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EC number: 481-740-5 | CAS number: 848301-67-7
- 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
Endpoint summary
Administrative data
Description of key information
- Acute oral toxicity study (SafePharm, 2006a), conducted according to OECD 420 (Acute Oral Toxicity - Fixed Dose Method) and GLP, reported a LD50 in male and female rats >5000 mg/kg bw.
- Acute dermal toxicity study (Huntingdon Life Sciences, 1997b), conducted on related substance with limited range (C8-C12), according to OECD 402 (Acute Dermal Toxicity) and GLP, reported an LD50 in male and female rats >2000 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2006-10-03 to 2006-10-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-study according to relevant guideline
- 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
- 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% of the 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 (free access to mains
drinking water and food 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. - 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
- 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
- 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: yes - Statistics:
- No statistical procedures were applied.
- Preliminary study:
- Following a preliminary test in which there were no deaths at a dose level of 5000 mg/kg, an additional 4 fasted Sprague-Dawley DC rats received a dose of 5000 mg of the undiluted test material per kg body weight by gavage.
- 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
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Since the substance is composed of aliphatic hydrocarbons and has low viscosity, it may present an aspiration hazard in humans following oral exposure. It is therefore appropriate to classify the substance as ‘Harmful: may cause lung damage if swallowed’.
- Conclusions:
- 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. Using the EU Globally Harmonised System (GHS), it would be ‘unclassified’. However, since the substance is composed of aliphatic
hydrocarbons and has low viscosity, it may present an aspiration hazard in humans following oral exposure. It is therefore appropriate to classify
the substance as ‘Harmful: may cause lung damage if swallowed’. - Executive summary:
'Distillates (Fischer-Tropsch), C8-26 branched and linear' was tested in an acute oral toxicity study according to the fixed dose method (OECD 420). Following a preliminary test in which there were no deaths at a dose level of 5000 mg/kg, an additional 4 fasted Sprague-Dawley DC rats received a dose of 5000 mg of the undiluted test material per kg body weight by gavage. There were no signs of toxicity, all animals showed normal gains in body weight, and there were no abnormalities on necropsy. 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.
Reference
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 |
0- No signs of systemic toxicity
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 | 213 | 247 | 268 | 34 | 21 |
5000 | Female 2 -0 | 190 | 213 | 216 | 23 | 3 |
5000 | Female 2 -1 | 216 | 251 | 273 | 35 | 22 |
5000 | Female 2 -2 | 198 | 236 | 249 | 36 | 15 |
5000 | Female 2 -3 | 206 | 229 | 238 | 23 | 9 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- The selected study is GLP compliant and has Klimisch score 1. Further reliable study on supporting substance with limited range (C8-16) confirms the result.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 02/1996 - 11/1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted on supporting substance (with limited range, C8-C12) in compliance with GLP; acceptable, well-documented study report which meets basic scientific principles
- 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
- 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; on completion of dosing, the animals were accommodated in individual cages
- Diet (e.g. ad libitum): ad libitum [pelleted rodent diet (RM1 (E)]
- 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 - 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
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
- 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
- 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 test material '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 'Kerosine (Fischer-Tropsch), limited-range, C8-12 - branched and linear' should be unclassified with regards to acute dermal toxicity. Using the EU Globally Harmonised System (GHS), it would be also ‘unclassified’. Finally, the analogue 'Distillates (Fischer-Tropsch), C8-26-branched and linear' also should not be classified. - Executive summary:
According to EU-Method B.3 the acute dermal toxicity of 'Kerosine (Fischer-Tropsch), limited-range, C8-12 - branched and linear'
, a structural analogue to 'Distillates (Fischer-Tropsch), C8 -26 - 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 acute dermal median lethal dosage (LD50) of the structural analogue 'Distillates (Fischer-Tropsch), C8 -26 - branched and linear` also should be greater than 2000 mg/kg bw.
Reference
1) Bodyweights(Dosage 2000mg/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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The study is GLP compliant and has Klimisch score 2 (due to read-across approach).
In addition, relevant acute dermal toxicity studies with rats and rabbits are available for a number of related substances following administration by the dermal route, covering the higher carbon numbers in the range C12-C24. The full study reports were not available for review, however, in all cases, the reported LD50 values are >2000 mg/kg bw (see Table below "Discussion").
Additional information
GTL Gasoil was tested in an acute oral toxicity study according to the fixed dose method (OECD 420). Following a preliminary test in which there were no deaths at a dose level of 5000 mg/kg, an additional 4 fasted Sprague-Dawley DC rats received a dose of 5000 mg of the undiluted test material per kg body weight by gavage. There were no signs of toxicity, all animals showed normal gains in body weight, and there were no abnormalities on necropsy (SafePharm 2006a).
In addition, relevant data are available for a number of related substances following administration by the dermal and inhalation route.
No acute dermal toxicity data are available for GTL Gasoil. A study on the acute dermal toxicity of the related substance GTL Kerosine with a limited range, (C8-C12) reported an LD50value of >2000 mg/kg bw for the test substance in rats (Huntingdon Life Sciences, 1997b). There were no deaths, no systemic toxicity or treatment related abnormalities at necropsy reported for the test substance.
In addition, relevant acute dermal toxicity studies with rats and rabbits are available for a number of related substances following administration by the dermal route, covering the higher carbon numbers in the range C12-C24. In all cases, the reported LD50values are >2000 mg/kg bw (see Table 5.2.2).
Taking all available acute dermal toxicity data for relevant carbon numbers into consideration it can be concluded that the LD50for GTL Gasoil (C8-C26) is >2000 mg/kg bw. The key study was selected as Huntingdon Life Sciences, 1997b, since the full study report was available for review and the test substance was derived from the Fischer-Tropsch process.
The following information is taken into account for any hazard / risk assessment:
The key acute oral toxicity study (SafePharm, 2006a), conducted according to OECD 420 (Acute Oral Toxicity - Fixed Dose Method) and GLP, reported an LD50in male and female rats >5000 mg/kg bw.
The key acute dermal toxicity study (Huntingdon Life Sciences, 1997b), conducted according to OECD 402 (Acute Dermal Toxicity) and GLP, reported an LD50in male and female rats >2000 mg/kg bw.
Value used for CSA:
- LD50(oral): >5000 mg/kg bw
- LD50(dermal): >2000 mg/kg/ bw.
The results of experimental studies are summarised in the following table (whereby only a few full study reports were available for review):
Table: Summary of relevant acute toxicity data
Substance |
Test method |
Result LD50(mg/kg) or LC50(mg/m3) |
Comments |
Reference (please see also attached CSR) |
Oral exposure |
||||
Distillates (Fischer-Tropsch), C8-26-branched, cyclic and linear |
OECD 420 |
>5000 (rat) |
GLP |
SafePharm, 2006a |
Limited range kerosine (C8 – C12) |
Annex V |
>5000 (rat) |
GLP |
HLS, 1996a |
Alkane 1 (C20 – C24) |
Not stated |
>5000 (rat) |
GLP |
Chevron, 1989a |
Alkane 2 (C24) |
Annex V |
>5000 (rat) |
GLP |
SafePharm, 1995a |
n-C14 – C16 |
- |
>5250 (rat) |
Non-GLP |
IUCLID 2000 dataset for CAS 90622-53-0 citing: Scientific Associates, Inc., Vista Chemical Company, 1982a |
n-C10 – C12 |
- |
>3990 (rat) |
Non-GLP |
IUCLID 2000 dataset for CAS 90622-53-0 citing: Scientific Associates, Inc., Vista Chemical Company, 1975 |
C14 – C17 |
OECD 401 |
>5000 (rat) |
|
IUCLID 2000 dataset for CAS 90622-53-0 citing: HCR Report 84448D/PEQ 1/AC, Sponsor: Petresa |
Alkane C14 |
Annex V |
>5000 (rat) |
Non-GLP |
IUCLID 2000 dataset for CAS 90622-53-0 citing: Acute oral toxicity (Acceptance No 7056 – 22/9/1987), Sponsor:, |
Dermal exposure |
||||
Limited range kerosine (C8 – C12) |
Annex V |
>2000 (rat) |
GLP |
HLS, 1996b |
Alkane 1 (C20 – C24) |
Not stated |
>2000 (rat) |
GLP |
Chevron, 1989b |
Alkane 2 (C24) |
Annex V |
>2000 (rat) |
GLP |
SafePharm, 1995c |
Alkane C14 |
OECD 402 |
>2000 (rat) |
GLP |
IUCLID 2000 dataset for CAS 90622-53-0 citing: HCR Report 84448D/PEQ 2/AC, Sponsor: Petresa |
n-C10 – C12 |
- |
3980 – 5730 (rabbit) |
Non-GLP |
IUCLID 2000 dataset for CAS 90622-53-0 citing: Scientific Associates, Inc., Vista Chemical Company, 1982b |
n-C12 – C14 |
- |
>2000 (rabbit) |
Non-GLP |
IUCLID 2000 dataset for CAS 90622-53-0 citing: Scientific Associates, Inc., Vista Chemical Company, 1982c |
n-C14 – C16 |
- |
>2000 (rabbit) |
Non-GLP |
IUCLID 2000 dataset for CAS 90622-53-0 citing: Scientific Associates, Inc., Vista Chemical Company, 1982d |
Justification for selection of acute toxicity – oral endpoint
Only one study available with the identify of test material same as for substance defined in section 1.
Justification for selection of acute toxicity – dermal endpoint
No acute dermal toxicity data are available for the substance defined in section 1. For the endpoint conclusion a study on the acute dermal toxicity of a related substance with a limited range, (C8-C12) was selected. Further studies on supporting substances, covering the higher carbon numbers in the range C12-C24, confirm the result.
Justification for classification or non-classification
On the basis of the available data, GTL Diesel does not require classification for lethal effects following a single exposure according to Regulation 1272/2008/EC.
Since the substance is composed of aliphatic hydrocarbons and has low viscosity (2 – 4.5 cSt at 40°C), it may present an aspiration hazard in humans following oral exposure. It is therefore appropriate to classify the substance as Aspiration Toxicity Category 1 according to Regulation 1272/2008/EC.
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