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EC number: 482-130-1 | 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2014-01-08 to 2014-01-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 482-220-0
- EC Name:
- -
- Cas Number:
- 848301-69-9
- IUPAC Name:
- C18-C50 branched, cyclic and linear hydrocarbons – Distillates
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar: (RccHan; WIST)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories Ltd, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 200 g
- Fasting period before study:
- Housing: housed individually during the exposure period; in groups of 5 by sex for the rest of the study period; housed in polypropylene cages
- Diet: 2014C Teklad Global Rodents diet, ad libitum
- Water: drinking water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 15 per hour
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back and flanks
- % coverage: 10 % of the total body surface area
- Type of wrap if used: surgical gauze
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the 24-hout exposure period the area was wiped with cotton wool moistened with arachis oil BP
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- Constant volume or concentration used: yes; 2.48 mL/kg - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were examined at 30 min, 1, 2, and 4 hours post-application, and every day for the 14 day study period. Body weights were recorded prior to the treatment and at days 7 and 14.
- Necropsy of survivors performed: yes; at the end of the study the animals were killed by cervical dislocation; external examination and opening of the abdominal and thoracic cavities were performed at necropsy
- Other examinations performed: behavioural and clinical observations, gross lesions, body weight changes, mortality and any other toxicological effects were noted during the 14 day study period. The test sites were examined for evidence of primary irritation and scored. - Statistics:
- No statistics were used in the study.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities occured.
- Clinical signs:
- other: No signs of systemic toxicity were observed.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- Slight desquamation was observed in 3 females on days 4, 5 and 6 of the 14-day study period.
Applicant's summary and conclusion
- Interpretation of results:
- other: EU-GHS criteria not met
- Conclusions:
- LD50 > 2000 mg/kg bw
- Executive summary:
An acute dermal toxicity study for 'Distillates (Fischer-Tropsch), heavy, C18-50-branched, cyclic and linear' was performed to assess the acute dermal toxicity in rat.
A single dose of 2000 mg/kg bw of undiluted test material was applied onto the skin of 5 male and 5 female rats. The test item was held in contact with the skin under semi-occluded dressing for 24 hours. Observations for clinical signs of toxicity were performed at 30 min, 1, 2, and 4 hours post-application and every day for the 14 day study period. Body weights were recorded prior to the treatment and at days 7 and 14. At the end of the study the tested animals were killed by cervical dislocation. External examination and opening of the abdominal and thoracic cavities were performed at necropsy. Behavioural and clinical observations, gross lesions, body weight changes, mortality and any other toxicological effects were noted during the 14 day study period. The test sites were examined for evidence of primary irritation and scored.
No mortalities occured at during the 14 -day study period. There were no signs of systemic toxicity. All females showed no body loss or gain in body weight during the first week and expected gain in body weight in the second week. The males showed expected gain in body weight during the 14 day study period. No abnormalities were noted at necropsy.
The LD50 value for 'Distillates (Fischer-Tropsch), heavy, C18-50-branched, cyclic and linear' was concluded to be > 2000 mg/kg bw. The study was conducted according to OECD TG 402, and in compliance with GLP.
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