAEL | oral | dog | COSMOS DB |
Showing 13 of 13 studies
Australian Status (AICIS)
Australian industrial chemicals inventory status and applicable conditions.
SOURCE
AICIS inventory
1 records
Inventory Status
listed
Cosmetic Safety Profile
Same-CAS cosmetic ingredient record for cross-vertical context.
SOURCE
CosIng / Ingredients DB
EU Status
permitted
Max
-
Category
colorant
Food Safety Data
Same-CAS food additive, ADI, and GRAS records where available.
SOURCE
EFSA
1 records
1 food-safety record found.
View full food safety profile →Frequently Asked Questions
What regulatory lists include Annatto?
Annatto appears on 10 regulatory/inventory lists including Personal care, Europe; Personal care, consumer_product, and 7 more. Source: EPA CPDat.
Is Annatto used in cosmetics?
Yes, Annatto is also indexed as a cosmetic ingredient under the name Annatto (Bixin/Norbixin). 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 Annatto come from?
Safety data is sourced from EPA ToxValDB, EPA CPDat, AICIS (Australian Industrial Chemicals Introduction Scheme), EPA DSSTox, CosIng / Ingredients DB, EFSA / FDA GRAS. All data traces to primary regulatory sources and is updated from official government databases.
Is Annatto used outside industrial chemicals?
Annatto also appears in cosmetics, food safety databases.