Reaction mass of 3-(octanoyloxy)propyl decanoate and propane-1,3-diyl didecanoate and propane-1,3-diyl dioctanoate

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:

August 1995

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

EG 92/69 C 1

Principles of method if other than guideline:

Highest and only measured concentration: 39 mg/L

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

No details available.

Vehicle:

no

Details on test solutions:

The test item was prepared with deionised water (1g/L) and shaked for 18h. Thereafter the solution was filtrated and the DOC value determined.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebra fish
- Strain: not available
- Source: West Aquarium, Bad Lauterberg
- Length at study initiation: 3 cm ± 0.5 cm

ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions: same as test conditions
- Type and amount of food during acclimation: TetraMin, 1% of the body weight
- Health during acclimation: mortality ≤ 5 %
- Treatment: 3 times a week Malachite green

FEEDING DURING TEST
No feeding during test

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

12 °dH

Test temperature:

19 - 20 °C

pH:

7.8 - 8.5

Dissolved oxygen:

86 - 108% Saturation

Nominal and measured concentrations:

Measured concentration: 39 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: aquarium
- Material, fill volume: glass, 10L
- Aeration: continuous
- Renewal rate of test solution: daily change
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- Biomass loading rate: 0.27 g / Fisch

TEST MEDIUM / WATER PARAMETERS
- Source of dilution water: Drinking water of Gelsenwasser AG

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16h light/ 8h dark
- Light intensity: no details available

EFFECT PARAMETERS MEASURED: Lethality (every 24 h)

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 39 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

39 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

> 39 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: no
- Other biological observations: no
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: no
- Any observations that might cause a difference between measured and nominal values: no

Sublethal observations / clinical signs:

Table 1: Analytical results

Concentration (mg/L)					Mean values of new solutions
0h	24h (old)	24h (new)	48h	72h
4.1	5.1	4.7	68*	81*	39

*Oversaturated solution, generation of droplets on surface

Validity criteria fulfilled:

yes

Conclusions:

In the fish acute test a EC50 value > 39 mg/L was determined.

Executive summary:

The toxicity of the test item to fish (Danio rerio) was determined according to the principles of OECD 203. The aim of the study was the determination of NOEC, LOEC, EC10- , EC20- and EC50-values of lethality over a period of 96 hours. The study was conducted under semi-static conditions with renewal of the test solution after 24 h. A stock solution of 1 g/L was prepared with deionised water. The concentration was calculated from the new solutions to be 39 mg/L. Two replicates were tested for the test item concentration and for the control. The environmental conditions were within the acceptable limits. No lethality was observed. The following results were determined: EC50 >39 mg/L, NOEC = 39 mg/L, LOEC > 39 mg/L.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September 1997

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

EG 92/69 C 1

Principles of method if other than guideline:

Highest and only measured concentration: 14 mg/L

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

The analytical determination of the stability of the test item was tested separately. Concentrations of 0.5, 1.2 and 2.4 mg/L were analyzed after 24, 48 and 72 h. The recovery rate was >80%, therefor nominal values were used for the test. During the test no concentrations were measured.

Vehicle:

no

Details on test solutions:

The test item was prepared with deionised water (1g/L) and shaked for 18h. Thereafter the solution was filtrated and the DOC value determined.

Test organisms (species):

Cyprinus carpio

Details on test organisms:

TEST ORGANISM
- Common name: Common carp
- Strain: not available
- Source: Bio International B.V ., Someren NL
- Length at study initiation: 2 - 4 cm

ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions: same as test conditions
- Type and amount of food during acclimation: TetraMin, 1% of the body weight
- Health during acclimation: mortality ≤ 5 %

FEEDING DURING TEST
No feeding during test

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

13 °dH

Test temperature:

20.3 - 21.9 °C

pH:

7.6 - 8.1

Dissolved oxygen:

70 - 98% Saturation

Nominal and measured concentrations:

Measured concentration: 14 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: aquarium
- Material, fill volume: glass, 10L
- Aeration: continuous
- Renewal rate of test solution: daily change
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- Biomass loading rate: 0.85 g / Fisch

TEST MEDIUM / WATER PARAMETERS
- Source of dilution water: Drinking water of Gelsenwasser AG

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16h light/ 8h dark
- Light intensity: no details available

EFFECT PARAMETERS MEASURED: Lethality (every 24 h)

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 14 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

14 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

> 14 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: no
- Other biological observations: no
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: no
- Any observations that might cause a difference between measured and nominal values: no

Sublethal observations / clinical signs:

Table 1: Analytical results

Concentration (mg/L)				Mean values of new solutions
0h	24h	48h	72h
19.1	19.2	14.4	2.9	14

Partial oversaturated solution, generation of droplets on surface

Validity criteria fulfilled:

yes

Conclusions:

In the fish acute test a EC50 value > 14 mg/L was determined.

Executive summary:

The toxicity of the test item to fish (Cyprinus carpio) was determined according to the principles of OECD 203. The aim of the study was the determination of NOEC, LOEC, EC10- , EC20- and EC50-values of lethality over a period of 96 hours. The study was conducted under semi-static conditions with renewal of the test solution after 24 h. A stock solution of 1 g/L was prepared with deionised water. The concentration was calculated from the new solutions to be 14 mg/L. Two replicates were tested for the test item concentration and for the control. The environmental conditions were within the acceptable limits. No lethality was observed. The following results were determined: EC50 >14 mg/L, NOEC = 14 mg/L, LOEC > 14 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

Justification for type of information:

Please refer to chapter 13.

Reason / purpose for cross-reference:

read-across source

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 39 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

39 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

> 39 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

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

Justification for type of information:

Please refer to chapter 13.

Reason / purpose for cross-reference:

read-across source

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 14 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

14 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

> 14 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Description of key information

No data on the test item is available. With the read-across substances the following results were obtained:

CAS 68583-51-7: EC50 > 39 mg/L, NOEC = 39 mg/L

CAS 853947-59-8: EC50 > 14 mg/L, NOEC = 14 mg/L

Additional information

No data on the test item is available. With the read-across substances the following results were obtained:

The toxicity of the read-across substance CAS 68583-51-7 to fish (Danio rerio) was determined according to the principles of OECD 203. The aim of the study was the determination of NOEC, LOEC, EC10- , EC20- and EC50-values of lethality over a period of 96 hours. The study was conducted under semi-static conditions with renewal of the test solution after 24 h. A stock solution of 1 g/L was prepared with deionised water. The concentration was calculated from the new solutions to be 39 mg/L. Two replicates were tested for the test item concentration and for the control. The environmental conditions were within the acceptable limits. No lethality was observed. The following results were determined: EC50 >39 mg/L, NOEC = 39 mg/L, LOEC > 39 mg/L.

The toxicity of the read-across substance CAS 853947-59-8 to fish (Cyprinus carpio) was determined according to the principles of OECD 203. The aim of the study was the determination of NOEC, LOEC, EC10- , EC20- and EC50-values of lethality over a period of 96 hours. The study was conducted under semi-static conditions with renewal of the test solution after 24 h. A stock solution of 1 g/L was prepared with deionised water. The concentration was calculated from the new solutions to be 14 mg/L. Two replicates were tested for the test item concentration and for the control. The environmental conditions were within the acceptable limits. No lethality was observed. The following results were determined: EC50 >14 mg/L, NOEC = 14 mg/L, LOEC > 14 mg/L.