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Short-term toxicity to fish

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Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 Mar - 01 Apr 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions (no control)
Qualifier:
according to guideline
Guideline:
ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 2: Semi-static method)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
no
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test substance was weighed directly into the test vessels, filled up with standard dilution water to a final volume of 5L and than stirred for 3 minutes by ultra-turrax.
- Controls: no data
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish
- Feeding during test: none
- Other: < 0.1% mortality prior to test
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
about 250 mg CaCO3/L
Test temperature:
22.5 - 23.5 °C
pH:
7.6 - 7.9
Dissolved oxygen:
58 - 99%
Nominal and measured concentrations:
Nominal: 3000 and 10000 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel (size, headspace, fill volume): 10 L fish basins containing 5 L test water
- Renewal rate of test solution (frequency/flow rate): daily
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Standard dilution water

OTHER TEST CONDITIONS
- Photoperiod: 16 h illumination per day

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Mortalities are recorded at 0, 6, 24, 48, 72 and 96 h.
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
>= 10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Behavioural abnormalities: None
Sublethal observations / clinical signs:

Table 1: Mortality [%] of Brachydaniorerio

Test concentration [mg product/L]

Incubation time [h]

0

6

24

48

72

96

3000

0

0

0

0

n.d.*

0

10000

0

0

0

0

n.d.*

0

 * n.d. = not determined

Validity criteria fulfilled:
yes
Conclusions:
The 96h LC50 was determined to be > 10000 mg/L. No mortality was observed in the study.
Executive summary:

The 96h LC50 was determined to be > 10000 mg/L. No mortality was observed in the study.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07 - 11 Jan 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions (no purity)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test solutions were prepared by direct addition of 1000 mg of test material per litre. The test solutions were then stirred thoroughly.
- Controls: Yes, freshwater control
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow trout
- Source: Upwey Trout Farm, Dorset, UK (27 Nov 1990)
- Feeding during test: None
- Other: The last medication given to the fish was a 1 mg/L treatment of malachite green on 30 November 1990 (5 weeks prior to the test).

ACCLIMATION
- Acclimation period: 1 week
- Acclimation conditions (same as test or not): Same as test (15 ± 1 °C, glass aquaria under daylight and artificial lighting)
- Type and amount of food: BP Mainstream (batch ref FF123)
- Feeding frequency: The fish was not fed for 24 h prior to the start of the test.
- Health during acclimation (any mortality observed): No mortality
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
37.3 - 38.0 mg/L as CaCO3
Test temperature:
14.4 - 15.2 °C
pH:
7.92 - 8.09
Dissolved oxygen:
9.0 - 9.8 mg/L
Conductivity:
136 - 142 µS/cm
Nominal and measured concentrations:
Nominal: 0 and 1000 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: 17 L glass vessels with a fill volume of 15 litres
- Aeration: gentle aeration
- Renewal rate of test solution (frequency): every 24 hours
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dechlorinated tap water supplied from a 100 m³ reservoir with an average retention time of 24 hours. It was passed through activated carbon, filtered to remove particulate material and dechlorinated with sodium thiosulphate. The treated water was then held in a secondary reservoir with a capacity of 36 m³ and an average retention time of 8 hours. It was delivered to the laboratory via a temperature controlled header tank at a nominal temperature of 15°C.
- Alkalinity: 20.4 mg/L as CaCO3
- Conductivity: 136 - 142 µS/cm
- Intervals of water quality measurement: Daily for pH, dissolved oxygen and temperature.

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

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Mortalities and symptoms of toxicity at 24, 48, 72 and 96 hours; the fish from the control were weighted and measured at the end of the exposure period.
Reference substance (positive control):
not specified
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)
Details on results:
- Observations on body length and weight: Control at the end of the exposure period: length 37 - 47 mm (mean 41 mm), weight 0.47 - 1.31 g (mean 0.81 g)
- Mortality of control: No
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: The test material did not dissolve completely in the dilution water.
Sublethal observations / clinical signs:

Table 1: Percentage mortalities during the test period

Nominal concentration of test substance (mg/L)

Percentage mortality observed

24 h

48 h

72 h

96 h

1000 (A)

0

0

0

0

1000 (B)

0

0

0

0

Dilution control water

0

0

0

0

 

Validity criteria fulfilled:
yes
Conclusions:
The 96h LC50 was determined to be > 1000 mg/L. No mortality was observed in the study.
Executive summary:

The 96h LC50 was determined to be > 1000 mg/L. No mortality was observed in the study.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
04 - 09 April 1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Water accommodated fraction (WAF) were prepared by stirring the test substance in the dilution water for 24 hours to reach equilibrium concentration. A 20 L complete glass basin was appointed with a glass tube, by what the aqueous phase could be take off witout contamination of the unsolved film of the hydrocarbon. Before the take off of the aqueous phase the preparation was left for 1 hour for complete phase separation.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish
- Source: MPI für Entwicklungsbiologie, Tübingen, Germany
- Length at study initiation (length definition, mean, range and SD): 3.1 - 3.5 cm
- Feeding during test: no

ACCLIMATION
- Acclimation period: At least 12 d
- Health during acclimation (any mortality observed): Mortality ≤ 5%
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Test temperature:
23 ± 2 °C
pH:
8.2 - 8.4
Dissolved oxygen:
> 91%
Nominal and measured concentrations:
Nominal: 10000 mg/L (WAF)
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: 10 L/ basin
- Aeration: yes, constant with Pasteur pipettes
- Renewal rate of test solution (frequency): every 24 h
- No. of organisms per concentration: 7

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: By aeration (1-2 d) dechlorinated tap water
- Intervals of water quality measurement: Oxygen content, pH-value and temperature were registered after 24 h, 48 h, 72 h and 96 h.

OTHER TEST CONDITIONS
- Photoperiod: 14 light, 10 h dark (Gro-Lux)

EFFECT PARAMETERS MEASURED: Schooling behaviour, activity (mobility), surfacing, floatability (equilibrium behaviour), dead animals, breathing frequency
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LL50
Effect conc.:
> 10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: WAF loading rate
Details on results:
- Behavioural abnormalities: 2 of the 7 test fish showed abnormal behaviour during the 96 h test period. This 2 fish were seperated from the school and showed lower activity. After 72 h the schooling behaviour of the rest of the fish was also disturbed. The activity and the equilibrium behaviour was equal to the control fish.
- Other biological observations: The feed ingestion after test end was only reduced at the 2 more reacted fish. All other fish showed the same behaviour as the control fish.
- Mortality of control: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: WAFs showed light turbidity, but contained no visible emulsion drops.
Sublethal observations / clinical signs:

No mortality of the fish could be observed in the control and the test concentration (10000 mg/l WAF) after 96h under conditions tested. 2 of the 7 test fish showed abnormal behaviour during the 96 h test period. This 2 fish were seperated from the swarm and showed lower activity. But after 72 h the swarm behaviour of the rest of the fish was also disturbed. However, the activity and the equilibrium behaviour was equal to the control fish. The feed ingestion after test end was only reduced at the 2 more reacted fish. All other fish showed the same behaviour as the control fish. As WAFs showed light turbidity and the water solubility of the test substance is < 0.3 mg/l, the abnormal behaviour could cause in unsolved test substance. Overall no mortality could be observed and therefore the LL50 is > 10000 mg/l. Due to the low water solubility (< 0.3 mg/l), no mortality within the water solubility of the test substance were observed and therewith the LC50 (96h) is > water solubility of the test substance.

Validity criteria fulfilled:
yes
Conclusions:
No mortality of the fish could be observed in the control and the test concentration (10000 mg/l WAF) after 96h under conditions tested. 2 of the 7 test fish showed abnormal behaviour during the 96 h test period. This 2 fish were seperated from the swarm and showed lower activity. But after 72 h the swarm behaviour of the rest of the fish was also disturbed. However, the activity and the equilibrium behaviour was equal to the control fish. The feed ingestion after test end was only reduced at the 2 more reacted fish. All other fish showed the same behaviour as the control fish. As WAFs showed light turbidity and the water solubility of the test substance is < 0.3 mg/l, the abnormal behaviour could cause in unsolved test substance. Overall no mortality could be observed and therefore the LL50 is > 10000 mg/l. Due to the low water solubility (< 0.3 mg/l), no mortality within the water solubility of the test substance were observed and therewith the LC50 (96h) is > water solubility of the test substance.
Executive summary:

No mortality of the fish could be observed in the control and the test concentration (10000 mg/l WAF) after 96h under conditions tested. 2 of the 7 test fish showed abnormal behaviour during the 96 h test period. This 2 fish were seperated from the swarm and showed lower activity. But after 72 h the swarm behaviour of the rest of the fish was also disturbed. However, the activity and the equilibrium behaviour was equal to the control fish. The feed ingestion after test end was only reduced at the 2 more reacted fish. All other fish showed the same behaviour as the control fish. As WAFs showed light turbidity and the water solubility of the test substance is < 0.3 mg/l, the abnormal behaviour could cause in unsolved test substance. Overall no mortality could be observed and therefore the LL50 is > 10000 mg/l. Due to the low water solubility (< 0.3 mg/l), no mortality within the water solubility of the test substance were observed and therewith the LC50 (96h) is > water solubility of the test substance.

Description of key information

No relevant studies are available for decanoic acid, mixed esters with heptanoic acid, octanoic acid and trimethylolpropane. Three acute fish toxicity studies are available for closely related structural analogues (CAS 11138-60-6, CAS 91050-89-4 and CAS 78-16-0).

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
1 000 mg/L

Additional information

Three acute fish toxicity studies are available for closely related structural analogues:

In the first study with CAS 11138-60-6 (conducted in accordance with OECD Guideline 203), no mortality was observed and therefore the LL50 was determined to be > 10000 mg/l WAF. Due to the low water solubility (< 0.3 mg/l), no mortality within the water solubility of the test substance was observed and therewith the LC50 (96h) is > water solubility of the test substance.

In the second study with CAS 91050-89-4 (conducted in accordance with ISO 7346 -1), the 96h LC50 was determined to be > 10000 mg/L. No mortality was observed in the study.

In the third study with CAS 78 -16 -0 (conducted in accordance with OECD Guideline 203), the 96h LC50 was determined to be > 1000 mg/L. No mortality was observed in the study.

Therefore, by read-across, decanoic acid, mixed esters with heptanoic acid, octanoic acid and trimethylolpropane is not considered to be acutely toxic to fish.

A report justifying the read-across approach is included in IUCLID Chapter 13.