Fatty acids, C16 and C18-unsaturated, methyl esters, chlorinated

Toxicity to soil macroorganisms except arthropods

Administrative data

Endpoint:

toxicity to soil macroorganisms except arthropods: short-term

Data waiving:

exposure considerations

Justification for data waiving:

the study does not need to be conducted because direct and indirect exposure of the soil compartment is unlikely

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

exposure-related information

Reference

Type of CSR:

Own CSR (own uses)

CSR contains:

Part B section 9 and 10

Chemical safety assessment/report tool used:

Chesar

Cross-reference 2

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 31, 2022

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes

Specific details on test material used for the study:

The average log Kow varied from 5.4 to 6.0.
The water solubility was from 0.8 mg L-1 for the congener containing 4 Cl atoms to 0.3 mg L-1 for the congener with 9 Cl atoms.

Analytical monitoring:

yes

Vehicle:

no

Details on test solutions:

WAF preparation:
Loading rates (nominal concentrations): A stock elution was prepare using a nominal concentration of 1000 mg/L. After adding salts, it was then diluted to get all the tested concentrations.
Sample weight: Direct addition of 1000 mg (actial weight = 999.8 mg) per liter for the stock elution
Ambient temperature 20°C. Orbital shaker 100 rpm- 7 days.
At the end of shaking, the eluate is slightly turbid and whitish, partly jellified and hard to filter. After longer decantation a thin a whitish layer settles on the bottom of the container.
Filtration: With vacuum filtration apparatus and membranes with 0.45 µm pores of cellulose nitrate. After filtrations, the stock eluate was added with the salts and dilutions were prepared using the cultivation medium. Oxygenation of the eluate and its dilutions followed, via air insufflation for 30’ prior to starting the test and acclimatation to test temperature (20 °C).

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

The fishes came from a single group of similar length (1-2 cm) and age.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

160 mg CaCO3/L

Test temperature:

23 °C

pH:

7.5

Dissolved oxygen:

≥ 60% (i.e. 5.14 mg/L at 23 °C and 1 atm)

Salinity:

0.13 ‰

Nominal and measured concentrations:

Limit test at 1000 mg/L

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 0.8 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat. (dissolved fraction)

Remarks:

The WAF of different congeners C19Cl4 - C19Cl9 has been determined, the mean concentration was 0.8 mg/L. Specifically, the concentration in C19Cl4 was 0.9, in C19Cl5 0.07, in C19Cl6 0.03, in Cl19Cl7 0.02, in C19Cl8 0.02, in C19Cl9 0.03.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Validity criteria fulfilled:

yes

Conclusions:

After 96h of exposure at the limit concentration of 1000 mg/L, the sample does not induce the mortality of any of the seven Zebrafish under test (0/7), that is an acceptable value for the limit test. Overall, LC50 @ 96h > 1000 mg/L.

Executive summary:

This technical report summarizes all the data collected during the study: the exposure conditions of the fish at the tested sample limit concentration and the calculation of results. When using vertebrates for scientific purposes, as forced by the EU regulations, the 3 Rs rule must be obeyed. It includes three principles: Replacement, Reduction, and Refinement. Reduction refers to the use of methods that enable researchers to obtain comparable levels of information from fewer animals, or to obtain more information from the same number of animals. Whenever possible, for eco-tests on fishes, the limit test (one single concentration) is to be preferred to the serial concentrations test (at least five concentrations). Seven Zebrafishes, with a recommended total length of 1-2 cm, are exposed to the sample at the chosen limit concentration in breeding water, for a period of 96 hours. Mortality is recorded at 24, 48, 72 and 96 hours and compared with the negative control.

Cross-reference 3

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

toxicity to aquatic algae and cyanobacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 31, 2022

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 201 (Freshwater Alga and Cyanobacteria, Growth Inhibition Test)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

WAF preparation:
Loading rates (nominal concentrations): A stock elution was prepare using a nominal concentration of 1000 mg/L. After adding salts, it was then diluted to get all the tested concentrations.
Sample weight: Direct addition of 1000 mg (actial weight = 999.8 mg) per liter for the stock elution
Ambient temperature 20°C. Orbital shaker 100 rpm- 7 days.
At the end of shaking, the eluate is slightly turbid and whitish, partly jellified and hard to filter. After longer decantation a thin a whitish layer settles on the bottom of the container.
Filtration: With vacuum filtration apparatus and membranes with 0.45 µm pores of cellulose nitrate. After filtrations, the stock eluate was added with the salts and dilutions were prepared using the cultivation medium. Oxygenation of the eluate and its dilutions followed, via air insufflation for 30’ prior to starting the test and acclimatation to test temperature (20 °C).

Analytical monitoring:

not specified

Details on sampling:

To obtain the medium to be tested with the sample, appropriate volumes of the stock WAF (added with salts) and its dilutions and of the algae inoculum were used. For the negative control, the WAF is replaced by the algae culture medium prepared using distilled water.
Tested concentrations from 50 mg/L to 1000 mg/L.

Vehicle:

no

Test organisms (species):

Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)

Test type:

not specified

Water media type:

other: ASTM Type III water

Limit test:

yes

Total exposure duration:

72 h

Test temperature:

23 °C

pH:

8.1

Nominal and measured concentrations:

A stock elution was prepare using a nominal concentration of 1000 mg/L.

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Key result

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

> 0.7 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat. (dissolved fraction)

Remarks:

The WAF of different congeners C19Cl4 - C19Cl9 has been determined, the higher concentration determined was 0.7 mg/L for congener C19Cl4. This has been used as worst case for EC50 determination.

Basis for effect:

growth rate

Key result

Duration:

72 h

Dose descriptor:

EC10

Effect conc.:

> 0.7 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat. (dissolved fraction)

Remarks:

The WAF of different congeners C19Cl4 - C19Cl9 has been determined, the higher concentration determined was 0.7 mg/L for congener C19Cl4. This has been used as worst case for EC50 determination.

Basis for effect:

growth rate

Key result

Duration:

72 h

Dose descriptor:

EC10

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Key result

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

growth rate

Details on results:

Acute toxicity: ErC50 > 1000 mg/L
After a 72h.exposure, growth rates at some tested concentrations are significantly different from that of the control. Nonetheless, the maximum percentage of inhibition of the average growh rate is %Ir 8.22%±0.04% for r the maximum tested concentration (1000 mg/L). Being %Ir < 50%, we have ErC50 > 1000 mg/L.
Chronic toxicity: NOEC ≥ 250 mg/L; ErC10 > 1000 mg/L
Based on the Dunnett’s Test, the maximum sample concentration with no significant difference from the control is 250 mg/L Thus, we have that the No Observed Effect Concentration NOEC ≥ 250 mg/L. Its actual value ranging between 250 and 500 mg/L. As above, being maximum %Ir <10%, we have ErC10 > 1000 mg/L

Validity criteria fulfilled:

yes

Conclusions:

Acute toxicity: ErC50 > 1000 mg/L
Chronic toxicity: NOEC ≥ 250 mg/L; ErC10 > 1000 mg/L

Executive summary:

Algae were exposed to the test substance in a range of concentrations to evaluate values of acute (ErC50) and chronic toxicity (NOEC, ErC10), by comparing the growth rated with those of the negative control after 24h, 48h and 72h. Overall, the following results were obtained:

Acute toxicity: ErC50 > 1000 mg/L
Chronic toxicity: NOEC ≥ 250 mg/L; ErC10 > 1000 mg/L

Cross-reference 4

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January 31, 2022

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

WAF preparation:
Loading rates (nominal concentrations): A stock elution was prepare using a nominal concentration of 1000 mg/L. After adding salts, it was then diluted to get all the tested concentrations.
Sample weight: Direct addition of 1000 mg (actial weight = 999.8 mg) per liter for the stock elution
Ambient temperature 20°C. Orbital shaker 100 rpm- 7 days.
At the end of shaking, the eluate is slightly turbid and whitish, partly jellified and hard to filter. After longer decantation a thin a whitish layer settles on the bottom of the container.
Filtration: With vacuum filtration apparatus and membranes with 0.45 µm pores of cellulose nitrate. After filtrations, the stock eluate was added with the salts and dilutions were prepared using the cultivation medium. Oxygenation of the eluate and its dilutions followed, via air insufflation for 30’ prior to starting the test and acclimatation to test temperature (20 °C).

Analytical monitoring:

not specified

Details on sampling:

The test containers were filled with 50 ml of the oxygenated sample dilutions or stock solution. The sole breeding medium was used as a negative control. The Daphnia specimens were then placed in the test vessels. For each concentration and for the control, 20 animals were used, divided into four groups of five animals each.

Vehicle:

no

Test organisms (species):

Daphnia magna

Test type:

not specified

Water media type:

other: distillated water ASTM Type III

Limit test:

no

Total exposure duration:

48 h

Hardness:

170 mg CaCO3/L

Test temperature:

20°C

pH:

7.3

Details on test conditions:

Tested concentrations:
• 50 mg/L
• 100 mg/L
• 250 mg/L
• 500 mg/L
• 1000 mg/L (stock eluate)*

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 0.7 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat. (dissolved fraction)

Remarks:

The WAF of different congeners C19Cl4 - C19Cl9 has been determined, the higher concentration determined was 0.7 mg/L for congener C19Cl4. This has been used as worst case for EC50 determination.

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Validity criteria fulfilled:

yes

Conclusions:

For the sample it was not possible to calculate the EC50 value via the PROBIT software, since a limited number of Daphnia specimen was immobilized after 48h at any of the tested concentrations, never reaching 50%.
The maximum number of immobilized animals is 2 out of 20 (10%). Overall, EC50 > 1000 mg/L.

Executive summary:

Young daphnids, aged less than 24 hours at the start of the test, were exposed to the test substance in a range of concentrations, for a period of 48 hours. The immobilisation was recorded at 24 hours and 48 hours and compared with the control. The results were analysed to assess the EC50 at 48h.

Overall, EC50 > 1000 mg/L.

Cross-reference 5

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 3-10-2019 to 01-11-2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 301 D (Ready Biodegradability: Closed Bottle Test)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Organo chlorinated compound 35 wt% Cl, corresponding to fatty acids, C16-C18 methyl ester
CAS: 95009-45-3
Name in the study report is different since the study report has been reported in 2019 when CAS number was not assigned yet.
Batch: R4003190123

Oxygen conditions:

aerobic

Inoculum or test system:

natural water

Remarks:

river water

Details on inoculum:

River water was sampled from the Rhine near Heveadorp, The Netherlands (26-09-2019). The nearest plant (Arnhem-Zuid) treating domestic wastewater biologically was 3 km upstream. The river water was aerated for 7 days before use to reduce the endogenous respiration (van Ginkel and Stroo, 1992). River water without particles was used as inoculum. The particles were removed by sedimentation after 1 day while moderately aerating.

Duration of test (contact time):

ca. 0 - ca. 28 d

Initial conc.:

ca. 0 mg/L

Based on:

test mat.

Parameter followed for biodegradation estimation:

O2 consumption

Reference substance:

acetic acid, sodium salt

Test performance:

The test was performed in 0.30 L BOD (biological oxygen demand) bottles with glass stoppers.

Key result

Parameter:

% degradation (O2 consumption)

Value:

ca. 66

Sampling time:

28 d

Key result

Parameter:

% degradation (O2 consumption)

Value:

ca. 65

Sampling time:

21 d

Key result

Parameter:

% degradation (O2 consumption)

Value:

ca. 54

Sampling time:

14 d

Key result

Parameter:

% degradation (O2 consumption)

Value:

ca. 15

Sampling time:

7 d

Key result

Parameter:

% degradation (O2 consumption)

Value:

ca. 0 ca.

Sampling time:

0 d

Validity criteria fulfilled:

yes

Interpretation of results:

readily biodegradable

Conclusions:

The test item was biodegraded by 66% at day 28 in the OECD 301D Closed Bottle test. Over 60% biodegradation was not achieved within a period of 10 days (14 days for the Closed Bottle test) immediately following the attainment of 10% biodegradation. The time window criterion should however not be applied because organo chlorinated compound 35 wt% Cl is a mixture of constituents (UVCB). The biodegradation of organo chlorinated compound 35 wt% is therefore an addition of different biodegradation curves and the time window should therefore not be used as a pass/fail criterion. Organo chlorinated compound 35 wt% is therefore classified as readily biodegradable based on the >60% biodegradation reached at day 28.
The test is valid as shown by an endogenous respiration of 0.75 mg/L and by the total mineralization of the reference compound, sodium acetate. Sodium acetate was degraded by 83% of its theoretical oxygen demand after 14 days. Finally, the most important criterion was met by oxygen concentrations >0.5 mg/L in all bottles during the test period

Executive summary:

To assess the biotic degradation of organo chlorinated compound 35 wt% Cl, a ready biodegradability test was performed which allows the biodegradability to be measured in an aerobic aqueous medium. The ready biodegradability was determined in the Closed Bottle test performed according to slightly modified OECD, EU and ISO Test Guidelines, and in compliance with the OECD principles of Good Laboratory Practice.
The test item (2.0 mg/L) was exposed to river water which was spiked with nutrients, dosed in closed bottles and incubated in the dark at 22.4-22.9°C for 28 days. The degradation of the test item was assessed by measuring oxygen consumption. According to the results of this study, the test item did not cause a reduction in the endogenous respiration at day 7.
The test substance is therefore considered to be non-inhibitory to the inoculum.
The test item was biodegraded by 66% at day 28 in the OECD 301D Closed Bottle test. Over 60% biodegradation was not achieved within a period of 10 days (14 days for the Closed Bottle test) immediately following the attainment of 10% biodegradation. The time window criterion should however not be applied because organo chlorinated compound 35 wt% Cl is a mixture of constituents (UVCB). The biodegradation of organo chlorinated compound 35 wt% is therefore an addition of different biodegradation curves and the time window should therefore not be used as a pass/fail criterion. Organo chlorinated compound 35 wt% is therefore classified as readily biodegradable based on the >60% biodegradation reached at day 28.
The test is valid as shown by an endogenous respiration of 0.75 mg/L and by the total mineralization of the reference compound, sodium acetate. Sodium acetate was degraded by 83% of its theoretical oxygen demand after 14 days. Finally, the most important criterion was met by oxygen concentrations >0.5 mg/L in all bottles during the test period.