Good Cosmetic Ingredient NOAEL Data

CI 75125 (Lycopene)

Also known as: EINECS 207-949-1, UNII-SB0N2N0WV6, Mexoryl SAQ, Tomat-O-Red, Redivivo (+3 more)

INCI: CI 75125

CI 75125 (Lycopene) (CAS 502-65-8) is a cosmetic cosmetic ingredient functioning as Colorant. Natural carotenoid pigment extracted from tomatoes (Lycopersicon. Reported NOAEL =100 mg/kg bw/day in Rat (INCHEM_WHO_jecfa_jecmono_v62je01); EU Regulation 1223/2009 status: permitted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety, pharmaceutical, and food safety data.

View industrial chemical safety profile for CAS 502-65-8 →

Auto-generated CPSR Part A draft with source citations

CAS Number

502-65-8

View industrial chemical safety profile →

Function

Colorant. Natural carotenoid pigment extracted from tomatoes (Lycopersicon esculentum), also known as Lycopene and Natural Red 73. Imparts red-orange coloration to cosmetic products. Oil-soluble dye from the carotene family. Also designated food colorant E160d. Permitted EU colorant subject to purity criteria per Commission Directive 95/45/EC.

Safety Rating

GOOD

Chemistry & Identifiers

Formula

C40H56

536.9 g/mol

PubChem CID

446925

IUPAC Name

(6E,8E,10E,12E,14E,16E,18E,20E,22E,24E,26E)-2,6,10,14,19,23,27,31-octamethyldotriaconta-2,6,8,10,12,14,16,18,20,22,24,26,30-tridecaene

InChIKey

OAIJSZIZWZSQBC-GYZMGTAESA-N

ChEBI: CHEBI:15948 UNII: SB0N2N0WV6 Wikidata: Q208130

Regulatory Status

EU EU Status permitted

US US Status restricted

US Notes FDA permanently lists Tomato Lycopene Extract (CAS 502-65-8) as a color additive exempt from certification under 21 CFR 73.585 for use in foods only. CI 75125 as a standalone cosmetic colorant is not listed in 21 CFR Parts 73 or 74 for cosmetic use. US cosmetic labeling as a color additive is not formally supported; lycopene may be used as a functional ingredient but not as a listed color additive for cosmetics.

For full compliance data across multiple jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for CI 75125 (Lycopene).

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for CI 75125 (Lycopene). 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	=100 mg/kg bw/day	-	Rat	Toxicology study	INCHEM_WHO_jecfa_jecmono_v62je01
NOAEL	=100 mg/kg bw/day	-	Rat	Toxicology study	INCHEM_WHO_jecfa_jecmono_v62je01
NOAEL	=500 mg/kg bw/day	-	-	Developmental toxicity	INCHEM_WHO_jecfa_jecmono_v62je01
NOAEL	=500 mg/kg bw/day	-	-	Developmental toxicity	INCHEM_WHO_jecfa_jecmono_v62je01
NOAEL	=616 mg/kg bw/day	oral	-	Toxicology study	INCHEM_WHO_jecfa_jecmono_v62je01
NOAEL	=616 mg/kg bw/day	oral	-	Toxicology study	INCHEM_WHO_jecfa_jecmono_v62je01
NOAEL	=1000 mg/kg bw/day	-	-	Toxicology study	INCHEM_WHO_jecfa_jecmono_v62je01
NOAEL	=1000 mg/kg bw/day	-	-	Toxicology study	INCHEM_WHO_jecfa_jecmono_v62je01
NOAEL	=3290 mg/kg bw/day	oral	-	Toxicology study	INCHEM_WHO_jecfa_jecmono_v62je01
NOAEL	=3290 mg/kg bw/day	oral	-	Toxicology study	INCHEM_WHO_jecfa_jecmono_v62je01

EPA ToxValDB — Toxicity Values

4 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).

Endpoint	Value	Species	Route	Duration	Source
NOEL	=1 mg/kg-day	Rat	oral	short-term	ECOTOX
NOAEL	=50 mg/kg-day	Rat	oral	chronic	EFSA
NOAEL	=50 mg/kg-day	Rat	oral	chronic	EFSA
NOAEL	=50 mg/kg-day	Rat	oral	chronic	EFSA

EU CosIng Annex Listing

European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.

Annex IV — Permitted Colorants

Product type: Yellow

Expanded Jurisdictional Detail

Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.

SA Saudi SFDA (IV - Colorants)

BRIN Brazil/India Cosmetics

India: Permitted Colorant

Additional Ingredient Properties

1 property record from structured ingredient metadata.

colorant

{"Common_Name": "Canthaxanthin", "Chemical_Name": "Canthaxanthin", "CAS_Number": "514-78-3", "Colorant_Type": "Natural Colorant", "Approved_Uses": "All cosmetics", "Max_Concentration_%": "No limit", "EU_Status": "Approved", "US_FDA_Status": "Approved", "Notes": "Orange-red carotenoid"}

PubChem Annotations

Safety and regulatory annotations from PubChem (NCBI) aggregated sources.

Regulatory (3)

JECFA Evaluation

LYCOPENE | 2009 | NOT SPECIFIED | Group ADI “not specified” for lycopene from all sources when used as food colour. Hence, the previous group ADI of 0–0.5 mg/kg for lycopene has been withdrawn. The group ADI “not specified” applies to synthetic lycopene, lycopene derived from the fungus Blakeslea trispora and lycopene extract from tomato that comply with the specifications, when used in accordance

Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)

JECFA Evaluation

Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)

JECFA Evaluation

Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)

Function Categories & List Membership

Cosmetic/Chemical Function Categories

Antioxidant Dye Flavouring and nutrient

Regulatory List Membership (3)

EU Regulated in Personal Care FDA Substances Added to Food (EAFUS) EU CosIng Cosmetics Ingredient Database

Expert Verdict

Expert safety assessment and concern-level summary for CI 75125 (Lycopene).

Regulatory Flags

natural-colorant carotenoid eu-annex-iv oil-soluble tomato-derived e160d food-grade-origin us-fda-food-only no-fda-cosmetic-color-listing fda_food_additive eu_cosing_listed

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to CI 75125 (Lycopene) by CAS number or substance name.

Studies

Lowest NOAEL

100 mg/kg bw/day

Highest NOAEL

4500 mg/kg bw/day

INCHEM_WHO_jecfa_jecmono_v62je01

Known Synonyms

EINECS 207-949-1 UNII-SB0N2N0WV6 Mexoryl SAQ Tomat-O-Red Redivivo (6E,8E,10E,12E,14E,16E,18E,20E,22E,24E,26E)-2,6,10,14,19,23,27,31-octamethyldotriaconta-2,6,8,10,12,14,16,18,20,22,24,26,30-tridecaene Lycopene 7 all-trans-lycopene

Chemical Function

Dye Antioxidant Flavouring and nutrient

Regulatory Lists

Europe; Personal care Canada; pharmaceutical Canada; pharmaceutical food_additive; Substances Added to Food (formerly EAFUS) (2/2019) Europe; Personal care Canada; pharmaceutical Canada; pharmaceutical

Cross-Vertical Safety Context

Same-CAS public records found in pharmaceutical and food safety data.

SOURCE ChEMBL / DrugCentral / FAERS DB_PHARMA CAS match

Pharmaceutical Data

Same-CAS rows from the pharmaceutical spoke database.

Compound

LYCOPENE

ChEMBL ID

CHEMBL501174

Max Phase

Adverse Event Associations

154

View full pharmaceutical profile →

SOURCE EFSA / FDA GRAS food_additives + fda_gras_enriched

Food Safety Data

Same-CAS food additive or FDA GRAS records from the core public database.

Food Name

Lycopene

E Number

E160d

ADI

0.5 mg/kg bw

FDA GRAS

FDA has no questions; some uses may require a color additive listing

GRN

173

Food Category

preservative

Ingredient in foods in general, except meat and poultry, at levels ranging from 5-575 parts per million

View full food safety profile →

Frequently Asked Questions

Is CI 75125 (Lycopene) safe in cosmetics?

CI 75125 (Lycopene) has a safety rating of "GOOD" in our database. EU status: permitted. US status: restricted. 10 toxicological study endpoint(s) are available in our database.

Is CI 75125 (Lycopene) allowed in the EU?

CI 75125 (Lycopene) EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does CI 75125 (Lycopene) do in cosmetics?

CI 75125 (Lycopene) functions as: Colorant. Natural carotenoid pigment extracted from tomatoes (Lycopersicon esculentum), also known as Lycopene and Natural Red 73. Imparts red-orange coloration to cosmetic products. Oil-soluble dye from the carotene family. Also designated food colorant E160d. Permitted EU colorant subject to purity criteria per Commission Directive 95/45/EC.. It is classified as a cosmetic ingredient in our database. CAS number: 502-65-8.

What is the NOAEL for CI 75125 (Lycopene)?

The NOAEL (No Observed Adverse Effect Level) for CI 75125 (Lycopene) is =100 mg/kg bw/day based on a Toxicology study study via oral route in Rat. A total of 10 study endpoints are available. Source: INCHEM_WHO_jecfa_jecmono_v62je01.

Is CI 75125 (Lycopene) used outside cosmetics?

CI 75125 (Lycopene) also appears in industrial chemical safety, pharmaceutical, and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

Compliance Tools

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Fragrance ingredient; skin conditioning

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Good Chemical family

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