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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
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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).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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