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EC number: 481-730-0 | CAS number: 848301-65-5
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 481-730-0
- EC Name:
- -
- Cas Number:
- 848301-65-5
- Molecular formula:
- main general molecular formula: CnH(2n+2)
- IUPAC Name:
- C4-C10 branched and linear hydrocarbons (light) – Naphtha
- Details on test material:
- - Name of test material (as cited in study report): Naphtha (Fischer-Tropsch), light C4-C10 branched and linear
- Substance type: Organic
- Physical state: clear colourless liquid
- Analytical purity: Not stated in test report
- Impurities (identity and concentrations): Not stated in test report
- Composition of test material, percentage of components: Not stated in test report
- Purity test date: Not stated in test report
- Lot/batch No.: Not stated in test report
- Expiration date of the lot/batch: Not stated in test report
- Stability under test conditions: Not stated in test report
- Storage condition of test material: Not stated in test report
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation:
At the start of the study the animals were eight to twelve weeks of age.
- Weight at study initiation:
The bodyweights fell within an interval of i 20% ofthe initial bodyweight of the first treated animal.
- Fasting period before study:
With the exception of an overnight fast immediately before dosing
and for approximately three to four hours after dosing, free access to mains drinking water and
food (Certified Rat and Mouse Diet (Code SLF2))
was allowed throughout the study.
- Housing:
On receipt the animals were randomly allocated to cages.
- Diet (e.g. ad libitum):
Overnight fast immediately before dosing and for approximately three to four hours after dosing.
was allowed throughout the study.
- Water (e.g. ad libitum):
Ad libitum
- Acclimation period:
At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
The temperature was set to achieve limits of 19 to 25°C.
- Humidity (%):
The relative humidity was set to achieve limits of 30 to 70%.
- Air changes (per hr):
The rate of air exchange was at least fifteen changes per hour.
- Photoperiod (hrs dark / hrs light):
Lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle:
Not applicable
- Amount of vehicle (if gavage):
Not applicable
- Justification for choice of vehicle:
Not applicable
- Lot/batch no. (if required):
Not applicable
- Purity:
Not applicable
MAXIMUM DOSE VOLUME APPLIED:
5000 mg/kg
DOSAGE PREPARATION (if unusual):
Not applicable
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
Not applicable - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Duration of observation period following administration: 14 days (or other?):
14 days
- Frequency of observations and weighing:
Day 0, 7 and 14
- Necropsy of survivors performed:
yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
yes - Statistics:
- No statistical procedures were required.
Results and discussion
- Preliminary study:
- no clinical signs of toxicity
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- Mortality: no deaths
- Clinical signs:
- other: Clinical observations: no signs of systemic toxicity
- Gross pathology:
- Necropsy: no abnormalities
- Other findings:
- None
Any other information on results incl. tables
Table 1: Individual Clinical Observations and Mortality Data
Dose level | Animal | Effects noted after dosing (hours) | Effects noted during period after dosing (days) | ||||||||||||||||
(mg/kg) | No. | 0,5 | 1 | 2 | 4 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 |
5000 | Female 1 -0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
5000 | Female 2 -0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
5000 | Female 2 -1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
5000 | Female 2 -2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
5000 | Female 2 -3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Table 2: Individual Body weights and Bodyweight changes
Dose level | Animal | Bodyweight at day (g) | Body weight gain during week (g) | |||
(mg/kg) | No. | Day 0 | Day 7 | Day 14 | Day 1 | Day 7 |
5000 | Female 1 -0 | 207 | 235 | 268 | 28 | 33 |
5000 | Female 2 -0 | 202 | 236 | 259 | 34 | 23 |
5000 | Female 2 -1 | 206 | 239 | 263 | 33 | 24 |
5000 | Female 2 -2 | 203 | 230 | 260 | 27 | 30 |
5000 | Female 2 -3 | 211 | 238 | 253 | 27 | 15 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of 'Naphtha (Fischer-Tropsch), light, C4-10 - branched and linear' in the female Sprague-Dawley CD strain rat was estimated to be greater than 5000 mg/kg bodyweight --> the test material is of low toxicity via the oral route; using EU GHS, it is unclassified.
- Executive summary:
An acute oral toxicity study with rats was performed according to OECD Guideline 420 (Fixed-dose method; adopted 2001) and Method B.1 of Commission Directive 2004/73/EC.
- Mortality: no deaths
- Clinical observations: no signs of systemic toxicity
- Body Weight: within expected gains
- Necropsy: no abnormalities
The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 5000 mg/kg bodyweight.
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