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Ecotoxicological information

Long-term toxicity to aquatic invertebrates

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Reference
Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2014
Justification for type of information:

Read across from this source substance to the target substance is considered conservative since the acute ecotoxicity of the source substance is higher than the acute toxicity of the target substance. Further information is provided in the read across documents.
Reason / purpose:
read-across source
GLP compliance:
yes (incl. certificate)
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
0.31 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Key result
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
0.15 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
> 0.4 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
growth
Remarks on result:
other: No adverse effect > 5 % observed, hence the EC10 is > 0.76 mg/L
Details on results:
- Mortality of parent animals: yes, used for EC10 calculation. In the control and at the lower mean measured concentrations up to and including 0.15 mg sulfosuccinate/L, the survival of the test animals at the end of the test was at least 90% or higher. At the mean measured concentration of 0.40 mg sulfosuccinate/L, the survival was 60%. At the highest test concentration of 0.76 mg sulfosuccinate/L, all test animals were dead at observation on Day 1. Mortality up to 20% is regarded as natural and tolerated by the test guideline. Thus, the survival of Daphnia magna after 21 days was reduced at the mean measured concentrations of 0.40 and 0.76 mg/L.. The EC10 for mortality was calculated to be at 0.31 mg/L.
- Body length and weight of parent animals: The mean body length of the daphnids in the control was 4.06 ± 0.09 mm (mean ± standard deviation). At any test concentration up to and including the mean measured concentration of 0.15 mg sulfosuccinate/L, the mean body length was not significantly smaller compared to the control (Williams t-test, one-sided smaller, alpha = 0.05). First at the next higher mean measured concentration of 0.40 mg/L, the mean body length of surviving daphnids was statistically significantly reduced to in the mean 97% compared to the control. Hence, the EC10 is greater than 0.76 mg/L
- Type and number of morphological abnormalities: no visible abnormalities were observed at the test animals during the test
- Type and number of behavioural abnormalities: no visible abnormalities were observed at the test animals during the test
- Effect concentrations exceeding solubility of substance in test medium: none

- Analytical results:The measured test item concentrations in the freshly prepared test media of the nominal test concentrations of 0.28 to 2.2 mg/L were between 45 and 81% of the nominal values. In the aged test media samples without food, the measured concentrations were in the range of 17 to 67% of the nominal values. In the aged test media samples including food particles the mean test item concentrations were slightly lower than in the aged test media samples without food, 22 to 49% of the nominal values. The biological results are based on mean measured sulfosuccinate concentrations (calculated as the time-weighted means over all measurements per test concentration with food)


One to one read across from this source substance to the target substance is considered conservative since the acute ecotoxicity of the source substance is higher than the acute toxicity of the target substance. Further information is provided in the read across documents.
 
Reported statistics and error estimates:
The mean reproduction rates and mean body lengths of the daphnids at the test concentrations were both compared to the control by multiple Williams t-tests, one-sided smaller, alpha = 0.05. Additionally, the EC10 for the inhibition of the reproduction rate and the immobility after 21 days was calculated by Probit Analysis using linear maximum likelihood regression.

After 21 days 0, 0, 0, 0, 10 and 60% mortality was observed in the control and at nominal test concentrations of 0.1375, 0.275, 0.55, 1.1 and 2.2 mg/L, respectively.

The reproduction per parent daphina was 124.6 (10), 145.6 (10), 126.9 (10), 131.7 (10), 127.0 (10), and 98.6 (10) living offspring per parental animal

(number of parental daphinds used to calculate the mean are given in brackets) in the control and 0.1375, 0.275, 0.55, 1.1 and 2.2 mg/L, respectively

.

Summary of the results after 21 days of exposure of the test animals

One to one read across from this source substance to the target substance is considered conservative since the acute ecotoxicity of the source substance is higher than the acute toxicity of the target substance. Further information is provided in the read across documents.

 

 

 

 

Control

Nominal (mean measured) concentration of sulfosuccinate

[mg/L]

 

0.042
(n.a.)

0.084
(n.a.)

0.17
(0.052)

0.34
(0.15)

0.67
(0.40)

1.3
(0.76)

Mortality [%] after 21 days of exposure

10#

0

0

0

0

40##

100##

Mean reproduction rate (living offspring per adult)

109.4

112.0

108.3

128.2

75.7*

74.8*

0*

Mean reproduction rate in % of control

100.0

102.3

99.0

117.1

69.2

68.3

0

Mean body length of the adults [mm]

4.06

4.05

4.07

4.08

4.10

3.92**

n.ap.

Mean body length of the adults in % of control

100.0

99.9

100.3

100.5

101.0

96.6

n.ap.

 

*:        statistically significantly lower than the control value, results of an U-test, one-sided smaller,a= 0.05

**:      statistically significantly lower than the control value, results of a Williams t-test, one-sided smaller,a= 0.05

#:         Mortality is regarded as biologically not relevant and the calculation is based on the surviving adults only.

##:        Mortality is regarded as a toxic effect of the test item and the calculation is based on all adults (independently of their survival).

n.a.:    not analyzed

n.ap.: not applicable since all adult test animals were dead at observation on Day 1

 

The biological results can be summarized as follows (on the basis of mean measured concentrations of the test item

Parameter

Inhibition of reproduction rate

Immobility

Inhibition of growth

(21 days)

(21 days)

 (21 days)

EC10  [mg/L]

0.15

0.31

>0.40

 

One to one read across from this source substance to the target substance is considered conservative since the acute ecotoxicity of the source substance is higher than the acute toxicity of the target substance. Further information is provided in the read across documents.

 

Validity criteria fulfilled:
yes
Conclusions:
21-day EC10: 0.15 mg/L
Executive summary:

In the Klimisch 2 (Klimisch 2 since read across, otherwise Klimisch 1) GLP study from Eckenstein (2015) the chronic toxicity of Butanedioic acid, sulfo-, 1,4-diisodecyl ester, sodium salt on Daphnia magna was determined in an 21 day semi-static test according to OECD 211. The test was performed with Control, 0.042 (n.a.), 0.084 (n.a.), 0.17 (0.052), 0.34 (0.15), 0.67 (0.40) and 1.3 (0.76) mg sulfosuccinate/L. The biological results are based on mean measured sulfosuccinate concentrations (calculated as the time-weighted means over all measurements per test concentration with food). The mean measured values are presented in brackets behind the nominal concentrations.

Ten replicates with 1 Daphnia each were set up. After 21 days 0, 0, 0, 0, 0, 40 and 100% mortality was observed in the control and at nominal test concentrations of 0.042 (n.a.), 0.084 (n.a.), 0.17 (0.052), 0.34 (0.15), 0.67 (0.40) and 1.3 (0.76) mg sulfosuccinate/L, respectively. The mean measured values are presented in brackets behind the nominal concentrations.

The reproduction per parent daphina was 109.4 (9), 112.0 (10), 108.3 (10), 128.2 (10), 75.7 (10), and 74.8 (10) living offspring per parental animal (number of parental daphinds used to calculate the mean are given in brackets) in the control and 0.042 (n.a.), 0.084 (n.a.), 0.17 (0.052), 0.34 (0.15), 0.67 (0.40) mg sulfosuccinate/L, respectively. The mean measured values are presented in brackets behind the nominal concentrations. Due to 100 % mortality at 1.3 (0.76) mg/L until day 1, there was no reproduction in the highest test concentration group.

 

The biological results were based on time weighed mean measured concentrations.

 

The EC10 for mortality is 0.31 mg/L, the EC10 for reproduction is 0.15 mg/L, the EC10 for growth is > 0.40 mg/L. For the risk assessment, the more conservative EC10, i.e., the EC10 for reproduction was used.

One to one read across from this source substance to the target substance is considered conservative since the acute ecotoxicity of the source substance is higher than the acute toxicity of the target substance. Further information is provided in the read across documents.

 

The result is considered relevant and reliable for the risk assessment.

Description of key information

21-d EC10 (reproduction): 0.15 mg/L

Key value for chemical safety assessment

EC10, LC10 or NOEC for freshwater invertebrates:
0.15 mg/L

Additional information

In the Klimisch 1 GLP study from Eckenstein (2015) the chronic toxicity of Butanedioic acid, sulfo-, 1,4-diisodecyl ester, sodium salt on Daphnia magna was determined in an 21 day semi-static test according to OECD 211. The test was performed with Control, 0.042 (n.a.), 0.084 (n.a.), 0.17 (0.052), 0.34 (0.15), 0.67 (0.40) and 1.3 (0.76) mg sulfosuccinate/L. The biological results are based on mean measured sulfosuccinate concentrations (calculated as the time-weighted means over all measurements per test concentration with food). The mean measured values are presented in brackets behind the nominal concentrations.

Ten replicates with 1 Daphnia each were set up. After 21 days 0, 0, 0, 0, 0, 40 and 100% mortality was observed in the control and at nominal test concentrations of 0.042 (n.a.), 0.084 (n.a.), 0.17 (0.052), 0.34 (0.15), 0.67 (0.40) and 1.3 (0.76) mg sulfosuccinate/L, respectively. The mean measured values are presented in brackets behind the nominal concentrations.

The reproduction per parent daphina was 109.4 (9), 112.0 (10), 108.3 (10), 128.2 (10), 75.7 (10), and 74.8 (10) living offspring per parental animal (number of parental daphinds used to calculate the mean are given in brackets) in the control and 0.042 (n.a.), 0.084 (n.a.), 0.17 (0.052), 0.34 (0.15), 0.67 (0.40) mg sulfosuccinate/L, respectively. The mean measured values are presented in brackets behind the nominal concentrations. Due to 100 % mortality at 1.3 (0.76) mg/L until day 1, there was no reproduction in the highest test concentration group.

 

The biological results were based on time weighed mean measured concentrations.

 

The EC10 for mortality is 0.31 mg/L, the EC10 for reproduction is 0.15 mg/L, the EC10 for growth is > 0.40 mg/L. For the risk assessment, the more conservative EC10, i.e., the EC10 for reproduction was used.

One to one read across from this source substance to the target substance is considered conservative since the acute ecotoxicity of the source substance is higher than the acute toxicity of the target substance. Further information is provided in the read across documents.

 

The result is considered relevant and reliable for the risk assessment.