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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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In vitro bacteria reverse mutation: Weigth of evidence: Two bacterial assays have been reported with contradictory results. The test substance chili pepper oleoresin was found as no mutagenic in a Salmonella / mammalian microsome mutagenicity assay (Buchanan1981) and the test substance red pepper oleoresin showed dose-response effects for the mutagenicity in SD1018 and SD7823 strains (Damhoeri1985).
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine-requiring gene in Salmonella typhimurium
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9 : livers of rats induced with phenobarbital.
- concentration or volume of S9 mix in the final culture medium: 0.5 mL/plate - Test concentrations with justification for top dose:
- 2.5, 25, 250, 2500 and 25000 µg/plate.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO.
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- other: N-methyl-N-nitro-N-nitrosoguanidine and picrolinic acid
- Remarks:
- Without metabolic activation.
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- Remarks:
- With metabolic activation.
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: 4
- Number of independent experiments: 1
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): Not specified.
- Test substance added in agar (plate incorporation) at a level of 0.5 mL/plate.
TREATMENT AND HARVEST SCHEDULE:
- Exposure duration/duration of treatment: 48 hr at 37ºC.
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method: background growth inhibition. - Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Conclusions:
- The test substance chili pepper oleoresin was found as no mutagenic in a Salmonella / mammalian microsome mutagenicity assay.
- Executive summary:
The test substance chili pepper oleoresin was tested for in vitro mutagenicity using the Salmonella / mammalian microsome mutagenicity assay similar to OECD Guideline 471. The experiments were performed with at least four replications, using Salmonella typhimurium strains TA 98, TA 100, TA 1535 and TA 1538 in the presence and absence of metabolic activation (S9 fraction prepared from the livers of rats). The test item was formulated in 0.1 mL DMSO as vehicle and concentrations of 2.5, 25, 250, 2500 and 25000 µg/plate were used in the assay. Vehicle control and appropriate positive controls (N-methyl-N-nitro-N-nitrosoguanidine and picrolinic acid without metabolic activation and 2-acetylamino-flourene with metabolic activation) were tested simultaneously. The test substance did not produce an increased reversion rate, while negative and positive controls were within expected ranges. These data indicates that the test substance is not mutagenic.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- - Principle of test:
Two streptomycin-dependent (SM (1)) strains, SD1018 and SD7823, were isolated from S. typhimurium TA100 and TA98, respectively, according to the method of Kada et al. (2), and used in spot tests ans plate incorporation tests.
- Short description of test conditions: For plate incorporation tests, two methods were employed, the SA method in which a 1-ml sample solution is mixed with 9ml of molten B2 broth agar (10g Kyokuto beef extract, 10g Daigo-Eiyo polypeptone, 5g NaCl and 15g Difco agar per liter, pH 7.0), and the PI method in which a 0.1 mL sample solution is incorporated into 2 mL of top agar (3). No metabolic activation of the samples was performed throughout this study.
(1) On leave from: Faculty of Agriculture, Tohoku University, Sendai, Japan.
(2) T. Kada, K. Aoki and T. Sugimura, Environ. Mutagenesis, 5, 9 (1983).
(3) D. M. Maron and B. N. Ames, Mutat. Res., 113, 173 (1983). - GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium, other: SD1018
- Additional strain / cell type characteristics:
- other: Streptomycin-dependent strain isolated from S. typhimurium TA100.
- Species / strain / cell type:
- S. typhimurium, other: SD7823
- Additional strain / cell type characteristics:
- other: Streptomycin-dependent strain isolated from S. typhimurium TA98.
- Metabolic activation:
- without
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: none
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-(2-furyl)-3-(5-nitro-2-furyl) acrylamide
- Details on test system and experimental conditions:
- METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): Not specified.
- Test substance added in agar (plate incorporation) - Key result
- Species / strain:
- S. typhimurium, other: SD1018
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium, other: SD7823
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- With the SA method, RPG values were in the order of around 1E2 for capsicum peppers. Higher RPG values for red pepper (1E3) were obtained by the PI method as compared with the SA method.
- Conclusions:
- The test substance red pepper oleoresin showed obvious dose-response effects for the mutagenicity in SD1018 and SD7823 strains.
- Executive summary:
The test substance red pepper oleoresin was tested for in vitro mutagenicity using 2 streptomycin-dependent strains, SD1018 and SD7823, isolated from S. typhimurium TA100 and TA98, respectively, in spot tests and plate incorporation tests. For plate incorporation tests, two methods were employed, the SA method in which a 1-ml sample solution is mixed with 9ml of molten B2 broth agar (10g Kyokuto beef extract, 10g Daigo-Eiyo polypeptone, 5g NaCl and 15g Difco agar per liter, pH 7.0), and the PI method in which a 0.1 mL sample solution is incorporated into 2 mL of top agar (3). No metabolic activation of the samples was performed throughout this study. The test substance showed obvious dose-response effects for the mutagenicity in SD1018 and SD7823 strains.
Referenceopen allclose all
The mutagenic effects of red pepper were unaffected by the different sterilization methods used for samples, autoclaving at 121ºC and nitration through a membrane filter, suggesting that the mutagenic factors in this spice are thermostable. On extraction of red pepper oleoresin with hexane, its major mutagenic and bactericidal factors were found to remain in the residues. Capsaicin, a major pungent principle of capsicum pepper, was negative for SD1018 and SD7823 in spot tests. This may suggest that capsaicin is not involved in capsicum pepper mutagenesis.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (positive)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
According to JECFA2009 (1) extracts of chilli peppers of different levels of purity have been tested, with mixed, inconsistent and often contradictory results.
The EFSA Panel (2) concluded that the limited information available from the open literature does not allow a reliable assessment of the genotoxicity of paprika extracts. Therefore, upon request of EFSA, two new GLP compliant genotoxicity studies using Paprika extract were performed: an OECD TG 471 mutation assay and a OECD TG 487in vitromicronucleus assay. Respective authors concluded that tested paprika extract did not induce mutation in the OECD test TG 471 mutation assay and did not induce micronuclei in cultured human peripheral blood lymphocytes. The Panel agreed with these conclusions.
Based on these results, the EFSA Panel concluded that paprika extracts used as a food colour do not raise a genotoxic concern.
References:
1. JECFA, 2009. Safety evaluation of certain food additives and contaminants. WHO Food Additives Series No. 59, 2008. Available online: http://apps.who.int/iris/bitstream/10665/43823/1/9789241660594_eng.pdf
2. EFSA ANS Panel (EFSA Panel on Food Additives and Nutrient Sources added to Food), 2015. Scientific Opinion on the re-evaluation of paprika extract (E 160c) as a food additive. EFSA Journal 2015;13(12):4320, 52 pp. doi:10.2903/j.efsa.2015.4320.
Justification for classification or non-classification
Based on the available information, the substance is considered to be negative for genetic toxicity, and therefore the substance is not classified in accordance with CLP Regulation (EC) no 1272/2008.
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