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EC number: 272-823-5 | CAS number: 68916-18-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- publication
- Title:
- SIDS Initial Assessment Report for SIAM 14: Caffeine (CAS 58-08-2)
- Author:
- OECD
- Year:
- 2 002
- Bibliographic source:
- OECD SIDS
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- 2 concentrations only
- Principles of method if other than guideline:
- A third test group (as required by the OECD guideline no. 403) was not included since a third dose level (higher than 4.94 mg/l) was expected to be lethal to all exposed animals.
- GLP compliance:
- no
- Test type:
- traditional method
- Limit test:
- no
Test material
- Reference substance name:
- Caffeine
- EC Number:
- 200-362-1
- EC Name:
- Caffeine
- Cas Number:
- 58-08-2
- Molecular formula:
- C8H10N4O2
- IUPAC Name:
- 1,3,7-trimethyl-3,7-dihydro-1H-purine-2,6-dione
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: caffeine, purity of 99.5 - 100% (dried substance)
- Expiration date of the lot/batch: not available
- Purity test date: not available
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not available
- Stability under test conditions: not available
- Solubility and stability of the test substance in the solvent/vehicle: soluble in water
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not available
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: not available
- Preliminary purification step (if any): not available
- Final dilution of a dissolved solid, stock liquid or gel: not available
OTHER SPECIFICS: none
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- other: Aerosil R 972 at 2%
- Details on inhalation exposure:
- The rats were exposed for 4 hours and observed for 14 days (day of exposure = day 0).
- Concentrations:
- Nominal concentrations of 2.48 and 4.94 mg/l
- No. of animals per sex per dose:
- 5
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- ca. 4.94 mg/L air (nominal)
- Mortality:
- No deaths were observed at the low dose level.
In the high dose group, 6/10 animals died. Late deaths were observed; one male each died at day 0 and 7, respectively; 2, 1, and 1 female died at day 0, 1, and 2, respectively. - Clinical signs:
- other: Clinical signs of toxicity included changes in respiration (irregular, accelerated, intermittent, gasping), eyelid closure, salivation, restlessness, attempts to escape, reddish nasal discharge, apathy, and (in the high dose group only) decreased pain ref
- Gross pathology:
- Pathology revealed general congestion, bloody ulcers in the glandular stomachs, and/or intensified hyperemia in the animals that died. No pathological changes were observed in the survivors.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- In an acute inhalation toxicity study in Wistar male and female rats conducted according to OECD test guideline 403, the LC50 value was determined at 4.94 mg/l for caffeine aerosol.
- Executive summary:
The acute inhalation toxicity study in Wistar male and female rats conducted according OECD test guideline 403 was performed to assess the acute toxicity potential of caffeine aerosol.
Groups of 5 Wistar rats per sex were exposed to caffeine aerosol at nominal concentrations of 2.48 and 4.94 mg/l using a head-nose inhalation system. The rats were exposed for 4 hours and observed for 14 days. No deaths were observed at the low dose level. In the high dose group, 6/10 animals died. Late deaths were observed; one male each died at day 0 and 7, respectively; 2, 1, and 1 female died at day 0, 1, and 2, respectively.
Clinical signs of toxicity included changes in respiration (irregular, accelerated, intermittent, gasping), eyelid closure, salivation, restlessness, attempts to escape, reddish nasal discharge, apathy, and (in the high dose group only) decreased pain reflex and death. Pathology revealed general congestion, bloody ulcers in the glandular stomachs, and/or intensified hyperemia in the animals that died. No pathological changes were observed in the survivors.
The value of the lethal concentration 50 (LC50) in this study has been determined at 4.94 mg/l, allocaing caffeine in Category 4 based on GHS criteria for acute toxicity classification.
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