Moderate Cosmetic Ingredient NOAEL Data SCCS/CIR Reviewed Sensitization Data

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

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

CAS Number
30007-47-7
Function
Preservative (antimicrobial; formaldehyde releaser)
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
EU Max Conc. 0.1%
๐Ÿ‡บ๐Ÿ‡ธ 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 55 jurisdictions, use the Substance Compliance tool.

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

2 study endpoints 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 ca.50 mg/kg bw/day oral rat oral REACH
NOAEL 50 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
Verdict: unknown

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: ESSCA 2019/20; IVDK; FDA

Expert Verdict

Formaldehyde releaser that requires careful formulation to avoid nitrosamine formation; must not be used with nitrosating agents or amine/amide-containing ingredients; requires formaldehyde labeling if free formaldehyde exceeds 0.05%.

โš ๏ธ
Concern Level: High

Regulatory Flags

preservative eu_children_restricted eu_cosing_listed

Frequently Asked Questions

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

Formaldehyde releaser that requires careful formulation to avoid nitrosamine formation; must not be used with nitrosating agents or amine/amide-containing ingredients; requires formaldehyde labeling if free formaldehyde exceeds 0.05%. The EU classifies 5-Bromo-5-Nitro-1,3-Dioxane as "permitted". Safety rating: MODERATE. 2 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by cir.

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 Margin of Safety for 5-Bromo-5-Nitro-1,3-Dioxane?

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

The NOAEL (No Observed Adverse Effect Level) for 5-Bromo-5-Nitro-1,3-Dioxane is ca.50 mg/kg bw/day based on a oral study via oral route in rat. A total of 2 study endpoints are available. Source: REACH.

๐Ÿ“ฑ

Is 5-Bromo-5-Nitro-1,3-Dioxane in Your Products?

Scan any product label with Piro โ€” our free ingredient scanner. Point your camera at the ingredients list and get instant safety scores for every ingredient.

Try Piro Free โ†’

Analyze Your Full Ingredient List

Paste any INCI list into the Decoder for instant safety analysis, or calculate the Margin of Safety for 5-Bromo-5-Nitro-1,3-Dioxane in your formulation.