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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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- publication
- Title:
- Acute toxicity of the aqueous extract of roasted and ground beans of Coffea canephora robusta in the Wistar rat
- Author:
- AKA Francis Beranger Angelo, Amonkan Kouao Augustin, Kahou Bi Gohi Parfait and NENE BI Semi Anthelme
- Year:
- 2 016
- Bibliographic source:
- The Pharma Innovation Journal 2016; 5(12): 01-05
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Remarks:
- No further information provided.
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- not applicable - High molecular weight constituents (Mwt > 719 g mol-1) such as polysaccharides, proteins and melanoidin polymers
- Molecular formula:
- not applicable - High molecular weight constituents (Mwt > 719 g mol-1) such as polysaccharides, proteins and melanoidin polymers
- IUPAC Name:
- not applicable - High molecular weight constituents (Mwt > 719 g mol-1) such as polysaccharides, proteins and melanoidin polymers
- 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
- Test material form:
- liquid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: roasted and ground beans of Coffea canephora robusta
- 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: refrigerated
- Stability under test conditions: not available
- Solubility and stability of the test substance in the solvent/vehicle: not available
- 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: The aqueous extract was obtained by infusion of roasted and ground beans of Coffea canephora robusta (Ccr). A filter coffee machine of Philips brand Daily collection insulated stainless timer HD7479/20, was used to prepare coffee. The infusion was made with 30 g of roast and ground beans of Ccr in 175 ml of distilled water. The filtrate obtained was evaporated in an oven at a temperature of 60 °C. The crystals obtained were pulverized. The captured fine powder was kept refrigerated in sterile glass jars sealed. This technique yielded 3g of dry extract.
- Preliminary purification step (if any): not available
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid: not applicable
OTHER SPECIFICS:
To extract caffeine, one gram of freeze-dried coffee ground powder was transferred to a volumetric flask of 50 ml. An amount of 35 ml of methanol was added and the resulting suspension was immersed in an ultrasonic bath for 10 minutes. The suspension was subsequently cooled to room temperature and filtered on Whatman paper N°4.
The HPLC system consisting of a pump, a UV detector, and controlled by a computer (software) was used for assaying the proportion of caffeine in the extract. Qualitative analysis of caffeine was obtained by comparison of retentions times of the compounds eluted to the retention times of the reference solutions. The concentrations were determined from the average of the peak areas of the reference solutions. Caffeine content being the average of 3 tests, the concentration of caffeine in the extract is given by the following formula:
SC = S area x CW/ W area, where
SC = sample concentration
CW = Concentration witness
W area = peak area witness
S area = peak area sample
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- albino
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Pasteur Institute Adipodoumé, Abidjan, Ivory Coast
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: 8-10 weeks
- Weight at study initiation: between 100 and 120 g
- Fasting period before study: not specified
- Housing: wire cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 3ºC
- Humidity (%): 50%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12 hours
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Test solutions and control solution were administered by a stomach tube.
- Doses:
- 2000 and 5000 mg/kg bw
- No. of animals per sex per dose:
- 3 female rats
- Control animals:
- yes
- Remarks:
- control animals received distiled water
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs were observed at 30 minutes, 1, 4, 8 , 24 and 48 hours.
The weight of each animal was determined before administration and then every third day.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Organs such as the kidney, liver and heart were removed and weighed.
The biochemical parameters such urea, blood sugar, creatinine, transaminases ASAT and ALAT and hematological parameters such as leukocytes, erythrocytes and platelets counts, hemoglobin, hematocrit, MCV, MCHC were determined. - Statistics:
- The statistical analysis was performed using the Graph Pad Prism 5 software. The analysis of variance ANOVA (One-way ANOVA) followed by the Tukey-Kramer test was used for comparison of results. The difference is considered statistically significant when P <0.05.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 - < 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Two deaths occured at the dose of 5000 mg/kg bw after 24 and 48 hours. No deaths related to the extract administration were recorded at the dose of 2000 mg/kg bw.
- Clinical signs:
- other: During the first hour after administration of the extract, the rats from experimental batches seemed agitated. This excitation was attributed to caffeine, which increases, neuromuscular transmission and increases the neural excitability reducing the disch
- Gross pathology:
- No effects were observed on liver, heart and kidney in experimental and control animals.
- Other findings:
- Caffeine content in the aqueous extract of roasted and ground beans of Coffea Canephora robusta was determined at 7.5%.
Any other information on results incl. tables
Effects on the organs weigh in animals receiving 2000 mg/kg of bw of the extract.
Organ (g) |
Control rats |
Experimental rats |
Liver |
4.08±0.41 |
4.17±0.28 |
Heart |
0.43±0.26 |
0.47±0.14 |
Kidney |
0.64±0.025 |
0.67±0.02 |
Effects on biochemical parameters in animals receiving 2000 mg/kg of bw of the extract.
Parameter |
Control rats |
Experimental rats |
Urea (g/L) |
0.19±0.01 |
0.18±0.02 |
Blood sugar (g/L) |
0.95±0.16 |
1.05±0.20 |
Creatinine (mg/L) |
8.67±0.95 |
7.67±1.04 |
Transaminase ASAT (U/L) |
35.33±3.06 |
32.0±4.57 |
Transaminase ALAT (U/L) |
39.33±1.67 |
37.67±2.62 |
Effects on leukocytes parameters in animals receiving 2000 mg/kg of bw of the extract.
Parameter |
Control rats |
Experimental rats |
Polymorphonuclear neutrophils (%) |
14.0±2.65 |
12.67±1.15 |
Polymorphonuclear eosinophils (%) |
1.67±0.58 |
1.33±0.58 |
Polymorphonuclear basophils (%) |
0.0±0.00 |
0.0±0.00 |
Lymphocytes (%) |
79.33±3.08 |
81.0±2.00 |
Monocytes (%) |
5.0±1.00 |
5.0±1.00 |
Effects on hematological parameters in animals receiving 2000 mg/kg of bw of the extract.
Parameter |
Control rats |
Experimental rats |
Leukocytes (109/L) |
8.43±2.21 |
10.53±1.77 |
Erythrocytes (1012/L) |
6.93±0.63 |
7.17±0.24 |
Hemoglobin (g/dL) |
13.07±0.57 |
13.73±0.40 |
Hematocrit (%) |
37.1±1.81 |
39.47±1.40 |
MCV (fl) |
51.60±1.15 |
54.37±1.30 |
MCH (pg) |
17.87±0.75 |
18.57±1.07 |
MCHC (g/dL) |
34.40±1.02 |
34.67±0.85 |
Platelets (109/L) |
728±109 |
753±127 |
Administration of roasted and ground beans of Coffea canephora robusta extract did not have any effect on biochemical and hematological parameters. Normal values of urea and creatinine suggest that this extract did not alter the structure and renal functions. In addition, the levels of transaminases (ALAT) and (ASAT) were not altered during the experiment indicating that liver and to a lesser degree, muscles were not affected.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute oral toxicity study in rats, conducted according to OECD test guideline 423, a LD50 value was determined between 2000 and 5000 mg/kg body weight for aqueous extract of roasted and ground beans of Coffea canephora robusta containing 7.5% of caffeine.
- Executive summary:
The acute oral toxicity study in rats, conducted according to OECD test guideline 423 was performed to assess the acute toxicity potential of aqueous extract of roasted and ground beans of Coffea canephora robusta.
Two sets of 3 animals received Coffea canephora robusta extract at 2000 mg/kg body weight, another set of 3 animals received a dose of 5000 mg/kg body weight and a control group were administered distilled water, by stomach tube.
Clinical signs including diarrhea, lethargy, excitability and death were observed at 30 minutes, 1, 4, 8, 24 and 48 hours. The relative weights of organs (kidneys, liver and heart) were recorded at the beginning of the study, and then every third day. At the end of the study, animals were sacrificed and gross pathology was performed. Additionally, the biochemical and hematological parameters were determined.
No deaths were observed at 2000 mg/kg body weight, two deaths occurred at the dose of 5000 mg/kg body weight after 24 and 48 hours. There were no significant effects on the body weight in animals receiving coffee extract in comparison to control animals. Additionally, all animals from control and treatment groups gained weight during the experiment.
The administration of aqueous extract of roasted and ground beans of Coffea Canephora robusta did not have any significant effect on the relative weights of organs and biochemical and hematological parameters
The value of the lethal dose 50 (LD50) in this study has been determined between 2000 and 5000 mg/kg body weight, indicating that the aqueous extract of roasted and ground beans of Coffea Canephora robusta containing 7.5% of caffeine has relatively low acute toxicity and does not meet GHS criteria for acute toxicity classification.
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