3-Nitro-P-Hydroxyethylaminophenol (CAS 65235-31-6) is a cosmetic cosmetic ingredient functioning as Dye. Reported NOAEL =100 mg/kg/day in rat (SCCS_vision_codex); EU Regulation 1223/2009 status: prohibited, max 3.0%. Industrial safety data is also available in the chemical safety database.
US NotesPermitted under FDA coal-tar hair dye exemption (FD&C Act §601(a)); no specific concentration limit in US regulations
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Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for 3-Nitro-P-Hydroxyethylaminophenol.
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Toxicological Studies
10 study endpoints found for 3-Nitro-P-Hydroxyethylaminophenol. 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
=100 mg/kg/day
-
rat
developmental toxicity
SCCS_vision_codex
NOAEL
=100 mg/kg
oral
rat
developmental toxicity
SCCS_vision_codex
NOAEL
=100 mg/kg/day
-
rat
developmental toxicity
SCCS_vision_codex
NOAEL
=100 mg/kg
oral
rat
developmental toxicity
SCCS_vision_codex
NOAEL
=100 mg/kg/day
-
rat
developmental toxicity
SCCS_vision_codex
NOAEL
=100 mg/kg
oral
rat
developmental toxicity
SCCS_vision_codex
NOAEL
=100 mg/kg/day
-
rat
developmental toxicity
SCCS_vision_codex
NOAEL
=100 mg/kg
oral
rat
developmental toxicity
SCCS_vision_codex
NOAEL
=200 mg/kg bw/day
-
rat
NOAEL study
SCCS_vision_codex
NOAEL
=200 mg/kg bw/day
-
rat
NOAEL study
SCCS_vision_codex
Sensitization Profile
Contact sensitization data for 3-Nitro-P-Hydroxyethylaminophenol based on clinical patch test studies and IFRA standards.
Sensitization Rate
low
Allergen Class
dye
EU Allergen Listed
no
Patch Test Positive Rate
0.2%
Cross-reactivity Group
para-amino-group
Reaction Type
contact-dermatitis
Source: IVDK; NACDG; ESSCA
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.
Public NOAEL study rows linked to 3-Nitro-P-Hydroxyethylaminophenol by CAS number or substance name.
Studies
20
Lowest NOAEL
100
Highest NOAEL
1000
Units vary across source rows: mg/kg/day, mg/kg, mg/kg bw/day
SCCS_vision_codex
Chemical Function
Dye
Regulatory Lists
Canada; Personal care; Substances in PCP - Canada (4/2014)Europe; Personal care - hair coloringchildren; Europe; Personal careEurope; Personal care - hair coloringEurope; Personal care - hair coloringEurope; Personal care; restricted
Australian Status
AICIS status:listed
Frequently Asked Questions
Is 3-Nitro-P-Hydroxyethylaminophenol safe in cosmetics?
3-Nitro-P-Hydroxyethylaminophenol has a safety rating of "MODERATE" in our database. EU status: prohibited. US status: permitted. 10 toxicological study endpoint(s) are available in our database.
Is 3-Nitro-P-Hydroxyethylaminophenol allowed in the EU?
3-Nitro-P-Hydroxyethylaminophenol EU regulatory status: prohibited. Maximum allowed concentration: 3.0%. This is based on EU Regulation 1223/2009 and its amendments.
What does 3-Nitro-P-Hydroxyethylaminophenol do in cosmetics?
3-Nitro-P-Hydroxyethylaminophenol functions as: Dye. It is classified as a cosmetic ingredient in our database. CAS number: 65235-31-6.
What is the NOAEL for 3-Nitro-P-Hydroxyethylaminophenol?
The NOAEL (No Observed Adverse Effect Level) for 3-Nitro-P-Hydroxyethylaminophenol is =100 mg/kg/day based on a developmental toxicity study via oral route in rat. A total of 10 study endpoints are available. Source: SCCS_vision_codex.
Compliance Tools
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