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

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 Apr - 19 Mai 1995

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 with acceptable restrictions (no information on type of filter).

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Concentrations: control - stock solution - 2.7 mg/L

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Application of 1 g/L in synthetic freshwater and stirred for 18 h. This solution was filtered and the DOC was analysed in the filtrate. The test substance concentration (2.7 mg/L nominal) was calculated on the basis of DOC measurement of stock solution.
- Eluate: No
- Differential loading: No
- Controls: yes, water control

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Strain: Clone 5
- Source: own breeding
- Age at study initiation (mean and range, SD): < 24 h
- Method of breeding: Daphnids were held in M4-medium in 1 L glass-beakers and fed with Scenedesmus subspicatus every day. The water was changed every second or third day and the offspring was removed. Every 4 weeks the offspring was used for further breeding.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test temperature:

20 ± 1 °C

pH:

7.8 - 8.1

Dissolved oxygen:

8.2 - 8.5 mg/L

Nominal and measured concentrations:

nominal: control - 2.7 mg/L
measured:
control: 0 mg/L (0 h), 0.19 mg/L (48 h)
stock solution: 3.0 mg/L (0 h)
2.7 mg/L test concentration: 2.5 mg/L (0 h), 2.3 mg/L (48 h)

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, fill volume: glass vessels, fill volume: 10 mL
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Synthetic freshwater was used for the preparation of mineral medium. Synthetic freshwater contained 294 mg/L CaCl2 x 2 H2O, 123 mg/L MgSO4 x 7 H2O, 63 mg/L NaHCO3, 5.5 mg/L KCl.

OTHER TEST CONDITIONS
- Photoperiod: complete darkness

EFFECT PARAMETERS MEASURED: Immobilisation was recorded after 24 and 48 h.

TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: The test concentration of 2.7 mg/L is the highest soluble concentration.

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Key result

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

> 2.4 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Remarks:

(WAF)

Basis for effect:

mobility

Details on results:

- Mortality of control: 0%

Results with reference substance (positive control):

- Results with reference substance valid? yes
- Mortality: 35% (1.0 mg/L), 100% (2.0 mg/L)

Table 1: Number of mobile and immobile daphnia after 24 and 48 h of exposure

Concentration [mg/L]	24 h			48 h
	No. mobile	No. immobile	% immobile	No. mobile	No. immobile	% immobile
Control	20	0	0	20	0	0
2.7 mg/L (nominal)	20	0	0	20	0	0

Validity criteria fulfilled:

yes

Conclusions:

After 48 hours the EL50 was determined to be > 2.4 mg/L.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997

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 with acceptable restrictions (Calculation of test concentration; No information on filter)

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Concentrations: Prior testing, the stock solution was sampled/measured once.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: 1 g/L was dissolved in water, stirred for 18 h and filtered.
- Eluate: no
- Differential loading: no
- Controls: yes, water control

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Strain: clone 5
- Source: In-house culture
- Age at study initiation: < 24 h
- Method of breeding: Daphnia were held in Elendt M4-medium in 1 L beakers. They were fed daily with Scenedesmus subspicatus. The water was changed every second or third day and the offspring was removed. After approx. 4 weeks the young daphnids were isolated and used for breeding.
- Feeding during test: none

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test temperature:

20 ± 1 °C

pH:

7.9 - 8.0

Dissolved oxygen:

7.7 - 8.1 mg/L

Nominal and measured concentrations:

nominal: 0, 1000 mg/L
measured: 2 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: test tubes
- Material, fill volume: glass, Fill volume: 10 mL
- Aeration: no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 1
- Biomass loading rate: approx. 2 mL/test organism

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline 92/69/EWG C.2
- Culture medium different from test medium: yes, Elendt M4 medium was used for breeding and synthetic freshwater was used for testing.

OTHER TEST CONDITIONS
- Photoperiod: complete darkness

EFFECT PARAMETERS MEASURED: Immobilisation was recorded every 24 h.

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Key result

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

> 2 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Remarks:

(WAF)

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

NOELR

Effect conc.:

>= 2 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Remarks:

(WAF)

Basis for effect:

mobility

Details on results:

- Mortality of control: 0%

Results with reference substance (positive control):

- Immobilisation: 40% (1 mg/L), 100% (2 mg/L)

Validity criteria fulfilled:

yes

Conclusions:

After 48 hours, the EL50 was determined to be > 2 mg/L and the NOEC was determined to be 2 mg/L.

Reference 3

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

key study

Study period:

1997

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 with acceptable restrictions (Calculation of test concentration; No information on filter)

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:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Concentrations: Prior testing, the stock solution was sampled/measured once.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: 1 g/L was dissolved in water, stirred for 18 h and filtered.
- Eluate: no
- Differential loading: no
- Controls: yes, water control

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Strain: clone 5
- Source: In-house culture
- Age at study initiation: < 24 h
- Method of breeding: Daphnia were held in Elendt M4-medium in 1 L beakers. They were fed daily with Scenedesmus subspicatus. The water was changed every second or third day and the offspring was removed. After approx. 4 weeks the young daphnids were isolated and used for breeding.
- Feeding during test: none

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test temperature:

20 ± 1 °C

pH:

7.9 - 8.0

Dissolved oxygen:

7.7 - 8.1 mg/L

Nominal and measured concentrations:

nominal: 0, 1000 mg/L
measured: 2 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: test tubes
- Material, fill volume: glass, Fill volume: 10 mL
- Aeration: no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 1
- Biomass loading rate: approx. 2 mL/test organism

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline 92/69/EWG C.2
- Culture medium different from test medium: yes, Elendt M4 medium was used for breeding and synthetic freshwater was used for testing.

OTHER TEST CONDITIONS
- Photoperiod: complete darkness

EFFECT PARAMETERS MEASURED: Immobilisation was recorded every 24 h.

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Key result

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

> 2 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Remarks:

(WAF)

Basis for effect:

mobility

Key result

Duration:

48 h

Dose descriptor:

NOELR

Effect conc.:

>= 2 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Remarks:

(WAF)

Basis for effect:

mobility

Details on results:

- Mortality of control: 0%

Results with reference substance (positive control):

- Immobilisation: 40% (1 mg/L), 100% (2 mg/L)

Validity criteria fulfilled:

yes

Conclusions:

After 48 hours, the EL50 was determined to be > 2 mg/L and the NOEC was determined to be 2 mg/L.

Reference 4

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

key study

Study period:

11 Apr - 19 Mai 1995

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 with acceptable restrictions (no information on type of filter).

Justification for type of information:

Please refer section 13 for read acrss justification.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Concentrations: control - stock solution - 2.7 mg/L

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Application of 1 g/L in synthetic freshwater and stirred for 18 h. This solution was filtered and the DOC was analysed in the filtrate. The test substance concentration (2.7 mg/L nominal) was calculated on the basis of DOC measurement of stock solution.
- Eluate: No
- Differential loading: No
- Controls: yes, water control

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Strain: Clone 5
- Source: own breeding
- Age at study initiation (mean and range, SD): < 24 h
- Method of breeding: Daphnids were held in M4-medium in 1 L glass-beakers and fed with Scenedesmus subspicatus every day. The water was changed every second or third day and the offspring was removed. Every 4 weeks the offspring was used for further breeding.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test temperature:

20 ± 1 °C

pH:

7.8 - 8.1

Dissolved oxygen:

8.2 - 8.5 mg/L

Nominal and measured concentrations:

nominal: control - 2.7 mg/L
measured:
control: 0 mg/L (0 h), 0.19 mg/L (48 h)
stock solution: 3.0 mg/L (0 h)
2.7 mg/L test concentration: 2.5 mg/L (0 h), 2.3 mg/L (48 h)

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, fill volume: glass vessels, fill volume: 10 mL
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Synthetic freshwater was used for the preparation of mineral medium. Synthetic freshwater contained 294 mg/L CaCl2 x 2 H2O, 123 mg/L MgSO4 x 7 H2O, 63 mg/L NaHCO3, 5.5 mg/L KCl.

OTHER TEST CONDITIONS
- Photoperiod: complete darkness

EFFECT PARAMETERS MEASURED: Immobilisation was recorded after 24 and 48 h.

TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: The test concentration of 2.7 mg/L is the highest soluble concentration.

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Key result

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

> 2.4 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Remarks:

(WAF)

Basis for effect:

mobility

Details on results:

- Mortality of control: 0%

Results with reference substance (positive control):

- Results with reference substance valid? yes
- Mortality: 35% (1.0 mg/L), 100% (2.0 mg/L)

Table 1: Number of mobile and immobile daphnia after 24 and 48 h of exposure

Concentration [mg/L]	24 h			48 h
	No. mobile	No. immobile	% immobile	No. mobile	No. immobile	% immobile
Control	20	0	0	20	0	0
2.7 mg/L (nominal)	20	0	0	20	0	0

Validity criteria fulfilled:

yes

Conclusions:

After 48 hours the EL50 was determined to be > 2.4 mg/L.

Description of key information

No toxic 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:

EC50

Effect concentration:

> 2 mg/L

Additional information

Since no studies investigating the short-term toxicity to aquatic invertebrates of Propyleneglycol dioleate (CAS 105-62-4) are available, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read across conducted to the two structurally related substances decanoic acid, mixed diesters with octanoic acid and propylene glycol (CAS 68583-51-7) and butylene glycol dicaprylate / dicaprate (CAS 853947-59-8). 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 with decanoic acid, mixed diesters with octanoic acid and propylene glycol was performed according to the EU Method C.2 under GLP conditions (Scholz, 1995). Daphnia magna was exposed to a measured concentration (geometric mean) of 2.4 mg/L in a static limit test for 48 h. Since the test solution was prepared by adding 1 g/L with subsequent filtration (WAF), the measured concentration of 2.4 mg/L represents the highest concentration which is soluble in water. No effects were observed resulting in an EL50 of > 2.4 mg/L.

The second study using butylene glycol dicaprylate / dicaprate supports this result (Scholz, 1997). It was conducted under the same conditions like the first study. Daphnia magna was exposed to a measured concentration (initial) of 2 mg/L in a static limit test for 48 h. The test concentration of 2 mg/L represents the highest soluble concentration, since 1 g/L was added to the test medium, stirred and subsequently filtered (WAF). No effects were observed, resulting in an EL50 of > 2 mg/L.

Based on the results from structurally related read-across substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile, it can be concluded that Propyleneglycol dioleate (CAS 105-62-4) will not exhibit acute toxic effects to aquatic invertebrates up to the limit of water solubility.