Good Active Ingredient NOAEL Data

Theobroma Cacao Seed Extract

INCI: THEOBROMA CACAO SEED EXTRACT

CAS Number
84649-99-0
Function
Antioxidant, Skin Conditioning
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes No FDA restriction. CIR assessed constituent methylxanthines (caffeine, theobromine, theophylline) in 2024 -- all found safe in cosmetics at present concentrations. No dedicated CIR monograph exists for Theobroma Cacao Seed Extract itself; CIR reviewed cocoa seed butter separately.

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
moderate
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

2 study endpoints found for Theobroma Cacao Seed Extract. 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 4280 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 2140 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB

Expert Verdict

Permitted in EU (not listed in Annexes II-VI of Regulation (EC) No 1223/2009; no concentration restrictions). Not restricted by FDA under MoCRA. CIR reviewed cocoa seed butter and constituent methylxanthines separately, concluding caffeine and theobromine are safe in cosmetics at present use levels. No dedicated CIR monograph for the seed extract itself.

โš ๏ธ
Concern Level: Low

Regulatory Flags

no-sccs-opinion no-cir-monograph read-across-safety no-llna-data no-hript-data theobromine-content-assess-separately dermal-absorption-default-only fda_food_additive

Frequently Asked Questions

Is Theobroma Cacao Seed Extract safe in cosmetics?

Permitted in EU (not listed in Annexes II-VI of Regulation (EC) No 1223/2009; no concentration restrictions). Not restricted by FDA under MoCRA. CIR reviewed cocoa seed butter and constituent methylxanthines separately, concluding caffeine and theobromine are safe in cosmetics at present use levels. No dedicated CIR monograph for the seed extract itself. The EU classifies Theobroma Cacao Seed Extract as "permitted". Safety rating: GOOD. 2 toxicological study endpoint(s) are available in our database.

Is Theobroma Cacao Seed Extract allowed in the EU?

Theobroma Cacao Seed Extract EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Theobroma Cacao Seed Extract do in cosmetics?

Theobroma Cacao Seed Extract functions as: Antioxidant, Skin Conditioning. It is classified as a Active Ingredient in our database. CAS number: 84649-99-0.

What is the Margin of Safety for Theobroma Cacao Seed Extract?

not established The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

What is the NOAEL for Theobroma Cacao Seed Extract?

The NOAEL (No Observed Adverse Effect Level) for Theobroma Cacao Seed Extract is 4280 mg/kg bw/day based on a Short Term Toxicity study via oral route in rat. A total of 2 study endpoints are available. Source: COSMOS_DB.

๐Ÿ“ฑ

Is Theobroma Cacao Seed Extract in Your Products?

Scan any product label with Piro โ€” our free ingredient scanner. Point your camera at the ingredients list and get instant safety scores for every ingredient.

Try Piro Free โ†’

Analyze Your Full Ingredient List

Paste any INCI list into the Decoder for instant safety analysis, or calculate the Margin of Safety for Theobroma Cacao Seed Extract in your formulation.