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EC number: 203-219-1 | CAS number: 104-61-0
- 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
- Endpoint:
- carcinogenicity
- Remarks:
- subcutaneous
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1964-1968
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Study performed via subcutaneous route using 16 female mice; individual animal data not reported; no data on body weight, food/water consumption, clinical observations and non-neoplastic histopathological findings
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 970
Materials and methods
- Principles of method if other than guideline:
- Carcinogenic study: γ-Nonalactone was administered via subcutaneous injections to a group of mice at a dose level of 15 mg/injection; 3 times a week for 4 weeks and the appearance of suspected neoplasms was recorded for 18-24 months.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Nonan-4-olide
- EC Number:
- 203-219-1
- EC Name:
- Nonan-4-olide
- Cas Number:
- 104-61-0
- Molecular formula:
- C9H16O2
- IUPAC Name:
- 5-pentyloxolan-2-one
- Details on test material:
- - Name of test material (as cited in study report): γ-Nonalactone
- Source: Givaudan-Delawanna, Inc., New York, USA
- Analytical purity: > 98 %
- Analytical method: Received test material was purified by fractional distillation under vacuum and/or column chromatography. Purity was determined by functional group analysis and microanalysis coupled with thin-layer, column, and gas-liquid chromatography (if applicable) and nuclear magnetic resonance spectroscopy.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss Webster
- Sex:
- female
Administration / exposure
- Route of administration:
- subcutaneous
- Vehicle:
- other: tricaprylin
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 4 weeks
- Frequency of treatment:
- 3 times a week for 4 weeks
- Post exposure period:
- 18-24 months
Doses / concentrations
- Remarks:
- Doses / Concentrations:
15 mg/injection
Basis:
other: injected
- No. of animals per sex per dose:
- - Treatment group: 16 female mice
- Vehicle control: 100 female mice
- Blank control (no treatment): 203 female mice - Control animals:
- yes, concurrent no treatment
- yes, concurrent vehicle
Results and discussion
Effect levels
- Dose descriptor:
- NOAEL
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: no evidence of carcinogenic activity
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified. Effect type:carcinogenicity (migrated information)
Any other information on results incl. tables
- Body weight: No excessive weight losses or gains were found as compared with untreated control groups
- Mortality: See table 7.7/1
- Neoplastic data: See table 7.7/1
Table 7.7/1: Summary of tests for carcinogenic activity in Swiss-Webster mice
Compound |
Alive/total mice* |
Subcutaneous sarcomas |
Pulmonary tumors |
Breast cancers |
Lymphomas |
Other tumors |
Tricaprylin |
97/100 |
0 |
4 |
2 |
0 |
4 |
No treatment |
171/203 |
1 |
10 |
14 |
0 |
2 |
γ-Nonalactone |
15/16 |
1 |
0 |
0 |
0 |
0 |
*No. of Swiss-Webster mice alive at 6 months/Total no. of mice at the beginning of the test
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, there was no evidence of carcinogenic activity of γ-nonalactone for female Swiss-Webster mice.
- Executive summary:
In a carcinogenic study, γ-nonalactone was administered via subcutaneous injections to a group of 16 female Swiss-Webster mice at a dose level of 15 mg/injection; 3 times a week for 4 weeks. Untreated and vehicle (tricaprylin) controls were also included in the study. All mice were weighed at the start of the experiments and at regular intervals throughout the ensuing period of observation of 18 to 24 months. Mice were observed twice weekly for the appearance of subcutaneous tumors. Animals with tumors or those in poor condition were killed and autopsied. Suspected neoplasms and other grossly abnormal tissues were removed and fixed in buffered 10 % formalin. All diagnoses were based on histological examination of sections stained with hematoxylin and eosin.
Total alive mice at 6 months were recorded to be 97/100, 171/203 and 15/16 in vehicle control, untreated and treatment groups, respectively. No excessive weight losses or gains were found as compared with untreated control groups. Subcutaneous sarcomas, breast cancers pulmonary and other tumors were identified in control groups. In treatment group, subcutaneous sarcoma was identified in only one mouse.
Under the test conditions, there was no evidence of carcinogenic activity of γ-nonalactone for female Swiss-Webster mice.
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