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EC number: 283-403-6 | CAS number: 84625-29-6 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Capsicum annuum, Solanaceae.
- 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
Carcinogenicity
Administrative data
Description of key information
Key study: Test method similar to OECD TG 451. In a 104-week carcinogenicity study, paprika color was found not carcinogenic to male or female F344 rats with dietary concentration up to 5% (2052 mg/kg bw/day for males and 2324 mg/kg bw/day for females).
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: Guidelines for Designation of Food Additives, and for Revision of Standard for Use of Food Additives
- Version / remarks:
- MHLW (Ministry of Health, Labor and Welfare of Japan), 1996b. Guidelines for Designation of Food Additives, and for Revision of Standard for Use of Food Additives. Article No. 29 of the Life and Sanitation Bureau.
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 451 (Carcinogenicity Studies)
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Stability under test conditions:
The stability of the test item contained in diet was assessed by San-Ei gen F.F.I., Inc. with test preparations of 5, 1, 0.2, and 0.04% paprika color (Lot No. 000927) in Oriental MF powder diet stored for 7, 14, 28, 56, and 84 days under the conditions of room lighting (approx 600 lx) at room temperature or in the dark at 5ºC. The color value of the chemical remained over 80% in the diet preparations for 28 days with the lighted condition and over 90% for 84 days in the dark. Therefore, diets were newly prepared every 2 weeks and preserved in the dark condition at 4ºC prior to use. - Species:
- rat
- Strain:
- Fischer 344/DuCrj
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Japan (Kanagawa, Japan)
- Age at study initiation: 6 weeks
- Weight at study initiation: Males: 120 g; females: 100 g
- Housing: The animals were housed in a room with a barrier system, in plastic cages (three or four rats/cage) on soft chip bedding (Sankyo Labo-service, Tokyo, Japan). Throughout the experiment, chips were renewed every 3 or 4 days.
- Diet (e.g. ad libitum): CRF-1 powder diet (Oriental Yeast Co., Ltd., Tokyo).
- Water (e.g. ad libitum): tap water ad libitum.
- Acclimation period: 2 weeks.
ENVIRONMENTAL CONDITIONS
- Temperature (ºC): 24 ± 1ºC
- Humidity (%): 55 ± 5 %
- Air changes (per hour): 18 / hour
- Photoperiod (hours dark / hours light): 12 hours dark / 12 hours light - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency): every 2 weeks
- Mixing appropriate amounts with (Type of food): CRF-1 powder diet (Oriental Yeast Co., Ltd., Tokyo).
- Storage temperature of food: 4ºC - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 104 weeks.
- Frequency of treatment:
- Daily
- Dose / conc.:
- 0 other: % in diet
- Dose / conc.:
- 2.5 other: % in diet
- Remarks:
- Equivalent to 1028 (males) and 1209 (females) mg/kg bw/day.
- Dose / conc.:
- 5 other: % in diet
- Remarks:
- Equivalent to 2052 (males) and 2324 (females) mg/kg bw/day.
- No. of animals per sex per dose:
- 50
- Control animals:
- yes, plain diet
- Positive control:
- Not required.
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: every week until week 5 and every 5 weeks thereafter.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes; necropsy performed on all animals. Weights of the brain, lungs, heart, spleen, liver, adrenals, kidneys and testes were measured.
HISTOPATHOLOGY: Yes; perfomed on all groups for both sexes for brain, lungs, heart, spleen, liver, adrenals, kidneys, testes, cranium with nasal cavity, pituitary, eyeballs, Harderian glands, spinal cord, salivary glands, stomach, small and large intestine, caecum, pancreas, urinary bladder, skin, mammary gland, lymph nodes, sternum, trachea, esophagus, thyroid gland, tongue, femoral muscle and bone, trigeminal and ischiatic nerve, epididymis, seminal vesicles, prostate gland, coagulating gland, uterus, ovary and vagina. - Statistics:
- The data for body weights, food consumption and organ weights were analyzed statistically. The Bartlett’s test was applied to test homogeneity of variance between groups. When the data were homogeneous, one-way analysis of variance (ANOVA) was applied. In the heterogeneous cases, the Kruskal–Wallis test was applied. When statistically significant differences were indicated, the Dunnett’s multiple test was employed for comparison between control and treated groups. Final survival rates and incidences of tumors and histopathological findings were compared with the Fisher’s exact probability test.
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No remarkable changes in general appearance were observed.
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- The survival rates for control, 2.5% and 5% groups were 76%, 80% and 78%, respectively, for males, and 76%, 76% and 72%, respectively, for females, with no significant differences observed among the groups.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- There were no significant differences between control and treated groups in body weight throughout the experimental period in either sex.
- Food consumption and compound intake (if feeding study):
- effects observed, non-treatment-related
- Description (incidence and severity):
- No test substance-related change was found, except for a dose-dependent tendency for decrease in both sexes.
Intake of paprika color for 2.5% and 5% groups were estimated to be 1028 and 2052 mg/kg bw/day for males, and 1209 and 2324 mg/kg bw/day for females. Thus, test substance showed a good correlation with the expected doses. - Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Significant decreases in absolute and relative weights of the spleen were observed in 5% males and 2.5% females.These effects were considered of little toxicological significance because of no dose-dependent manner.
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Neoplastic lesions such as adenomas in the pituitary glands, large granular lymphocytic leukemia in the hematopoietic organs, interstitial cell tumors in the testes and endometrial stromal polyps in the uteri, and adenomas/fibroadenomas/fibromas in the mammary glands were noted in all groups, but no significant increases in their incidences were observed with the treatment.
- Other effects:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 2 052 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- histopathology: neoplastic
- Remarks on result:
- other: Based on no evidence of long-term carcinogenic activity up to 5% of test item in the diet.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 2 324 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- histopathology: neoplastic
- Remarks on result:
- other: Based on no evidence of long-term carcinogenic activity up to 5% of test item in the diet.
- Key result
- Critical effects observed:
- no
- Conclusions:
- Paprika color was found not carcinogenic to male or female F344 rats in a 104-week carcinogenicity study.
- Executive summary:
In a carcinogenicity toxicity study performed similarly to OECD Guideline 451, F344 rats divided in 3 groups each consisting of 50 males and 50 females were fed powder diet containing paprika color at dose levels of 0 (basal diet), 2.5 and 5% (maximum) for 104 weeks. Clinical signs and general appearance were observed once a day and body weights and food consumption were measured every week until week 5 and every 5 weeks thereafter. An autopsy was performed at the end of the experiment and histopathological examinations were carried out on all groups for both sexes. The test substance did not induce specific tumors nor did it exert significant influence on the development of spontaneous tumors in any of the organs examined. In conclusion, paprika color was not carcinogenic to male and female F344 rats under the present experimental conditions.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 2 052 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- One study available with a Klimisch score of 2.
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available information, the substance is not classified for carcinogenicity according to CLP Regulation (EC) no. 1272/2008.
Additional information
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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