RestrictedBinding ruleJPRegulator-hosted provisional English translationOfficial-source import checked

Thioctic acid

Japan Standards for Cosmetics: Thioctic acid

The provisional English translation of the MHLW Standards for Cosmetics lists this ingredient with the stated limit or use matrix.

Regulatory decision and full conditions

Status
Restricted
Legal role
Binding rule
Regulatory summary
The provisional English translation of the MHLW Standards for Cosmetics lists this ingredient with the stated limit or use matrix.
Conditions and restrictions
Published three-column use matrix (rinse-off / leave-on / mucosal; blank means prohibited, ○ means no upper limit): 0.01 0.01

Substance identity

Official source name
Thioctic acid
CAS
1077-28-7
EC
214-071-2
Identity mapping
exact INCI name
Linked ingredient
THIOCTIC ACID

Linked CosIng identity data

Names and aliases

THIOCTIC ACIDThioctic acid [JAN]

CosIng description: 1,2-Dithiolane-3-pentanoic acid, (+/-)-

Recorded cosmetic function: ANTIOXIDANT

Function pages:ANTIOXIDANT

View the complete ingredient profile

Cross-market snapshot for this identity

Exact linked records currently present in this site. An absent market means no imported exact match, not permission to use the substance.

1 market dataset
PubChem 2D chemical structure for CAS 1077-28-7
CAS 1077-28-7PubChem CID 864

Verified chemistry for CAS 1077-28-7

alpha Lipoic acid

IUPAC name
5-(dithiolan-3-yl)pentanoic acid
Molecular formula
C8H14O2S2
Molecular weight
206.3 g/mol
Exact mass
206.04352203 Da
Monoisotopic mass
206.04352203 Da
XLogP3
1.7
Topological polar surface area
87.9 Ų
Molecular complexity
150.0
Formal charge
0
Hydrogen-bond donors
1
Hydrogen-bond acceptors
4
Rotatable bonds
5
Heavy atoms
12
Covalent units
1

Names and synonyms reported to PubChem

thioctic acidalpha-Lipoic acid6,8-Thioctic acidBiletanDL-6,8-Thioctic acidThioctsanthioctateThiocacid
16 more reported names
ThioctanTioctic AcidAcidum thiocticumA-lipoicum acidumLipoic acid, dl-Lipoic acid, alphabiomoliponAlphaLipogammabiomo liponespa liponAlpha LipogammaPleomix AlphaVerla LiponAlphaLipon StadaAlpha Lippon ALAlpha Lipon Stada
External database identifiers
Advanced structure statistics
Defined atom stereocentres
0
Undefined atom stereocentres
1
Defined bond stereocentres
0
Undefined bond stereocentres
0
3D pharmacophore features
5
3D rings
1
3D hydrophobes
1
3D acceptor features
2
3D donor features
0
3D anionic centres
1
3D cationic centres
0
3D conformers
10
Effective 3D rotors
6.0
Machine-readable structure identifiers
SMILES
C1CSSC1CCCCC(=O)O
InChI
InChI=1S/C8H14O2S2/c9-8(10)4-2-1-3-7-5-6-11-12-7/h7H,1-6H2,(H,9,10)
InChIKey
AGBQKNBQESQNJD-UHFFFAOYSA-N

Evidence from additional scientific databases

NIH PubChem PUG-View
Exact identifier match864

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

  • Note: This chemical does not meet GHS hazard criteria for 6.5% (28 of 430) of reports. Source: European Chemicals Agency (ECHA)
  • Signal: Warning Source: European Chemicals Agency (ECHA)
  • GHS Hazard Statements: H302 (93.5%): Harmful if swallowed [Warning Acute toxicity, oral]; H315 (48.6%): Causes skin irritation [Warning Skin corrosion/irritation]; H317 (46.5%): May cause an allergic skin reaction [Warning Sensitization, Skin]; H319 (47%): Causes serious eye irritation [Warning Serious eye damage/eye irritation]; H411 (46.5%): Toxic to aquatic life with long lasting effects [Hazardous to the aquatic environment, long-term hazard] Source: European Chemicals Agency (ECHA)
  • Precautionary Statement Codes: P261, P264, P264+P265, P270, P272, P273, P280, P301+P317, P302+P352, P305+P351+P338, P321, P330, P332+P317, P333+P317, P337+P317, P362+P364, P391, 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 430 reports by companies from 16 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.; Reported as not meeting GHS hazard criteria per 28 of 430 reports by companies.; There are 14 notifications provided by 402 of 430 reports by companies with hazard statement code(s).; 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)
  • Note: This chemical does not meet GHS hazard criteria for 42.3% (52 of 123) of reports. Source: European Chemicals Agency (ECHA)
  • GHS Hazard Statements: H302 (57.7%): Harmful if swallowed [Warning Acute toxicity, oral]; H315 (31.7%): Causes skin irritation [Warning Skin corrosion/irritation]; H319 (31.7%): Causes serious eye irritation [Warning Serious eye damage/eye irritation]; H335 (31.7%): May cause respiratory irritation [Warning Specific target organ toxicity, single exposure; Respiratory tract irritation]; H412 (19.5%): Harmful to aquatic life with long lasting effects [Hazardous to the aquatic environment, long-term hazard] Source: European Chemicals Agency (ECHA)
  • Precautionary Statement Codes: P261, P264, P264+P265, P270, P271, P273, P280, P301+P317, P302+P352, P304+P340, P305+P351+P338, P319, P321, P330, P332+P317, P337+P317, P362+P364, P403+P233, 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 123 reports by companies from 8 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.; Reported as not meeting GHS hazard criteria per 52 of 123 reports by companies.; There are 7 notifications provided by 71 of 123 reports by companies with hazard statement code(s).; 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)
  • Health Effects: Acute exposure to cholinesterase inhibitors can cause a cholinergic crisis characterized by severe nausea/vomiting, salivation, sweating, bradycardia, hypotension, collapse, and convulsions. Increasing muscle weakness is a possibility and may result in death if respiratory muscles are involved. Accumulation of ACh at motor nerves causes overstimulation of nicotinic expression at the neuromuscular junction. When this occurs symptoms such as muscle weakness, fatigue, muscle cramps, fasciculation, and paralysis can be seen. When there is an accumulation of ACh at autonomic ganglia this causes overstimulation of nicotinic expression in the sympathetic system. Symptoms associated with this are hypertension, and hypoglycemia. Overstimulation of nicotinic acetylcholine receptors in the central nervous system, due to accumulation of ACh, results in anxiety, headache, convulsions, ataxia, depression of respiration and circulation, tremor, general weakness, and potentially coma. When there is expression of muscarinic overstimulation due to excess acetylcholine at muscarinic acetylcholine receptors symptoms of visual disturbances, tightness in chest, wheezing due to bronchoconstriction, incre Source: Toxin and Toxin Target Database (T3DB)
  • Toxicity Summary: ALA is generally considered a safe drug. A daily dose of 200 mg/day to 2400 mg/day of ALA is deemed safe without significant adverse effects. However, there is no reported safe dose in children.; A notable case in literature demonstrated status epilepticus (SE) that subsided within a few days. The seizures were treated per normal standards for SE.; In the last 2 decades, there have been few reported cases of ALA toxicity in humans. Most of these cases occur in children and are treatable. Though there is no established lethal dosage of ALA for humans, studies have shown that a high dose of 121 mg/kg body weight/day was associated with alterations in liver enzymes and liver function. Therefore, there are potentially harmful adverse effects from overdosing on ALA, and more studies are necessary to determine the toxicity. Source: StatPearls
  • Toxicity Summary: (R)-lipoic acid is a cholinesterase or acetylcholinesterase (AChE) inhibitor. A cholinesterase inhibitor (or 'anticholinesterase') suppresses the action of acetylcholinesterase. Because of its essential function, chemicals that interfere with the action of acetylcholinesterase are potent neurotoxins, causing excessive salivation and eye-watering in low doses, followed by muscle spasms and ultimately death. Nerve gases and many substances used in insecticides have been shown to act by binding a serine in the active site of acetylcholine esterase, inhibiting the enzyme completely. Acetylcholine esterase breaks down the neurotransmitter acetylcholine, which is released at nerve and muscle junctions, in order to allow the muscle or organ to relax. The result of acetylcholine esterase inhibition is that acetylcholine builds up and continues to act so that any nerve impulses are continually transmitted and muscle contractions do not stop. Among the most common acetylcholinesterase inhibitors are phosphorus-based compounds, which are designed to bind to the active site of the enzyme. The structural requirements are a phosphorus atom bearing two lipophilic groups, a leaving group (such as Source: Toxin and Toxin Target Database (T3DB)
  • Uses: Nutrition, biochemical research /Thioctic acid, dl-form/ Source: Hazardous Substances Data Bank (HSDB)
  • Uses: THERAPEUTIC CATEGORY: Treatment of liver disease; antidote to poisonous mushrooms (Amanita species). Source: Hazardous Substances Data Bank (HSDB)
  • Uses: Use (kg; approx.) in Germany (2009): >7500; Consumption (g per capita; approx.) in Germany (2009): 0.0916; Calculated removal (%): 96.4 Source: NORMAN Suspect List Exchange
  • Uses: For nutritional supplementation, also for treating dietary shortage or imbalance. Source: Toxin and Toxin Target Database (T3DB)

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 2026-08-31 by checksum-valid CAS matching. Chemical properties do not replace the regulatory decision on this page.

Official source and provenance

Registered source
Japan MHLW Standards for Cosmetics
Source reference
Appendix 2 section 3, entry 2
Source record ID
appendix-2-3:2
Source version
MHLW Notification No. 331 provisional translation, retrieved 2026-08-30
Source language
English provisional translation; Japanese text is canonical
Translation status
Regulator-hosted provisional English translation · English translation
Snapshot checked
2026-08-30 04:11 UTC
Validation method
pdftotext -layout plus strict per-table row counts
SHA-256
117fc949a82789ca66017163f19041cf2fcf6b5902708077c8e4f56c482dc8e2

Registered dataset notes

Dataset coverage
Prohibited and restricted ingredient appendices with concentration and use conditions
Authority note
Official MHLW standard; validate later Japanese updates before presenting current status

How this record fits the market dataset

117
current Japan records
87
records marked Restricted
117
records from this source version
32
market records with CAS identity

Status distribution

Condition text is present on 117 of 117 current records. An empty condition field is interpreted according to the record type above; it is never converted into an unrestricted-use claim.

Japan market context

Complete Standards appendices dataset

Coverage version: MHLW Standards for Cosmetics official English source and Japanese amendments checked for the imported snapshot

Prohibited ingredients, restricted ingredients and permitted preservative/UV/colourant appendices present in the official standard source.

Verification checklist

  1. Search Japanese/English identity and CAS where present.
  2. Apply category and maximum-amount conditions.
  3. Check later MHLW notices against the Japanese source.
  4. Verify marketing licence, notification, labelling and quasi-drug classification.

Official market sources

Verification workflow and record completeness

Before using this result in a compliance decision

  1. Confirm that “Thioctic acid” and every CAS/EC identifier refer to the material in your supplier specification.
  2. Search Japanese/English identity and CAS where present.
  3. Apply category and maximum-amount conditions.
  4. Check later MHLW notices against the Japanese source.
  5. Verify marketing licence, notification, labelling and quasi-drug classification.
  6. Document the source version and recheck the regulator before manufacture, notification or market placement.

Fields available in this record

  • Official substance nameAvailable
  • CASAvailable
  • ECAvailable
  • Separate condition textAvailable
  • Effective dateNot supplied
  • Snapshot hash and methodAvailable

Questions this page answers

This substance is not unrestricted: cosmetic use is subject to the conditions in the cited official record. Check product type, body area, concentration, purity and warning requirements before deciding whether a formulation is compliant.

If this row does not reproduce conditions, open the cited official detail because omission does not mean unrestricted use. The Japanese text and subsequent notices are canonical; no local match is not a product-compliance conclusion.

The record cites Appendix 2 section 3, entry 2, source version MHLW Notification No. 331 provisional translation, retrieved 2026-08-30. Open the official source.

No. CAS helps resolve identity, but jurisdictions can classify the same substance differently and can apply different product scopes, limits, warnings and transition dates.

Stable citation

Thioctic acid. Appendix 2 section 3, entry 2. Japan. Source version MHLW Notification No. 331 provisional translation, retrieved 2026-08-30. CosIng Checker regulatory record: https://cosingchecker.com/regulations/jp/records/633/

Cite the regulator as the legal authority. This page is a structured evidence index and verification aid, not a substitute for the official text or professional legal assessment.

Interpretation and limits for Japan

This substance is not unrestricted: cosmetic use is subject to the conditions in the cited official record.

Check product type, body area, concentration, purity and warning requirements before deciding whether a formulation is compliant.

How to interpret the legal role

The cited row forms part of a binding rule or legally incorporated list for this market.

Evidence on this page

  • Recorded outcome: Restricted
  • Legal role: Binding rule
  • Source version: MHLW Notification No. 331 provisional translation, retrieved 2026-08-30

What it does not prove

The Japanese text and subsequent notices are canonical; no local match is not a product-compliance conclusion.

Further authoritative substance research

These sources can add identity, safety, exposure or hazard context. A link is not evidence that the database contains this exact substance, and none of these sources overrides the market decision above.

Cosmetic Ingredient Review safety assessments

Expert Panel conclusions, assessed ingredient groups, use conditions, dates and report documents

Independent expert review considered by FDA; not a government approval or binding market rule

Research this identity at the source

FDA Global Substance Registration System

UNII identifiers, preferred names, substance types, codes and public substance relationships

Identity registry only; UNII availability does not imply FDA review or approval

Research this identity at the source

ILO/WHO International Chemical Safety Cards

Hazards, symptoms, first aid, storage, incompatibilities and physical properties for covered chemicals

International occupational chemical-safety reference; not cosmetic-use approval

Research this identity at the source

Japan NITE-CHRIP

Chemical identity, Japanese and foreign legal lists, GHS hazards and exposure-related information

Chemical-management evidence; cosmetic status remains governed by the applicable MHLW standard and market rules

Research this identity at the source

NIOSH Pocket Guide to Chemical Hazards

REL, PEL, IDLH, properties, exposure routes, symptoms, target organs, first aid and measurement methods for covered workplace chemicals

US occupational-health guidance and limits; not a cosmetic ingredient decision

Research this identity at the source

OECD eChemPortal

Gateway to authority-owned physical-property, fate, ecotoxicity, toxicity, exposure and GHS records

Discovery gateway; each linked authority remains responsible for its data

Research this identity at the source

US EPA CompTox CTX APIs

API key required for import

DTXSID identity, experimental and predicted properties, toxicity, bioactivity, exposure and environmental data

Scientific and computational evidence; predictions must remain labelled and do not determine cosmetic legality

Research this identity at the source