Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 307-301-9 | CAS number: 97593-01-6
- 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
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992-09-04 to 1992-09-12
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable with restriction because although it is an acceptable and well documented study report the GLP compliance was unknown.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Heptenes
- IUPAC Name:
- Heptenes
- Reference substance name:
- Alkenes, C6-8-branched, C7-rich
- EC Number:
- 307-298-4
- EC Name:
- Alkenes, C6-8-branched, C7-rich
- Cas Number:
- 97592-99-9
- IUPAC Name:
- Alkenes, C6-8-branched, C7-rich
- Details on test material:
- - Name of test material (as cited in study report): Heptenes (CAS 68526-53-4)
- Physical state: colourless liquid
Stability, identity, strength, purity, and composition are the responsibility of the sponsor and not provided in the study report.
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Raleigh
- Age at study initiation: approximately 7 to 9 weeks
- Weight at study initiation: Between 19 to 28 grams
- Assigned to test groups randomly: Chosen by body weight by computer generated sorting system.
- Fasting period before study: not reported
- Housing: Single after approximately one week in suspended stainless steel
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 24 degrees Celsius
- Humidity (%): 40 to 70% humidity
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hours dark/ 12 hours light.
IN-LIFE DATES: From: 1992-09-01 To: 1992-11-04
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: corn oil
- Justification for choice of solvent/vehicle: not reported
- Concentration of test material in vehicle: equal amounts of test material and vehicle.
- Amount of vehicle (if gavage or dermal): Same amount as test material (1.25, 2.05, or 5.0 g/kg/bw
- Purity: 100% - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The test material was weighed on the day of dosing and mixed with the corn oil to provide stock solution such that each individual animal dose volume did not exceed 1.0 ml/100 grams bw.
DIET PREPARATION - test material administered by oral gavage
- Rate of preparation of diet (frequency): not applicable
- Mixing appropriate amounts with (Type of food): not applicable
- Storage temperature of food: not applicable - Duration of treatment / exposure:
- Animals from the appropriate groups were sacrificed approximately 24, 48, and 72 hours after dose administration. Animals dosed with cyclophosphamide were sacrificed at 24 hours only.
- Frequency of treatment:
- Test material was administered by oral gavage as a single dose
- Post exposure period:
- Not applicable.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
1.25 g/kg bw
Basis:
other: Corn oil was dosed with the test material at the same volume as the test material.
- Remarks:
- Doses / Concentrations:
2.5 g/kg bw
Basis:
other: Corn oil was dosed with the test material at the same volume as the test material.
- Remarks:
- Doses / Concentrations:
5.0 g/kg bw
Basis:
other: Corn oil was dosed with the test material at the same volume as the test material.
- No. of animals per sex per dose:
- 15 animals per sex per dose
- Control animals:
- not specified
- Positive control(s):
- cyclophosphamide
- Justification for choice of positive control(s): not reported
- Route of administration: oral gavage
- Doses / concentrations: equal volume to the test material dose volume
Examinations
- Tissues and cell types examined:
- Bone marrow from femurs.
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: Not reported
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): No additional data reported
DETAILS OF SLIDE PREPARATION:
Two slides were prepared per animals, labelled with animal identification number and study number. Prior to microscopic evaluation, slides were trained using acridine orange. Polychromatic erythrocytes stain fluorescent red/orange, normochromatic erythrocytes are unstained or stain a dull green, and micronuclei stain fluorescent bright yellow.
METHOD OF ANALYSIS:
OTHER: - Evaluation criteria:
- Criteria for scoring micronuclei are circular appearance and diameter between 1/20 and 1/5 of the cell's diameter. 1000 polychromatic erythrocytes (PCE) from each animal were examined for micronuclei, and the ratio of PCE's to normochromatic erythrocytes (NCE) was determined for each animal by counting 1000 erythrocytes.
- Statistics:
- Calculation of means and standard deviations of the micronuclei data and a test of equality of group means by a standard one way analysis of variance at each time period. When the ANOVA was significant, Duncan's Multiple Range Test was used to compare carrier control to dosed group means. A standard regression analysis was performed to test for a dose response.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- None reported
Applicant's summary and conclusion
- Conclusions:
- negative
The test material did not induce statistically significant decrease in the mean percent of polychromatic erythrocytes which is a measure of bone marrow toxicity. Thus the test material was not toxic to mouse bone marrow under the conditions of the test. This test material did not induce a statistically significant increase in the mean number of micronucleated polychromatic erythrocytes. Both positive and negative controls for the assay responded in an appropriate manner. The test material did not produce clastogenic abnormalities in the bone marrow cells of B6C3F1 mice at doses up to and including 5.0 g/kg under the conditions of the assay. - Executive summary:
In a B6C3F1 bone marrow micronucleus assay 65 male and 65 female mice were treated via oral gavage with heptenes at doses of 1.25, 2.5, and 5.0 g/kg bw. Bone marrow cells were harvested at 24, 48, and 72 hours post treatment. The vehicle was corn oil via oral gavage.
The test material did not induce statistically significant decrease in the mean percent of polychromatic erythrocytes which is a measure of bnbone marrow toxicity. Thus the test material was not toxic to mouse bone marrow under the conditions of the test. This test material did not induce a statistically significant increase in the mean number of micronucleated polychromatic erythrocytes. both positive and negative controls for the assay responded in an appropriate manner. The test material did not produce clastogenic abnormalities in the bone marrow cells of B6C3F1 mice at dose up to and including 5.0 g/kg under the conditions of the assay.
This study received a Klimisch score of two and is classified as reliable with restriction because although it is an acceptable and well documented study report it, GLP compliance was unknown.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
