타크로리무스(tacrolimus), 그 염류 및유도체
Listed by the Korean MFDS as a substance that may not be used in cosmetics.
Regulatory decision and full conditions
- Status
- Prohibited
- Legal role
- Binding rule
- Regulatory summary
- Listed by the Korean MFDS as a substance that may not be used in cosmetics.
- Conditions and restrictions
- 타크로리무스
Substance identity
- Official source name
- 타크로리무스(tacrolimus), 그 염류 및유도체
- CAS
- 104987-11-3
- EC
- Not supplied in this source row
- Identity mapping
- standalone:official_korean_name
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.
South Korea
Current record1 linked record · 1 with specific conditions
Open supporting recordVerified chemistry for CAS 104987-11-3
Tacrolimus
- IUPAC name
- (1R,9S,12S,13R,14S,17R,18E,21S,23S,24R,25S,27R)-1,14-dihydroxy-12-[(E)-1-[(1R,3R,4R)-4-hydroxy-3-methoxycyclohexyl]prop-1-en-2-yl]-23,25-dimethoxy-13,19,21,27-tetramethyl-17-prop-2-enyl-11,28-dioxa-4-azatricyclo[22.3.1.04,9]octacos-18-ene-2,3,10,16-tetrone
- Molecular formula
- C44H69NO12
- Molecular weight
- 804.0 g/mol
- Exact mass
- 803.48197664 Da
- Monoisotopic mass
- 803.48197664 Da
- XLogP3
- 2.7
- Topological polar surface area
- 178.0 Ų
- Molecular complexity
- 1480.0
- Formal charge
- 0
- Hydrogen-bond donors
- 3
- Hydrogen-bond acceptors
- 12
- Rotatable bonds
- 7
- Heavy atoms
- 57
- Covalent units
- 1
Names and synonyms reported to PubChem
16 more reported names
External database identifiers
- ChEBI:CHEBI:61049
- ChEBI:CHEBI:93221
- ChEMBL:CHEMBL269732
- EPA DTXSID:DTXSID5046354
- PubMed:30545944
- PubMed:17965516
- PubMed:16702731
- PubMed:16021174
- PubMed:15896681
- PubMed:14661025
- PubMed:11145792
- PubMed:9857082
- PubMed:2445721
- PubMed:1715244
Advanced structure statistics
- Defined atom stereocentres
- 14
- Undefined atom stereocentres
- 0
- Defined bond stereocentres
- 2
- Undefined bond stereocentres
- 0
- 3D conformers
- 0
Machine-readable structure identifiers
- SMILES
C[C@@H]1C[C@@H]([C@@H]2[C@H](C[C@H]([C@@](O2)(C(=O)C(=O)N3CCCC[C@H]3C(=O)O[C@@H]([C@@H]([C@H](CC(=O)[C@@H](/C=C(/C1)\C)CC=C)O)C)/C(=C/[C@@H]4CC[C@H]([C@@H](C4)OC)O)/C)O)C)OC)OC- InChI
InChI=1S/C44H69NO12/c1-10-13-31-19-25(2)18-26(3)20-37(54-8)40-38(55-9)22-28(5)44(52,57-40)41(49)42(50)45-17-12-11-14-32(45)43(51)56-39(29(6)34(47)24-35(31)48)27(4)21-30-15-16-33(46)36(23-30)53-7/h10,19,21,26,28-34,36-40,46-47,52H,1,11-18,20,22-24H2,2-9H3/b25-19+,27-21+/t26-,28+,29+,30-,31+,32-,33+,34-,36+,37-,38-,39+,40+,44+/m0/s1- InChIKey
QJJXYPPXXYFBGM-LFZNUXCKSA-N
Evidence from additional scientific databases
EMBL-EBI ChEBI
tacrolimus (anhydrous)
A macrolide lactam containing a 23-membered lactone ring, originally isolated from the fermentation broth of a Japanese soil sample that contained the bacteria Streptomyces tsukubaensis.
- Formula
- C44H69NO12
- Average mass
- 804.031 g/mol
- Monoisotopic mass
- 803.48198 Da
- Formal charge
- 0
- macrolide lactam — is a (CHEBI:145565)
- bacterial metabolite — has role (CHEBI:76969)
- immunosuppressive agent — has role (CHEBI:35705)
- bacterial metabolite — has role (CHEBI:76969)
- immunosuppressive agent — has role (CHEBI:35705)
- macrolide lactam — is a (CHEBI:145565)
Additional curated names
Cross-references from this source
- CAS: 104987-11-3 — KEGG COMPOUND
- CAS: 104987-11-3 — ChemIDplus
- CAS: 104987-11-3 — KEGG DRUG
- REGISTRY_NUMBER: 3647477 — Reaxys
- REGISTRY_NUMBER: 8821611 — Reaxys
- MANUAL_X_REF: C01375 — KEGG COMPOUND
- MANUAL_X_REF: D08556 — KEGG DRUG
- MANUAL_X_REF: DB00864 — DrugBank
- MANUAL_X_REF: EP184162 — Patent
- MANUAL_X_REF: FK5 — PDBeChem
- MANUAL_X_REF: LMPK04000003 — LIPID MAPS
- MANUAL_X_REF: US5665727 — Patent
Mapped by: Exact CAS cross-reference in the ChEBI compound record. Source updated: 2019-12-03. Retrieved: 2026-08-31. Open source record
NIH PubChem PUG-View
Attributed physical-property, hazard, environmental and use annotations.
- LogP: 3.3 Source: DrugBank
- Melting Point: 126 °C Source: DrugBank
- Solubility: Insoluble Source: DrugBank
- IARC Carcinogenic Agent: Tacrolimus Source: International Agency for Research on Cancer (IARC)
- IARC Carcinogenic Classes: Group 1: Carcinogenic to humans Source: International Agency for Research on Cancer (IARC)
- IARC Monographs: Volume 137: (2026) Hydrochlorothiazide, Voriconazole, and Tacrolimus Source: International Agency for Research on Cancer (IARC)
- Publication Year: 2026 online Source: International Agency for Research on Cancer (IARC)
- Evaluation Year: 2024 Source: International Agency for Research on Cancer (IARC)
- Carcinogen Classification: No indication of carcinogenicity to humans (not listed by IARC). Source: Toxin and Toxin Target Database (T3DB)
- Exposure Routes: Absorption of tacrolimus from the gastrointestinal tract after oral administration is incomplete and variable. The absolute bioavailability in adult kidney transplant patients is 17Њ±10%; in adults liver transplant patients is 22Њ±6%; in healthy subjects is 18Њ±5%. The absolute bioavailability in pediatric liver transplant patients was 31Њ±24%. Tacrolimus maximum blood concentrations (Cmax) and area under the curve (AUC) appeared to increase in a dose-proportional fashion in 18 fasted healthy volunteers receiving a single oral dose of 3, 7, and 10 mg. When given without food, the rate and extent of absorption were the greatest. The time of the meal also affected bioavailability. When given immediately after a meal, mean Cmax was reduced 71%, and mean AUC was reduced 39%, relative to the fasted condition. When administered 1.5 hours following the meal, mean Cmax was reduced 63%, and mean AUC was reduced 39%, relative to the fasted condition. Source: Toxin and Toxin Target Database (T3DB)
- Signal: Danger Source: European Chemicals Agency (ECHA)
- GHS Hazard Statements: H301 (97.6%): Toxic if swallowed [Danger Acute toxicity, oral]; H361 (92.7%): Suspected of damaging fertility or the unborn child [Warning Reproductive toxicity]; H372 (91.5%): Causes damage to organs through prolonged or repeated exposure [Danger Specific target organ toxicity, repeated exposure] Source: European Chemicals Agency (ECHA)
- Precautionary Statement Codes: P203, P260, P264, P270, P280, P301+P316, P318, P319, P321, P330, 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 82 reports by companies from 13 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)
- GHS Hazard Statements: H301 (100%): Toxic if swallowed [Danger Acute toxicity, oral]; H361 (100%): Suspected of damaging fertility or the unborn child [Warning Reproductive toxicity]; H372 (100%): Causes damage to organs through prolonged or repeated exposure [Danger Specific target organ toxicity, repeated exposure] Source: European Chemicals Agency (ECHA)
- ECHA C&L Notifications Summary: The GHS information provided by 1 company from 1 notification to the ECHA C&L Inventory. Source: European Chemicals Agency (ECHA)
- Signal: Danger Source: Hazardous Substances Data Bank (HSDB)
- GHS Hazard Statements: H301: Toxic if swallowed [Danger Acute toxicity, oral] Source: Hazardous Substances Data Bank (HSDB)
- Precautionary Statement Codes: P264, P270, P301+P316, P321, P330, P405, and P501 (click each P-code to see the statement) Source: Hazardous Substances Data Bank (HSDB)
- Toxicity Summary: IDENTIFICATION AND USE: Tacrolimus is white to off-white crystalline powder. It is a calcineurin-inhibitor immunosuppressant available in several preparations. Tacrolimus in both oral capsules and a solution for IV injection is used for prophylaxis of organ rejection in patients receiving liver, kidney or heart transplants. Tacrolimus topical ointment is used as a second-line therapy for the short-term and non-continuous chronic treatment of moderate to severe atopic dermatitis in non-immunocompromised adults and children. HUMAN EXPOSURE AND TOXICITY: While most acute overdosages of tacrolimus at up to 30 times the intended dose have been asymptomatic and all patients recovered with no sequelae, some acute overdosages were followed by adverse reactions including tremors, abnormal renal function, hypertension, and peripheral edema. At therapeutic doses, patients receiving tacrolimus are at increased risk of developing lymphomas and other malignancies, particularly of the skin, as well as an increased risk of developing bacterial, viral, fungal, and protozoal infections, including opportunistic infections. These infections may lead to serious, including fatal, outcomes. While there a Source: Hazardous Substances Data Bank (HSDB)
- Toxicity Summary: Signs and Symptoms of Overdose; Tacrolimus toxicity commonly presents as acute kidney injury. Close monitoring of serum creatinine, glomerular filtration rate, and urine output is necessary for patients on tacrolimus. Toxicity may also present as adverse effects, including tremors, electrolyte disturbances, and headaches. Monitor for neurotoxicity, nephrotoxicity, and hypertension. Investigations may indicate increased serum creatinine. An electrocardiogram should be obtained to rule out QT prolongation.; Management of Overdose; No specific antidote is currently available for tacrolimus toxicity, and the drug is not removed by hemodialysis. Management focuses on supportive care, including symptom monitoring and management. Consultation with the poison control center is recommended for current guidance and treatment recommendations. Source: StatPearls
- Toxicity Summary: The mechanism of action of tacrolimus in atopic dermatitis is not known. While the following have been observed, the clinical significance of these observations in atopic dermatitis is not known. It has been demonstrated that tacrolimus inhibits T-lymphocyte activation by first binding to an intracellular protein, FKBP-12. A complex of tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin is then formed and the phosphatase activity of calcineurin is inhibited. This prevents the dephosphorylation and translocation of nuclear factor of activated T-cells (NF-AT), a nuclear component thought to initiate gene transcription for the formation of lymphokines. Tacrolimus also inhibits the transcription for genes which encode IL-3, IL-4, IL-5, GM-CSF, and TNF-, all of which are involved in the early stages of T-cell activation. Additionally, tacrolimus has been shown to inhibit the release of pre-formed mediators from skin mast cells and basophils, and to downregulate the expression of FceRI on Langerhans cells. Source: Toxin and Toxin Target Database (T3DB)
- Uses: THERAPEUTIC CATEGORY: Immunosupressant; dermatological treatment of atopic eczema Source: Hazardous Substances Data Bank (HSDB)
- Uses: Immunosuppressive Agents Source: Hazardous Substances Data Bank (HSDB)
- Uses: MEDICATION Source: Hazardous Substances Data Bank (HSDB)
- Uses: Use (kg; approx.) in Germany (2009): >25; Use (kg) in USA (2002): 45; Consumption (g per capita; approx.) in Germany (2009): 0.000305; Consumption (g per capita) in the USA (2002): 0.00016; Calculated removal (%): 6 Source: NORMAN Suspect List Exchange
- Uses: For use after allogenic organ transplant to reduce the activity of the patient's immune system and so the risk of organ rejection. It was first approved by the FDA in 1994 for use in liver transplantation, this has been extended to include kidney, heart, small bowel, pancreas, lung, trachea, skin, cornea, and limb transplants. It has also been used in a topical preparation in the treatment of severe atopic dermatitis. 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
| Source | Result | Checked |
|---|---|---|
| EMBL-EBI ChEBI | Exact match | 2026-08-31 |
| NIH PubChem PUG-View | Exact match | 2026-08-31 |
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
- South Korea MFDS cosmetic ingredient data
- Source reference
- 화장품 안전기준 등에 관한 규정, 별표 1, record 1-946
- Source record ID
1-946- Source version
- 2026-19
- Source language
- Korean
- Translation status
- No English translation
- Effective date
- 2026-03-18
- Source updated
- 2026-03-18
- Snapshot checked
- 2026-08-30 04:33 UTC
- Validation method
- MFDS JSON appendices 1–2 parse; 1077 prohibited, 243 restricted
- SHA-256
056de35b843a5e31f709073f9e79d5e6e18f7c9164eb537bb099b185a37ef7d8
Registered dataset notes
- Dataset coverage
- Ingredient identity and separate restriction/regulation data endpoints
- Authority note
- Korean source is canonical; English materials alone are not complete enough for certification
How this record fits the market dataset
Status distribution
Condition text is present on 638 of 1320 current records. An empty condition field is interpreted according to the record type above; it is never converted into an unrestricted-use claim.
South Korea market context
Complete current appendix dataset
Coverage version: MFDS Notice 2026-19, effective 18 March 2026
All rows in official Appendix 1 (prohibited) and Appendix 2 (restricted) of the Safety Standards for Cosmetics.
Verification checklist
- Match the Korean canonical substance name and identifiers.
- Review all Appendix 1 and 2 matches and conditions.
- Check functional-cosmetic and positive-list requirements where applicable.
- Confirm current MFDS notice, responsible seller and label obligations.
Official market sources
- South Korea MFDS cosmetic ingredient dataKorean source is canonical; English materials alone are not complete enough for certification
Verification workflow and record completeness
Before using this result in a compliance decision
- Confirm that “타크로리무스(tacrolimus), 그 염류 및유도체” and every CAS/EC identifier refer to the material in your supplier specification.
- Match the Korean canonical substance name and identifiers.
- Review all Appendix 1 and 2 matches and conditions.
- Check functional-cosmetic and positive-list requirements where applicable.
- Confirm current MFDS notice, responsible seller and label obligations.
- Document the source version and recheck the regulator before manufacture, notification or market placement.
Fields available in this record
- Official substance nameAvailable
- CASAvailable
- ECNot supplied
- Separate condition textAvailable
- Effective dateAvailable
- Snapshot hash and methodAvailable
Questions this page answers
Stable citation
타크로리무스(tacrolimus), 그 염류 및유도체. 화장품 안전기준 등에 관한 규정, 별표 1, record 1-946. South Korea. Source version 2026-19. CosIng Checker regulatory record: https://cosingchecker.com/regulations/kr/records/1595/
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 South Korea
This official record identifies the substance as prohibited for cosmetic use in the stated market scope.
Do not rely on a formulation containing this identity until the cited source, effective date and exact substance match have been verified.
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: Prohibited
- Legal role: Binding rule
- Source version: 2026-19
- Effective date: 2026-03-18
What it does not prove
Korean source wording is canonical and other positive lists/notices may still apply to the formulation.
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 sourceFDA 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 sourceILO/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 sourceJapan 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 sourceNIOSH 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 sourceOECD 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 sourceUS EPA CompTox CTX APIs
API key required for importDTXSID 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