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EC number: 931-082-4 | 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:
- key study
- Study period:
- 02/1996 - 11/1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study on supporting substance (with limited range, C8-C12) conducted in compliance with GLP; acceptable, well-documented study report which meets basic scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.1100 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Kerosine (Fischer-Tropsch), limited-range, C8-12 - branched and linear
- IUPAC Name:
- Kerosine (Fischer-Tropsch), limited-range, C8-12 - branched and linear
- Details on test material:
- - Substance type: Organic
- Physical state: Liquid
- Analytical purity: 100%
- Impurities (identity and concentrations): Information not available
- Expiration date of the lot/batch: Information not available
- Stability under test conditions: Stable under normal temperature and pressure
- Storage condition of test material: Under cool conditions (approximately 4°C)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: male animals were approximately 7 - 8 weeks, the females approximately 10 - 11 weeks old
- Weight at study initiation: 208 - 240 g for males and 212 - 232 g for females
- Fasting period before study: none
- Housing: stainless steel grid cages (RS Biotech, England); on completion of dosing, the animals were accommodated in individual
cages (North Kent Plastic Cages Limited, England)
- Diet (e.g. ad libitum): ad libitum [pelleted rodent diet (RM1 (E) SQC, from Special Diets Services Limited, Witham, Essex, England]
- Water (e.g. ad libitum): ad libitum (tap water)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23.5
- Humidity (%): 46-52
- Air changes (per hr): at least 10 complete air changes per hour without recirculation
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: approximately December 1995 (female)/ January 1996 (male) To: 07 March 1996
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: body surface area
- % coverage: 5 cm x 5 cm area (approximately 10% of the body surface area)
- Type of wrap if used: 5 cm x 5 cm gauze patch, occluded with aluminium foil; the foil was kept in place and protected by a pad of cotton wool and a bandage of waterproof plaster and tape (Blenderm and Sleek, Community Care Products, 3M Health Care, Loughborough, England and TJ Smith and Nephew Medicals Limited, Kingston-upon-Hull, England)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the dermal site was gently wiped with wet disposable tissues to remove residual test material
- Time after start of exposure: 24 hours after administration
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): not available - quantity of dose was determined for each animal according to its bodyweight
- Constant volume used: no
VEHICLE
none - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 male and 5 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- observations: three separate recordings of signs were made during the first hour after administration and two further recordings during the
remainder of Day 1; from Day 2 onwards, the animals were inspected twice daily and recordings of systemic and local signs were made once daily
- weighing: on days 1, 8 and 15
- Necropsy of survivors performed: yes - Statistics:
- none
Results and discussion
- Preliminary study:
- A preliminary study was carried out using one male and one female rat given 'Kerosine (Fischer-Tropsch), limited-range, C8-12 - branched and linear' at a dosage of 2000 mg/kg. There was no death; no other data for this preliminary study is reported.
On the basis of this result, the main study was carried out using one group of five male and five female rats given 'Kerosine (Fischer-Tropsch), limited-range, C8-12 - branched and linear' at the maximum practicable dosage of 2000 mg/kg (Regulatory Limit test). Since no rat died as a result of treatment the low toxicity of 'Kerosine (Fischer-Tropsch), limited-range, C8-12 - branched and linear' was demonstrated and no further groups of animals were employed.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- no death
- Clinical signs:
- other: no local or systemic sign of reaction to treatment
- Gross pathology:
- necropsy revealed no significant macroscopic lesion
- Other findings:
- none
Any other information on results incl. tables
1) Bodyweights (Dosage 2000 mg/kg bw):
Bodyweight [g] | |||||
Male-1 | Male-2 | Male-3 | Male-4 | Male-5 | |
Day -1 | 227 | 226 | 208 | 240 | 239 |
Day 1 | 232 | 238 | 214 | 246 | 248 |
Day 8 | 259 | 278 | 227 | 285 | 281 |
Day 15 | 296 | 331 | 264 | 337 | 323 |
Increment | 69 | 105 | 56 | 97 | 84 |
Mean of Increment | 82 |
Bodyweight [g] | |||||
Female-1 | Female-2 | Female-3 | Female-4 | Female-5 | |
Day -1 | 232 | 217 | 212 | 221 | 231 |
Day 1 | 237 | 221 | 215 | 225 | 234 |
Day 8 | 252 | 238 | 244 | 235 | 244 |
Day 15 | 265 | 253 | 237 | 255 | 280 |
Increment | 33 | 36 | 25 | 34 | 49 |
Mean of Increment | 35 |
2) Necropsy observations (Dosage 2000 mg/kg bw):
Animal and sex | Died or Sacrificed | Time of death | Necropsy observations |
Male-1 | Sacrificed | Day 15 | External Application site: No significant lesion Other: No significant lesion Internal No significant lesion |
Male-2 | Sacrificed | Day 15 | |
Male-3 | Sacrificed | Day 15 | |
Male-4 | Sacrificed | Day 15 | |
Male-5 | Sacrificed | Day 15 | |
Female-1 | Sacrificed | Day 15 | External Application site: No significant lesion Other: No significant lesion Internal No significant lesion |
Female-2 | Sacrificed | Day 15 | |
Female-3 | Sacrificed | Day 15 | |
Female-4 | Sacrificed | Day 15 | |
Female-5 | Sacrificed | Day 15 |
3) Systemic and local signs (Dosage 2000 mg/kg bw):
Number of animals showing signs+ | ||
Male | Female | |
No abnormality detected | 5 | 5 |
Total number of survivors | 5 | 5 |
+ Five animals in each sex-group
4) Mortality (Dosage 2000 mg/kg bw):
Mortality | |||
Male | Female | Combined | |
Dosage 2000 mg/kg bw | 0/5 | 0/5 | 0/10 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- There was no death and no local or systemic sign of reaction to treatment. All animals achieved anticipated bodyweight gains and necropsy revealed
no significant macroscopic lesion. Under the conditions of this study, the acute dermal median lethal dosage (LD50) of the supporting substance 'Kerosine (Fischer-Tropsch), limited-range, C8-12 - branched and linear' was greater than 2000 mg/kg. According to Annex VI of Council Directive 67/548/EEC (and Regulation EC 1272/2008) 'Kerosine (Fischer-Tropsch), limited-range, C8-12 - branched and linear' is unclassified with regards to acute dermal toxicity; hence, 'Kerosine (Fischer-Tropsch), full range, C8-16-branched and linear' should also not be classified. - Executive summary:
According to EU-Method B.3 the acute dermal toxicity of an analogue with limited range 'Kerosine (Fischer-Tropsch), limited-range, C8 -12 - branched and linear' was investigated in a group of five male and five female CD rats. The test material was applied to the closely-clipped dorsum of each animal at a dosage of 2000 mg/kg bodyweight, and was covered by an occlusive dressing for 24 hours.
Mortality, systemic and local signs of reaction to treatment were recorded during a subsequent 14-day period of observation. The animals were killed on the following day and subjected to necropsy.
There was no death and no local or systemic sign of reaction to treatment. All animals achieved anticipated bodyweight gains and necropsy revealed no significant macroscopic lesion. Under the conditions of this study, the acute dermal median lethal dosage (LD50) of the test material was greater than 2000 mg/kg bw. Finally, the LD50 of 'Kerosine (Fischer-Tropsch), full range, C8 -16 - branched and linear` should be also greater than 2000 mg/kg bw.
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