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EC number: 481-670-5 | CAS number: 848301-66-6
- 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 Toxicity Oral: Acute study oral (gavage), rat (Sprague-Dawley), female (OECD guideline 420, EU Method B.1, GLP), (LD50 (oral) >5000 mg/kg bw;
- Acute Toxicity Dermal: Acute study dermal (occlusive), rat (Sprague-Dawley) male/female(OECD guideline 402, EU Method B.3, EPA OTS 798.1100, GLP), LD50 (dermal) >2000 mg/kg/ bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- This endpoint is covered by two GLP guideline studies, one on the registered substance itself (which has consequently a reliability 1) and the other performed on an analogue substance with represents a shorter chain length spectrum (C8-C12) as the registered substance 'Kerosines (Fischer-Tropsch), C8 -16 branched and linear'. However, since the analogue substance represent the part of the registered UVCB substance, which might be toxicologically more critical to to the shorter chain lenghts, both studies should be considered equally when assessing possible health hazards. Additionally, both studies revealed consistent results, i.e. a LD50 > 5000 mg/kg bw.
In conclusion, the database can be considered to be of very good quality.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The effect level was derived from five independent studies, where the key study was acceptable, well documented and compliant to GLP. There is no acute dermal toxicity data are available for the full range (C8-C16) GTL Kerosine, but the available studies in a sum cover the whole chain length distribution of the registered substance. The quality of the supporting studies is not assignable with th available information. Nevertheless all study results show a very good consistance of the results as all five studies revealed an LD50 > 2000 mg/kg bw.
So taking into account the number of availabe studies and the consistency of the results, the quality of the whole database can be considered to be very good.
Additional information
The results of experimental studies for the acute oral and dermal toxicitiy are summarised in the following two tables:
Table 1: Overview of experimental studies on acute toxicity after oral administration
Method |
Results |
Remarks |
Reference |
rat (Sprague-Dawley) female oral: gavage according to OECD Guideline 420 (Acute Oral Toxicity) |
LD50: > 5000 mg/kg bw (female) based on: test mat. (No test substance-related deaths.) |
1 (reliable without restriction) key study experimental result Test material (EC name): Kerosine (Fischer-Tropsch), full range, C8-16 - branched and linear |
Sanders, 2006 |
rat (Sprague-Dawley) male/female oral: gavage according to OECD Guideline 401 (Acute Oral Toxicity) |
LD50: > 5000 mg/kg bw (male/female) based on: test mat. (No test substance-related deaths.) |
1 (reliable without restriction) supporting study experimental result Test material (EC name): Kerosine (Fischer-Tropsch), limited range, C8-12 - branched and linear |
Huntingdon Life Sciences, 1997a |
Table 2: Overview of experimental studies on acute toxicity after dermal administration
Method |
Results |
Remarks |
Reference |
rat (Sprague-Dawley) male/female Coverage: occlusive according to OECD Guideline 402 (Acute Dermal Toxicity)
|
LD50: > 2000 mg/kg bw (male/female) based on: test mat. (No deaths occurred.) |
1 (reliable without restriction) key study experimental result Test material (EC name):Kerosine (Fischer-Tropsch), limited range, C8-C12 - branched and linear |
HuntingdonLife Sciences, 1997b |
rat according to OECD Guideline 402 (Acute Dermal Toxicity) |
LD50: > 2000 mg/kg bw |
4 (reliability not assignable) supporting study read-across from supporting substance (structural analogue or surrogate) Test material : Alkanes C14-C17 |
IUCLID 2000 dataset for CAS 90622-53-0 citing:HRC Report 84411D/PEQ 2/AC; Sponsor: PETRESA
|
rabbit no guideline stated |
LD50: > 3980 – 5730 mg/kg bw |
4 (reliability not assignable) supporting study read-across from supporting substance (structural analogue or surrogate) Test material : n-C10 and n-C12 alkanes |
IUCLID 2000 dataset for CAS 90622-53-0 citing:Scientific Associates, Inc., Vista Chemical Company, 1982b |
rabbit no guideline stated |
LD50: > 2000 mg/kg bw |
4 (reliability not assignable) supporting study read-across from supporting substance (structural analogue or surrogate) Test material : n-C12 and n-C14 alkanes |
IUCLID 2000 dataset for CAS 90622-53-0 citing:Scientific Associates, Inc., Vista Chemical Company, 1982c |
rabbit no guideline stated |
LD50: > 2000 mg/kg bw |
4 (reliability not assignable) supporting study read-across from supporting substance (structural analogue or surrogate) Test material : n-C14 and n-C16 alkanes |
IUCLID 2000 dataset for CAS 90622-53-0 citing:Scientific Associates, Inc., Vista Chemical Company, 1982c |
The key acute oral toxicity of GTL Kerosine (full range, C8 -C16) reported an LD50value of >5000 mg/kg bw for the test substance in female rats (Sanders, 2006). There were no deaths, no systemic toxicity or treatment related abnormalities at necropsy reported for the test substance. The study was conducted in accordance with OECD 420 (Fixed Dose Method) and GLP.
In a supporting study (Huntingdon Life Sciences, 1997a), conducted according to the now-deleted OECD 401 and GLP, the LD50for GTL Kerosine (limited range, C8-C12) was also >5000 mg/kg bw.
No acute dermal toxicity data are available for the full range (C8-C16) GTL Kerosine. A study on the acute dermal toxicity of 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 data are available for a number of related substances following administration by the dermal route, covering the higher carbon numbers in the range C12-C16. In all cases, the reported LD50values are >2000 mg/kg bw.
Taking all available acute dermal toxicity data for relevant carbon numbers into consideration it can be concluded that the LD50is >2000 mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
There are two studies on acute oral toxicity available, and a LD50 > 5000 mg/kg bw was determined in both studies. However, the endpoint "Acute toxicity: oral, 2041/0046" (Sanders, 2006) was selected as both key study and most relevant study for this endpoint because the testing substance represents the registered substance more precisely: Here, the test item is identical with the registered substance 'Kerosines (Fischer-Tropsch), C8 -16 branched and linear', whereas the study outlined in endpoint "RA - Acute toxicity: oral, 97.1212" (Huntingdon Life Sciences, 1997a) was performed on "Kerosine (Fischer-Tropsch), limited range, C8-12 - branched and linear", which only represents a limited chain length range of the registered substance. Nevertheless, the allocation of the study has no influence on the effect level as in both studies a LC50 of >5000 mg/kg bw was determined.
Justification for selection of acute toxicity – inhalation endpoint
In accordance with Column 2 of REACH Annex VIII, the acute toxicity study via the inhalation route (required in Section 8.5.2 of REACH Annex VIII) does not need to be conducted as reliable data are available for the oral and dermal routes.
Justification for selection of acute toxicity – dermal endpoint
No acute dermal toxicity data are available for the full range (C8-C16) GTL Kerosine.
The acute toxicity via dermal route was assessed in an approach using data on the toxicologically more relevant derivatives with shorter chain lengths, supported by four studies on analogues with different chain lenth distributions, which cover in a sum the full range of the chain lengths of (C8-C16) GTL Kerosine. The study "RA Acute toxicity: dermal, 97-1213" was selected because the full study report was available for review and the test substance was derived from the Fischer-Tropsch process. An LD50 value of >2000 mg/kg bw for the test substance in rats (Huntingdon Life Sciences, 1997b) was reported. There were no deaths, no systemic toxicity or treatment related abnormalities at necropsy reported for the test substance.
This result is consistent with the results derived from the other four studies on analogue substances with different chain lengths; in all cases, the reported LD50 values are >2000 mg/kg bw. Hence, the endpoint selection has no influence of the effect level used for risk assessment (LD50 >2000 mg/kg).
Justification for classification or non-classification
On the basis of the available oral and dermal data, GTL Kerosine 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 (measured kinematic viscosity 0.921 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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