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Annex II Entry 1594 CMR30/07/2020

Spiroxamine (ISO); 8-tert-butyl-1,4-dioxaspirol[4.5]decan-2-ylmethyl(ethyl)(propyl)amine

Spiroxamine (ISO); 8-tert-butyl-1,4-dioxaspirol[4.5]decan-2-ylmethyl(ethyl)(propyl)amine is listed in Annex II as a prohibited substance for cosmetic products placed on the EU market.

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Prohibited substance— Annex II, EU Regulation 1223/2009
Entry: 1594
CMR

Chemical identity and properties

PubChem 2D chemical structure for CAS 118134-30-8
CAS 118134-30-8PubChem CID 86160

Spiroxamine

Spiroxamine is the spiroketal resulting from the formal condensation of 4-tert-butylcyclohexanone with 3-[ethyl(propyl)amino]propane-1,2-diol. An inhibitor of ergosterol synthesis, it is a broad spectrum agricultural fungicide used particularly against powdery mildew in the production of cereals, bananas and grapes. It has a role as a xenobiotic, an environmental contaminant, a sterol biosynthesis inhibitor and an antifungal agrochemical. It is a dioxolane, a tertiary amino compound and a spiroketal. — ChEBI

IUPAC name
N-[(8-tert-butyl-1,4-dioxaspiro[4.5]decan-3-yl)methyl]-N-ethylpropan-1-amine
Molecular formula
C18H35NO2
Molecular weight
297.5 g/mol
Exact mass
297.266779359 Da
XLogP3
4.2
Topological polar surface area
21.7 Ų
Hydrogen-bond donors
0
Hydrogen-bond acceptors
3
Covalent units
1
Defined stereocentres
0

Also known as

ImpulseOUT5YHB7BOKWG4168KWG-4168CHEBI:92421,4-Dioxaspiro(4.5)decane-2-methanamine, 8-(1,1-dimethylethyl)-N-ethyl-N-propyl-8-(1,1-dimethylethyl)-N-ethyl-N-propyl-1,4-dioxaspiro(4.5)decane-2-methanamineN-[(8-tert-butyl-1,4-dioxaspiro[4.5]dec-2-yl)methyl]-N-ethylpropan-1-amine
16 more reported names
(8-Tert-butyl-1,4-dioxa-spiro(4.5)dec-2-ylmethyl)-ethyl-propyl-amine(8-tert-Butyl-1,4-dioxa-spiro[4.5]dec-2-ylmethyl)-ethyl-propyl-amine8-(1,1-dimethylethyl)-N-ethyl-N-propyl-1,4-dioxaspiro[4.5]decane-2-methanamineN-((8-tert-butyl-1,4-dioxaspiro(4.5)dec-2-yl)methyl)-N-ethylpropan-1-amineRefChem:184959((8-tert-butyl-1,4-dioxaspiro(4.5)decan-2-yl)methyl)(ethyl)propylaminespiroxamine (ISO); 8-tert-butyl-1,4-dioxaspiro(4.5)decan-2-ylmethyl(ethyl)(propyl)amine601-505-4ProsperN-((8-(tert-Butyl)-1,4-dioxaspiro[4.5]decan-2-yl)methyl)-N-ethylpropan-1-amineSpiroxamine [ISO]C18H35NO2N-[(8-tert-Butyl-1,4-dioxaspiro[4.5]dec-2-yl)methyl]-N-ethylpropan-1-aminUNII-OUT5YHB7BOpiroxamineN-Ethyl-N-propyl-8-tert-butyl-1,4-dioxaspiro[4.5]dec-2-ylmethylamine
Open full PubChem recordPubChem annotations3D structure image
External database identifiers

Evidence from additional scientific databases

NIH PubChem PUG-View
Exact identifier match86160

Attributed physical-property, hazard, environmental and use annotations.

  • Signal: Warning Source: Regulation (EC) No 1272/2008 of the European Parliament and of the Council
  • GHS Hazard Statements: H302: Harmful if swallowed [Warning Acute toxicity, oral]; H312: Harmful in contact with skin [Warning Acute toxicity, dermal]; H315: Causes skin irritation [Warning Skin corrosion/irritation]; H317: May cause an allergic skin reaction [Warning Sensitization, Skin]; H332: Harmful if inhaled [Warning Acute toxicity, inhalation]; H361d: Suspected of damaging the unborn child [Warning Reproductive toxicity]; H373: May causes damage to organs through prolonged or repeated exposure [Warning Specific target organ toxicity, repeated exposure]; H400: Very toxic to aquatic life [Warning Hazardous to the aquatic environment, acute hazard]; H410: Very toxic to aquatic life with long lasting effects [Warning Hazardous to the aquatic environment, long-term hazard] Source: Regulation (EC) No 1272/2008 of the European Parliament and of the Council
  • Precautionary Statement Codes: P203, P260, P261, P264, P270, P271, P272, P273, P280, P301+P317, P302+P352, P304+P340, P317, P318, P319, P321, P330, P332+P317, P333+P317, P362+P364, P391, P405, and P501 (click each P-code to see the statement) Source: Regulation (EC) No 1272/2008 of the European Parliament and of the Council
  • Signal: Warning Source: European Chemicals Agency (ECHA)
  • GHS Hazard Statements: H302+H312+H332 (64.8%): Harmful if swallowed, in contact with skin or if inhaled [Warning Acute toxicity, oral; acute toxicity, dermal; acute toxicity, inhalation]; H302 (100%): Harmful if swallowed [Warning Acute toxicity, oral]; H312 (100%): Harmful in contact with skin [Warning Acute toxicity, dermal]; H315 (100%): Causes skin irritation [Warning Skin corrosion/irritation]; H317 (100%): May cause an allergic skin reaction [Warning Sensitization, Skin]; H332 (100%): Harmful if inhaled [Warning Acute toxicity, inhalation]; H361d (23.8%): Suspected of damaging the unborn child [Warning Reproductive toxicity]; H373 (24.6%): May causes damage to organs through prolonged or repeated exposure [Warning Specific target organ toxicity, repeated exposure]; H400 (100%): Very toxic to aquatic life [Warning Hazardous to the aquatic environment, acute hazard]; H410 (100%): Very toxic to aquatic life with long lasting effects [Warning Hazardous to the aquatic environment, long-term hazard] Source: European Chemicals Agency (ECHA)
  • Precautionary Statement Codes: P203, P260, P261, P264, P270, P271, P272, P273, P280, P301+P317, P302+P352, P304+P340, P317, P318, P319, P321, P330, P332+P317, P333+P317, P362+P364, P391, P405, and P501 (click each P-code to see the statement) Source: European Chemicals Agency (ECHA)
  • ECHA C&L Notifications Summary: Aggregated GHS information provided per 122 reports by companies from 7 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.; Information may vary between notifications depending on impurities, additives, and other factors. The percentage value in parenthesis indicates the notified classification ratio from companies that provide hazard codes. Only hazard codes with percentage values above 10% are shown. For more detailed information, please visit ECHA C&L website. Source: European Chemicals Agency (ECHA)
  • Signal: Warning Source: Hazardous Chemical Information System (HCIS), Safe Work Australia
  • GHS Hazard Statements: H302: Harmful if swallowed [Warning Acute toxicity, oral]; H312: Harmful in contact with skin [Warning Acute toxicity, dermal]; H315: Causes skin irritation [Warning Skin corrosion/irritation]; H317: May cause an allergic skin reaction [Warning Sensitization, Skin]; H332: Harmful if inhaled [Warning Acute toxicity, inhalation]; H361d: Suspected of damaging the unborn child [Warning Reproductive toxicity]; H373: May causes damage to organs through prolonged or repeated exposure [Warning Specific target organ toxicity, repeated exposure]; H410: Very toxic to aquatic life with long lasting effects [Warning Hazardous to the aquatic environment, long-term hazard] Source: Hazardous Chemical Information System (HCIS), Safe Work Australia
  • Precautionary Statement Codes: P203, P260, P261, P264, P270, P271, P272, P273, P280, P301+P317, P302+P352, P304+P340, P317, P318, P319, P321, P330, P332+P317, P333+P317, P362+P364, P391, P405, and P501 (click each P-code to see the statement) Source: Hazardous Chemical Information System (HCIS), Safe Work Australia

Mapped by: Existing checksum-valid CAS to unique PubChem CID match. Retrieved: 2026-08-31. Open source record

Scientific classifications and hazard annotations provide context and do not replace the market-specific regulatory decision shown above.

Additional source coverage and match status
SourceResultChecked
NIH PubChem PUG-ViewExact match2026-08-31

A recorded no-match is useful evidence that the source was checked; it is not a claim that the substance does not exist elsewhere.

Retrieved from NIH PubChem on 2026-09-02 by checksum-valid CAS matching. Chemical properties do not replace the regulatory decision on this page.

Record details

Chemical name

Spiroxamine (ISO); 8-tert-butyl-1,4-dioxaspirol[4.5]decan-2-ylmethyl(ethyl)(propyl)amine

Chemical / IUPAC name

Spiroxamine (ISO); 8-tert-butyl-1,4-dioxaspirol[4.5]decan-2-ylmethyl(ethyl)(propyl)amine

Regulatory information

Regulation

(EU) 2019/831

See every entry this act set

CMR

CategoryCarcinogenicMutagenicReprotoxic
Cat. 2——✓

Key data

CAS
118134-30-8
EC
601-505-4
Annex
II
Entry number
1594

Direct matches are limited for this record, so nearby entries from Annex II are shown as well.

Annex II 1589
Nearby record in the same annex

Imidazole

CAS: 288-32-4
EC: 206-019-2

What Annex II means for Spiroxamine (ISO); 8-tert-butyl-1,4-dioxaspirol[4.5]decan-2-ylmethyl(ethyl)(propyl)amine

Spiroxamine (ISO); 8-tert-butyl-1,4-dioxaspirol[4.5]decan-2-ylmethyl(ethyl)(propyl)amine is listed as a prohibited substance under Annex II of EU Cosmetics Regulation 1223/2009 and must not be intentionally added. Article 17 separately addresses unintended small quantities that are technically unavoidable under good manufacturing practice and compatible with the Article 3 safety requirement.

Formulators must screen their ingredients and raw materials to ensure none contain this substance. Suppliers should provide documentation confirming absence when requested.

The page also surfaces 12 related annex records with overlapping identifiers, annex logic or naming patterns.

Compliance checklist

  • Verify this substance is absent from all raw materials and finished formulations.
  • Request absence confirmation or CoA from raw material suppliers.
  • Document the screening result in the Product Information File (PIF).
  • This substance has CMR classification. Review the CMR table above and verify current Annex II/III status before use.

Frequently asked questions

Yes. Spiroxamine (ISO); 8-tert-butyl-1,4-dioxaspirol[4.5]decan-2-ylmethyl(ethyl)(propyl)amine is listed in Annex II of EU Cosmetics Regulation 1223/2009 and is prohibited as an intentionally added cosmetic ingredient. Article 17 provides a narrow exception for unintended small quantities that are technically unavoidable under good manufacturing practice, provided the product remains safe under Article 3.

CAS 118134-30-8 is the unique numerical identifier assigned to Spiroxamine (ISO); 8-tert-butyl-1,4-dioxaspirol[4.5]decan-2-ylmethyl(ethyl)(propyl)amine by the Chemical Abstracts Service. In cosmetic compliance work, the CAS number is used to cross-reference the substance across regulatory databases, raw material specifications and safety assessment reports. Multiple EU annex entries may share the same CAS number if the same substance appears under different conditions or in different annexes.

Spiroxamine (ISO); 8-tert-butyl-1,4-dioxaspirol[4.5]decan-2-ylmethyl(ethyl)(propyl)amine has a CMR (carcinogenic, mutagenic or reprotoxic) classification under EU CLP Regulation. Under Article 15 of EU Cosmetics Regulation 1223/2009, CMR substances of category 1A or 1B are prohibited in cosmetics unless specifically permitted. Category 2 CMR substances may be used only if assessed safe by the SCCS. Always verify current annex status and any applicable derogations before use.

Use the INCI Checker tool on this site to paste your full ingredient list (INCI) and scan it against all Annex II–VI entries. The tool highlights any ingredients that match restricted, prohibited or allergen-flagged records. This is useful for rapid compliance screening of finished product formulas or raw material declarations.
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Source note for Annex II record Spiroxamine (ISO); 8-tert-butyl-1,4-dioxaspirol[4.5]decan-2-ylmethyl(ethyl)(propyl)amine

This page summarizes one Annex II record for Spiroxamine (ISO); 8-tert-butyl-1,4-dioxaspirol[4.5]decan-2-ylmethyl(ethyl)(propyl)amine from public European Commission cosmetic materials and adds linked inventory or identifier matches when available.

Use this record page to review Annex II conditions for Spiroxamine (ISO); 8-tert-butyl-1,4-dioxaspirol[4.5]decan-2-ylmethyl(ethyl)(propyl)amine, but confirm any final regulatory decision against the current official annex wording and source files.

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