Octadecene, reaction products with hexadecene, hydrogenated

Bioaccumulation: aquatic / sediment

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

bioaccumulation in aquatic species: fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 May - 6 August 2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

This test was conducted to meet the requirements of Japanese national legislation and to undertake notification in Japan.

Qualifier:

according to guideline

Guideline:

OECD Guideline 305 (Bioaccumulation in Fish: Aqueous and Dietary Exposure) -III: Dietary Exposure Bioaccumulation Fish Test

Qualifier:

according to guideline

Guideline:

other: Test Method Relating to New Chemical Substances "Bioconcentration test of chemical substances in fish and shellfish (Dietary exposure )" (Japanese notification, Y akushokuhatsu 0331 No.7, Heisei 23.03.29 Seikyoku No.5, Kanpokihatsu No.110331009

GLP compliance:

yes (incl. QA statement)

Details on preparation of test solutions, spiked fish food or sediment:

Preparation and Storage of the Test Diet
1) Test diet for test group
Diet (150 g) was weighed into a stainless vat, to which 150 mL of adding solution was added for the test group. The amount added to the diet was 1000 mg/kg for the test substance and 500 mg/kg for the reference substance. The surface of the diet was flatten so that all the diet was immersed in the adding solutions and stored it stably in a draft chamber until the next day to evaporate the solvent. This treated diet was used as the test diet for the test group and stored in a refrigerator.

2) Test diet for control group
Diet (150 g) was weighed into a stainless vat, to which 150 mL of adding solution was added for the control group. The amount added to the diet was 500 mg/kg for the reference substance. The surface of the diet was flatten so that all the diet was immersed in the adding solutions and stored it stably in a draft chamber until the next day to evaporate the solvent. This treated diet was used as the test diet for the control group and stored in a refrigerator.

Test organisms (species):

Cyprinus carpio

Details on test organisms:

Species: Carp (Cyprinus carpio)
Kitamura-yourijou
Source: 12-388, Gunchiku, Yatsushiro, Kumamoto 866-0001, Japan
Total length: 8 +/- 4 cm
Body weight: Approximately 10g at the start of acclimation. Approximately 12 g at the start of the exposure period.
Age: Yearling fish.
Number of fish (at the start of acclimation):
Test group: 23 fish in 50 L dilution water (≥ 1 L/day/g)
Control group: 23 fish in 50 L dilution water (≥ 1 L/day/g)
Mortality 1 week before testing: < 5%

Route of exposure:

feed

Justification for method:

dietary exposure method used because stable, measurable water concentrations cannot be maintained

Test type:

flow-through

Water / sediment media type:

natural water: freshwater

Total exposure / uptake duration:

14 d

Total depuration duration:

0 min

Test temperature:

24 +-/ 2 °C

pH:

6.0-8.5

Dissolved oxygen:

> 60% of the saturation concentration (􀀨 5 mg/L at 24 °C)

Details on test conditions:

Dilution water supply: Continuous flow-through 800 L/day (Turnover rate: 16 volumes/day)
Number of fish (at the start of the exposure period):
Test group: 18 fish in 50 L dilution water (≥1 L/day/g)
Control group: 18 fish in 50 L dilution water (≥ 1 L/day/g)
Water temperature: 24 +/- 2 °C
Dissolved oxygen: ≥ 60% of the saturation concentration (≥ 5 mg/L at 24 °C)
Aeration: Continuous
pH: 6.0 to 8.5
Lighting: Approx. 16 hour/day, Hf fluorescent lamp (wavelength 400-700 nm)
Test diet: Prepared diet for each group
Feeding amount: The test diet was given daily equivalent to approximately 2.5% of the fish body weight.
Exposure period: 14 days
Depuration period: None (Reason: The BMF of the test substance at the end of the exposure period was less than 0.007.)

Nominal and measured concentrations:

Nominal 1000 mg/kg

Reference substance (positive control):

yes

Remarks:

o-Terphenyl CAS 84-15-1

Conc. / dose:

1 000 other: mg/kg

Temp.:

24 °C

pH:

6

Type:

BMF

Value:

< 0.003

Basis:

whole body w.w.

Remarks on result:

other: Based on Dimers (Peak A)

Details on results:

Result of the Test Diet Analysis
The mean concentration of the quantitative components (dimers, peak A) of the test substance in the test group diet at the end of the exposure period was within +/- 20% of the mean concentration before the start of the exposure period. In addition, the variation of the test substance concentration in the test group diet measured three times (n=3) before the start of the exposure period was within +/- 15% of the mean value. The concentration of the dimers (peak A) in the control group diet was below the lower limit of quantification.

Result of the Test Fish Analysis
The concentrations of the quantitative components (dimers, peak A) in the test fish at the end of the exposure period were below the lower limit of quantification in both the test and the control groups. The BMF of the dimers at the end of the exposure period was < 0.0027 for the test group. The monitored components (trimers, peak B) were checked for the fish samples taken at the end of the exposure period (days 14). No significant peak of the monitored components was detected in the fish body in both the test and the control groups. The BMF of the reference substance at the end of the exposure period was 0.0244 for the test group and 0.0153 for the control group.

Condition of the fish
No fish were dead, and the surviving fish showed no abnormality in appearance, swimming or feeding behavior. Therefore, the test fish were confirmed to be reared appropriately. During the exposure period, no test diet remained in the test fish tank within 1 hour of the first feeding.
The mean body weight of the test fish in each test group is shown below:.
At the start of the exposure period (fish sampled for lipid content measurement): Test group 11.83 g, Control group 12.00 g
At the end of the exposure period (all sampled fish): Test group 21.81 g, Control group 21.24 g


Validity of test
This test is judged to be valid because all results satisfied the validity criteria.

Results of the lipid content

Lipid content of test diet

	Mean lipid content (%)
	Before the start of the exposure (n=3)	At the end of the exposure (n=3)	Total mean (n=6)
Test group	13.8	13.9	13.9
Control group	13.3	13.5	13.4

 

Lipid content of test fish

	Mean lipid content (%)
	Before the start of the exposure (n=3)	At the end of the exposure (n=3)	Total mean (n=6)
Test group	4.7	4.7	4.7
Control group	3.9	3.3	3.6

Calculation of BMF

The calculation results of BMF at the end of the exposure period are shown below.

Since the quantitative components (dimers, peak A) were not detected in the fish body, it was certain that the components hardly accumulated in lipids of fish body. Therefore, the lipid­ corrected biomagnification factor (BMFL) of the dimers was not calculated.

 

	Test substance (Dimers, Peak A)	Reference substance
	Test group	Test group	Control group
BMF	< 0.0027	0.0244	0.0153
BMFL	-	0.0722	0.0569

Validity criteria fulfilled:

yes

Conclusions:

The BMF of the quantitative components (dime1·, peak A) was less than 0.007, which is the criterion for bioconcentration potential under the Chemical Substances Control Law. No significant peak of the monitored components (trimers, peak B) was detected from fish samples. The BMF of the reference substance was 0.0244 for the test group and 0.0153 for the control group. Since these results were similar to the already known BMF value of 0.0343* of the reference substance, it was judged that the test was conducted properly.
It can be concluded from the above results that the bioconcentration potential of the test substance in fish is not high.
* BMF value after 13 days of exposure period described in the test guideline.

Reference 2

Endpoint:

bioaccumulation in aquatic species: fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

8 - 24 September 2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

This test was conducted to meet the requirements of Chinese national legislation and to undertake notification in China.

Qualifier:

according to guideline

Guideline:

other: National Standardization Technical Committee for Management of Hazardous Chemicals. GB/T 21800-2008 Chemical Bioconcentration: Flow-through Fish Test [S]. Beijing: China Standard Press, 2008.

Qualifier:

according to guideline

Guideline:

other: State Environmental Protection Administration of China. HJ/T 153-2004, The Guidelines for the test of chemical [S]. Beijing: China Environmental Science Press. 2004.

Qualifier:

according to guideline

Guideline:

other: Chemical Registration Center of MEP. The Guidelines for the Testing of Chemicals, Degradation and Accumulation, 305 Bioconcentration: Flow-through Fish Test[S]. Second Edition, Beijing, China Environmental Science Press. 2013: 118-133.

Qualifier:

according to guideline

Guideline:

OECD Guideline 305 (Bioaccumulation in Fish: Aqueous and Dietary Exposure) -III: Dietary Exposure Bioaccumulation Fish Test

GLP compliance:

yes (incl. QA statement)

Details on sampling:

Sampling for concentration measurement
Collection of stock solution: test substance concentrations were sampled and analysed before the start of test and at the end of the uptake phase.
Collection of test water: 100 ml of test water was collected from the central of test tank before feeding, and the analysed water samples were obtained after pre-treatment
Collection of test fish: Fish were taken from each test container, immediately euthanized after rinse with test water, drained the body water and group. The length and weight were recorded individual and used for the analysed fish samples.
Control group: days 0 and 14
Test group: days 0, 3, 7, 10, 14
Collection of food: after the food prepared and stored for 7 days, triplicate spiked food and one control food (0.200 g per sample) were sampled for concentration analysis.


Pre-treatment and concentration analysis
Stock solution
a) 0.5ml of the test substance stock solution was accurately added into a 50ml volumetric flask, dilute with n-hexane and make the volume to the mark line for concentration analysis
b) Samples analysed immediately on the same day after processing. If not it was stored in dark conditions 2-8˚C and measured within 7 days.
Test water
a) Collected water filter with 0.45µm polyester sulfone filter membrane and the filtrate was immediately processed.
b) Samples analysed immediately on the same day after processing. If not it was stored in dark conditions 2-8˚C and measured within 7 days.
c) Filtered samples analysed by two injections using GCMS and concentrations were calculated by sample peal area to standard solution peak area ratio.
Test fish
a) Fish samples were immediately processed
b) Samples analysed immediately on the same day after processing. If not it was stored in dark conditions 2-8˚C and measured within 7 days.
c) Fish samples analysed by two injections using GCMS and concentrations were calculated by sample peal area to standard solution peak area ratio.
Test food
a) Fish food were immediately processed
b) Samples analysed immediately on the same day after processing. If not it was stored in dark conditions 2-8˚C and measured within 7 days.
c) Fish food analysed by two injections using GCMS and concentrations were calculated by sample peal area to standard solution peak area ratio.

Vehicle:

no

Details on preparation of test solutions, spiked fish food or sediment:

Test water
Dechlorinated tap water was prepared and used in the test. Before test, the test water was aired to removing the chlorine and the dissolved oxygen content in the water reach above 90% of saturation value. The total hardness of test water is about 10mg/L to 250 mg/L expressed as CaCO3, the pH is in the range of 6.0 to 8.5, and the TOC is <2 mg/L.

Test Phase:
Uptake phase: 14 days
Depuration phase: None (Test substance in test fish at the end of the exposure was less than the LOD.
The uptake phase of dietary exposure was to 14 days, which was the longest time of normal uptake phase (7-14 days). Depuration phrase continued until the test substance was not detected in fish. At the end of the 14 day uptake phase, no test substance was detected in fish, so the depuration phase was not in this test.


Spiked food concentrations
Control group: 1 nominal concentration of 0mg test substance / kg food
Test group: 1 nominal concentration of 500 mg test substance / kg food
In the preliminary test, the nominal concentration of 100 mg and 500 mg test substance / kg food was fed to fish and no death or abnormal behaviour was observed. The test substance was not detected in the test fish during the uptake phase lasted for 29 days by GCMS. According to the analytical sensitivity and preliminary test results, the concentration of 500 mg test substance / kg food was set which was within the range of 1-1000 mg/kg specified in the guideline.
Preparation of spiked food
(1) Preparation of test solutions: 25.02 mg of test substance was weighed into a beaker, an appropriate amount of n-hexane was added to dissolve the test substance, transferred it into a 50mL volumetric flask. The n-hexane was added to the mark line to obtain the stock solution with nominal concentrations of 500 mg/L.
(2) 10000g of food was weighed into a petri dish, 10mL of the test substance stock solution was slowly and evenly added to the feed. Placed in a fume hood overnight to make the solvent volatilize completely. Stirred the food evenly to obtain spiking food containing 500 mg test substance /kg food, which was used as the food for test group.
Preparation of control food: test substance stock solution was instead n-hexane, the same operation was performed to obtain control group food, which was used as the food for control group at uptake phase. Pure food was used for test and control group at depuration phase.
Food preparation time and storage: The spiked food and the control food were prepared every 7 days. After the preparation, they were kept in a tightly sealed place at low temperature and avoid light.

Test organisms (species):

other: Rare minnow (Gobiocypris rarus)

Details on test organisms:

Rare Minnow (Gobiocypris rarus)
Supplier: Breeding by the test laboratory
Batch No.: FGr20210224-0225
Age: Adult fish, approximately 6 month old.
Number of test fish: 30 fish of blank control and 60 fish of test group (90 fish total).
Reason for selection of species: The test species is endemic to China, easy to obtain and raise and very sensitive to chemicals, which meet the requirements of Chinese New Chemicals Environmental Management Measures (Ecology and Environmental Management Measures (Ecology and Environmental Ministry Order No. 12) and “OECD Guidelines for the Testing of Chemicals, 305-2012”.
Acclimation: The population of fish was acclimated at least 2 weeks, under the same conditions of the test. Morality of the fish less than 5% within the 7 days, which meet the requirement of the testing guideline.

Route of exposure:

feed

Justification for method:

dietary exposure method used because stable, measurable water concentrations cannot be maintained

Test type:

flow-through

Water / sediment media type:

other: Dechlorinated tap water

Total exposure / uptake duration:

14 d

Total depuration duration:

0 min

Hardness:

10mg/L to 250 mg/L expressed as CaCO3

Test temperature:

23.9-24.4˚C

pH:

6-8.5

Dissolved oxygen:

at least 60% of the air saturation

TOC:

<2 mg/L.

Details on test conditions:

Exposure conditions
Test system: Flow-through
Test volume: 30 mL test water / tank
Test water: About 150L / tank / day (>5 times of changes / day)
Control group: 30 fish / 30 L test water
Test group: 60 fish / 30 L test water
Test temperature: 23.9-24.4˚C
pH: 6.0-8.5
Dissolved oxygen: at least 60% of the air saturation
Light period: 14h light / 10h darkness, artificial light of white fluorescent lamp
Loading rate: 0.1g-1.0g fish weight/L
Feeding amount: feed at about 2% fish weight per day

Nominal and measured concentrations:

Control group: 1 nominal concentration of 0mg test substance / kg food
Test group: 1 nominal concentration of 500 mg test substance / kg food

Key result

Conc. / dose:

500 other: mg/kg test substance / kg food

Temp.:

>= 23.9 - <= 24.4 °C

pH:

6

Type:

BMF

Value:

< 0.003

Basis:

whole body w.w.

Remarks on result:

other: No other details available

Details on results:

Test conditions
Dissolved oxygen 78-89%, greater than 60% of the air saturation concentration
Water temperature: 23.9-24.4˚C, water temperature variation is less than ± 2 ˚C
pH: 7.93-8.39, withing range of fish rearing (6.0-8.5)
TOC: The TOC of test group was 1.26 - 1.68 mg/L. The TOC of control group was 1.06-1.64 mg/L. All satisfied < 2mg/L
Hardness: Test water measured at the start of the test was 105 mg/L (CaCO3)

Condition of fish
During the test: Surviving fish in the control group and test group showed no abnormalities in appearance, swimming or feeding.
At the end of test: No fish died in control or test group.

Test substance concentration in solution
LOD = 0.0429 mg/L
Quantitative LOD: 0.143 mg/L
Average recovery rate: 0.418 mg/L, 4.18 mg/L and 18.8 mg/L was 97.1%, 86.8% and 106% respectively.
RSD 0.31%,1.0% and 0.13% respectively.
GC-MS showed no test substance detected in water for each test group during test period.

Test substance concentration in food
LOD2: 23.2 mg/kg
LOQ2: 77.3 mg/kg
Average recovery rate 313 mg/kg, 1044 mg/kg, 4698 mg/kg were 95.8%, 98.9% and 110% respectively.
RSD 0.97%, 1.1% and 4% Respectively
Preparation of old and new: homogeneity of the test substance in food, based on three samples for the substance taken at test start, that the changes range of test substance concentration in test food was 3.17% - 3.58% and 0.85% - 5.71% which dose not vary more than ± 15% from the mean. Results showed a good homogeneity.
Measured concentration of old/new: the concentration of the test substance in fish food before and at the end of the replace phase was within a range of ± 25% (based on three samples at both time points that the concentration change range of test substance 4.45% and 6.61%). So the concentration of the food was indicated as a nominal concentration of 500 mg/kg when calculating BMF.
Food for the control group: Not detected (less than LOD2=23.2 mg/kg).

Test substance concentration in fish
LOD3: 1.48 mg/kg
LODQ3: 4.92 mg/kg
Average recovery rate of [10.4, 10.4, 10.4] mg/kg, [104, 105,105] mg/kg and [208, 208, 208] mg/kg were 97.1%, 81.9% and99.9% respectively
RSD 1.5%, 0.61% and 0.31% respectively.
Control group less than LOD3 = 1.48 mg/kg
Test group less than LOD3 = 1.48 mg/kg

Fish body weight and fat content
At the beginning of the uptake phase, the fish weighed of blank control was 0.297 ± 0.028 g, the fish weighed of test group was 0.271 ± 0.027 g, At the end of the uptake phase, the fish weighed of blank control was 0.332 ± 0.022g; and the fish weighed of test group was 0.342 ± 0.048g.
Regression curve was plot using the mean log of average fish weight at days 0, 3, 7, 10, 14 and time as the abscissa, which yielding the growth rate constant Kg of 0.0146.
Fat contents of fish at 0 and 14 days
Control group: 2.47% and 3.40%
Test group: 2.18% and 3.59%
The fat contents of food at 0 and 14 days:
Control group: 13.6% and 11.7%
Test group: 13.3% and 12.1%

Calculation of BMF
Under the test conditions, test substance in the fish was not detected, and the BMF was calculated as 0.00296 at a detection limit of 1.48 mg/kg, which was less than 0.00296 for Gobiocypris rarus. That was the BMF of 500 mg/kg test substance / kg food for the Gobiocypris rarus was less than 0.00296.

Validity criteria fulfilled:

yes

Conclusions:

Under the test conditions, after a 14 day uptake phase exposure test, the 500 mg test substance / kg food was calculated as biomagnification factor (BMF) for Gobiocypris rarus as less than 0.00296

Reference 3

Endpoint:

bioaccumulation: aquatic / sediment

Type of information:

calculation (if not (Q)SAR)

Adequacy of study:

supporting study

Study period:

Not specified

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

accepted calculation method

Justification for type of information:

Scientific evaluation and expert statement on the basis of:
Biodegradation test data
Log Pow Study data and calculations
Quantitative Structural Activity Relationships (QSAR)
Molecular Size Data
Metabolic Absorption test data
Literature data as appropriate.

Principles of method if other than guideline:

The substance is a hydrocarbon UVCB. The purpose of the report is to provide an assessment of the propensity of SynNova Baseoik to bioaccumulate and prepare a suitable scientific comment paper for the purposes of supporting the notification of the material in various regulatory schemes (specifically China). The report utilises:

• Biodegradation test data
• Log Pow Study data and calculations
• Quantitative Structural Activity Relationships (QSAR)
• Molecular Size Data
• Metabolic Absorption test data
• Literature data as appropriate.

The outcome and results of the assessment are detailed below.

GLP compliance:

no

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material:Not Applicable - Scientific evaluation and expert statement

Radiolabelling:

no

Details on sampling:

Not Applicable - Scientific evaluation and expert statement

Details on preparation of test solutions, spiked fish food or sediment:

Not Applicable - Scientific evaluation and expert statement

Details on test organisms:

Not Applicable - Scientific evaluation and expert statement

Route of exposure:

other: Scientific evaluation and expert statement

Test type:

other: Scientific evaluation and expert statement

Water / sediment media type:

not specified

Hardness:

Not Applicable - Scientific evaluation and expert statement

Test temperature:

Not Applicable - Scientific evaluation and expert statement

pH:

Not Applicable - Scientific evaluation and expert statement

Dissolved oxygen:

Not Applicable - Scientific evaluation and expert statement

TOC:

Not Applicable - Scientific evaluation and expert statement

Salinity:

Not Applicable - Scientific evaluation and expert statement

Conductivity:

Not Applicable - Scientific evaluation and expert statement

Details on test conditions:

Not Applicable - Scientific evaluation and expert statement

Nominal and measured concentrations:

Not Applicable - Scientific evaluation and expert statement

Reference substance (positive control):

not required

Details on estimation of bioconcentration:

The substance is a hydrocarbon UVCB. The purpose of the report is to provide an assessment of the propensity of SynNova Base Oil to bioaccumulate and prepare a suitable scientific comment paper for the purposes of supporting the notification of the material in various regulatory schemes (specifically China). The report utilises:

• Biodegradation test data
• Log Pow Study data and calculations
• Quantitative Structural Activity Relationships (QSAR)
• Molecular Size Data
• Metabolic Absorption test data
• Literature data as appropriate.

The outcome and results of the assessment are detailed below.

Key result

Type:

BCF

Value:

>= 15.76 - <= 31.33 L/kg

Basis:

whole body w.w.

Remarks on result:

other: Calculation by US EPA On-Line EPI Suite™ BCFBAF v3.01 model

Details on kinetic parameters:

Not Applicable - Scientific evaluation and expert statement

Metabolites:

Not Applicable - Scientific evaluation and expert statement

Results with reference substance (positive control):

Not Applicable - Scientific evaluation and expert statement

Details on results:

The following was evaluated:
Biodegradation test data
As the substance shows significant biodegradation under environmental conditions, it is not persistent. The absence of the substance within the environment for any considerable length of time therefore indicates that it is not available for uptake and subsequent bioaccumulation within aquatic organisms. As such, the substance is not considered to be potentially bioaccumulative on the consideration that it is not present within the environment for sufficient time to enable bioaccumulation to take place.

Log Pow Study data and calculations
It is considered that sufficient evidence exists for avoidance of classification for bioaccumulative effects. White oils are not absorbed within the body, nor do they demonstrate any toxicity to mammalian or environmental organisms. As such, the “high” calculated Log Kow value ranging between 15.76 to 31.33 associated with these types of substances is not proposed to be indicative of the propensity of the substance to become bioaccumulated. No classification is proposed on this basis.

Quantitative Structural Activity Relationships (QSAR)
Using the US EPA On-Line EPI Suite™ BCFBAF v3.01 model, the bioaccumulation range is predicted to be 3.162 to 1944 L/kg wet-wt. This is below the threshold for concern for bioaccumulation, and enforces the fact that significant uptake of the material in the mammalian studies was not observed. The substance is not considered to be potentially bioaccumulative.

Molecular Size Data
Evaluation of the above molecules, taking into account the assumption that these are only a few of possible thousands of variants, indicates that approximately 11% of the molecules are of a Dmax average of greater than 17 Å (1.7 nm) plus a molecular weight of greater than 700 (Da). This indicates, within a weight of evidence approach and with expert judgment, that a proportion of the substance is deemed to not be very bioaccumulative (i.e., unlikely to have a BCF > 5,000) on the basis of physical size. In conjunction with the other data available, it is considered that bioaccumulation is not relevant for this substance.

Metabolic Absorption test data
In conclusion, under the conditions of this study, single oral (gavage) administration of SynNova Base Oil at the dose level of 2000 mg/kg body weight did not cause any test item related effects.
It is therefore considered that SynNova Base Oil is significantly not absorbed when ingested. It is also unlikely that the substance will easily pass across fish gill membranes and therefore is unlikely to have a high bioconcentration factor (BCF) in fish.

Literature data as appropriate.
Specific data on the bioaccumulation of white oils is limited with respect to substances like SynNova Base Oil This is presumably because materials of this nature are not expected to demonstrate a propensity towards bioaccumulation, based on their intrinsic properties.

Overall conclusion
The substance is a hydrocarbon UVCB. Assessment using the US EPA On-Line EPI Suite™ KOWWIN version 1.68 model, the log Kow range is predicted to be 15.76 to 31.33. As the substance shows log Kow values of > 10, it is proposed that the substance is not indicative of being potentially bioaccumulative, on the basis of the partition coefficient values observed.
The substance is, however, considered to be not bioavailable to aqueous organisms as demonstrated by the lack of toxicity. Furthermore, the high log Kow is considered to be more a consequence of poor water solubility than a lipophilic tendency and is considered to be not indicative of the tendency to bioaccumulate in lipid tissues of aquatic organisms. This is based in part on an evaluation of literature data which demonstrates a tendency for the Bioconcentration Factor (BCF) to decrease as Log Pow increases above 6. This assumption is further confirmed by the data set available on the substance which demonstrates that it is poorly absorbed, both on the basis of the toxicity (or lack of) observed.
The above opinion is also confirmed via use of the EPIWIN BCFBAF v3.01 for assessment of bioaccumulation of BCF 3.162 L/kg wet-wt the evaluated values are less that <2000, indicating that the substance is not proposed to be bioaccumulative.

Evaluation of predicted molecular size data indicates that approximately 11% of the molecules are of a Dmax average of greater than 17 Å (1.7 nm) plus a molecular weight of greater than 700 (Da).

Taking into account the following:

• Lack of absorption
• Lack of persistency
• High predicted log Kow value.
• Low predicted bioaccumulation potential
• Molecular size data not being indicative of the propensity towards bioaccumulation.


This indicates, within a weight of evidence approach and with expert judgment, that SynNova Base Oil is deemed to not be bioaccumulative in aquatic organisms.

Reported statistics:

Not Applicable - Scientific evaluation and expert statement

Please refer to attached report below.

 

Validity criteria fulfilled:

yes

Conclusions:

The substance is a hydrocarbon UVCB. Assessment using the US EPA On-Line EPI Suite™ KOWWIN version 1.68 model, the log Kow range is predicted to be 7.49 to 31.33. As the substance shows log Kow values in the main of > 10, it is proposed that the substance is not indicative of being potentially bioaccumulative, on the basis of the partition coefficient values observed.

The substance is, however, considered to be not bioavailable to aqueous organisms as demonstrated by the lack of toxicity. Furthermore, the high log Kow is considered to be more a consequence of poor water solubility than a lipophilic tendency and is considered to be not indicative of the tendency to bioaccumulate in lipid tissues of aquatic organisms. This is based in part on an evaluation of literature data which demonstrates a tendency for the Bioconcentration Factor (BCF) to decrease as Log Pow increases above 6. This assumption is further confirmed by the data set available on the substance which demonstrates that it is poorly absorbed, both on the basis of the toxicity (or lack of) observed, plus the absorption study which demonstrated the lack significant absorption in the rat.
The above opinion is also confirmed via use of the EPIWIN BCFBAF v3.01 for assessment of bioaccumulation. The smallest and largest theoretical molecular weight substances were assessed and the following results were demonstrated:
Smallest: BCF 1944 L/kg wet-wt
Largest: BCF 3.162 L/kg wet-wt

All evaluated values are less that <2000, indicating that the substance is not proposed to be bioaccumulative.

Evaluation of predicted molecular size data indicates that approximately 29% of the molecules are of a Dmax average of greater than 17 Å (1.7 nm) plus a molecular weight of greater than 700 (Da).

Taking into account the following:

• Lack of absorption
• Lack of persistency
• High predicted log Kow value.
• Low predicted bioaccumulation potential
• Molecular size data not being indicative of the propensity towards bioaccumulation.

This indicates, within a weight of evidence approach and with expert judgment, that SynNova Base Oil is deemed to not be bioaccumulative in aquatic organisms.

Executive summary:

The substance is a hydrocarbon UVCB. Assessment using the US EPA On-Line EPI Suite™ KOWWIN version 1.68 model, the log Kow range is predicted to be15.76 to 31.33.As the substanceshows log Kow values of > 10,it is proposed that the substance is not indicative of being potentially bioaccumulative, on the basis of the partition coefficient values observed.

The substance is, however, considered to be not bioavailable to aqueous organisms as demonstrated by the lack of toxicity. Furthermore, the high log Kow is considered to be more a consequence of poor water solubility than a lipophilic tendency and is considered to be not indicative of the tendency to bioaccumulate in lipid tissues of aquatic organisms. This is based in part on an evaluation of literature data which demonstrates a tendency for the Bioconcentration Factor (BCF) to decrease as Log Pow increases above 6. This assumption is further confirmed by the data set available on the substance which demonstrates that it is poorly absorbed, both on the basis of the toxicity (or lack of) observed.

The above opinion is also confirmed via use of the EPIWIN BCFBAF v3.01 for assessment of bioaccumulation of BCF 3.162 L/kg wet-wt the evaluated values are less that <2000, indicating that the substance is not proposed to be bioaccumulative.

 

Evaluation of predicted molecular size data indicates that approximately 11% of the molecules are of a Dmax average of greater than 17 Å (1.7 nm) plus a molecular weight of greater than 700 (Da). 

 

Taking into account the following:

 

·        Lack of absorption

·        Lack of persistency

·        High predicted log Kow value.

·        Low predicted bioaccumulation potential

·        Molecular size data not being indicative of the propensity towards bioaccumulation.

 

This indicates, within a weight of evidence approach and with expert judgment, that SynNova Base Oils deemed to not be bioaccumulative in aquatic organisms.

Description of key information

Bioaccumulation Study in Carp using SynNova® Base Oil

The BMF of the quantitative components (dimer, peak A) was less than 0.007, which is the criterion for bioconcentration potential under the Chemical Substances Control Law. No significant peak of the monitored components (trimers, peak B) was detected from fish samples. The BMF of the reference substance was 0.0244 for the test group and 0.0153 for the control group. Since these results were similar to the already known BMF value of 0.0343* of the reference substance, it was judged that the test was conducted properly.
It can be concluded from the above results that the bioconcentration potential of the test substance in fish is not high.
* BMF value after 13 days of exposure period described in the test guideline.

Bioaccumulation Study in Rare Minnow using SynNova® Base Oil

Under the test conditions, after a 14 day uptake phase exposure test, the 500 mg test substance / kg food was calculated as biomagnification factor (BMF) for Gobiocypris rarus as less than 0.00296

This is further reinforced by assessment of the properties of the substance. The substance is considered to be not bioavailable to aqueous organisms as demonstrated by the lack of toxicity. Furthermore, the high log Kow is considered to be more a consequence of poor water solubility than a lipophilic tendency and is considered to be not indicative of the tendency to bioaccumulate in lipid tissues of aquatic organisms. This is based in part on an evaluation of literature data which demonstrates a tendency for the Bioconcentration Factor (BCF) to decrease as Log Pow increases above 6. This assumption is further confirmed by the data set available on the substance which demonstrates that it is poorly absorbed, both on the basis of the toxicity (or lack of) observed. The above opinion is also confirmed via use of the EPIWIN BCFBAF v3.01 for assessment of bioaccumulation of BCF 3.162 L/kg wet-wt the evaluated values are less that <2000, indicating that the substance is not proposed to be bioaccumulative. Evaluation of predicted molecular size data indicates that approximately 11% of the molecules are of a Dmax average of greater than 17 Å (1.7 nm) plus a molecular weight of greater than 700 (Da). 

Taking into account the following:

·        Lack of absorption

·        Lack of persistency

·        High predicted log Kow value.

·        Low predicted bioaccumulation potential

·        Molecular size data not being indicative of the propensity towards bioaccumulation.

This indicates, within a weight of evidence approach and with expert judgment, that SynNova® Base Oils deemed to not be bioaccumulative in aquatic organisms.

Key value for chemical safety assessment

BMF in fish (dimensionless):

0.007