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EC number: 246-919-2 | CAS number: 25377-82-6
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- 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:
- No urinalysis was conducted.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- 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 C6
- 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
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: (P) approximately 11 wks
- Weight at study initiation: (P) 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 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, or 200 mg/mL
- Amount of vehicle (if gavage): 5 mL/kg
- Lot/batch no. (if required): RE1547
- Purity: Not reported - Details on mating procedure:
- - M/F ratio per cage: One to one
- Length of cohabitation: 14 days
- Proof of pregnancy: Vaginal plug or sperm in vaginal smear referred to as day 0 of pregnancy
- After 14 days of unsuccessful pairing the mating phase was concluded.
- After successful mating each pregnant female was caged (how): Individual plastic boxes with nesting material on gestational day 18 - 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:
nominal conc.
- 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. - Positive control:
- None
Examinations
- Parental animals: Observations and examinations:
- 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 at sacrifice (day 34 for males and 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
WATER CONSUMPTION: No
OTHER: Haematology and clinical chemistry were conducted on blood collected at sacrifice as part of the short-term toxicity phase. An abbreviated functional battery observational test was conducted prior to study initiation and weekly thereafter as part of the short-term toxicity phase. Motor actiNity was also tested. - Oestrous cyclicity (parental animals):
- Not determined
- Sperm parameters (parental animals):
- Not determined
- Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: No
PARAMETERS EXAMINED
The following parameters were examined in F1 offspring: number and sex of pups, stillbirths, live births, presence of gross anomalies, weight gain
GROSS EXAMINATION OF DEAD PUPS:
yes, for external and internal abnormalities; possible cause of death was not determined for pups born or found dead. - Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals were sacrificed on day 34.
- Maternal animals: All surviving animals were sacrificed on lactational day 4.
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations including the cervical, thoracic, and abdominal viscera.
HISTOPATHOLOGY / ORGAN WEIGHTS
The tissues indicated in Table 1 were prepared for microscopic examination and weighed, respectively. However, histopathology was not routinely performed on the females in the reproduction phase of the study and was performed on the females in the short-term toxicity phase of the study. - Postmortem examinations (offspring):
- SACRIFICE
- The F1 offspring were sacrificed at 4 days of age.
HISTOPATHOLOGY / ORGAN WEIGHTS: Histopathology and organ weights were not obtained on the offspring. - 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
- Reproductive indices:
- Mating index, female fertility index, gestation index, deliveries with stillborn pups and with all stillborn pups, implantation sites, and corpora lutena
- Offspring viability indices:
- Live birth index, pups dying in the first 4 days of birth, viability index (pups surviving to day 4), live pups per litter, and pup weight
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
Details on results (P0)
BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS):There was no treatment-related effect on body weight.
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS): There were no treatment-related effects on reproductive performance.
ORGAN WEIGHTS (PARENTAL ANIMALS): 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. There were no other changes related to treatment.
GROSS PATHOLOGY (PARENTAL ANIMALS): There were no treatment-related changes in gross pathology.
HISTOPATHOLOGY (PARENTAL ANIMALS): 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.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not examined
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
Details on results (F1)
CLINICAL SIGNS (OFFSPRING): There were no treatment-related effects.
BODY WEIGHT (OFFSPRING): There were no treatement-related effects.
GROSS PATHOLOGY (OFFSPRING): There were no treatment-related effects.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Based on the lack of significant adverse clinical effects, the systemic toxicity and reproductive toxicity NOAEL for C6 alkenes is 1000 mg/kg/day.
- Executive summary:
- The
potential reproductive/developmental effects of C6 alkenes, following oral
administration were assessed in male and female rats. The test conditions
complied with guideline requirements, and the statistical methods used
were appropriate.
C6 alkenes dissolved in corn oil were administered via oral gavage to F0 male and female Sprague-Dawley rats at dose levels of 100, 500 and 1000 mg/kg/day for at least 4 weeks. For the reproduction phase of the study, males and females were mated after 14 days of treatment. Mating was allowed for 14 days if no evidence of pregnancy. Treatment continued until sacrifice with males sacrificed on day 34 and females sacrificed on lactation day 4.
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, 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 necroscopy evaluations revealed no significant adverse effects subsequent to oral treatment with C6 alkenes.
There was no mortality or adverse signs of toxicity observed at any dose level in the reproductive/developmental toxicity screening study. F0 mating, fertility indices, mean gestation lengths, mean number of pups delivered, F1 live birth index, F1 viability index, F1 pups per litter, and F1 pup sex ratios were comparable between control and treatment groups.
Gross necroscopy of F0 females and F1 pups revealed no significant treatment-related findings. Organ weight determinations in F0 rats did not reveal any significant difference between treatment and control animals.
Based on the lack of significant adverse clinical effects, the systemic toxicity and reproductive toxicity NOAEL for C6 alkenes is 1000 mg/kg.
This study received a Klimisch score of 1 and 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.
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.
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