Moderate Cosmetic Ingredient NOAEL Data SCCS/CIR Reviewed Sensitization Data

P-AMINOPHENOL

CAS Number
123-30-8
Function
Hair Dyeing
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status Restricted
EU Max Conc. III/272 - (EC) No 1197/2013
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes CIR: S - IJT 34(Suppl.3):5-42, 2015

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Toxicological Studies

7 study endpoints found for P-AMINOPHENOL. 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 47 mg/kg bw/day oral rat Subchronic COSMOS_DB
LOAEL 133 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 10 mg/kg bw/day oral rat Subchronic COSMOS_DB
LOAEL 30 mg/kg bw/day oral rat Subchronic COSMOS_DB
LOEL 30 mg/kg bw/day oral rat oral REACH
NOAEL 20 mg/kg bw/day oral rat oral REACH
LOAEL 133 mg/kg bw/day oral rat oral REACH

Safety Opinions

Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).

cir Number 3, 1988
Verdict: unknown

Sensitization Profile

Contact sensitization data for P-AMINOPHENOL based on clinical patch test studies and IFRA standards.

Sensitization Rate
moderate
Allergen Class
dye
EU Allergen Listed
no
Patch Test Positive Rate
1.0%
Cross-reactivity Group
para-amino-group
Reaction Type
contact-dermatitis

Source: IVDK; NACDG; ESSCA

Expert Verdict

P-AMINOPHENOL is listed in the EU CosIng database with functions: Hair Dyeing It is restricted under EU Cosmetics Regulation. Restriction: III/272 - (EC) No 1197/2013.

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Concern Level: Medium

Regulatory Flags

cosing-sourced eu-restricted needs-enrichment endocrine_disruptor eu_cosing_listed

Frequently Asked Questions

Is P-AMINOPHENOL safe in cosmetics?

P-AMINOPHENOL is listed in the EU CosIng database with functions: Hair Dyeing It is restricted under EU Cosmetics Regulation. Restriction: III/272 - (EC) No 1197/2013. The EU classifies P-AMINOPHENOL as "Restricted". Safety rating: MODERATE. 7 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by cir.

Is P-AMINOPHENOL allowed in the EU?

P-AMINOPHENOL EU regulatory status: Restricted. Maximum allowed concentration: III/272 - (EC) No 1197/2013. This is based on EU Regulation 1223/2009 and its amendments.

What does P-AMINOPHENOL do in cosmetics?

P-AMINOPHENOL functions as: Hair Dyeing. It is classified as a cosmetic ingredient in our database. CAS number: 123-30-8.

What is the NOAEL for P-AMINOPHENOL?

The NOAEL (No Observed Adverse Effect Level) for P-AMINOPHENOL is 47 mg/kg bw/day based on a Subchronic study via oral route in rat. A total of 7 study endpoints are available. Source: COSMOS_DB.

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