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EC number: 941-364-9 | CAS number: -
- 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:
- supporting study
- Study period:
- 24-Feb-2021 to 19-Mar-2021
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Preliminary 14 day dose range finding study designed to allow selection of appropriate dose levels for a subsequent 90-day repeated dose toxicity study with the reproduction/developmental toxicity screening test by oral gavage
- GLP compliance:
- no
- Remarks:
- Preliminary dose range finding study
- Limit test:
- yes
Test material
- Reference substance name:
- 3-methyldecane; benzene; cyclooctane; nonane
- EC Number:
- 941-364-9
- Molecular formula:
- Not applicable to UVCB substance
- IUPAC Name:
- 3-methyldecane; benzene; cyclooctane; nonane
- Test material form:
- other: Low visocosity, liquid hydrocarbon
- Details on test material:
- Batch number: 204377961
Physical description: Colourless or pale yellow coloured liquid
Purity: 100% UVCB
Expiry date: 20 August 2022 if kept under storge conditions
Source and site of characterisation: Repsol Refinery, Carretera de la Calzada s/n, Apartado de Correos 12, 13500 Puertollano, Ciudad Real, Spain
Storage conditions: Store under controlled humidity conditions and temperature (18-25 °C) in a sealed container, protecting the product from sunlight (opaque container or in a cabinet)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl: WI (Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Test animals
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at initiation of dosing: 6-7 weeks
- Weight at study initiation:126-142 g
- Housing:Animals were group housed (up to 3 animals of the same dosing group together) in polycarbonate cages (Macrolon, MIV type, height 18 cm)
- Diet:Ad libitum access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany)
- Water:ad libitum
- Acclimation period:9 days prior to the commencement of dosing
Environmental Conditions:
- Temperature: 19 to 21°C
- Humidity: 49 to 63%
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Remarks:
- Specific gravity: 0.92
- Details on oral exposure:
- Preparation of dosing solutions:
Test item dosing formulations (w/w) will be homogenized to visually acceptable levels at appropriate concentrations to meet dose level requirements.
The dosing formulations will be prepared at least weekly, filled out in daily portions and stored in the refrigerator protected from light. Dosing formulations will be removed from the refrigerator at least 30 minutes before dosing and will be stirred at room temperature. The dosing formulations will be kept at room temperature until dosing. If practically possible, the dosing formulations will be continuously stirred until and during dosing.
Dosing Details:
Oral gavage using plastic catheter attached to plastic disposable syringe. - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 14 days
- Frequency of treatment:
- once daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Remarks:
- Group 1
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Remarks:
- Group 2
- No. of animals per sex per dose:
- 3 females per dose
- Control animals:
- no
- Details on study design:
- The dose levels were selected based on the results of an acute oral toxicity study in rats (LD50 >2000 mg/kg; registration dossier, echa.europe.eu).
Examinations
- Observations and examinations performed and frequency:
- Mortality:
- Twice daily throughout the study
Cage Side Clinical Observation:
- At least 3 times daily up to the day prior to necropsy: 0-15 min, 45-75 min, 2.5-3.5 hr post-dose
Detailed Clinical Observation:
- Weekly and on the day of necropsy
Body Weight:
- Day 1 prior to dosing and Days 4, 8, 11 and 14 (body weight gain will be calculated against the body weight of Day 1 of treatment of each period).
Food Consumption:
- over Days 1-4, 4-8, 8-11, and 11-14
- Animals showing pain, distressed or discomdort which was considered not transient in nature or was likely to become more severe, were sacrificed for humane reasons based on OECD guideline document on humane endpoints. - Sacrifice and pathology:
- Animals surviving until the scheduled euthanasia were deeply anaesthetised using isoflurane and subsequently exsanguinated
Animals were subjected to an external, thoracic and abdominal examination. Terminal bodyweight, liver and kidney weights were recorded. Organ weight relative to body weight were calculated against the terminal body weight for scheduled intervals. Macroscopic observations were recorded, but not retained.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Group 1: slight salivation was observed in 3/3 females on Days 13 and 14
Group 2: slight salivation was observed in 3/3 females on 1 to 3 days of treatment - 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:
- not examined
- Clinical biochemistry findings:
- not examined
- Endocrine findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Kidney and liver weights were slightly increased in Group 2 (1000 mg/kg bw)
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
- Details on results:
- Mortality
Group 1: no mortality.
Group 2: no mortality.
Clinical observations
Group 1: slight salivation was observed in 3/3 females on Days 13 and 14.
Group 2: slight salivation was observed in 3/3 females on 1 to 3 days of treatment.
Body weight
Group 1: normal.
Group 2: normal.
Food consumption
Group 1: normal.
Group 2: normal.
Organ weights
Group 1: Kidney and liver weights were considered normal.
Group 2: Kidney and liver weights were slightly increased
Macroscopic examination
Group 1: no abnormalities noted.
Group 2: no abnormalities noted.
Effect levels
- Dose descriptor:
- NOAEL
- Remarks on result:
- not determinable
Applicant's summary and conclusion
- Conclusions:
- Based on the results of the Dose Range Finder, selected dose levels for the 90-Day Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test by Oral Gavage (Test Facility Study No. 20276349) are 100, 300 and 1000 mg/kg/day.
- Executive summary:
The objective of this study was to determine the highest tolerated dose level of Petroleum gas oil fraction, co-processed with renewable hydrocarbons of plant and/or animal origin (EC 941-364-9) and to determine the peak effect of occurrence of clinical signs after dosing when given orally by gavage in non-pregnant rats. This study was performed as a Dose Range Finding study for the subsequent 90-Day Repeated Dose Toxicity study with the reproduction/developmental toxicity screening test by oral gavage.
Based on the results of the Dose Range Finder, selected dose levels for the 90-Day Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test by Oral Gavage are 100, 300 and 1000 mg/kg/day.
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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