What is the NOAEL for Lutein?
Lutein has 11 NOAEL studies in the database. The lowest reported value is 1 mg/kg bw/day in Consumers. Source: EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx.
NOAEL Data
Cosmetic Ingredient
Lutein
Also known as: beta,epsilon-Carotene-3,3'-diol, (3R,3'R,6'R)-, .beta.,.epsilon.-Carotene-3,3'-diol, (3R,3'R,6'R)-, EINECS 204-840-0, Lutein, all-trans-, NSC 59193 (+8 more)
CAS 127-40-2
Lutein (CAS 127-40-2) is a chemical substance. Key regulatory status: 8 regulatory/inventory lists, cosmetic ingredient cross-reference; source data from EPA ToxValDB, EPA CPDat, AICIS.
SOURCE
noael studies public
NOAEL studies
11
SOURCE
chemical inventory jurisdictions
Regulatory lists
8
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
19 fields
Name
Lutein
CAS Number
127-40-2
DTXSID
DTXSID8046749
Molecular Formula
C40H56O2
InChI Key
KBPHJBAIARWVSC-RGZFRNHPSA-N
Monoisotopic Mass
568.428031
Synonyms
beta,epsilon-Carotene-3,3'-diol, (3R,3'R,6'R)-.beta.,.epsilon.-Carotene-3,3'-diol, (3R,3'R,6'R)-EINECS 204-840-0Lutein, all-trans-NSC 59193Xanthophyll, all-trans-(+)-UNII-X72A60C9MT(4R)-4-[(1E,3E,5E,7E,9E,11E,13E,15E,17E)-18-[(4R)-4-hydroxy-2,6,6-trimethylcyclohex-1-en-1-yl]-3,7,12,16-tetramethyloctadeca-1,3,5,7,9,11,13,15,17-nonaen-1-yl]-3,5,5-trimethylcyclohex-2-en-1-ol3,3'-Dihydroxy-alpha-caroteneBo-XanE 161bLutein ester
Functional Uses
Industrial and product-use categories associated with this substance.
SOURCE
EPA CPDat
3 records
Softener and conditionerHumectant
Regulatory Lists
Inventory, screening, and regulatory list matches from public chemical databases.
SOURCE
EPA CPDat
8 records
| List | Keyword | Source |
|---|---|---|
| Canada; pharmaceutical | DrugBank | DrugBank |
| Canada; pharmaceutical | DrugBank | DrugBank |
| Canada; pharmaceutical | DrugBank | DrugBank |
| Canada; Personal care; Substances in PCP - Canada (4/2014) | Government of Canada | CPCat |
| food_additive; Substances Added to Food (formerly EAFUS) (2/2019) | FDA | United States Food and Drug Administration (FDA) |
| Canada; pharmaceutical | DrugBank | DrugBank |
| Canada; pharmaceutical | DrugBank | DrugBank |
| Canada; pharmaceutical | DrugBank | DrugBank |
NOAEL Studies
Toxicology endpoints rendered from public NOAEL study rows.
SOURCE
NOAEL studies
Showing 11 of 11 studies
| Value | Unit | Endpoint | Route | Species | Source |
|---|---|---|---|---|---|
| =1 | mg/kg bw/day | ADI | - | Consumers | EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx |
| =1 | mg/kg bw/day | ADI | - | Consumers | EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx |
| <=2 | mg/kg | ADI | oral | Human | ToxValDB_WHO_JECFA_ADI |
| X72A60C9MT | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| X72A60C9MT | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| X72A60C9MT | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| X72A60C9MT | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| =260 | mg/kg bw/day | LEL | oral | Rat | ToxValDB_EFSA |
| =200 | mg/kg bw/day | NOAEL | oral | Rat | ToxValDB_EFSA |
| =200 | mg/kg bw/day | NOAEL | oral: feed | Rat | EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx |
| =200 | mg/kg bw/day | NOAEL | oral: feed | Rat | EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx |
Showing 11 of 11 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
Pharmaceutical Data
Same-CAS pharmaceutical records from drug and bioactivity sources.
SOURCE
EMBL-EBI ChEMBL
LUTEIN
ChEMBL Phase
3
Adverse Events
1157
Bioactivity
1
Food Safety Data
Same-CAS food additive, ADI, and GRAS records where available.
SOURCE
EFSA / FDA GRAS
2 records
E161b — FDA GRAS: FDA has no questions; some uses may require a color additive listing
View full food safety profile →Cannabis Data
Same-CAS cannabis compliance and lab records where available.
SOURCE
Cannabis regulatory / lab data
efsa substances
1 cannabis record found in efsa substances.
View full cannabis profile →Frequently Asked Questions
What regulatory lists include Lutein?
Lutein appears on 3 regulatory/inventory lists including Canada; pharmaceutical, Canada; Personal care; Substances in PCP - Canada (4/2014), food_additive; Substances Added to Food (formerly EAFUS) (2/2019). Source: EPA CPDat.
Is Lutein used in cosmetics?
Yes, Lutein is also indexed as a cosmetic ingredient under the name Xanthophylls. 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 Lutein come from?
Safety data is sourced from EPA ToxValDB, EPA CPDat, AICIS (Australian Industrial Chemicals Introduction Scheme), EPA DSSTox, CosIng / Ingredients DB, ChEMBL / DailyMed, EFSA / FDA GRAS, cannabis regulatory/lab databases. All data traces to primary regulatory sources and is updated from official government databases.
Is Lutein used outside industrial chemicals?
Lutein also appears in cosmetics, pharmaceutical, food safety, cannabis databases.