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EC number: 283-640-5 | CAS number: 84696-21-9 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Hydrocotyle asiatica, Umbelliferae.
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- Hydrocotyle asiatica, ext.
- EC Number:
- 283-640-5
- EC Name:
- Hydrocotyle asiatica, ext.
- Cas Number:
- 84696-21-9
- Molecular formula:
- not applicable
- IUPAC Name:
- Hydrocotyle asiatica, ext.
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Details on species / strain selection:
- young healthy adult
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 5 of each sex per dose group
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- The test item was suspended in 0.9% NaCl
- Duration of treatment / exposure:
- Single application
- Post exposure period:
- Bone marrow cells of the treated animals were collected 24 h and 48 h after the single application.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 2 000 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- Dose / conc.:
- 400 mg/kg bw/day
- Dose / conc.:
- 100 mg/kg bw/day
- No. of animals per sex per dose:
- 5 of each sex per dose group
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Yes: CPA; Cyclophosphamide
Examinations
- Tissues and cell types examined:
- Bone marrow was obtained from the femurs
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Within the main experiment the chosen concentration of 2000 mg/kg bw led to severe signs of toxicity as well as lethality within the first 24 hours. Based on animal welfare aspects the remaining animals of the 2000 mg/kg bw dose group were euthanized. Thus, as a result of the observed severe toxicity and lethality the maximal tolerable dose were adjusted.
1MTD: 1000 mg/kg bw
0.4 MTD: 400 mg/kg bw
0.1 MTD: 100 mg/kg bw
The animals treated with doses of 0.1 MTD, 0.4 MTD and 1 MTD showed dose-dependent mild to moderate signs of systemic toxicity. The animals treated with 1 MTD (24 h and 48 h) showed moderate signs of systemic toxicity such as reduction of spontaneous activity, catalepsis, prone position, constricted abdomen, piloerection, bradykinesia, kyphosis, recumbency, opisthotonos, ataxia, half eyelid closure and eye closure (Table 4, 5). 24 hours (1 MTD, 24 h), respectively 48 hours (1 MTD, 48h) after the treatment, no signs of toxicity were observed any more. Animals treated with 400 mg/kg bw (0.4 MTD) showed the same signs of toxicity as displayed for the 1 MTD dose group animals (Table 4, 5), except bradykinesia, recumbency and eye closure. 24 hours after treatment no toxic symptoms were observed anymore. Animals treated with 0.1 MTD showed mild signs of toxicity. 24 hours after treatment no signs of toxicity were observed anymore for the 0.1 MTD dose group animals.
For all dose groups, including positive and negative controls, 2000 polychromatic erythrocytes per animal were scored for incidence of micronucleated immature erythrocytes. The negative controls (24 h, 48 h) were within the range of the historical control data. The mean values noted for all dose groups, which were treated with the test item (24 h, 48 h), were within the historical negative control data range.
No biologically relevant increase of micronuclei was found after treatment with the test item in any of the dose groups evaluated.
The nonparametric Mann-Whitney Test was performed to verify the results. No statistically significant increases/decreases (p<0.05) of cells with micronuclei were noted in the dose groups of the test item evaluated.
Cyclophosphamide (40 mg/kg bw) administered ip was used as positive control which induced a significant increase in micronucleus frequency. This demonstrates the validity of the assay.
Applicant's summary and conclusion
- Conclusions:
- In conclusion, it can be stated that during the study described and under the experimental conditions reported, the test item Centella asiatica purified dry extract did not induce structural and/or numerical chromosomal damage in the immature erythrocytes of the mouse.
Therefore, Centella asiatica purified dry extract is considered to be non-mutagenic with respect to clastogenicity and/or aneugenicity in the Mammalian Erythrocyte Micronucleus Test. - Executive summary:
This study was performed to investigate the potential of Centella asiatica purified dry extract to induce micronuclei in polychromatic erythrocytes (PCE) in the bone marrow of the mouse, which is the endpoint of this test to assess genotoxicity.
The test item was suspended in 0.9% NaCl. The volume administered i.p. was 10 mL/kg bw. Bone marrow samples were collected for micronuclei analysis 24 h and 48 h after a single application of the test item.
No biologically relevant increase of micronuclei was found after treatment with the test item in any of the dose groups evaluated.
Therefore, Centella asiatica purified dry extract is considered to be non-mutagenic with respect to clastogenicity and/or aneugenicity in the Mammalian Erythrocyte Micronucleus Test.
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