Provenance

Reference data from EU CLP Annex VI and published regulations — verify against your supplier's SDS before use.

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Substance profile

Theophylline

Theophylline is a white, crystalline alkaloid and is odorless.

CAS 58-55-9 C7H8N4O2 180.16 g/mol Danger

01 · Identification

What Theophylline is

Theophylline is a white, crystalline alkaloid and is odorless. Its molecular formula is C7H8N4O2 and its molecular weight is 180.16 g/mol. It melts at 274 °C.

Under the GHS it carries the signal word Danger.

02 · Identifiers

Theophylline identifiers and molecular data

Theophylline CAS number and EC number

CAS number58-55-9
EC number200-385-7
Index number (CLP Annex VI)613-342-00-6

Theophylline molecular formula and molecular weight

Molecular formulaC7H8N4O2
Molecular weight180.16 g/mol

Other names for Theophylline

  • 1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione

03 · GHS classification

Theophylline hazard classification

Harmonised classification under CLP Annex VI. This is the legally binding classification in the EU; other jurisdictions may differ.

Theophylline pictograms and signal word

Signal wordDanger

Theophylline hazard statements (H-codes)

Hazard statements assigned to Theophylline
CodeHazard statement
H360D May damage the unborn child.

This page lists only the codes assigned to Theophylline. The full reference lives on the hazard statements hub, the precautionary statements hub and the GHS pictograms hub.

Safety Data Sheet

Getting an SDS for Theophylline

A Safety Data Sheet is written for a product, not for a substance: the supplier of the grade you actually buy issues it, so two suppliers of Theophylline issue two different sheets. That is why there is no single authoritative SDS for a substance to download — what there is, is the job of collecting the sheets for the products you hold and keeping them current as suppliers revise them.

04 · Precautionary statements

Theophylline precautionary statements

CLP Annex VI assigns 4 precautionary statements to Theophylline. They are grouped the way a label groups them: what to do before handling, what to do when something has already happened, how to store it and how to dispose of it.

Response

What to do once exposure, spillage or fire has already happened.

Reading the notation. is a blank the supplier fills in — not a truncated sentence.· [square brackets] mark a part printed only when it applies.

05 · Names in the regulation

Theophylline name in 23 EU languages

CLP Annex VI Part 3 is published in every language edition of the regulation, and the identification column is written out in each of them. Nothing below is translated by us: each line is the name as that edition prints it. Under Art. 18(2) the substance name from Annex VI is a lawful product identifier, so this is the wording to put on a label going to that market — and where the cell lists several designations, any one of them qualifies.

Language Name in CLP Annex VI Part 3
Bulgarian български теофилин 1,3-диметил-3,7-дихидро-1 Н -пурин-2,6-дион
Spanish español Teofilina 1,3-dimetil-3,7-dihidro-1 H -purina-2,6-diona
Czech čeština theofylin 1,3-dimethyl-3,7-dihydro-1 H -purin-2,6-dion
Danish dansk theophyllin 1,3-dimethyl-3,7-dihydro-1 H -purin-2,6-dion
German Deutsch Theophyllin 1,3-Dimethyl-3,7-dihydro-1 H -purin-2,6-dion
Estonian eesti teofülliin 3,7-dihüdro-1,3-dimetüül-1 H -puriin-2,6-dioon
Greek ελληνικά θεοφυλλίνη 1,3- διμεθυλο-3,7-διυδρο-1 H -πουρινο-2,6-διόνη
English English theophylline 1,3-dimethyl-3,7-dihydro-1 H -purine-2,6-dione
French français théophylline 1,3-diméthyl-3,7-dihydro-1 H -purine-2,6-dione
Croatian hrvatski teofilin 1,3-dimetil-3,7-dihidro-1 H -purin-2,6-dion
Italian italiano teofillina 1,3-dimetil-3,7-diidro-1H-purina-2,6-dione
Latvian latviešu teofilīns 1,3-dimetil-3,7-dihidro-1 H -purīn-2,6-dions
Lithuanian lietuvių teofilinas 1,3-dimetil-3,7-dihidro-1 H -purin-2,6-dionas
Hungarian magyar teofillin 1,3-dimetil-3,7-dihidro-1 H -purin-2,6-dion
Maltese Malti teofillina 1,3-dimetil-3,7-diidro-1 H -purina-2,6-dion
Dutch Nederlands theofylline 1,3-dimethyl-3,7-dihydro-1 H -purine-2,6-dion
Polish polski teofilina 3,7-Dihydro-1,3-dimetylo-1 H -puryno-2,6-dion
Portuguese português teofilina 1,3-dimetil-3,7-di-hidro-1 H -purina-2,6-diona
Romanian română teofilină 1,3-dimetil-3,7-dihidro-1 H -purina-2,6-dionă
Slovak slovenčina teofilină 1,3-dimetil-3,7-dihidro-1 H -purina-2,6-dionă
Slovenian slovenščina teofilin 1,3-dimetil-3,7-dihidro-1 H -purin-2,6-dion
Finnish suomi teofylliini 1,3-dimetyyli-3,7-dihydro-1 H -puriini-2,6-dioni
Swedish svenska teofyllin 1,3-dimetyl-3,7-dihydro-1 H -purin-2,6-dion

All 23 language editions of Annex VI carry this entry. Irish is the twenty-fourth official EU language and has no line here for a different reason: no consolidated CLP text has ever been published in Irish, so there is no Irish edition of Annex VI to quote a name from. Source: consolidated CLP, CELEX 02008R1272, language editions. © European Union, https://eur-lex.europa.eu — only the electronic Official Journal of the European Union is authentic.

06 · Label elements

Theophylline GHS label elements

Everything CLP Annex VI fixes for Theophylline, laid out the way it appears on a label. The greyed lines are the parts only the supplier can fill in.

GHS08 Health hazard pictogram

Danger

Theophylline

  • May damage the unborn child.
  • Obtain special instructions before use.
  • Wear protective gloves/protective clothing/eye protection/face protection/hearing protection/
  • IF exposed or concerned:
  • Get medical advice/attention.

Supplier name, address and telephone number· Product identifier·Nominal quantity

Need this as an actual label? Open Theophylline in the GHS label constructor →

07 · Health hazards

Theophylline health hazards and exposure limits

Theophylline carcinogenicity classification

IARC classification Group 3 — Not classifiable as to its carcinogenicity to humans
IARC monographs Volume 51: (1991) Coffee, Tea, Mate, Methylxanthines and Methylglyoxal

Under the conditions of these 2-year gavage studies, there was no evidence of carcinogenic activity of theophylline in male or female F344/N rats administered 7.5, 25, or 75 mg/kg. There was no evidence of carcinogenic activity of theophylline in male B6C3F1 mice administered 15, 50, or 150 mg/kg or female B6C3F1 mice administered 7.5, 25, or 75 mg/kg.

Source: US National Toxicology Program · TR-473: Toxicology and Carcinogenesis Studies of Theophylline in F344/N Rats and B6C3F1 Mice (Feed and Gavage Studies) (1998 )

Evaluation: There is inadequate evidence for the carcinogenicity in humans of theophylline. There is inadequate evidence for the carcinogenicity in experimental animals of theophylline. Overall evaluation: Theophylline is not classifiable as to its carcinogenicity to humans (Group 3).

Source: Hazardous Substances Data Bank (HSDB)

An IARC group and a CLP classification answer different questions. IARC judges whether the evidence for cancer in humans is strong enough; CLP Annex VI is the legally binding EU classification. A substance can carry one and not the other.

08 · Physical and chemical properties

Theophylline properties

Every value is shown with the conditions it was measured under and the source it came from. Where sources disagree, all values are listed rather than one being picked — the difference is usually a different form of the substance, not an error.

Theophylline melting point

Property Value Conditions Source
Melting point 274 °C (525.2 °F) HSDB
273.06 °C (523.5 °F) range, midpoint shown CAMEO
272 °C (521.6 °F) range, midpoint shown ICSC

Theophylline density

Property Value Conditions Source
Density g/cm³ ICSC

Theophylline solubility

Property Value Conditions Source
Solubility Slightly soluble in water HSDB
Slightly soluble in ethanol, ether, chloroform HSDB
In water, 7,360 mg/L at 25 °C at 25 °C HSDB

Theophylline vapor pressure

Property Value Conditions Source
Vapor pressure negligible ICSC

Values compiled from PubChem Laboratory Chemical Safety Summary. Temperatures converted to Fahrenheit for reference.

09 · Handling and storage

Theophylline storage and handling

Theophylline safe storage

Separated from food and feedstuffs.

Source: ILO-WHO International Chemical Safety Cards (ICSCs)

Theophylline storage conditions

Store at 20 deg -25 °C (68 deg - 77 °F); excursions permitted between 15 deg - 30 °C (59 deg - 86 °F).

Source: Hazardous Substances Data Bank (HSDB)

Theophylline incompatible materials

Incompatible materials: Strong oxidizing agents.

Source: Hazardous Substances Data Bank (HSDB)

Theophylline reactivity

THEOPHYLLINE neutralizes acids in exothermic reactions to form salts plus water. May be incompatible with isocyanates, halogenated organics, peroxides, phenols (acidic), epoxides, anhydrides, and acid halides. Flammable gaseous hydrogen may be generated in combination with strong reducing agents, such as hydrides.

Source: CAMEO Chemicals

Planning storage for a mix of chemicals? Check Theophylline in the storage compatibility matrix →

10 · Questions

Theophylline — frequently asked questions

What is the CAS number of Theophylline?

The CAS number of Theophylline is 58-55-9. Its EC number is 200-385-7.

What is the chemical formula of Theophylline?

The molecular formula of Theophylline is C7H8N4O2 and its molecular weight is 180.16 g/mol.

What does a Theophylline label have to show?

Under CLP Annex VI the label for Theophylline carries the pictogram Health hazard and the signal word is Danger.

Is Theophylline flammable?

CLP Annex VI assigns Theophylline no flammability hazard class. That is not a statement that it cannot burn: the harmonised list only records the hazards that were assessed for it.

Is Theophylline a carcinogen?

CLP Annex VI records no harmonised carcinogenicity classification for Theophylline. Annex VI is a list of agreed classifications, not a list of substances found safe, so this is an absence of a classification rather than a clean bill of health. IARC places it in Group 3: not classifiable as to its carcinogenicity to humans.

What is the melting point of Theophylline?

The melting point reported for Theophylline is 274 °C (525.2 °F) (HSDB).

How should Theophylline be stored?

Store at 20 deg -25 °C (68 deg - 77 °F); excursions permitted between 15 deg - 30 °C (59 deg - 86 °F). (Hazardous Substances Data Bank (HSDB))

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