ProhibitedBinding ruleINOriginal is EnglishOfficial-source import checked

Methylphenidate (*) and its salts (CAS no. 113-45-1)

IS 4707 Part 2:2025 Annex A lists this ingredient as one that must not form part of a cosmetic product in India.

Regulatory decision and full conditions

Status
Prohibited
Legal role
Binding rule
Regulatory summary
IS 4707 Part 2:2025 Annex A lists this ingredient as one that must not form part of a cosmetic product in India.
Conditions and restrictions
Must not form part of the composition of cosmetic products. Apply the general trace and safety notes published after Annex A.

Substance identity

Official source name
Methylphenidate (*) and its salts (CAS no. 113-45-1)
CAS
113-45-1
EC
Not supplied in this source row
Identity mapping
standalone:official_bis_record

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.

10 market datasets
PubChem 2D chemical structure for CAS 113-45-1
CAS 113-45-1PubChem CID 4158

Verified chemistry for CAS 113-45-1

Methylphenidate

IUPAC name
methyl 2-phenyl-2-piperidin-2-ylacetate
Molecular formula
C14H19NO2
Molecular weight
233.31 g/mol
Exact mass
233.141578849 Da
Monoisotopic mass
233.141578849 Da
XLogP3
0.2
Topological polar surface area
38.3 Ų
Molecular complexity
249.0
Formal charge
0
Hydrogen-bond donors
1
Hydrogen-bond acceptors
3
Rotatable bonds
4
Heavy atoms
17
Covalent units
1

Names and synonyms reported to PubChem

MethylphenidanPhenidylateCalocainPlimasineMethyl phenidylacetateMetilfenidatoMethylphenidatumMethyl phenidate
16 more reported names
4311/B CibaDaytranaalpha-Phenyl-2-piperidineacetic acid methyl esterMethyl alpha-phenyl-alpha-(2-piperidyl)acetateNCI-C56280Methyl 2-phenyl-2-(piperidin-2-yl)acetate2-Piperidineacetic acid, alpha-phenyl-, methyl esterCotempla XR-ODTMethyl alpha-phenyl-alpha-2-piperidinylacetatealpha-Phenyl-alpha-(2-piperidyl)acetic acid methyl esterMetilfenidat hydrochlorideThreo-dl-methylphenidatePrc-063Methylphenidate extended releaseRitalineRefChem:6033
External database identifiers
Advanced structure statistics
Defined atom stereocentres
0
Undefined atom stereocentres
2
Defined bond stereocentres
0
Undefined bond stereocentres
0
3D pharmacophore features
5
3D rings
2
3D hydrophobes
0
3D acceptor features
1
3D donor features
1
3D anionic centres
0
3D cationic centres
1
3D conformers
10
Effective 3D rotors
5.2
Machine-readable structure identifiers
SMILES
COC(=O)C(C1CCCCN1)C2=CC=CC=C2
InChI
InChI=1S/C14H19NO2/c1-17-14(16)13(11-7-3-2-4-8-11)12-9-5-6-10-15-12/h2-4,7-8,12-13,15H,5-6,9-10H2,1H3
InChIKey
DUGOZIWVEXMGBE-UHFFFAOYSA-N

Evidence from additional scientific databases

NIH PubChem PUG-View
Exact identifier match4158

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

  • Exposure Routes: Oral. Readily absorbed in a biphasic manner when orally administered (tablets) to children diagnosed with ADHD and to healthy adults. In children and adults males, after administration of a single oral dose of Ritalin LA and Ritalin given in two doses 4 hours apart, peak plasma concentration is reached approximately 2 hours for the first phase and 5-6 hours for the second phase. The absolute oral bioavailability of methylphenidate in children was 22±8% for d-methylphenidate and 5±3% for l-methylphenidate. These low values suggest that methylphenidate is highly metabolized presystemically. Source: Toxin and Toxin Target Database (T3DB)
  • Signal: Warning Source: European Chemicals Agency (ECHA)
  • GHS Hazard Statements: H302 (100%): Harmful if swallowed [Warning Acute toxicity, oral]; H315 (100%): Causes skin irritation [Warning Skin corrosion/irritation]; H319 (100%): Causes serious eye irritation [Warning Serious eye damage/eye irritation]; H341 (100%): Suspected of causing genetic defects [Warning Germ cell mutagenicity] Source: European Chemicals Agency (ECHA)
  • Precautionary Statement Codes: P203, P264, P264+P265, P270, P280, P301+P317, P302+P352, P305+P351+P338, P318, P321, P330, P332+P317, P337+P317, P362+P364, P405, and P501 (click each P-code to see the statement) 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: H302: Harmful if swallowed [Warning Acute toxicity, oral]; H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled [Danger Sensitization, respiratory] Source: Hazardous Substances Data Bank (HSDB)
  • Precautionary Statement Codes: P233, P260, P264, P270, P271, P284, P301+P317, P304+P340, P330, P342+P316, P403, and P501 (click each P-code to see the statement) Source: Hazardous Substances Data Bank (HSDB)
  • Health Effects: Using large amounts of these drugs can result in a condition known as amphetamine psychosis -- which can result in auditory, visual and tactile hallucinations, intense paranoia, irrational thoughts and beliefs, delusions, and mental confusion. Source: Toxin and Toxin Target Database (T3DB)
  • Toxicity Summary: IDENTIFICATION AND USE: Methylphenidate Hydrochloride is a psychostimulant used to treat different behavioral disorders. Indications: Used to treat narcolepsy and hyperkinetic states in children (as an adjunct to psychological, educational and social measures) for amphetamine, dextroamphetamine and ethylphenidate. It is misused for performance enhancement and relief of fatigue. Abuse either orally or by injection is extremely common. HUMAN EXPOSURE AND TOXICITY: Main risks include: Acute central nervous system (CNS) stimulation, cardiotoxicity causing tachycardia, arrhythmias, hypertension and cardiovascular collapse. High risk of dependency and abuse. Cardiovascular effects include: palpitation, chest pain, tachycardia, arrhythmias and hypertension; cardiovascular collapse can occur in severe poisoning. Myocardial ischemia, infarction and ventricular dysfunction are described. CNS effects include: stimulation of CNS, tremor, restlessness, agitation, insomnia, increased motor activity, headache, convulsions, coma and hyperreflexia. Stroke and cerebral vasculitis have been observed. Gastrointestinal effects include: vomiting, diarrhea and cramps. Genitourinary effects include: incre Source: Hazardous Substances Data Bank (HSDB)
  • Toxicity Summary: The first step in a medication overdose is to immediately contact a poison control center for the appropriate management steps. Doses that exceed 60 mg of the immediate-release formulation or 120 mg of the extended-release formulation can be considered toxic. If the overdosed quantity is unknown, the patient should be assessed for signs and symptoms such as tremors, hyperreflexia, convulsions, euphoria, confusion, hallucinations, delirium, flushing, and fever, in addition to the common adverse effects mentioned above. Supportive care with supplemental oxygen, intravenous fluids, and external cooling methods is the mainstay of treatment. Multiple studies have shown that benzodiazepines are an option, especially if dystonia, agitation, or convulsions are present. Source: StatPearls
  • Toxicity Summary: Methylphenidate blocks dopamine uptake in central adrenergic neurons by blocking dopamine transport or carrier proteins. Methylphenidate acts at the brain stem arousal system and the cerebral cortex and causes increased sympathomimetic activity in the central nervous system. Alteration of serotonergic pathways via changes in dopamine transport may result. Source: Toxin and Toxin Target Database (T3DB)
  • Environmental Bioconcentration: An estimated BCF of 3 was calculated in fish for methylphenidate(SRC), using a log Kow of 0.20(1) and a regression-derived equation(2). According to a classification scheme(2), this BCF suggests the potential for bioconcentration in aquatic organisms is low(SRC). Source: Hazardous Substances Data Bank (HSDB)
  • Environmental Fate: TERRESTRIAL FATE: Based on a classification scheme(1), an estimated Koc value of 1600(SRC), determined from a structure estimation method(2), indicates that methylphenidate is expected to have low mobility in soil(SRC). The pKa of methylphenidate is 8.9(3), indicating that this compound will exist partially in the cation form in the environment and cations generally adsorb more strongly to soils containing organic carbon and clay than their neutral counterparts(4). Volatilization of the neutral species of methylphenidate from moist soil surfaces is not expected to be an important fate process(SRC) given an estimated Henry's Law constant of 4.4X10-9 atm-cu m/mole(SRC), using a fragment constant estimation method(5). Methylphenidate is not expected to volatilize from dry soil surfaces(SRC) based upon an estimated vapor pressure of 5.9X10-5 mm Hg at 25 °C(SRC), determined from a fragment constant method(2). Biodegradation data in soil were not available(SRC, 2015). Source: Hazardous Substances Data Bank (HSDB)
  • Environmental Fate: AQUATIC FATE: Based on a classification scheme(1), an estimated Koc value of 1600(SRC), determined from a structure estimation method(2), indicates that methylphenidate is expected to adsorb to suspended solids and sediment(SRC). Volatilization of the neutral species from water surfaces is not expected(3) based upon an estimated Henry's Law constant of 4.4X10-9 atm-cu m/mole(SRC), developed using a fragment constant estimation method(4). A pKa of 8.9(5) indicates methylphenidate will exist partially in the cation form at pH values of 5 to 9 and, therefore, volatilization from water surfaces is not expected to be an important fate process(SRC). According to a classification scheme(6), an estimated BCF of 3(SRC), from its log Kow of 0.20(7) and a regression-derived equation(2), suggests the potential for bioconcentration in aquatic organisms is low(SRC). Base-catalyzed second-order hydrolysis rate constant half-lives of 23 and 2.3 years at pH values of 7 and 8, respectively(2), suggest that hydrolysis may be a slow environmental fate process. Biodegradation data in water were not available(SRC, 2015). Source: Hazardous Substances Data Bank (HSDB)
  • Environmental Fate: ATMOSPHERIC FATE: According to a model of gas/particle partitioning of semivolatile organic compounds in the atmosphere(1), methylphenidate, which has an estimated vapor pressure of 5.9X10-5 mm Hg at 25 °C(SRC), determined from a fragment constant method(2), will exist in both the vapor and particulate phases in the ambient atmosphere. Vapor-phase methylphenidate is degraded in the atmosphere by reaction with photochemically-produced hydroxyl radicals(SRC); the half-life for this reaction in air is estimated to be 1 hr(SRC), calculated from its rate constant of 1.1X10-10 cu cm/molecule-sec at 25 °C(SRC) that was derived using a structure estimation method(3). Particulate-phase methylphenidate may be removed from the air by wet and dry deposition(SRC). Methylphenidate contains chromophores that absorb at wavelengths >290 nm(4) and, therefore, may be susceptible to direct photolysis by sunlight(SRC). Source: Hazardous Substances Data Bank (HSDB)
  • Uses: Methylphenidate (DEA Code Number: 1724) is a Schedule II controlled substance. Source: Hazardous Substances Data Bank (HSDB)
  • Uses: Schedule II Controlled Substance: (A) The drug or other substance has a high potential for abuse; (B) The drug or other substance has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions; and (C) Abuse of the drug or other substances may lead to severe psychological or physical dependence. Source: Hazardous Substances Data Bank (HSDB)
  • Uses: MEDICATION (VET) Source: Hazardous Substances Data Bank (HSDB)
  • Uses: MEDICATION Source: Hazardous Substances Data Bank (HSDB)
  • Uses: Central Nervous System Stimulants; Dopamine Uptake Inhibitors Source: Hazardous Substances Data Bank (HSDB)
  • Uses: Use (kg) in Switzerland (2009): >250; Use (kg; approx.) in Germany (2009): >1000; Use (kg) in USA (2002): 9090; Consumption (g per capita) in Switzerland (2009): 0.032; Consumption (g per capita; approx.) in Germany (2009): 0.012; Consumption (g per capita) in the USA (2002): 0.032; Excretion rate: 0.1; Calculated removal (%): 92.1 Source: NORMAN Suspect List Exchange
  • Uses: For use as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. 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
India BIS IS 4707 cosmetic ingredient standards
Source reference
IS 4707 (Part 2):2025 Annex A, entry 173
Source record ID
annex-a:173
Source version
IS 4707 (Part 2):2025, fifth revision
Source language
English
Translation status
Original is English
Effective date
2025-08-09
Source updated
2025-08-09
Snapshot checked
2026-08-31 15:30 UTC
Validation method
206 text layers; Annex A 1-1614 and Annex B 1-313 with seven lettered source rows
SHA-256
905dd0326361c53da8a354b948331946951ac3ae27d60d8e2474efb051239603

Registered dataset notes

Dataset coverage
Complete current Part 2:2025 Annex A prohibited and Annex B restricted rows; Parts 1, 3 and 4 remain linked official checks
Authority note
Indian Standards referenced by the cosmetics regulatory framework; use the controlled current editions

How this record fits the market dataset

1931
current India records
1614
records marked Prohibited
1931
records from this source version
1836
market records with CAS identity

Status distribution

Condition text is present on 1931 of 1931 current records. An empty condition field is interpreted according to the record type above; it is never converted into an unrestricted-use claim.

India market context

Complete current Part 2 dataset plus official workflow for Parts 1, 3 and 4

Coverage version: Cosmetics Rules 2020 plus current BIS IS 4707 parts (1:2020, 2:2025, 3:2025, 4:2022)

All 1,614 prohibited Annex A rows and 317 numbered/lettered restricted Annex B rows from IS 4707 Part 2:2025; official checks remain for colourants, preservatives and UV filters in Parts 1, 3 and 4.

Verification checklist

  1. Confirm product class and current Cosmetics Rules/gazette amendments.
  2. Check all applicable parts of IS 4707 by exact identity.
  3. Apply Schedule S/other finished-product standards where relevant.
  4. Verify licence/import registration, labelling and testing requirements.

Official market sources

Verification workflow and record completeness

Before using this result in a compliance decision

  1. Confirm that “Methylphenidate (*) and its salts (CAS no. 113-45-1)” and every CAS/EC identifier refer to the material in your supplier specification.
  2. Confirm product class and current Cosmetics Rules/gazette amendments.
  3. Check all applicable parts of IS 4707 by exact identity.
  4. Apply Schedule S/other finished-product standards where relevant.
  5. Verify licence/import registration, labelling and testing requirements.
  6. 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

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.

A prohibition entry may contain no separate condition text because the regulatory outcome is the prohibition itself. The standards are separate controlled publications; absence from a locally indexed excerpt is not permission.

The record cites IS 4707 (Part 2):2025 Annex A, entry 173, source version IS 4707 (Part 2):2025, fifth revision. 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

Methylphenidate (*) and its salts (CAS no. 113-45-1). IS 4707 (Part 2):2025 Annex A, entry 173. India. Source version IS 4707 (Part 2):2025, fifth revision. CosIng Checker regulatory record: https://cosingchecker.com/regulations/in/records/14767/

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 India

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: IS 4707 (Part 2):2025, fifth revision
  • Effective date: 2025-08-09

What it does not prove

The standards are separate controlled publications; absence from a locally indexed excerpt is not permission.

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