Good Cosmetic Ingredient NOAEL Data

CI 42053

CAS Number
2353-45-9
Function
Colorant (green triphenylmethane dye)
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Permitted โ€” FD&C Green No. 3; permanently listed, certification required; eye area (incl. Al lake), lips, and external use

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
low
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for CI 42053. 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 1250 mg/kg bw/day oral rabbit Developmental COSMOS_DB
NOAEL 1250 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 2000 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 2500 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 3000 mg/kg bw/day oral mouse Chronic COSMOS_DB
NOAEL 500 mg/kg bw/day oral dog Chronic COSMOS_DB
NOAEL 1000 mg/kg bw/day oral rat Multigeneration Reproductive COSMOS_DB
NOAEL 1000 mg/kg bw/day oral rat Reproductive-developmental COSMOS_DB
NOAEL 3602 mg/kg bw/day oral rat Chronic COSMOS_DB
NOAEL 3602 mg/kg bw/day oral rat Carcinogenicity COSMOS_DB

Expert Verdict

Synthetic coal-tar derivative colorant with rare allergic reactions in sensitive individuals; certification required for use in eye area, lips, and external applications.

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Concern Level: Low

Regulatory Flags

colorant eu_banned_cosmetics eu_children_restricted epa_safer_alternative ifra_fragrance fda_food_additive eu_cosing_listed

Frequently Asked Questions

Is CI 42053 safe in cosmetics?

Synthetic coal-tar derivative colorant with rare allergic reactions in sensitive individuals; certification required for use in eye area, lips, and external applications. The EU classifies CI 42053 as "permitted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.

Is CI 42053 allowed in the EU?

CI 42053 EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does CI 42053 do in cosmetics?

CI 42053 functions as: Colorant (green triphenylmethane dye). It is classified as a cosmetic ingredient in our database. CAS number: 2353-45-9.

What is the Margin of Safety for CI 42053?

adequate 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 CI 42053?

The NOAEL (No Observed Adverse Effect Level) for CI 42053 is 1250 mg/kg bw/day based on a Developmental study via oral route in rabbit. A total of 10 study endpoints are available. Source: COSMOS_DB.

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