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

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 Aug - 06 Oct 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 (Oily drops of the test substance were observed on the surface of test solutions).

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Concentrations: filtered stock solution of 1000 mg/L

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: 1000 mg test substance was added to 1 L drinking water, stirred for approx. 18 h and filtered. Stock solution was prepared daily.
- Eluate: No
- Differential loading: No
- Controls: yes, water control
- Evidence of undissolved material: After 72 and 96 h oily drops were observed on top of the test solution in the test vessels.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebra fish
- Source: West Aquarium, Bad Lauterbach, Germany
- Length at study initiation (length definition, mean, range and SD): 3 cm ± 0.5 cm
- Feeding during test: none

ACCLIMATION
- Type and amount of food: Tetramin in an amount of approx. 1% of the body weight
- Feeding frequency: daily
- Health during acclimation (any mortality observed): Fish were healthy without any behavioural abnormalities. The mortality was <= 5% 7 d prior to test initiation.
- Other: Fish were treated with malachite green three times a week with a 14-day quarantine.

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

approx. 12 °dH

Test temperature:

19 - 20 °C

pH:

7.8 - 8.5

Dissolved oxygen:

86 - 108%

Nominal and measured concentrations:

nominal: control, 1000 mg/L
measured: 4.1 mg/L (0 h), 4.7 mg/L (24 h), 68 mg/L (48 h), 81 mg/L (72 h)

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: glass aquaria, 20 L, headspace: 10 L, fill volume: 10 L
- Aeration: continuous aeration
- Renewal rate of test solution: every day
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: drinking water from the Gelsenwasser AG

OTHER TEST CONDITIONS
- Photoperiod: 16 h light / 8 h dark

EFFECT PARAMETERS MEASURED: mortality was observed every day

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LL0

Effect conc.:

>= 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

(WAF)

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LL0

Effect conc.:

>= 39 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Remarks:

(WAF)

Basis for effect:

mortality (fish)

Details on results:

- Mortality of control: 0%
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: Oily drops on the water surface after 72 h and 96 h of exposure.

Sublethal observations / clinical signs:

The effect concentration is based on the nominal concentration because great differences were found in the measured concentrations (Table 1). Oily drops were observed after 72 and 96 h indicating an oversaturated solution. Stability testing of the test substance resulted in a deviation of < 20% from the concentration at the beginning. The test substance was biologically available.

Table 1: Measured concentrations in filtered stock solution (TOC analysis)

	Concentration [mg/L]				Mean [mg/L]
	0 h	24 h	72 h	96 h
Filtered stock solution	4.1	4.7	68*	81*	39

*) oversaturated solution, oily drops on the surface of test solutions

Validity criteria fulfilled:

yes

Conclusions:

After 96 h the LL0 was determined to ne > 1000 mg/L (nominal concentraion) and > 39 mg/L (measured concentration)

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 Aug - 10 Oct 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 with acceptable restrictions (Temperature and fish length not in line with recommendations in guideline; no analytical purity of the test substance).

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

Temperature ranged from 24.5 – 27.0 °C (mean 25.3 °C). Not all fish were in the range of 2.0 ± 1.0 cm.

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

yes

Remarks:

Temperature ranged from 24.5 – 27.0 °C (mean 25.3 °C).

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: At 0 h 1.25 g of the test substance was weighed and dispersed in 5 L of hot (approx. 60 °C) carbon filtered tap water by high shear mixing at 15000 rpm for 15 min in a 5 L conical flask resulting in a 250 mg/L stock solution. Stock solution was prepared daily.
- Eluate: No
- Differential loading: No
- Controls: Yes, water control

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebra fish
- Source: In-house culture (from batch 48Z spawned on 15 May 1997)
- Length at study termination (mean from control tank): 3.1 cm
- Weight at study termination (mean from control tank): 0.23 g
- Method of breeding: Reared in carbon-filtered tap water and maintained under the following conditions: pH 6.5 – 8.0, temperature 25 ± 2 °C, dissolved oxygen > 60% saturated (> 4.8 mg/L) and photoperiod 16 h light and 8 h dark.
- Feeding during test: No

ACCLIMATION
- Acclimation period: 72 h (fish were starved 24 h prior to the start of the test)
- Acclimation conditions (same as test or not): Same as test conditions.
- Type and amount of food: Live and proprietary fish food (Artemia and Tetramin)
- Health during acclimation (any mortality observed): No significant mortalities in the week prior to the test.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

109 - 117 mg CaCO3/L

Test temperature:

24.5 - 27.0 °C

pH:

7.2 - 8.1

Dissolved oxygen:

5.3 - 8.0 mg O2/L

Nominal and measured concentrations:

nominal: 0, 10, 18, 32, 56, 100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: all-glass tanks, 6 L, headspace: 1 L, fill volume: 5 L
- Aeration: yes
- Renewal rate of test solution (frequency/flow rate): every 24 h
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline OECD 203

OTHER TEST CONDITIONS
- Photoperiod: 16 h light / 8 h dark
- Light intensity: not measured

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): mortality and other abnormalities in swimming activity and loss of balance were observed daily.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.7

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: not observed

Validity criteria fulfilled:

yes

Conclusions:

After 96 hours the LC50 was determined to be > 100 mg/L and the NOEC was determined to be 100 mg/L.

Reference 3

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

key study

Study period:

28 Aug - 06 Oct 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 (Oily drops of the test substance were observed on the surface of test solutions).

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.1 (Acute Toxicity for Fish)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Concentrations: filtered stock solution of 1000 mg/L

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: 1000 mg test substance was added to 1 L drinking water, stirred for approx. 18 h and filtered. Stock solution was prepared daily.
- Eluate: No
- Differential loading: No
- Controls: yes, water control
- Evidence of undissolved material: After 72 and 96 h oily drops were observed on top of the test solution in the test vessels.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebra fish
- Source: West Aquarium, Bad Lauterbach, Germany
- Length at study initiation (length definition, mean, range and SD): 3 cm ± 0.5 cm
- Feeding during test: none

ACCLIMATION
- Type and amount of food: Tetramin in an amount of approx. 1% of the body weight
- Feeding frequency: daily
- Health during acclimation (any mortality observed): Fish were healthy without any behavioural abnormalities. The mortality was <= 5% 7 d prior to test initiation.
- Other: Fish were treated with malachite green three times a week with a 14-day quarantine.

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

approx. 12 °dH

Test temperature:

19 - 20 °C

pH:

7.8 - 8.5

Dissolved oxygen:

86 - 108%

Nominal and measured concentrations:

nominal: control, 1000 mg/L
measured: 4.1 mg/L (0 h), 4.7 mg/L (24 h), 68 mg/L (48 h), 81 mg/L (72 h)

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: glass aquaria, 20 L, headspace: 10 L, fill volume: 10 L
- Aeration: continuous aeration
- Renewal rate of test solution: every day
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: drinking water from the Gelsenwasser AG

OTHER TEST CONDITIONS
- Photoperiod: 16 h light / 8 h dark

EFFECT PARAMETERS MEASURED: mortality was observed every day

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LL0

Effect conc.:

>= 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

(WAF)

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LL0

Effect conc.:

>= 39 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Remarks:

(WAF)

Basis for effect:

mortality (fish)

Details on results:

- Mortality of control: 0%
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: Oily drops on the water surface after 72 h and 96 h of exposure.

Sublethal observations / clinical signs:

The effect concentration is based on the nominal concentration because great differences were found in the measured concentrations (Table 1). Oily drops were observed after 72 and 96 h indicating an oversaturated solution. Stability testing of the test substance resulted in a deviation of < 20% from the concentration at the beginning. The test substance was biologically available.

Table 1: Measured concentrations in filtered stock solution (TOC analysis)

	Concentration [mg/L]				Mean [mg/L]
	0 h	24 h	72 h	96 h
Filtered stock solution	4.1	4.7	68*	81*	39

*) oversaturated solution, oily drops on the surface of test solutions

Validity criteria fulfilled:

yes

Conclusions:

After 96 h the LL0 was determined to ne > 1000 mg/L (nominal concentraion) and > 39 mg/L (measured concentration)

Reference 4

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

key study

Study period:

18 Aug - 10 Oct 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 with acceptable restrictions (Temperature and fish length not in line with recommendations in guideline; no analytical purity of the test 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 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

Temperature ranged from 24.5 – 27.0 °C (mean 25.3 °C). Not all fish were in the range of 2.0 ± 1.0 cm.

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

yes

Remarks:

Temperature ranged from 24.5 – 27.0 °C (mean 25.3 °C).

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: At 0 h 1.25 g of the test substance was weighed and dispersed in 5 L of hot (approx. 60 °C) carbon filtered tap water by high shear mixing at 15000 rpm for 15 min in a 5 L conical flask resulting in a 250 mg/L stock solution. Stock solution was prepared daily.
- Eluate: No
- Differential loading: No
- Controls: Yes, water control

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebra fish
- Source: In-house culture (from batch 48Z spawned on 15 May 1997)
- Length at study termination (mean from control tank): 3.1 cm
- Weight at study termination (mean from control tank): 0.23 g
- Method of breeding: Reared in carbon-filtered tap water and maintained under the following conditions: pH 6.5 – 8.0, temperature 25 ± 2 °C, dissolved oxygen > 60% saturated (> 4.8 mg/L) and photoperiod 16 h light and 8 h dark.
- Feeding during test: No

ACCLIMATION
- Acclimation period: 72 h (fish were starved 24 h prior to the start of the test)
- Acclimation conditions (same as test or not): Same as test conditions.
- Type and amount of food: Live and proprietary fish food (Artemia and Tetramin)
- Health during acclimation (any mortality observed): No significant mortalities in the week prior to the test.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

109 - 117 mg CaCO3/L

Test temperature:

24.5 - 27.0 °C

pH:

7.2 - 8.1

Dissolved oxygen:

5.3 - 8.0 mg O2/L

Nominal and measured concentrations:

nominal: 0, 10, 18, 32, 56, 100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: all-glass tanks, 6 L, headspace: 1 L, fill volume: 5 L
- Aeration: yes
- Renewal rate of test solution (frequency/flow rate): every 24 h
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline OECD 203

OTHER TEST CONDITIONS
- Photoperiod: 16 h light / 8 h dark
- Light intensity: not measured

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): mortality and other abnormalities in swimming activity and loss of balance were observed daily.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.7

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: not observed

Validity criteria fulfilled:

yes

Conclusions:

After 96 hours the LC50 was determined to be > 100 mg/L and the NOEC was determined to be 100 mg/L.

Description of key information

No toxic effects to fish up to the limit of water solubility.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

EC50

Effect concentration:

> 100 mg/L

Additional information

Since no studies investigating the short-term toxicity to fish of the test substance are available, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read across was conducted to the two structurally related substances decanoic acid, mixed diesters with octanoic acid and propylene glycol (CAS 68583-51-7) and propylene glycol diisostearate (CAS 68958-54-3). 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 the read-across substance decanoic acid, mixed diesters with octanoic acid and propylene glycol was performed as a limit test according to the EU Method C.1 (GLP) with the zebrafish Brachydanio rerio under semi-static conditions (Scholz, 1995). A Water Accommodated Fraction (WAF) of 1000 mg/L did not result in any effects although oily drops were visible after 72 and 96 h. The analytical determination of the test substance based on TOC-analysis resulted in very different values since they were oversaturated, whereas the effect concentration was based on the nominal values. Thus, a LL50 of > 1000 mg/L was determined.

The second study with the read-across substance propylene glycol diisostearate was performed according to OECD 203 under GLP conditions with the zebrafish Danio rerio (van Egmond, 1997). Five concentrations up to 100 mg/L were tested in a semi-static exposure regime. No effects were observed after an exposure of 96 h resulting in a LC50 > 100 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 effects to fish up to the limit of water solubility.