Moderate Cosmetic Ingredient NOAEL Data

Caramel

Also known as: (Caramel) (AP 680) (BC 420 (Color)) (Burnt sugar) (Burnt sugar coloring), BC 420, Burnt sugar, Burnt sugar coloring, Caramel flavor (+6 more)

INCI: CARAMEL

Caramel (CAS 8028-89-5) is a cosmetic cosmetic ingredient functioning as Colorant (brownish-orange to dark brown), burnt sugar coloring. Reported NOAEL =10 mg/kg bw/day in Rat (ToxValDB_ECHA_IUCLID); 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 data.

View industrial chemical safety profile for CAS 8028-89-5 →

Auto-generated CPSR Part A draft with source citations
Function
Colorant (brownish-orange to dark brown), burnt sugar coloring
Safety Rating
MODERATE

Chemistry & Identifiers

EC Number
232-435-9

Regulatory Status

EU EU Status permitted
US US Status permitted
US Notes Permanently listed, exempt from certification - Foods, Drugs, Cosmetics generally, including eye area use

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

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Caramel.

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

3 study endpoints found for Caramel. 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 =10 mg/kg bw/day oral Rat subchronic ToxValDB_ECHA_IUCLID
NOAEL =15 mg/kg bw/day oral Rat subchronic ToxValDB_ECHA_IUCLID
NOAEL =20 mg/kg bw/day oral Rat subchronic ToxValDB_ECHA_IUCLID

ECHA REACH Registration

European Chemicals Agency REACH dossier and Substances of Very High Concern listing.

Registration Type
Full
Tonnage Band
100 - 1,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No

Additional Ingredient Properties

2 property records from structured ingredient metadata.

colorant_formulator
{"ci_number": "75130", "ci_name": "Natural Brown 10", "color_category": "brown", "color_hex_code": "#964B00", "natural_or_synthetic": "natural", "organic_or_inorganic": "organic", "lake_or_dye": "dye", "fda_approved_use": "general", "eu_approved_cosmetic": "yes", "japan_approved": "yes", "china_approved": "yes", "coverage_opacity": "transparent", "tinting_strength": "low", "lightfastness_rating": …
self_tanning
{"cas_number": "8028-89-5", "ingredient_class": "instant_bronzer", "tanning_mechanism": "cosmetic_colorant", "color_development_onset_hours": "0.0", "full_color_development_hours": "0", "color_duration_days": "0", "color_depth": "medium", "undertone": "warm_golden", "color_uniformity": "excellent", "DHA_concentration_if_applicable_pct": "0", "erythrulose_concentration_pct": "0", "pH_dependent_colo…

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Deodorizer Dye Flavouring and nutrient Fragrance Pigment Solvent Tracer
Regulatory List Membership (5)
EU Regulated in Personal Care IFRA Fragrance Transparency List EPA Safer Chemical Ingredients List (SCIL) FDA Substances Added to Food (EAFUS) EU CosIng Cosmetics Ingredient Database

Expert Verdict

Expert safety assessment and concern-level summary for Caramel.

Regulatory Flags

colorant natural-origin epa_safer_alternative ifra_fragrance fda_food_additive eu_cosing_listed

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Caramel by CAS number or substance name.

Studies
3
Lowest NOAEL
10 mg/kg bw/day
Highest NOAEL
20 mg/kg bw/day
ToxValDB_ECHA_IUCLID

Known Synonyms

(Caramel) (AP 680) (BC 420 (Color)) (Burnt sugar) (Burnt sugar coloring) BC 420 Burnt sugar Burnt sugar coloring Caramel flavor Caramel liquid EINECS 232-435-9 FEMA No. 2235 Natural brown 10 UNII-T9D99G2B1R Caramel (color)

Chemical Function

Dye Deodorizer Fragrance

Regulatory Lists

SCIL (9/2019) inert_ingredient; Pesticides inert_ingredient; non_food_use; Pesticides general_foods pharmaceutical Personal care Europe; Personal care food_additive; Substances Added to Food (formerly EAFUS) (2/2019) IFRA Transparency SCIL (9/2019)

Australian Status

AICIS status: listed

Frequently Asked Questions

Is Caramel safe in cosmetics?

Caramel has a safety rating of "MODERATE" in our database. EU status: permitted. US status: permitted. 3 toxicological study endpoint(s) are available in our database.

Is Caramel allowed in the EU?

Caramel EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Caramel do in cosmetics?

Caramel functions as: Colorant (brownish-orange to dark brown), burnt sugar coloring. It is classified as a cosmetic ingredient in our database. CAS number: 8028-89-5.

What is the NOAEL for Caramel?

The NOAEL (No Observed Adverse Effect Level) for Caramel is =10 mg/kg bw/day based on a subchronic study via oral route in Rat. A total of 3 study endpoints are available. Source: ToxValDB_ECHA_IUCLID.

Is Caramel used outside cosmetics?

Caramel also appears in industrial chemical safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

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