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EC number: 404-240-0 | CAS number: 95962-14-4 NECTALACTONE; NECTARYL; NECTARYL-LRG 1371
- 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:
- 13 March 1989 to 12 October 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- Cyclopentanone, 2-[(2R)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2S)-rel-
- Molecular formula:
- C14H24O1
- IUPAC Name:
- Cyclopentanone, 2-[(2R)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2S)-rel-
- Reference substance name:
- Cyclopentanone, 2-[(2S)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2R)-rel-
- Molecular formula:
- C15H24O
- IUPAC Name:
- Cyclopentanone, 2-[(2S)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2R)-rel-
- Reference substance name:
- Cyclopentanone, 2-[(2S)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2S)-rel-
- Molecular formula:
- C15H24O
- IUPAC Name:
- Cyclopentanone, 2-[(2S)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2S)-rel-
- Reference substance name:
- Cyclopentanone, 2-[(2R)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2R)-rel-
- Molecular formula:
- C15H24O
- IUPAC Name:
- Cyclopentanone, 2-[(2R)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2R)-rel-
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
- Specific details on test material used for the study:
- Name (as stated in the report) : NECTARYL - LRG 1371
Identification of the test item for the study: 07683 D9 001
Aspect: colourless slightly viscous liquid
Batch Number: AS1241001
Test animals
- Species:
- mouse
- Strain:
- other: OFl mouse (IOPS Caw).
- Details on species / strain selection:
- The mouse is currently used in this type of test and is recommended by the different legislative authorities.
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Iffa-Credo (69210 L'Arbresle - France).
- Age at study initiation: young adults, aged from 6 to 8 weeks
- Weight at study initiation: values between 28.3 g and 36.9 g for the males, and between 21.2 g and 28.8 g for the females.
- Cages : housed in groups of 5 (or 2 in the preliminary studies), by sex in translucent polypropylene VS cages (internal dimensions 205 x 115 x 129 mm).
- Air changes: at least 10 per hour
- Temperature: 22, 3° C
- Humidity: 30 to 70% R.H
- Lighting: artificial, 12 hours out of 24 (photoperiod = 07,30 - 19,30).
- Hygiene: cages changed for each study.
Administration / exposure
- Route of administration:
- other: Oral route (test substance and negative control) and intraperitoneal route (positive control).
- Vehicle:
- The test substance was diluted in sterile Codex liquid paraffin (Aguettant, Batch 6170 B, March 1993)
- Details on exposure:
- Preliminary study: 4 groups made up of 2 males and 2 females each treated respectively at the dose levels of 9600*, 4800, 960 and 192 mg/kg. A complementary study was performed at the dose levels of 4800 and 960 mg/kg to confirm the clinical observations.
Main study: The dose level of 4800 mg/kg was administered in the main study - Duration of treatment / exposure:
- Oral administration: 10 ml/kg of live body weight
- Frequency of treatment:
- The test substance was administered once only
- Post exposure period:
- Observations were carried out within the first hour and then 15 minutes, 24, 48 and 72 hours after administration.
Doses / concentrations
- Dose / conc.:
- 4 800 mg/kg bw/day (nominal)
- Remarks:
- Dose conc of the main study was determined from the complementary study where no mortality occured at the dose level of 4800 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females per group / 1 dose concentration per group
- Control animals:
- yes
- yes, concurrent vehicle
- Positive control(s):
- A solution of cyclophosphamide (Sigma, Batch 114 F 0393) in sterile water for injection (Aguettant, Batch 85456, July 1991) was prepared. Used concentration: 10 mg/ml
Examinations
- Details of tissue and slide preparation:
- For each animal both femurs were removed. The femoral bone marrow was extracted with the aid of syringe, and suspended in foetal calf serum. After centrifugation and resuspension the smears were prepared (2 slides per animal). The slides were stained with May-Grunwald- Giemsa. Microscopic examination of the slides was performed. For each animal 1000 erythrocytes were examined (500 cells per slide, 2 slides). A count of the number of polychromatophile erythrocytes bearing micronuclei was performed. At the same time the ratio of normochromatophile erythrocytes to polychromatophile erythrocytes was established by the observation of 400 cells per animal (200 cells per slide, 2 slides).
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- see "additional information on results" field below
- Vehicle controls validity:
- not examined
- Remarks:
- test item was administered pure
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The normochromatic / polychromatic erythrocytes ratio, is enhanced by a factor of 2 to 3 in the animals treated by the test substance. This observation shows the slightly toxic effect of the test substance on the bone marrow cells.
Applicant's summary and conclusion
- Conclusions:
- No significant increase of the number of polychromatophile erythrocytes bearing micronuclei was observed in the animals treated with the test substance, at the dose level of 4800 mg/kg and killed 24, 48 or 72 hours after administration.
In contrast, significant results were observed in the animals treated with the positive control. The normochromatic / polychromatic erythrocytes ratio, is enhanced by a factor of 2 to 3 in the animals treated by the test substance. This observation shows the slightly toxic effect of the test substance on the bone marrow cells.
From these experimental results, it may be concluded that the test substance does not induce any mutagenic effect in the mouse. - Executive summary:
The mutagenic potential of the test substance was tested in the mouse using the micronucleus test OECD Guideline No. 474. The test substance was administered by the oral route at the dose level of 4800mg/kg as described in the preliminary study.
A negative control (administration of vehicle) and a positive control (administration of a standard mutagenic substance) were included in this study.
The animals (5 males and 5 females per group) were killed 24, 48 or 72 hours after the administration of the test substance. For each animal an examination of 1000 polychromatophile erythrocytes obtained from the femoral bone marrow was performed. The frequency of micronuclei was calculated for each animal and for each group.
Under the experimental conditions employed,the test substance NECTARYL did not induce mutagenic effects in the mouse.
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