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Ecotoxicological information

Long-term toxicity to fish

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Reference
Endpoint:
fish early-life stage toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
Further information are included in the Read-Across Justification Document.
Reason / purpose:
read-across source
Key result
Duration:
155 d
Dose descriptor:
NOEC
Effect conc.:
0.3 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
number hatched
Remarks on result:
other: Duration equivalent to 120d post hatch
Key result
Duration:
155 d
Dose descriptor:
NOEC
Effect conc.:
0.3 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: Duration equivalent to 120d post hatch
Key result
Duration:
155 d
Dose descriptor:
NOEC
Effect conc.:
0.3 mg/L
Nominal / measured:
meas. (not specified)
Conc. based on:
test mat.
Basis for effect:
growth rate
Remarks on result:
other: Duration equivalent to 120d post hatch
Details on results:
- Mortality/survival at embryo and larval stages: 100% survival at hatching
- Overall mortality/survival: 95-98% in all groups including controls see table below
- Days to hatch and numbers hatched: 35-36 20/replicate & 2 replicates /group
- Data for length and weight of surviving fish: see table below
- Type of and number with morphological abnormalities: 0 in all groups
- Type of and number with behavioural abnormalities: 0 in all groups
- Other biological observations: No
- Effect concentrations exceeding solubility of substance in test medium: N/A
- Incidents in the course of the test which might have influenced the results: day 148 injector delivery tubes removed for 5.5h resulted in a temporary reduction in DUP concentrations.
During growth phase dissolved oxygen concentrations d42-155, within & across concentrations exhibited a downward trend; from d112-119 there were occasional dips below 60% saturation (min 6.2 mg/l). From day 119 an O2 injection system was used to try and improve the concentrations which remained low despite further modifications involving discontinuation of gaseous oxygen.
Results with reference substance (positive control):
N/A
Reported statistics and error estimates:
Embryo hatchability &survival: Fisher's Exact Test & Frequency analysis
Growth & wet body weight: t test for differences between controls; ANOVA & Dunnett's test (1 tailed) for differences between vehicle control and DUP treated groups

Swim up began on day 45, 10 days post hatch and was completed by day 50, 15 days post hatch. It began & proceeded at the same rate in all groups.

There were no DUP related effects on appearance, behaviour or feeding. Length and wet weight were also not affected by exposure to DUP at any of the concentrations tested.

Embryo hatchability and survival of rainbow trout exposed to diundecyl phthalate

Parameters (%)

0 (Control)

0 (Vehicle control)

Mean measured concentrations of DUP (mg/l)

0.026

0.039

0.075

0.15

0.30

Embryo hatch

100

100

100

100

100

100

100

60 d post hatch survival

953

98

95

98

98

100

95

90 d post hatch survival

95

972

95

97

98

100

95

120 d post hatch survival

95

97

95

97

98

100

95

 

 

 

 

 

 

 

 

1 = no. in each replicate n = 20; 2 n = 19, 1 escaped from 1 replicate & not included in value for mortality; 3 = n= 18, 2 escaped from 1 replicate & not included in value for mortality; 4 = n= 17, 3 escaped from 1 replicate & not included in value for mortality

 

Post hatch mean standard length & blotted wet weight of rainbow trout exposed to diundecyl phthalate

Parameters (%)

0 (Control)

0 (Vehicle control)

Mean measured concentrations of DUP (mg/l)

0.026

0.039

0.075

0.15

0.30

Standard length (mm)

 

 

 

 

 

 

 

60 d post hatch

53.807 (3.529)

54.499 (2.532)

55.997 (2.896)

55.149 (3.315)

55.630 (2.762)

56.631 (2.894)

57.884 (2.935)

90 d post hatch

79.003 (5.828)

79.680 (5.368)

81.575 (6.062)

80.236 (6.437)

80.729 (4.176)

81.945 (5.883)

84.404 (5.815)

120 d post hatch

108.34 (9.123)

106.46 (8.035)

110.89 (10.135)

108.27 (9.879)

107.93 (6.655)

108.91 (9.127)

112.35 (8.965)

 

 

 

 

 

 

 

 

Blotted wet weight (g)

 

 

 

 

 

 

 

120 d post hatch

20.676 (5.817)

19.957 (5.118)

22.735 (6.496)

21.230 (6.099)

20.107 (4.310)

20.776 (5.986)

23.433 (6.491)

 

 

 

 

 

 

 

 

Validity criteria fulfilled:
yes
Conclusions:
Under the conditions of this test the NOEL mean measured concentration for DUP was 0.30 mg/l, the maximum water solubility in these conditions.
Executive summary:

Long-term toxicity to fish with the structurally related substance Diundecyl phthalate has been determined in a fish early life stage test with rainbow trout. Under the conditions of the test the NOEC, based on the mean measured concentration, was 0.30 mg/l, the highest concentration investigated and regarded as the maximum water solubility under the test conditions.

Description of key information

The NOEC in fish for the structural related substance 1,2-Benzenedicarboxylic acid, diundecyl ester is reported as 0.3 mg/l and hence well above the limit of water solubility. Therefore it can be concluded that no toxicity occurred up to the limit of water solubility.

Key value for chemical safety assessment

Additional information

Long-term toxicity to fish has been determined with the structurally related substance 1,2-Benzenedicarboxylic acid, diundecyl ester in a fish early life stage test with rainbow trout. Under the conditions of the test the NOEC (155d), based on the mean measured concentration, was 0.30 mg/l, the highest concentration investigated and regarded as the maximum water solubility under the test conditions.

Further supporting these findings, no effects or either effects far above the limit of water solubility were found in Early life stage tests with the lower-molecular-weight phthalate esters, 1,2-Benzenedicarboxylic acid, dihexyl ester (Rainbow trout, 143 d) and 1,2-Benzenedicarboxylic acid, dioctyl ester (Fathead minnow, 28 d), 0.22 mg/L (NOEC) and 3.2 mg/L (NOEC) respectively.

All values are well above the level of water solubility (see Staples et al., 1997).