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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
Toxicity to birds
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to birds: dietary toxicity test
- 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
- Key result
- Duration (if not single dose):
- 5 d
- Dose descriptor:
- LC50
- Effect level:
- > 5 000 mg/kg bw
- Conc. / dose based on:
- test mat.
- Basis for effect:
- mortality
- Remarks on result:
- other: No test item related mortalities and no symptoms were observed within the observation period. At necropsy, no macroscopic findings were observed for the treated animals
- Key result
- Duration (if not single dose):
- 5 d
- Dose descriptor:
- NOEC
- Effect level:
- >= 5 000 mg/kg bw
- Conc. / dose based on:
- test mat.
- Basis for effect:
- other:
- Remarks on result:
- other: No test item related mortalities and no symptoms were observed within the observation period. At necropsy, no macroscopic findings were observed for the treated animals.
- Mortality and sub-lethal effects:
- 1.1 Mortality
Results of the limit test are presented in Appendix A.
Pre-Test
In the pre-test, the test item was administered to 5 Japanese quails each at dose levels of 200, 1000 and 5000 mg/kg diet. No mortality and no symptoms were observed during a
5-day observation period in all of the dose groups. Therefore, a limit test was performed with a concentration level of 5000 mg/kg diet.
Limit-Test
In the limit test at a concentration level of 5000 mg/kg diet, no mortality of the treated birds was observed within the observation period of 8 days. Therefore, the LC50 level for the test item was > 5000 mg/kg diet.
Three of the 20 control animal died. However, taking into account the 20 control animals of a second study (Harlan Laboratories Study D19794) and 17 reserve animals, in total, only 3 of 57 non-treated animals died during the test period. This is confirmation that the maintenance of the birds was appropriate.
Clinical Signs
Results are presented in the attached Appendix A.
No symptoms were observed at a concentration level of 5000 mg/kg diet. Therefore, the NOEC (no observed effect concentration) was > 5000 mg/kg diet.
Macroscopic Findings
For the Limit test, all animals of groups 1-3 were necropsied at the end of the observation period. The results are presented in the attached Appendix B.
No findings were observed in all the animals necropsied at the end of the study. In one of the control animals that died during the test, inflammatory foci were seen on the outside of the heart. One animal had coagulated blood in the abdominal cavity, probably resulting form the i.p. injection of Esconarkon.
Body Weight
Tabulated body weights are presented in the attached Appendix C.
Average body weights before the start of the treatment ranged from 84.2 to 93.0 g for groups 1 to 3. The body weight of the treated animals was on average 124.6 ± 10.2 g on day 5 and 144.3 ± 11.6 on day 8. These weights were similar to the weights of control groups 1 and 2.
Food Consumption and Test Item Intake
Results are presented in the attached Appendix D.
Individual food consumption
The Individual Food Consumption (IFC) during observation days 0-5 (average values, per animal per day) in group 3 (20.2 g food/animal/day) was similar to the IFC of groups 1 and 2 (17.9-20.3 g) Also after termination of the treatment, the IFC for group 3 (21.1 g) was similar to the control groups (21.0-22.5 g).
Relative food consumption
The Relative Food Consumption (RFC) during observation days 0-5 was 176.1 g (average values, per kg body weight per day) of group 3 (234.1g/kg body weight/day) was similar to the RFC of control group 2 (231.0 g). RFC of group 1 (188.8 g was slightly lower when compared to groups 2 and 3. After termination of the treatment, the relative food consumption of all three groups was similar (169.5-177.4 g).
In conclusion, there was no difference in individual food consumption and relative food consumption between the treated group and the control groups.
Test item intake
The test item intake (TII) was calculated based on the food consumption and the nominal test item concentration in the diet:
Group 3: 1170.6 mg test item per kg body weight per day
The LC50 based on test item intake was therefore > 1170.6 mg per kg body weight per day. - Validity criteria fulfilled:
- yes
- Conclusions:
- The median lethal concentration (LC50) for the dietary oral toxicity of the read across substance GTL Base Oil Distillates in young Japanese quails was determined as > 5000 mg test item/kg diet.
No test item related mortalities and no symptoms were observed within the observation period. At necropsy, no macroscopic findings were observed for the treated animals. Therefore, the NOEC (no observed effect concentration) was determined as > 5000 mg/kg diet.
Body weights were similar for treated group and the control groups. Food consumption was also similar for the treated group and the control groups.
The LC50 based on test item intake was > 1170.6 mg per kg body weight per day. - Executive summary:
In a dose range finding pre-test, the read across substance 'Distillates (Fischer-Tropsch), heavy, C18-50 - branched, cyclic and linear' was administered to 5 Japanese quails each at dietary dose levels of 200, 1000 and 5000 mg/kg diet. All quails survived an observation period of 5 days and no symptoms were observed.
Based on the pre-test, a limit test was performed. The test item was administered to one group of 10 Japanese quails by dietary ingestion at a nominal dose level of 5000 mg test item/kg diet for 5 treatment days followed by 3 observation days where the animals obtained basal diet.
No mortality was observed in the main study at a dose level of 5000 mg/kg diet, therefore, the LC50 of 'Distillates (Fischer-Tropsch), heavy, C18-50 - branched, cyclic and linear' was determined as > 5000 mg/kg diet.
No symptoms and no macroscopic findings were observed in the treated animals. Therefore, the NOEC (no observed effect concentration) was determined as >5000 mg/kg diet.
Body weights and food consumption were similar for treated group and the control groups.
The mean test item intake over the treatment period of five days was as follows:
Group
Dietary test item concentration (mg/kg)
IFC
g food
per animal
per day
RFC
g per kg body weight per dayTII
mg test item per kg body weight per day1
0
17.9
188.8
2
0
20.3
231.0
3
5000
20.0
234.1
1170.6
IFC: Individual Food Consumption
RFC: Relative Food Consumption
TII: Test Item Intake
CONCLUSION
The median lethal concentration (LC50) for the dietary oral toxicity of the test item in young Japanese quails was determined as > 5000 mg test item/kg diet.
No test item related mortalities and no symptoms were observed within the observation period. At necropsy, no macroscopic findings were observed for the treated animals. Therefore, the NOEC (no observed effect concentration) was determined as >5000 mg/kg diet.
Body weights were similar for treated group and the control groups. Food consumption was also similar for the treated group and the control groups.
The LC50 based on test item intake was >1170.6 mg per kg body weight per day.
Reference
Analysis of Test Item in the Diet
Results are presented in the attached Appendix E.
The mean concentration of the substance in the diet samples was 106.9% (see “Results” of the analytical report) of the nominal concentration.
Maximal deviation of the homogeneity samples was 8.8% of the mean concentration. Therefore, the test item was found to be homogeneously distributed in the diet. Furthermore, the test item was found to be sufficiently stable in the diet during storage at room temperature for 6 days (average 88.6%).
Schedule
Limit test:
Groups |
Hatch |
Arrival of animals |
Start of the limit test |
End of the limit test |
1-3 |
28-JAN-2011 |
08-FEB-2011 |
14-FEB-2011 |
22-FEB-2011 |
Description of key information
LC50 (5d): > 5000 mg/kg test mat. based on: mortality
NOEC (5d): >= 5000 mg/kg test mat.
Key value for chemical safety assessment
Additional information
An acute avian toxicity study has been conducted with the read across substance GTL Base Oil Distillates. The test was conducted in accordance with OECD 205 and GLP. A limit test was performed with a nominal concentration of 5000 mg/kg diet. Additionally, two control groups received diet without test item.
The acute oral LC50of the test substance in Japanese quail was determined to be >5000 mg/kg diet. The NOEC was determined to be ≥5000 mg/kg diet. The LC50based on test substance intake was >1170 mg/kg body weight/day.
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