Moderate Cosmetic Ingredient NOAEL Data SCCS/CIR Reviewed Sensitization Data

5-Bromo-5-Nitro-1,3-Dioxane

Also known as: 1,3-Dioxane, 5-bromo-5-nitro-, BRN 4668673, 5-Bromo-5-nitro-m-dioxane, Bronidox, EINECS 250-001-7 (+2 more)

INCI: 5-BROMO-5-NITRO-1,3-DIOXANE

5-Bromo-5-Nitro-1,3-Dioxane (CAS 30007-47-7) is a cosmetic cosmetic ingredient functioning as Preservative (antimicrobial; formaldehyde releaser). NOAEL 50 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted, max 0.1%; 1 safety opinion reviewed (CIR Safety Assessment). Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.

View industrial chemical safety profile for CAS 30007-47-7 →

Auto-generated CPSR Part A draft with source citations
Function
Preservative (antimicrobial; formaldehyde releaser)
Safety Rating
MODERATE

Chemistry & Identifiers

EC Number
250-001-7

Regulatory Status

EU EU Status permitted
EU Max Conc. 0.1%
US US Status permitted
US Notes CIR concluded safe up to 0.1%, except where it can form nitrosamines/nitrosamides with amines or amides

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

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for 5-Bromo-5-Nitro-1,3-Dioxane.

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

1 study endpoint found for 5-Bromo-5-Nitro-1,3-Dioxane. 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 =45 mg/kg bw/day oral Rat developmental ECHA

Safety Opinions

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

CIR Safety Assessment
Verdict: unknown

Pre-Calculated Safety Assessment

Pre-calculated NOAEL → SED → MoS audit trail for 5-Bromo-5-Nitro-1,3-Dioxane across SCCS product categories, with measured dermal absorption where available.

Sensitization Profile

Contact sensitization data for 5-Bromo-5-Nitro-1,3-Dioxane based on clinical patch test studies and IFRA standards.

Sensitization Rate
low
Allergen Class
preservative
EU Allergen Listed
no
Patch Test Positive Rate
0.5%
Cross-reactivity Group
formaldehyde-releaser-group
Reaction Type
contact-dermatitis

Source: FDA

ECHA REACH Registration

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

Registration Type
Full
Tonnage Band
10 - 100 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No

EU CosIng Annex Listing

European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.

Annex V — Permitted Preservatives
Product type: Rinse-off products
Max: 0.1%

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.

KR Korea MFDS Annex 2 (Restricted)
Category: Preservative. Max: 0.1% (rinse-off only). Leave-on & amine-containing prohibited
SA Saudi SFDA (V - Preservatives)
Product type: Rinse-off products. Max: 0.001.
BRIN Brazil/India Cosmetics
Brazil: Permitted Preservative · max 0,1%
India: Permitted Preservative · max 0.001
Additional Jurisdictional Restrictions (4)
Jurisdiction Status Max % Product Type
IN permitted_preservative 0.1 rinse-off products only
BR permitted_preservative 0.1 Prohibited in leave-on products; avoid nitrosamine formation
CA restricted 0.1% All cosmetics except amine-containing formulations
ASEAN permitted_preservative 0.1% Rinse-off products only

Additional Ingredient Properties

3 property records from structured ingredient metadata.

allergen_detail
{"eu_allergen_listed": "no", "allergen_class": "preservative", "cross_reactivity_group": "formaldehyde-releaser-group", "patch_test_frequency_pct": "0.5", "sensitization_rate": "low", "common_reaction_type": "contact-dermatitis", "ifra_restricted": "no", "source": "ESSCA 2019/20; IVDK; FDA"}
pregnancy_detail
{"pregnancy_safe": "avoid", "breastfeeding_safe": "avoid", "trimester_restriction": "all", "risk_category": "not-rated", "reason": "Formaldehyde releaser", "alternative_ingredient": "Phenoxyethanol", "source": "dermatology literature"}
regulatory
{"eu_status": "banned", "us_status": "allowed", "eu_max_concentration": "0", "restricted_in": "all products", "ban_date": "2019-04-01", "regulation_reference": "Annex II/1391"}

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Preservative
Regulatory List Membership (3)
EU Regulated in Personal Care EU Restricted for Children (Cosmetics) EU CosIng Cosmetics Ingredient Database

Expert Verdict

Expert safety assessment and concern-level summary for 5-Bromo-5-Nitro-1,3-Dioxane.

Regulatory Flags

preservative eu_children_restricted eu_cosing_listed

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to 5-Bromo-5-Nitro-1,3-Dioxane by CAS number or substance name.

Studies
1
Lowest NOAEL
45 mg/kg bw/day
Highest NOAEL
45 mg/kg bw/day
ECHA

Known Synonyms

1,3-Dioxane, 5-bromo-5-nitro- BRN 4668673 5-Bromo-5-nitro-m-dioxane Bronidox EINECS 250-001-7 5-Brom-5-nitro-1,3-dioxan UNII-U184I9QBNM

Chemical Function

Preservative

Regulatory Lists

Europe; Personal care children; Europe; Personal care - body hygiene - body wash children; Europe; Personal care - specialized bath products - bubble bath children; Europe; Personal care children; Europe; Personal care children; Europe; Personal care children; Europe; Personal care active_ingredient; Europe; Pesticides

Australian Status

AICIS status: listed

Cross-Vertical Safety Context

Same-CAS public records found in pharmaceutical data.

SOURCE ChEMBL / DrugCentral / FAERS DB_PHARMA CAS match

Pharmaceutical Data

Same-CAS rows from the pharmaceutical spoke database.

ChEMBL ID
CHEMBL3185787
View full pharmaceutical profile →

Frequently Asked Questions

Is 5-Bromo-5-Nitro-1,3-Dioxane safe in cosmetics?

5-Bromo-5-Nitro-1,3-Dioxane has a safety rating of "MODERATE" in our database. EU status: permitted. US status: permitted. 1 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by CIR Safety Assessment.

Is 5-Bromo-5-Nitro-1,3-Dioxane allowed in the EU?

5-Bromo-5-Nitro-1,3-Dioxane EU regulatory status: permitted. Maximum allowed concentration: 0.1%. This is based on EU Regulation 1223/2009 and its amendments.

What does 5-Bromo-5-Nitro-1,3-Dioxane do in cosmetics?

5-Bromo-5-Nitro-1,3-Dioxane functions as: Preservative (antimicrobial; formaldehyde releaser). It is classified as a cosmetic ingredient in our database. CAS number: 30007-47-7.

What is the NOAEL for 5-Bromo-5-Nitro-1,3-Dioxane?

The NOAEL (No Observed Adverse Effect Level) for 5-Bromo-5-Nitro-1,3-Dioxane is =45 mg/kg bw/day based on a developmental study via oral route in Rat. Source: ECHA.

Is 5-Bromo-5-Nitro-1,3-Dioxane used outside cosmetics?

5-Bromo-5-Nitro-1,3-Dioxane also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

Does 5-Bromo-5-Nitro-1,3-Dioxane have different safety status in cosmetics vs industrial chemicals?

5-Bromo-5-Nitro-1,3-Dioxane is classified GHS Danger (H302, H314, H315, H317, H318, H373, H400, H410) in the chemicals database but is allowed in EU cosmetics at max 0.1%.

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