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EC number: 200-362-1 | CAS number: 58-08-2
- 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

Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 44.37 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 6
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 25.17 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 24
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
A DNEL was only determined for worker exposure in an industrial setting, since Caffeine is produced in a closed system and for general population exposure is regulated by the pharmaceutical law, the European cosmetic legislation and the European Food Safety Authorisation (EFSA).
Short-term systemic and local effects / long-term exposure and local effects:
Acute/short-term DNELs were not calculated as they are covered by calculation of long-term DNELs.
No local dermal effects or skin and eye irritation/corrosion as well as no respiratory irritation were observed. No sensitizing activity was detected.
Therefore the following DNEL(s) for local effects and short term exposure were not determined:
- Dermal DNEL for acute / short-term exposure - systemic effects
- Inhalation DNEL for acute / short-term exposure - systemic effects
- Dermal DNEL for acute / short-term exposure - local effects
- Inhalation DNEL for acute / short-term exposure - local effects
- Dermal DNEL for long-term exposure - local effects
- Inhalation DNEL for long-term exposure - local effects
Long-term exposure - systemic effects
Based on the No-(Adverse)-Effect-Level for oral repeated-dose toxicity of Caffeine (CAS No. 58-08-2)the endpoint-specific Derived-No-Effect-Level (DNEL) was calculated. For Caffeine, following subchronic exposure in a drinking water study (NTP 1983) a NOAEL of 151 mg/kg body weight/day was determined. Using an over all assessment factor, including the assessment factors for interspecies extrapolation of 4 (allometric scaling rat to human), intraspecies extrapolation of 3 for worker according to ECETOC 2003, exposure duration of 2 (sub-chronic to chronic) and for remaining factors, dose response and quality of database of 1, respectively, the DNEL (Worker) for oral exposure was calculated as follows: 151 mg/kg/day/ (4*3*2*1*1*1) = 6.292 mg/kg body weight /day.
- Dermal DNEL for long-term exposure - systemic effects
For the determination of the dermal DNEL, the NOAEL of 151 mg/kg bw/day of the same rat oral subchronic repeated dose study (NTP 1983) was used.
The dermal absorption was assumed as 25 % according to van de Sandt et al., 2004 (Reg Tox and Pharma 39, 271 -281. Accordingly, for dermal exposure the corrected starting point was calculated as 604 mg/kg body weight/day. Using the overall assessment factor of 24, including assessment factors for interspecies extrapolation of 4 (allometric scaling rat to human), intraspecies extrapolation of 3 for worker according to ECETOC 2003, exposure duration of 2 (sub-acute to chronic) and for remaining factors, dose response and quality of database of 1, respectively, the DNEL (Worker) for dermal exposure was calculated as follows: 604 mg/kg/day/ (4*3*6*1*1*1) = 25.167 mg/kg body weight /day.
- Inhalation DNEL for long-term exposure - systemic effects
Using the same rat oral subchronic repeated dose study (NTP 1983), the calculation of the endpoint specific DNEL for inhalation repeated-dose toxicity for workers was performed. The conversion of the rat oralNOAEL of 151 mg/kg bw/day to a corrected inhalatoryhuman NOAEL was based on the different respiratory volume of the rat (0.38 m³/kg/day and the different rate during light activity at work (10 m³) and standard conditions (6.7 m³).
CorrectedNOAEL= 151 mg / m³ * 1/0.38 m³/kg/day * 6.7 m³ (8h) / 10 m³ (8h) = 266.2 mg/m³.Using the overall assessment factor of 18, including assessment factors for intraspecies extrapolation of 3 for worker according to ECETOC 2003, exposure duration of 2 (sub-chronic to chronic) and for remaining factors, dose response and quality of database of 1, respectively, the DNEL (Worker) for inhalative exposure was calculated as follows: 266.2mg/m³/ (3*2*1*1*1) = 44.373mg/m³.
General Population - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
For general population no DNEL was calculated, since Caffeine is produced in a closed system and for general population exposure is regulated by the pharmaceutical law (tablets), the European cosmetic legislation (cosmetics) and the European Food Safety Authorisation (EFSA) (drinks).
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