Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 700-962-8 | CAS number: 93924-10-8
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-06-11 to 2002-10-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This study is classified as reliable without restrictions because the study was compliant with GLPs set forth by OECD [ENV/MC/CHEM(98)17], and the study design was based on OECD guideline 422. The study is well documented and scientifically acceptable.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- yes
- Remarks:
- A urinalysis was not conducted.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Alkene, C6
- IUPAC Name:
- Alkene, C6
- Reference substance name:
- Alkenes, C6-
- EC Number:
- 271-208-9
- EC Name:
- Alkenes, C6-
- Cas Number:
- 68526-52-3
- IUPAC Name:
- hex-3-ene
- Details on test material:
- - Name of test material (as cited in study report): C6-Olefin/Hexene
- Substance type: Alkene 6
- Physical state: Liquid
- Analytical purity: 85.31%
- Impurities (identity and concentrations): Water (0.0065%), C4 and lights (0.12%), C5 hydrocarbon (13.06%), and C7 hydrocarbon (1.52%)
- Lot/batch No.: None provided
- Stability under test conditions: The compound is stable under the test conditions.
- Storage condition of test material: In a non-flammable cabinet at ambient conditions.
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Portage, Michigan and Raleigh, North Carolina
- Age at study initiation: approximately 11 weeks
- Weight at study initiation: Males: 237 to 296 grams; Females: 170 to 226 grams; weights were obtained on the day after receipt
- Housing: Individually except during mating
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 17 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 26
- Humidity (%): 41% to 53%
- Air changes (per hr): 10 to 15
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light
IN-LIFE DATES: From: 2002-06-11 To: 2002-08-08
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: A specific amount of test compound was weighed into a precalibrated beaker. A sufficient amount of corn oil was added to the beaker to achieve the desired concentration and the solution was stirred for 30 minutes. The dose formulations were prepared twice during the first week and weekly thereafter. Dose solutions were stirred continuously prior to and during dosing.
VEHICLE
- Justification for use and choice of vehicle (if other than water): None provided
- Concentration in vehicle: 0, 20, 100, 200 mg/mL
- Amount of vehicle (if gavage): 5 mL/kg
- Lot/batch no. (if required): RE1547
- Purity: Not reported - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The test solution was determined to be homogeneous and stable for at least 14 days. The first, third, fifth, seventh, and final dose preparation were tested for concentration verification. The concentrations were found to be within acceptable ranges and were within 15% of the nominal concentration.
- Duration of treatment / exposure:
- 4 weeks
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 500, or 1000 mg/kg/day
Basis:
actual ingested
- No. of animals per sex per dose:
- Twelve animals per sex per dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: The doses were selected to produce a graded response, but there was no rationale as to why these specific doses were selected.
- Rationale for animal assignment (if not random): Animals were randomly assigned based on body weights.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Once daily
- Cage side observations checked for overt signs of toxicity.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Weekly and on day of sacrifice
BODY WEIGHT: Yes
- Time schedule for examinations: Days 0, 3, 7, 12, 16, 20, 23, 27, 30 and the day of sacrifice (day 34 for males and day 38 for females)
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
FOOD EFFICIENCY: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: At sacrifice
- Anaesthetic used for blood collection: Yes (light isoflurane)
- Animals fasted: Yes
- How many animals: All surviving animals
- Parameters checked in table 1 were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: At sacrifice
- Animals fasted: Yes
- How many animals: All surviving animals
- Parameters checked in table 2 were examined.
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: Weekly
- Dose groups that were examined: All groups
- Battery of functions tested: An abbreviated functional observational battery test was conducted weekly and a full test was conducted on day 28. Motor activity was also measured.
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes (see table 3) - Other examinations:
- The following organs were weighed: adrenals, brain, heart, kidneys, liver, spleen, epididymides, testes, and thymus.
- Statistics:
- A one-way analysis of variance followed by Tukey-Kramel test or Dunnett's test was used on continuous data. Organ weight data was first checked for homogeneity with Levene's test. Non-parametric organ weight was analyzed using a Kruskal-Wallis followed by Dunn's test. Categorical data was analyzed using Fischer's exact test or RxC chi-square test followed by a Fischer's exact test.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY: There were no treatment-related mortalities. High-dose males and females had occasional post dosing salivation. There were no other clinical signs of toxicity.
BODY WEIGHT AND WEIGHT GAIN: There were no treatment-related effects.
FOOD CONSUMPTION: There were no treatment-related effects.
HAEMATOLOGY:There were no treatment-related effects.
CLINICAL CHEMISTRY: Although there were a few statistically significant changes in clinical chemistry parameters in males, the results were within historical control ranges and are not considered toxicologically significant.
NEUROBEHAVIOUR: There were no treatment-related effects.
ORGAN WEIGHTS : Absolute kidney weight was increased in all groups of males and relative kidney weights were increased in the 500 and 1000 mg/kg/day groups. The increase in kidney weight is related to hydrocarbon nephropathy, which is specific for male rats and is not considered to be toxicologically significant. Females also had an increased relative kidney weight in the 500 and 1000 mg/kg/day groups, but there was no histopathological changes in the kidney. High-dose males and females had an increase in relative liver weight, but there was no histopathological changes. Therefore, the changes in organ weight are considered not to be toxicologically significant.
GROSS PATHOLOGY: There were no treatment-related changes in gross pathology.
HISTOPATHOLOGY: NON-NEOPLASTIC: The only histopathology changes related to treatment were associated with the hydrocarbon nephropathy in males. This is not considered toxicologically significant because the effect is specific to male rats.
OTHER FINDINGS
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
There were no toxicologically significant results related to treatment. Changes were either associated with hydrocarbon nephropathy, which is specific to male rats, or were incidental.
Applicant's summary and conclusion
- Conclusions:
- Based on the lack of significant adverse clinical effects, the NOAEL for C6 alkenes is 1000 mg/kg.
- Executive summary:
In a short-term repeat dose toxicity study, C6 alkenes dissolved in corn oil were administered via oral gavage to male and female Sprague-Dawley rats (12/sex/dose) at dose levels of 100, 500 and 1000 mg/kg/day for 34 (males) or 38 (females) days.
There was no mortality observed in either male or female rats at any of the doses tested in the oral toxicity study. Besides post-dosing salivation at 1000 mg/kg/day group, no significant signs of clinical toxicity were observed at any dose level. Functional observational evaluations revealed no significant differences between the treatment and control animals. Mean body weight, body weight gain, food consumption, haematology and clinical chemistry parameters were comparable to controls at all dose levels. Organ weight and gross necropsy evaluations revealed no significant adverse effects subsequent to oral treatment with C6 alkenes.
Based on the lack of significant adverse clinical effects, the NOAEL for C6 alkenes is 1000 mg/kg.
This study received a Klimisch score of 1 and is classified as reliable without restrictions becausethe study was compliant with GLPs set forth by OECD [ENV/MC/CHEM(98)17], and the study design was based on OECD guideline 422.
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.