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EC number: 833-435-7 | CAS number: 2133415-29-7
- 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
No acute oral, dermal, or inhalation toxicity data is available for the registered substance. However, key oral toxicity and supporting dermal and inhalation toxicity data is available from structurally related substances, C18-C50 branched, cyclic and linear hydrocarbons – Distillates (CAS# 848301-69-9) and C8-C26 branched and linear hydrocarbons – Distillates (CAS# 848301-67-7) and is presented below.
1) Acute oral toxicity: The acute oral median lethal dose (LD50) of C18-C50 branched, cyclic and linear hydrocarbons – Distillates (CAS# 848301-69-9) in the female Sprague-Dawley CD strain rat was estimated to be greater than 5000 mg/kg bodyweight.
2) Acute inhalation and dermal
toxicity: Based on lack of skin irritation and systemic effects in a
read across skin irritation study, the registered substance is not
considered to be acutely harmful in contact with skin. Moreover, the
substance is unlikely to form aerosols or particles of inhalable size.
Therefore it is considered justifiable not to conduct these studies.
Supporting data on a related substance C8-C26 branched and linear hydrocarbons – Distillates (CAS# 848301-67-7) indicate the low dermal and inhalation toxicity:
a) Acute inhalation toxicity study
(Shell, 2013a), conducted according to OECD 436 and GLP, reported an
acute inhalation median lethal concentration (4 hr LC50) of
Distillates (Fischer-Tropsch), C8-26-branched and linear, in the
RccHanTM: WIST strain rat >5 mg/L.
b) Acute dermal toxicity study (Shell,
2015a), conducted according to OECD 402 (Acute Dermal Toxicity) and GLP,
reported an LD50 in male and female rats >2000 mg/Kg bw.
The above data is used for read across to Alkanes, C16 -47, branched and linear.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Preliminary study:
- There was no death and no signs of systemic toxicity at 5000 mg/kg.
In the absence of toxicity at 5000 mg/kg, an additional group of 4 animals was treated at a dose level of 5000 mg/kg. - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: No signs of systemic toxicity were noted.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- 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.
- Executive summary:
Introduction.
The study was performed to assess the acute oral toxicity of the test material 'Distillates (Fischer-Tropsch), heavy C18-50 - branched, cyclic and linear' in the Sprague-Dawley CD strain rat. The method was designed to meet the requirements of the following:
• OECD Guidelines for Testing of Chemicals No 420 "Acute Oral Toxicity - Fixed Dose Method" (adopted 17 December 2001)
• Method B1 bis Acute Toxicity (Oral) of Commission Directive 2004/73/EC Method.
Method.
Following a preliminary test in which there was no death at a dose level of 5000 mg/kg, an additional four fasted female animals were given a single oral dose of undiluted test material at a dose level of 5000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
Mortality.
There were no deaths.
Clinical Observations.
There were no signs of systemic toxicity.
Bodyweight.
All animals showed expected gains in bodyweight.
Necropsy.
No abnormalities were noted at necropsy.
Conclusion.
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 (Globally Harmonised Classification System - Unclassified).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- The study is GLP compliant and has Klimisch score 1.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Duration of exposure:
- h
- Preliminary study:
- Not applicable
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 1 - 5 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- 1 male (Day 2) and 3 females (Day 1) animals were found dead post-exposure
1 male (Day 2) and 1 female (Day 1) animal were found dead post-exposure - Clinical signs:
- other: Common abnormalities noted during the study included increased respiratory rate, hunched posture, pilo-erection and wet fur. There were occasional instances of tip-toe gait, isolated occurrences of labored respiration and ataxia were also noted. Survivi
- Body weight:
- Group 1 – All surviving animals exhibited body weight losses on Day 1 post-exposure. None of the female animals survived past Day 1 post-exposure, however, reasonable body weight development was noted in both of the surviving male animals during the remainder of the recovery period.
Group 2 – All animals exhibited body weight losses on Day 1 post-exposure. Reasonable body weight development was noted in all surviving male animals during the remainder of the recovery period. In contrast, two surviving female animals exhibited a slight body weight loss or showed no body weight gain from Days 1 to 3 post-exposure. Reasonable body weight gains were noted in these two animals during the remainder of the recovery period. - Gross pathology:
- Pale patches on the lungs were noted in one of two surviving animals from Group 1 at necropsy. Dark patches on the lungs or pale lungs were noted in all four surviving animals from Group 2 at necropsy.
Abnormally dark lungs were detected in the animals that died during the course of the study at necropsy.
From consideration of results of Histopathological examinations of tissues retained from a study conducted on a similar test item (Harlan Study Number: 41300142) the deaths noted during this study may be attributable to hydrocarbon aspiration induced inflammation (i.e. a chemical pneumonitis). - Other findings:
- Not Applicable
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Criteria used for interpretation of results: other: Globally Harmonized Classification System
- Conclusions:
- Four out of six animals died at a mean achieved atmosphere concentration of 5.09 mg/L, whereas, two deaths occurred in a group of six rats exposed to a mean achieved atmosphere concentration of 1.05 mg/L. It was therefore considered that the acute inhalation median lethal concentration (4 hr LC50) of GTL Base oil 3, in the RccHanTM : WIST strain rat, was in the range >1 mg/L to 5 mg/L (Globally Harmonized Classification System – Category 4).
- Executive summary:
Introduction
A study was performed to assess the acute inhalation toxicity of the test item. The method used was compatible with that described in the OECD Guidelines for Testing of Chemicals (2009) No. 436 “Acute Inhalation Toxicity – Acute Toxic Class Method”.
Methods.......
Two groups of six RccHan™ : WIST strain rats (three males and three females) were exposed to an aerosol atmosphere. The animals were exposed for four hours using a nose only exposure system, followed by a fourteen day observation period.
Results……..
The mean achieved atmosphere concentration was as follows:
Group Number
Atmosphere Concentration
Mean Achieved (mg/L)
Standard Deviation
Nominal (mg/L)
1
5.09
0.07
12.7
2
1.05
0.06
2.14
The characteristics of the achieved atmosphere were as follows:
Group Number
Mean Achieved Atmosphere Concentration (mg/L)
Mean Mass Median Aerodynamic Diameter (µm)
Inhalable Fraction
(% <4 µm)
Geometric Standard Deviation
1
5.09
1.92
77.3
2.69
2
1.05
1.64
89.4
2.05
The mortality data were summarized as follows:
Group Number
Mean Achieved Atmosphere Concentration
(mg/L)
Deaths
Male
Female
Total
1
5.09
1/3
3/3
4/6
2
1.05
1/3
1/3
2/6
Clinical Observations
Common abnormalities noted during the study included increased respiratory rate, hunched posture, pilo-erection and wet fur. There were occasional instances of tip-toe gait, isolated occurrences of labored respiration and ataxia were also noted. Surviving Group 1 animals recovered to appear normal on Day 8 post-exposure. Surviving Group 2 animals recovered to appear normal from Days 7 to 13 post-exposure.
Body Weight
Group 1 – All surviving animals exhibited body weight losses on Day 1 post-exposure. None of the female animals survived past Day 1 post-exposure, however, reasonable body weight development was noted in both of the surviving male animals during the remainder of the recovery period.
Group 2 – All animals exhibited body weight losses on Day 1 post-exposure. Reasonable body weight development was noted in all surviving male animals during the remainder of the recovery period. In contrast, two surviving female animals exhibited a slight body weight loss or showed no body weight gain from Days 1 to 3 post-exposure. Reasonable body weight gains were noted in these two animals during the remainder of the recovery period.
Necropsy
Pale patches on the lungs were noted in one of two surviving animals from Group 1 at necropsy. Dark patches on the lungs or pale lungs were noted in all four surviving animals from Group 2 at necropsy.
Abnormally dark lungs were detected in the animals that died during the course of the study at necropsy.
From consideration of results of Histopathological examinations of tissues retained from a study conducted on a similar test item (Harlan Study Number: 41300142) the deaths noted during this study may be attributable to hydrocarbon aspiration induced inflammation (i.e. a chemical pneumonitis).
Conclusion
Four out of six animals died at a mean achieved atmosphere concentration of 5.09 mg/L, whereas, two deaths occurred in a group of six rats exposed to a mean achieved atmosphere concentration of 1.05 mg/L. It was therefore considered that the acute inhalation median lethal concentration (4 hr LC50) ofGTL Base oil3, in the RccHanTM: WIST strain rat, was in the range >1 mg/L to 5 mg/L (Globally Harmonized Classification System – Category 4).
Reference
Exposure Chamber Atmosphere Concentrations – Dose Group 1
Duration of Exposure (minutes) |
Net Weight of Sample (mg) |
Volume of Air Sampled (L) |
Chamber Flow Rate (L/min) |
Atmosphere Concentration (mg/L) |
5 |
10.16 |
2 |
60 |
5.08 |
15 |
10.51 |
2 |
60 |
5.26 |
30 |
10.15 |
2 |
60 |
5.08 |
45 |
10.03 |
2 |
60 |
5.02 |
60 |
10.22 |
2 |
60 |
5.11 |
75 |
10.14 |
2 |
60 |
5.07 |
90 |
10.11 |
2 |
60 |
5.06 |
105 |
10.05 |
2 |
60 |
5.03 |
120 |
10.18 |
2 |
60 |
5.09 |
135 |
9.94 |
2 |
60 |
4.97 |
150 |
10.38 |
2 |
60 |
5.19 |
165 |
10.41 |
2 |
60 |
5.21 |
180 |
10.00 |
2 |
60 |
5.00 |
195 |
10.17 |
2 |
60 |
5.09 |
210 |
10.12 |
2 |
60 |
5.06 |
225 |
10.24 |
2 |
60 |
5.12 |
238 |
10.14 |
2 |
60 |
5.07 |
Exposure Chamber Atmosphere Concentrations – Dose Group 2
Duration of Exposure (minutes) |
Net Weight of Sample (mg) |
Volume of Air Sampled (L) |
Chamber Flow Rate (L/min) |
Atmosphere Concentration (mg/L) |
5 |
4.85 |
4 |
60 |
1.21 |
15 |
4.87 |
4 |
60 |
1.22 |
30 |
4.21 |
4 |
60 |
1.05 |
45 |
4.08 |
4 |
60 |
1.02 |
60 |
4.01 |
4 |
60 |
1.00 |
75 |
4.13 |
4 |
60 |
1.03 |
90 |
4.03 |
4 |
60 |
1.01 |
105 |
4.08 |
4 |
60 |
1.02 |
120 |
4.04 |
4 |
60 |
1.01 |
135 |
4.03 |
4 |
60 |
1.01 |
150 |
4.17 |
4 |
60 |
1.04 |
165 |
4.09 |
4 |
60 |
1.02 |
180 |
4.15 |
4 |
60 |
1.04 |
195 |
4.11 |
4 |
60 |
1.03 |
210 |
4.15 |
4 |
60 |
1.04 |
225 |
4.10 |
4 |
60 |
1.03 |
238 |
4.29 |
4 |
60 |
1.07 |
Particle Size Distribution – Dose Group 1
Cascade Impactor Data
Impactor Stage Number |
Cut Point (µm) |
Amount Collected (mg) per Sample Number |
Mean Amount Collected (mg) |
||
1 |
2 |
3 |
|||
3 |
8.9 |
0.12 |
0.14 |
0.06 |
0.11 |
4 |
6.2 |
0.17 |
0.11 |
0.09 |
0.12 |
5 |
3.6 |
0.48 |
0.36 |
0.27 |
0.37 |
6 |
1.6 |
1.09 |
0.71 |
0.66 |
0.82 |
7 |
0.93 |
0.15 |
0.13 |
0.11 |
0.13 |
8 |
0.37 |
0.57 |
0.38 |
0.40 |
0.45 |
Back-up Filter |
<0.37 |
0.16 |
0.05 |
0.14 |
0.12 |
Total Mean Amount of Test Item Collected |
2.12 |
Calculation
Cut Point (µm) |
Log10 Cut Point |
Mean Cumulative Amount Less Than Cut Point |
||
(mg) |
(%) |
Probit |
||
8.9 |
0.949 |
2.01 |
94.8 |
6.63 |
6.2 |
0.792 |
1.89 |
89.2 |
6.24 |
3.6 |
0.556 |
1.52 |
71.7 |
5.57 |
1.6 |
0.204 |
0.70 |
33.0 |
4.56 |
0.93 |
-0.032 |
0.57 |
26.9 |
4.38 |
0.37 |
-0.432 |
0.12 |
5.66 |
3.42 |
Results
Mean Mass Median Aerodynamic Diameter (MMAD) =1.92µm
Geometric Standard Deviation (GSD) =2.69
Predicted amount less than 4 µm =77.3%
Particle Size Distribution – Dose Group 2
Cascade Impactor Data
Impactor Stage Number |
Cut Point (µm) |
Amount Collected (mg) per Sample Number |
Mean Amount Collected (mg) |
||
1 |
2 |
3 |
|||
3 |
8.9 |
0.00 |
0.00 |
0.02 |
0.01 |
4 |
6.2 |
0.00 |
0.02 |
0.02 |
0.01 |
5 |
3.6 |
0.05 |
0.09 |
0.11 |
0.08 |
6 |
1.6 |
0.26 |
0.59 |
0.58 |
0.48 |
7 |
0.93 |
0.00 |
0.09 |
0.00 |
0.03 |
8 |
0.37 |
0.11 |
0.28 |
0.26 |
0.22 |
Back-up Filter |
<0.37 |
0.00 |
0.04 |
0.03 |
0.02 |
Total Mean Amount of Test Item Collected |
0.85 |
Calculation
Cut Point (µm) |
Log10 Cut Point |
Mean Cumulative Amount Less Than Cut Point |
||
(mg) |
(%) |
Probit |
||
8.9 |
0.949 |
0.84 |
98.8 |
7.27 |
6.2 |
0.792 |
0.83 |
97.6 |
6.99 |
3.6 |
0.556 |
0.75 |
88.2 |
6.19 |
1.6 |
0.204 |
0.27 |
31.8 |
4.53 |
0.93 |
-0.032 |
0.24 |
28.2 |
4.42 |
0.37 |
-0.432 |
0.02 |
2.35 |
3.01 |
Results
Mean Mass Median Aerodynamic Diameter (MMAD) = 1.64 µm
Geometric Standard Deviation (GSD) = 2.05
Predicted amount less than 4 µm = 89.4 %
KEY TO CLINICAL OBSERVATIONS
A |
= |
ataxia |
H |
= |
hunched posture |
P |
= |
pilo-erection |
Ri |
= |
increased respiratory rate |
Rl |
= |
labored respiration |
Wf |
= |
wet fur |
Wt |
= |
tip-toe gait |
0 |
= |
no abnormalities detected |
X |
= |
animal dead |
Individual Clinical Observations (Day of Exposure) – Dose Group 1
Mean Achieved Atmosphere Concentration (mg/L) |
Animal Number and Sex |
Hours During Exposure |
On Removal From Chamber |
One Hour Post-Exposure |
||
1 |
2 |
3 |
||||
5.09 |
1 Male |
Wf Ri |
Wf Ri |
Wf Ri |
Wf H P Ri Wt |
H P Ri Wt |
2 Male |
Wf |
Wf Ri |
Wf Ri |
Wf H P Ri |
H P Ri |
|
3 Male |
Wf Ri |
Wf Ri |
Wf Ri |
Wf H P Ri |
Wf H P Ri |
|
4 Female |
Wf |
Wf Ri |
Wf Ri |
Wf H P Ri Wt |
Wf H P Ri Wt |
|
5 Female |
Wf |
Wf Ri |
Wf Ri |
Wf H P Ri Wt |
Wf H P Ri Wt |
|
6 Female |
Wf |
Wf Ri |
Wf Ri |
Wf H P Ri |
H P Ri |
Individual Clinical Observations (Recovery Period) – Dose Group 1
Mean Achieved Atmosphere Concentration (mg/L) |
Animal Number and Sex |
Days Post Exposure |
|||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 - 14 |
||
5.09 |
1 Male |
H P Ri |
X |
|
|
|
|
|
|
2 Male |
H P Ri |
H P Ri |
H Ri |
H Ri |
H Ri |
Ri |
Ri |
0 |
|
3 Male |
H P Ri |
H P Ri |
H Ri |
H Ri |
Ri |
Ri |
Ri |
0 |
|
4 Female |
X |
|
|
|
|
|
|
|
|
5 Female |
X |
|
|
|
|
|
|
|
|
6 Female |
H P Ri Rl A Xlater in the day |
|
|
|
|
|
|
|
Individual Clinical Observations (Day of Exposure) – Dose Group 2
Mean Achieved Atmosphere Concentration (mg/L) |
Animal Number and Sex |
Hours During Exposure |
On Removal From Chamber |
One Hour Post-Exposure |
||
1 |
2 |
3 |
||||
1.05 |
7 Male |
Wf Ri |
Wf Ri |
Wf Ri |
Wf H P Ri |
Wf H P Ri |
8 Male |
Wf |
Wf Ri |
Wf Ri |
Wf H P Ri |
Wf H P Ri |
|
9 Male |
Wf Ri |
Wf Ri |
Wf Ri |
Wf H P Ri |
Wf H P Ri |
|
10 Female |
Wf Ri |
Wf Ri |
Wf Ri |
Wf H P Ri |
Wf H P Ri |
|
11 Female |
Wf |
Wf Ri |
Wf Ri |
Wf H P Ri |
Wf H P Ri |
|
12 Female |
Wf Ri |
Wf Ri |
Wf Ri |
Wf H P Ri |
Wf H P Ri |
Individual Clinical Observations (Recovery Period) – Dose Group 2
Mean Achieved Atmosphere Concentration (mg/L) |
Animal Number and Sex |
Days Post Exposure |
||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
||
1.05 |
7 Male |
H P Ri |
H P Ri |
P Ri |
P Ri |
Ri |
Ri |
0 |
8 Male |
H P Ri |
X |
|
|
|
|
|
|
9 Male |
H P Ri |
H P Ri |
P Ri |
P Ri |
Ri |
Ri |
0 |
|
10 Female |
H P Ri |
H P Ri |
H P Ri |
H P Ri |
Ri |
Ri |
Ri |
|
11 Female |
H P Ri |
H P Ri |
H P Ri Rl |
H P Ri |
Ri |
Ri |
Ri |
|
12 Female |
H P Ri A XLater in the day |
|
|
|
|
|
|
(Continued) Individual Clinical Observations (Recovery Period) – Dose Group 2
Mean Achieved Atmosphere Concentration (mg/L) |
Animal Number and Sex |
Days Post Exposure |
||||||
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
1.05 |
7 Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
8 Male |
|
|
|
|
|
|
|
|
9 Male |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
10 Female |
Ri |
Ri |
Ri |
Ri |
Ri |
0 |
0 |
|
11 Female |
Ri |
Ri |
Ri |
Ri |
Ri |
0 |
0 |
|
12 Female |
|
|
|
|
|
|
|
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 5 000 mg/m³ air
- Quality of whole database:
- The available studies are GLP compliant and have Klimisch score 2.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: There were no signs of systemic toxicity.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- Very slight erythema and crust formation and/or small superficial scattered scabs were noted at the test sites of four females. There were no signs of dermal irritation noted at the test sites of the remaining animals.
- Interpretation of results:
- other: Not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- An LD50 value of >2000 mg/kg bw is reported in a reliable study conducted according to an OECD test guideline and in compliance with GLP.
- Executive summary:
The acute dermal toxicity study is a reliable test performed with Distillates (Fischer-Tropsch), C8-26 – branched and linear, in accordance with OECD 402 and in compliance with GLP. 2000 mg/kg bw of test substance was applied to five male and five female Wistar rats for a twenty-four hour exposure period under semiocclusive conditions. The animals were observed for deaths or overt signs of toxicity, and the test sites were observed for primary irritation for fourteen days before sacrifice and necroscopy. No deaths occurred and no signs of overt toxicity were observed. There were no abnormalities noted at necroscopy. Very slight erythema and crust formation and/or small superficial scattered scabs were noted at the test sites of four females. There were no signs of dermal irritation noted at the test sites of the remaining animals.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The available study is GLP compliant and have Klimisch score 2.
Additional information
No acute oral, dermal, or inhalation toxicity data is available for the registered substance. However, key oral toxicity and supporting dermal and inhalation toxicity data is available from structurally related substances, C18-C50 branched, cyclic and linear hydrocarbons – Distillates (CAS# 848301-69-9) and C8-C26 branched and linear hydrocarbons – Distillates (CAS# 848301-67-7) and is presented below.
Acute oral toxicity:
The study was performed to assess the acute oral toxicity of C18-C50 branched, cyclic and linear hydrocarbons – Distillates (CAS# 848301-69-9) in the Sprague-Dawley CD strain rat. The method was designed to meet the requirements of OECD Guideline No 420 "Acute Oral Toxicity - Fixed Dose Method" and Method B1 bis Acute Toxicity (Oral) of Commission Directive 2004/73/EC. A dose level of 5000 mg/kg bodyweight resulted in no deaths, no signs of systemic toxicity, expected gains in bodyweight and no abnormalities at necropsy, in a total of 5 animals. 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.
Acute inhalation and dermal toxicity:
No studies conducted on the registered substance. However, based on lack of skin irritation and systemic effects in a skin irritation study the substance is not considered to acute harmful in contact with skin. The substance is unlikely to form aerosols or particles of inhalable size and therefore it is considered justifiable not to conduct inhalation study.
Moreover, supporting data on a related substance (with range C8 -26) indicate the low toxicity of the test substance:
- Acute inhalation toxicity study (Shell, 2013a), conducted according to OECD 436 and GLP, reported an acute inhalation median lethal concentration (4 hr LC50) of Distillates (Fischer-Tropsch), C8-26-branched and linear, in the RccHanTM: WIST strain rat >5 mg/L.
- Acute dermal toxicity study (Shell, 2015a), conducted according to OECD 402 (Acute Dermal Toxicity) and GLP, reported an LD50 in male and female rats >2000 mg/kg bw.
Justification for selection of
acute toxicity – oral endpoint
No study available for substance defined in Section 1. For the
endpoint conclusion a study of a related substance C18-C50 branched,
cyclic and linear hydrocarbons – Distillates (CAS# 848301-69-9) was
selected.
Justification for selection of acute toxicity – inhalation endpoint
No study available for substance defined in section 1. For the
endpoint conclusion a study of a related substance with a limited range
(C8-C26) was selected.
Justification for selection of acute toxicity – dermal endpoint
No study available for substance defined in section 1. For the
endpoint conclusion a study of a related substance with a limited range
(C8-C26) was selected.
Justification for classification or non-classification
On the basis of the available read across oral, inhalation and dermal data, the registered substance does not require classification for lethal effects following a single exposure according to Regulation 1272/2008/EC.
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