Is CI 75130 (Beta-Carotene) safe in cosmetics?
CI 75130 (Beta-Carotene) has a safety rating of "EXCELLENT" in our database. EU status: permitted. US status: permitted. 10 toxicological study endpoint(s) are available in our database.
CI 75130 (Beta-Carotene)
Also known as: trans-beta-Carotene, beta-Carotene, EC No.: 230-636-6, C.I. 40800, Cyclohexene, 1,1'-(3,7,12,16-tetramethyl-1,3,5,7,9,11,13,15,17-octadecanonaene-1,18-diyl)bis(2,6,6-trimethyl-, (all-E)- (+15 more)
INCI: CI 75130
CI 75130 (Beta-Carotene) (CAS 7235-40-7) is a cosmetic cosmetic ingredient functioning as Colorant. Synthetic or plant-derived carotenoid pigment; also known as. Reported NOAEL =13 mg/kg bw/day (INCHEM_WHO_jecfa_jecmono_v1020je01); 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 and pharmaceutical data.
View industrial chemical safety profile for CAS 7235-40-7 →
Auto-generated CPSR Part A draft with source citations
Function
Colorant. Synthetic or plant-derived carotenoid pigment; also known as Beta,beta-Carotene, Natural Yellow 26, Food Orange 5, and food colorant E160a. Imparts orange-yellow coloration to cosmetic products. Precursor to Vitamin A in the body. Oil-soluble dye with antioxidant properties.
Safety Rating
EXCELLENT
Chemistry & Identifiers
IUPAC Name
1,3,3-trimethyl-2-[(1E,3E,5E,7E,9E,11E,13E,15E,17E)-3,7,12,16-tetramethyl-18-(2,6,6-trimethylcyclohexen-1-yl)octadeca-1,3,5,7,9,11,13,15,17-nonaenyl]cyclohexene
InChIKey
OENHQHLEOONYIE-JLTXGRSLSA-N
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
FDA permanently lists Beta-Carotene as a color additive exempt from certification for cosmetics generally including eye area use (21 CFR 73.2095), externally applied drugs including eye area use (21 CFR 73.1095), and ingested drugs generally (21 CFR 73.95). Broadly approved across food, drug, and cosmetic categories.
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 75130 (Beta-Carotene).
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for CI 75130 (Beta-Carotene). 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 | =13 mg/kg bw/day | oral | - | Toxicology study | INCHEM_WHO_jecfa_jecmono_v1020je01 |
| NOAEL | =13 mg/kg bw/day | oral | - | Toxicology study | INCHEM_WHO_jecfa_jecmono_v1020je01 |
| NOAEL | =14 mg/kg bw/day | dermal | - | Dermal toxicity | INCHEM_WHO_jecfa_jecmono_v1020je01 |
| NOAEL | =14 mg/kg bw/day | dermal | - | Dermal toxicity | INCHEM_WHO_jecfa_jecmono_v1020je01 |
| NOAEL | =30 mg/kg bw/day | - | Rat | Toxicology study | INCHEM_WHO_jecfa_jecmono_v1020je01 |
| NOAEL | =30 mg/kg bw/day | - | Rat | Toxicology study | INCHEM_WHO_jecfa_jecmono_v1020je01 |
| NOAEL | =50 mg/kg bw/day | oral | Human; Rat | Reproductive toxicity | INCHEM_WHO_jecfa_jecmono_v1020je01 |
| NOAEL | =50 mg/kg bw/day | oral | Human; Rat | Reproductive toxicity | INCHEM_WHO_jecfa_jecmono_v1020je01 |
| NOAEL | =64 mg/kg bw/day | - | Rat | Toxicology study | INCHEM_WHO_jecfa_jecmono_v1020je01 |
| NOAEL | =64 mg/kg bw/day | - | Rat | Toxicology study | INCHEM_WHO_jecfa_jecmono_v1020je01 |
EPA ToxValDB — Toxicity Values
3 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| LEL | >=20 mg/day | Human | oral | - | EFSA |
| LEL | <=15 mg/day | Human | oral | chronic | EFSA |
| LD50 | >2000 mg/kg | Rat | oral | - | ECHA IUCLID |
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
10 - 100 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
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.
Additional Jurisdictional Restrictions (3)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| CN | permitted_colorant | - | All cosmetics (Class 1) |
| BR | permitted_colorant | - | Column 1: All products |
| ASEAN | permitted_colorant | - | All products |
Additional Ingredient Properties
1 property record from structured ingredient metadata.
colorant
{"Common_Name": "Beta-Carotene", "Chemical_Name": "Beta-carotene", "CAS_Number": "7235-40-7", "Colorant_Type": "Natural Colorant", "Approved_Uses": "All cosmetics", "Max_Concentration_%": "No limit", "EU_Status": "Approved", "US_FDA_Status": "Approved", "Notes": "Orange, antioxidant"}
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Regulatory (6)
JECFA Evaluation
beta,beta-CAROTENE | 2019 | WITHDRAWN | The Committee reaffirmed the conclusion from the eighty-fourth meeting that rats are not an appropriate model for deriving an ADI for β-carotene due to the relatively low bioavailability of β-carotene in rats compared with humans. Therefore, the Committee withdrew the two group ADIs of 0–5 mg/kg bw for (1) the sum of the synthetic carotenoids β-carotene, β-a
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)
JECFA Evaluation
CAROTENES (natural) | 1989 | NO ADI ALLOCATED | TRS 789-JECFA 35/21 | NOT PREPARED
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)
EU Food Improvement
Food additives
Source: EU Food Improvement Agents
EU Food Improvement
Food additives
Source: EU Food Improvement Agents
EU Food Improvement
Food additives
Source: EU Food Improvement Agents
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Antioxidant
Dye
Flavouring and nutrient
Fragrance
Pharmaceutical
Processing aids not otherwise specified
Softener and conditioner
Surface modifier
Regulatory List Membership (5)
EU Regulated in Personal Care
EU Restricted for Children (Cosmetics)
IFRA Fragrance Transparency List
FDA Substances Added to Food (EAFUS)
EU CosIng Cosmetics Ingredient Database
Expert Verdict
Expert safety assessment and concern-level summary for CI 75130 (Beta-Carotene).
Regulatory Flags
natural-colorant
carotenoid
eu-annex-iv
fda-exempt-certification
oil-soluble
vitamin-a-precursor
e160a
eye-area-permitted
food-drug-cosmetic-approved
antioxidant
eu_children_restricted
ifra_fragrance
fda_food_additive
eu_cosing_listed
jecfa_concern
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to CI 75130 (Beta-Carotene) by CAS number or substance name.
Studies
72
Lowest NOAEL
10
Highest NOAEL
50000
Units vary across source rows: mg/kg bw/day, mg/kg diet
INCHEM_WHO_jecfa_jecmono_v1020je01
INCHEM_WHO_jecfa_jecmono_v78je01
Known Synonyms
trans-beta-Carotene
beta-Carotene
EC No.: 230-636-6
C.I. 40800
Cyclohexene, 1,1'-(3,7,12,16-tetramethyl-1,3,5,7,9,11,13,15,17-octadecanonaene-1,18-diyl)bis(2,6,6-trimethyl-, (all-E)-
Diet,beta-carotene supplementation
EINECS 230-636-6
Natural Yellow 26
1,1'-(3,7,12,16-Tetramethyl-1,3,5,7,9,11,13,15,17-octadecanonaene-1,18-diyl)bis(2,6,6-trimethylcyclohexene), (all E)-
Betacaroteno
Betacarotenum
Karotin
Zlut prirodni 26
UNII-01YAE03M7J
(all-E)-1,1'-(3,7,12,16-Tetramethyl-1,3,5,7,9,11,13,15,17-octadecanonaene-1,18-diyl)bis
(all-E)-1,1'-(3,7,12,16-tetramethyl-1,3,5,7,9,11,13,15,17-octadecanonaene-1,18-diyl)bis[2,6,6-trimethyl-Cyclohexene
1,1'-[(1E,3E,5E,7E,9E,11E,13E,15E,17E)-3,7,12,16-tetramethyloctadeca-1,3,5,7,9,11,13,15,17-nonaene-1,18-diyl]bis(2,6,6-trimethylcyclohexene)
1,3,3-trimethyl-2-[(1E,3E,5E,7E,9E,11E,13E,15E,17E)-3,7,12,16-tetramethyl-18-(2,6,6-trimethyl-1-cyclohexenyl)octadeca-1,3,5,7,9,11,13,15,17-nonaenyl]cyclohexene
1,3,3-trimethyl-2-[(1E,3E,5E,7E,9E,11E,13E,15E,17E)-3,7,12,16-tetramethyl-18-(2,6,6-trimethylcyclohex-1-en-1-yl)octadeca-1,3,5,7,9,11,13,15,17-nonaen-1-yl]cyclohex-1-ene
1,3,3-trimethyl-2-[(1E,3E,5E,7E,9E,11E,13E,15E,17E)-3,7,12,16-tetramethyl-18-(2,6,6-trimethylcyclohexen-1-yl)octadeca-1,3,5,7,9,11,13,15,17-nonaenyl]cyclohexene
Chemical Function
Dye
Softener and conditioner
Flavouring and nutrient
Fragrance
Pharmaceutical
Regulatory Lists
IFRA Transparency
Australia; Food and drug - smoking-related products
Europe; Personal care
Canada; pharmaceutical
Canada; pharmaceutical
general_foods
pharmaceutical
Personal care
Europe; supplements
Europe; food_additive; supplements
Europe; Personal care
children; Europe; Personal care
children; Europe; Personal care - general moisturizing - hand/body lotion
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
pharmaceutical
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
BETA CAROTENE
ChEMBL ID
CHEMBL1293
Max Phase
4
Adverse Event Associations
1526
Frequently Asked Questions
Is CI 75130 (Beta-Carotene) allowed in the EU?
CI 75130 (Beta-Carotene) EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does CI 75130 (Beta-Carotene) do in cosmetics?
CI 75130 (Beta-Carotene) functions as: Colorant. Synthetic or plant-derived carotenoid pigment; also known as Beta,beta-Carotene, Natural Yellow 26, Food Orange 5, and food colorant E160a. Imparts orange-yellow coloration to cosmetic products. Precursor to Vitamin A in the body. Oil-soluble dye with antioxidant properties.. It is classified as a cosmetic ingredient in our database. CAS number: 7235-40-7.
What is the NOAEL for CI 75130 (Beta-Carotene)?
The NOAEL (No Observed Adverse Effect Level) for CI 75130 (Beta-Carotene) is =13 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_v1020je01.
Is CI 75130 (Beta-Carotene) used outside cosmetics?
CI 75130 (Beta-Carotene) also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check CI 75130 (Beta-Carotene) compliance across multiple jurisdictions:
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Substance Compliance
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MoS Calculator
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Heavy Metal Limits
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