What is the GHS hazard classification for Theophylline?
Theophylline (CAS 58-55-9) is classified under EU CLP Annex VI as Repr. 1B with signal word Danger. Hazard statements: H360D. Source: EU CLP Annex VI (ECHA).
Danger
GHS08
NOAEL Data
IARC Group 3
REACH Registered
Cosmetic Ingredient
Theophylline
Also known as: 1H-Purine-2,6-dione, 3,7-dihydro-1,3-dimethyl-, 1H-Purine-2,6-dione, 3,9-dihydro-1,3-dimethyl-, EINECS 200-385-7, Purine-2,6(1H,3H)-dione, 1,3-dimethyl-, Theophylline, anhydrous (+15 more)
CAS 58-55-9
Theophylline (CAS 58-55-9) is a chemical substance with GHS signal word Danger; key hazard signal: H360D. Key regulatory status: REACH registered, 9 regulatory/inventory lists, cosmetic ingredient cross-reference; source data from ECHA CLP, EPA ToxValDB, EPA CPDat, IARC, ECHA REACH, ILO ICSC.
Cross-Vertical Regulatory Divergence
Theophylline is prohibited in EU cosmetics but has active industrial GHS classifications (H360D).
SOURCE
Cross-vertical comparison
Cosmetics: ingredients.eu_status; Chemicals: eu_clp_annex_vi.signal_word/hazard_statement_code
SOURCE
NOAEL studies
NOAEL studies
44
SOURCE
Chemical inventory jurisdictions
Regulatory lists
9
SOURCE
EU CLP Annex VI
GHS signal
Danger
Chemical Identity
CAS, identifiers, formula, and alternate names for the matched substance record.
SOURCE
DSSTox identifiers
25 fields
Name
Theophylline
CAS Number
58-55-9
Molecular Formula
C7H8N4O2
InChI Key
ZFXYFBGIUFBOJW-UHFFFAOYSA-N
Monoisotopic Mass
180.064726
Synonyms
1H-Purine-2,6-dione, 3,7-dihydro-1,3-dimethyl-1H-Purine-2,6-dione, 3,9-dihydro-1,3-dimethyl-EINECS 200-385-7Purine-2,6(1H,3H)-dione, 1,3-dimethyl-Theophylline, anhydrousXanthine, 1,3-dimethyl-TheodurUNII-0I55128JYK1,3-dimethyl-2,3,6,7-tetrahydro-1H-purine-2,6-dione1,3-dimethyl-7H-purine-2,6-dioneAcet-theocinAerolate III
IARC Carcinogen Classification
Carcinogenic hazard classification from IARC monograph evaluations.
SOURCE
IARC Monographs on the Identification of Carcinogenic Hazards to Humans
1 records
| Group | Meaning | Evaluated | Volume |
|---|---|---|---|
| Group 3 | Not classifiable | 1990 | 51 |
GHS / CLP Classification
EU harmonized hazard classification, hazard statements, pictograms, and signal word.
SOURCE
EU CLP Annex VI (ECHA)
1 classifications
| Hazard Class | H-Statements | Pictograms | Signal |
|---|---|---|---|
| Repr. 1B | H360D | GHS08 | Danger |
ICSC Chemical Safety
International Chemical Safety Card hazard and exposure summary.
SOURCE
WHO/JECFA
1 records
| Field | Value |
|---|---|
| GHS Signal Word | DANGER |
| GHS Hazard Statements | Toxic if swallowed May be harmful if inhaled May cause harm to breast-fed children Causes damage to vascular system and kidneys Causes damage to the kidneys through prolonged or repeated exposure |
| Short-term Effects | The substance may cause effects on the heart and central nervous system. This may result in cardiac dysrhythmia and convulsions. The effects may be delayed. |
| Routes of Exposure | The substance can be absorbed into the body in hazardous amounts by ingestion. |
Functional Uses
Industrial and product-use categories associated with this substance.
SOURCE
EPA CPDat
3 records
HumectantSoftener and conditionerPharmaceutical
Regulatory Lists
Inventory, screening, and regulatory list matches from public chemical databases.
SOURCE
EPA CPDat
9 records
| List | Keyword | Source |
|---|---|---|
| active_ingredient; Australia | Australian Pesticides and Veterinary Medicines Authority | CPCat |
| active_ingredient; animal_products; Europe; pharmaceutical; residue | EU | CPCat |
| Europe; pharmaceutical | Drinking Water Inspectorate | CPCat |
| detected; Europe; surface_water; wastewater | Drinking Water Inspectorate | CPCat |
| detected; MN Chemical Screening; pharmaceutical; surface_water | Minnesota Pollution Control Agency | State of Minnesota |
| detected; MN Chemical Screening; surface_water | Minnesota Pollution Control Agency | State of Minnesota |
| detected; MN Chemical Screening; pharmaceutical; surface_water | Minnesota Pollution Control Agency | State of Minnesota |
| detected; MN Chemical Screening; surface_water | NPS & EPA | State of Minnesota |
| Canada; pharmaceutical | DrugBank | DrugBank |
NOAEL Studies
Toxicology endpoints rendered from public NOAEL study rows.
SOURCE
NOAEL studies
Showing 44 of 44 studies
| Value | Unit | Endpoint | Route | Species | Source |
|---|---|---|---|---|---|
| 0.7788 | uL/min/10^6 cells | Clint | - | Human | NTP ICE adme parameters |
| =0.54 | mg/m3 | DNEL systemic | inhalation | Human | ToxValDB GESTIS DNEL |
| 0I55128JYK | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 0.61 | fraction | Fu | - | Human | NTP ICE adme parameters |
| 3 | IARC group | IARC carcinogenicity classification | - | - | IARC Monographs |
| 3 | unitless | IARC group | - | - | NTP ICE cancer |
| =7.5 | mg/kg bw/day | LEL | oral | rat (fischer; Fischer 344) | EPA ToxRefDB v3 |
| =25 | mg/kg bw/day | LEL | oral | Mouse | ToxValDB ToxRefDB |
| =25 | mg/kg bw/day | LEL | oral | mouse (b6c3f1; B6C3F1) | EPA ToxRefDB v3 |
| =75 | mg/kg bw/day | LEL | oral | rat (fischer; Fischer 344) | EPA ToxRefDB v3 |
| =125 | mg/kg bw/day | LEL | oral | Rat | ToxValDB ToxRefDB |
| =125 | mg/kg bw/day | LEL | oral | rat (fischer; Fischer 344) | EPA ToxRefDB v3 |
| =150 | mg/kg bw/day | LEL | oral | mouse (b6c3f1; B6C3F1) | EPA ToxRefDB v3 |
| =175 | mg/kg bw/day | LEL | oral | Mouse | ToxValDB ToxRefDB |
| =175 | mg/kg bw/day | LEL | oral | mouse (b6c3f1; B6C3F1) | EPA ToxRefDB v3 |
| =225 | mg/kg bw/day | LEL | oral | Mouse | ToxValDB ToxRefDB |
| =225 | mg/kg bw/day | LEL | oral | mouse (b6c3f1; B6C3F1) | EPA ToxRefDB v3 |
| =300 | mg/kg bw/day | LEL | oral | Mouse | ToxValDB ToxRefDB |
| =300 | mg/kg bw/day | LEL | oral | mouse (b6c3f1; B6C3F1) | EPA ToxRefDB v3 |
| ~7.5 | mg/kg bw/day | LOAEL | oral | Rat | ECHA |
| =37.5 | mg/kg bw/day | LOAEL | oral | Rat | ECHA |
| =75 | mg/kg bw/day | LOAEL | oral | Rat | ECHA |
| =126 | mg/kg bw/day | LOAEL | oral | Mouse | ECHA |
| =150 | mg/kg bw/day | LOAEL | oral | Rat | ToxValDB ToxRefDB |
| =150 | mg/kg bw/day | LOAEL | oral | rat (fischer; Fischer 344) | EPA ToxRefDB v3 |
| =175 | mg/kg bw/day | LOAEL | oral | Mouse | ECHA |
| =225 | mg/kg bw/day | LOAEL | oral | Mouse | ECHA |
| =100 | mg/L | LOEL | environmental | Rat | ToxValDB ECOTOX |
| 0 | unitless | Model Score | - | - | NTP ICE endocrine |
| >0 | mg/kg bw/day | NEL | oral | rat (fischer; Fischer 344) | EPA ToxRefDB v3 |
| =7.5 | mg/kg bw/day | NEL | oral | mouse (b6c3f1; B6C3F1) | EPA ToxRefDB v3 |
| =37.5 | mg/kg bw/day | NEL | oral | rat (fischer; Fischer 344) | EPA ToxRefDB v3 |
| =50 | mg/kg bw/day | NEL | oral | mouse (b6c3f1; B6C3F1) | EPA ToxRefDB v3 |
| =150 | mg/kg bw/day | NEL | oral | mouse (b6c3f1; B6C3F1) | EPA ToxRefDB v3 |
| ~7.5 | mg/kg bw/day | NOAEL | oral | Mouse | ECHA |
| =30 | mg/kg bw/day | NOAEL | injection | Rabbit | ECHA |
| ~50 | mg/kg bw/day | NOAEL | oral | Mouse | ECHA |
| >=75 | mg/kg bw/day | NOAEL | oral | Mouse | ECHA |
| =124 | mg/kg bw/day | NOAEL | oral | Rat | ECHA |
| >=150 | mg/kg bw/day | NOAEL | oral | Mouse | ECHA |
| ~282 | mg/kg bw/day | NOAEL | oral | Mouse | ECHA |
| <37.5 | mg/kg bw/day | NOEL | oral | Rat | ToxValDB HESS |
| 75 | mg/kg | Top dose | Gavage; Dosed feed | Rat | NTP ICE cancer |
| 150 | mg/kg | Top dose | Gavage; Dosed feed | Mouse | NTP ICE cancer |
Showing 44 of 44 studies
REACH Registration
Registration status from the ECHA REACH registered substances database.
SOURCE
ECHA
1 records
| Status | Name | EC Number | Link |
|---|---|---|---|
| Registered | Theophylline | 200-385-7 | ECHA overview → |
Cosmetic Safety Profile
Same-CAS cosmetic ingredient record for cross-vertical context.
SOURCE
CosIng / Ingredients DB
EU Status
prohibited
Max
-
Category
Skin Conditioning
Pharmaceutical Data
Same-CAS pharmaceutical records from drug and bioactivity sources.
SOURCE
ChEMBL / DailyMed
THEOPHYLLINE ANHYDROUS
ChEMBL Phase
4
Adverse Events
728
Bioactivity
22
Frequently Asked Questions
What is the NOAEL for Theophylline?
Theophylline has 44 NOAEL studies in the database. The lowest reported value is 0.54 mg/m3 via inhalation in Human. Source: ToxValDB GESTIS DNEL.
What regulatory lists include Theophylline?
Theophylline appears on 7 regulatory/inventory lists including active_ingredient; Australia, active_ingredient; animal_products; Europe; pharmaceutical; residue, Europe; pharmaceutical, and 4 more. Source: EPA CPDat.
Is Theophylline a carcinogen according to IARC?
Theophylline is classified by IARC as Group 3 — not classifiable as to its carcinogenicity to humans (evaluated 1990). Source: IARC Monographs on the Identification of Carcinogenic Hazards to Humans.
Is Theophylline used in cosmetics?
Yes, Theophylline is also indexed as a cosmetic ingredient under the name Theophylline. View the full cosmetic safety profile on the ingredient page for detailed safety data, SCCS opinions, and regulatory status.
Where does the safety data for Theophylline come from?
Safety data is sourced from ECHA CLP Annex VI, EPA ToxValDB, EPA CPDat, EPA DSSTox, IARC Monographs, ECHA REACH, ILO/WHO ICSC, CosIng / Ingredients DB, ChEMBL / DailyMed. All data traces to primary regulatory sources and is updated from official government databases.
Does Theophylline have different safety status in cosmetics vs industrial chemicals?
Theophylline is prohibited in EU cosmetics but has active industrial GHS classifications (H360D).
Is Theophylline used outside industrial chemicals?
Theophylline also appears in cosmetics, pharmaceutical databases.