Fatty acids, C16-18 and C18-unsatd., esters with propylene glycol

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 Feb - 23 Mai 2001

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

GLP Guideline study. In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Hessisches Ministerium für Umwelt, Landwirtschaft und Forsten, Wiesbaden, Germany

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0, 6.25, 12.5, 25, 50, 100 mg/L (Only the undiluted filtrate of stock suspension was analysed.)
- Sampling method: Duplicate samples were taken from all test concentrations and the control on day 0, 7 and 16. On days 2, 9 and 19 a sufficient volume from the old test media of all test concentrations and the control were sampled for the determination of the stability of the test item. One of these three stability control treatments last for 72 h (weekend), two for 48 h, corresponding to the different test medium renewal periods.
- Sample storage conditions before analysis: Samples were analysed directly.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: For each treatment a concentrated stock suspension of the test item of nominal 100 mg/L was prepared by suspending 200 and 500 mg test item into 2 and 5 L test water, respectively. The suspensions were ultrasonically treated for 15 min and stirred between 48 and 73 h. Stock suspensions were filtered through a cellulose nitrate filter (pore size 0.45 µm). Adequate amounts of stock solution were diluted with test water to prepare the test media of the lower test concentrations.
- Eluate: no
- Differential loading: no
- Controls: yes, test water control

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Strain/clone: clone 5
- Source: Originally supplied 1997 by the Umweltbundesamt, Institut für Wasser-, Boden- und Lufthygiene, Berlin, Germany.
- Feeding during test
- Food type: Green algae (Scenedesmus subspicatus)
- Amount: Based on the total organic carbon (TOC) in the algal food suspension. 0.1 mg TOC/Daphnia (day 0,1), 0.15 mg TOC/Daphnia (day 5-8, 12-13), 0.2 mg TOC/Daphnia (day 2, 14-15, 19-20), 0.3 mg TOC/Daphnia (day 9), 0.4 mg TOC/Daphnia (day 16)
- Frequency: every day

ACCLIMATION
- Acclimation conditions: same as test

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

21 d

Test temperature:

21 °C

pH:

7.8 - 8.5

Dissolved oxygen:

7.7 - 8.9 mg/L

Nominal and measured concentrations:

nominal: 0, 6.25, 12.5, 25, 50, 100 mg/L
measured: 0.04 – 0.06 mg/L (day 0), 0.023 – 0.030 mg/L (day 7), 0.025 – 0.035 mg/L (day 16)

Details on test conditions:

TEST SYSTEM
- Test vessel: beakers
- Material, size, headspace, fill volume: glass, 100 mL, headspace: 20 mL, fill volume: 80 mL
- Renewal rate of test solution (frequency/flow rate): renewed on day 2, 5, 7, 9, 12, 14, 16, 19
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to OECD guideline 211
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Photoperiod: 16 h light / 8 h dark
- Light intensity: approx. 400 - 420 lux

EFFECT PARAMETERS MEASURED: Mortality of adults and number of young daphnids was recorded every day. Offspring were removed at the same time.

RANGE-FINDING STUDY
- Other: A range-finding study was performed to determine the test concentrations for the definitive study. Results were not reported.

Reference substance (positive control):

no

Key result

Duration:

21 d

Dose descriptor:

NOELR

Effect conc.:

>= 0.02 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Remarks:

(WAF)

Basis for effect:

reproduction

Key result

Duration:

21 d

Dose descriptor:

EL50

Effect conc.:

> 0.02 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Remarks:

(WAF)

Basis for effect:

reproduction

Key result

Duration:

21 d

Dose descriptor:

NOELR

Effect conc.:

>= 0.02 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Remarks:

(WAF)

Basis for effect:

mortality

Key result

Duration:

21 d

Dose descriptor:

EL50

Effect conc.:

> 0.02 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Remarks:

(WAF)

Basis for effect:

mortality

Details on results:

- Mortality of parent animals: 0%
- Time to first brood release or time to hatch: between day 8 and 9

The 21-day NOEC was determined to be at least up to the solubility of the test item in water.

No particular signs of intoxication, no mortality and no effects on the mean reproduction rate were observed throughout the test.

In the analysed freshly prepared filtrate in the mean 0.03 mg test item/L were determined. During the test medium renewal periods of 48 and 72 h the concentrations were below the determination limit of 0.01 mg/L. The biological results are related to the mean measured test concentration of the undiluted filtrate, calculated as the average of all measurements during exposure period.

Validity criteria fulfilled:

yes

Conclusions:

After 21 days the NOELR was determined to be >= 0.02 mg/L and the EL50 was determined to be > 50 mg/L.

Reference 2

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

21 Feb - 23 Mai 2001

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

GLP Guideline study. In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Justification for type of information:

Please refer section 13 for read across justification.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Hessisches Ministerium für Umwelt, Landwirtschaft und Forsten, Wiesbaden, Germany

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0, 6.25, 12.5, 25, 50, 100 mg/L (Only the undiluted filtrate of stock suspension was analysed.)
- Sampling method: Duplicate samples were taken from all test concentrations and the control on day 0, 7 and 16. On days 2, 9 and 19 a sufficient volume from the old test media of all test concentrations and the control were sampled for the determination of the stability of the test item. One of these three stability control treatments last for 72 h (weekend), two for 48 h, corresponding to the different test medium renewal periods.
- Sample storage conditions before analysis: Samples were analysed directly.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: For each treatment a concentrated stock suspension of the test item of nominal 100 mg/L was prepared by suspending 200 and 500 mg test item into 2 and 5 L test water, respectively. The suspensions were ultrasonically treated for 15 min and stirred between 48 and 73 h. Stock suspensions were filtered through a cellulose nitrate filter (pore size 0.45 µm). Adequate amounts of stock solution were diluted with test water to prepare the test media of the lower test concentrations.
- Eluate: no
- Differential loading: no
- Controls: yes, test water control

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Strain/clone: clone 5
- Source: Originally supplied 1997 by the Umweltbundesamt, Institut für Wasser-, Boden- und Lufthygiene, Berlin, Germany.
- Feeding during test
- Food type: Green algae (Scenedesmus subspicatus)
- Amount: Based on the total organic carbon (TOC) in the algal food suspension. 0.1 mg TOC/Daphnia (day 0,1), 0.15 mg TOC/Daphnia (day 5-8, 12-13), 0.2 mg TOC/Daphnia (day 2, 14-15, 19-20), 0.3 mg TOC/Daphnia (day 9), 0.4 mg TOC/Daphnia (day 16)
- Frequency: every day

ACCLIMATION
- Acclimation conditions: same as test

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

21 d

Test temperature:

21 °C

pH:

7.8 - 8.5

Dissolved oxygen:

7.7 - 8.9 mg/L

Nominal and measured concentrations:

nominal: 0, 6.25, 12.5, 25, 50, 100 mg/L
measured: 0.04 – 0.06 mg/L (day 0), 0.023 – 0.030 mg/L (day 7), 0.025 – 0.035 mg/L (day 16)

Details on test conditions:

TEST SYSTEM
- Test vessel: beakers
- Material, size, headspace, fill volume: glass, 100 mL, headspace: 20 mL, fill volume: 80 mL
- Renewal rate of test solution (frequency/flow rate): renewed on day 2, 5, 7, 9, 12, 14, 16, 19
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to OECD guideline 211
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Photoperiod: 16 h light / 8 h dark
- Light intensity: approx. 400 - 420 lux

EFFECT PARAMETERS MEASURED: Mortality of adults and number of young daphnids was recorded every day. Offspring were removed at the same time.

RANGE-FINDING STUDY
- Other: A range-finding study was performed to determine the test concentrations for the definitive study. Results were not reported.

Reference substance (positive control):

no

Key result

Duration:

21 d

Dose descriptor:

NOELR

Effect conc.:

>= 0.02 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Remarks:

(WAF)

Basis for effect:

reproduction

Key result

Duration:

21 d

Dose descriptor:

EL50

Effect conc.:

> 0.02 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Remarks:

(WAF)

Basis for effect:

reproduction

Key result

Duration:

21 d

Dose descriptor:

NOELR

Effect conc.:

>= 0.02 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Remarks:

(WAF)

Basis for effect:

mortality

Key result

Duration:

21 d

Dose descriptor:

EL50

Effect conc.:

> 0.02 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Remarks:

(WAF)

Basis for effect:

mortality

Details on results:

- Mortality of parent animals: 0%
- Time to first brood release or time to hatch: between day 8 and 9

The 21-day NOEC was determined to be at least up to the solubility of the test item in water.

No particular signs of intoxication, no mortality and no effects on the mean reproduction rate were observed throughout the test.

In the analysed freshly prepared filtrate in the mean 0.03 mg test item/L were determined. During the test medium renewal periods of 48 and 72 h the concentrations were below the determination limit of 0.01 mg/L. The biological results are related to the mean measured test concentration of the undiluted filtrate, calculated as the average of all measurements during exposure period.

Validity criteria fulfilled:

yes

Conclusions:

After 21 days the NOELR was determined to be >= 0.02 mg/L and the EL50 was determined to be > 50 mg/L.

Description of key information

No chronic effects to aquatic invertebrates up to the limit of water solubility.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

NOEC

Effect concentration:

>= 0.02 mg/L

Additional information

Since no studies investigating the long-term toxicity to aquatic invertebrates of the test substance are available, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read across to another structurally related substance butylene glycol dicaprylate / dicaprate (CAS 853947-59-8) was conducted. This read-across is justified in detail in the overall summary (IUCLID chapter 6.1) and within the analogue justification in IUCLID Section 13.

The study was performed according to the OECD Guideline 211 under GLP conditions (Hertl, 2001). Daphnia magna was exposed to individually prepared Water Accommodated Fractions (WAF’s) of nominal 6.25, 12.5, 25, 50 and 100 mg/L under semi-static conditions. Analytical determination of test solution concentration resulted in very low concentrations of 0.03 mg/L in freshly prepared medium and concentrations below the detection limit of 0.01 mg/L before test medium renewal periods after every 48 or 72 h, respectively. After 21 d, no particular signs of intoxication, no mortality and no effects on the mean reproduction rate were observed throughout the test resulting in an EL50 of > 0.02 mg/L (measured, arithm. mean) and a NOELR of ≥ 0.02 mg/L (measured, arithm. mean).

Based on the results from a structurally related read-across substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which is characterized by a similar ecotoxicological profile, it can be concluded that the test substance will not exhibit chronic effects to aquatic invertebrates up to the limit of water solubility.