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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH

1. HYPOTHESIS FOR THE ANALOGUE APPROACH
For details please refer to Read Across Justification Document, Section 13.2

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
For details please refer to Read Across Justification Document, Section 13.2

3. ANALOGUE APPROACH JUSTIFICATION
For details please refer to Read Across Justification Document, Section 13.2

4. DATA MATRIX
For details please refer to Read Across Justification Document, Section 13.2
Reason / purpose for cross-reference:
read-across source
Key result
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
> 5.1 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Remarks:
based on measurement of C12 constituent
Basis for effect:
reproduction
Key result
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
5.1 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Remarks:
based on measurement of C12 constituent
Basis for effect:
reproduction
Key result
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
5.1 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Remarks:
C12
Basis for effect:
mortality
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
5.1 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Remarks:
based on measurement of C12 constituent
Basis for effect:
growth
Key result
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
> 3.6 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Remarks:
based on measurement of C14 constituent
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
3.6 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Remarks:
based on measurement of C14 constituent
Basis for effect:
reproduction
Key result
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
3.6 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Remarks:
based on measurement of C14 constituent
Basis for effect:
mortality
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
3.6 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
act. ingr.
Remarks:
based on measurement of C14 constituent
Basis for effect:
growth
Details on results:
- Behavioural abnormalities:
- Observations on body length and weight: see table below
- Other biological observations: none
- Mortality of control: 10%
- Other adverse effects control: no
- Abnormal responses: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: none
- Effect concentrations exceeding solubility of substance in test medium: no
Reported statistics and error estimates:
See "Any other information on materials and methods" (above).

The cladoceran,Daphnia magna,was exposed to the test substance, the aqueous solution of butanedioicacid, 2 (or 3)-sulfo-, 4-[2-[(1-oxo (C12-C18 (Even Numbered) and C18 unsaturated)alkyl))amino]ethyl]esters, disodium salts,at time-weighted mean measured concentrations of 0.092, 0.18, 0.42, 1.4 and 5.1 mg a.i/L based on C12 component and from 0.091, 0.18, 0.40, 0.97 and 3.6 mg a.i./L based on C14 component under semi-static conditions for 21 days. There were no statistically significant treatment-related effects on survival, reproduction or growth at concentrations ≤5.1 mg a.i./L based on C12 component or ≤3.6 mg a.i./L based on C14 component of the test item. Consequently, the NOEC, LOEC and EC10, EC50and the corresponding 95% confidence interval were as follows:

 

 

 

 

Survival

Reproduction (mean number of live neonates)

 

 

Length

 

 

Dry Weight

Per Surviving Adult

Per Adult at Start

Based on time-weighted mean measured concentration of C12 component (mg a.i./L)1

 

 

 

 

 

EC10& 95% confidence interval

--

>5.1 (NA)

>5.1 (NA)

--

--

EC50& 95% confidence interval

>5.1 (NA)

>5.1 (NA)

>5.1 (NA)

--

--

NOEC

5.1

5.1

5.1

5.1

5.1

LOEC

>5.1

>5.1

>5.1

>5.1

>5.1

Based on time-weighted mean measured concentration of C14 component (mg a.i./L)1

 

 

 

 

 

EC10& 95% confidence interval

--

>3.6 (NA)

>3.6 (NA)

--

--

EC50& 95% confidence interval

>3.6 (NA)

>3.6 (NA)

>3.6 (NA)

--

--

NOEC

3.6

3.6

3.6

3.6

3.6

LOEC

>3.6

>3.6

>3.6

>3.6

>3.6

1  Mean measured test concentrations were calculated using time-weight average as described in OECD 211, Annex 6.

   NA = Not applicable; the 95% confidence intervals were overly wide or outside of the data range used for the calculation.

   -- = not estimated as it was not required.

Summary of Survival, Reproduction and Growth of Daphnia magna Exposed to the Test Item for 21 Days

 

 

Nominal Test

Concentration

(mg a.i./L)

Time-Weighted Mean

Measured Concentration

(mg a.i./L)

 

 

Percent Adult

Survival1

Mean No. Neonates

Per Surviving Adult

(# Surviving Adults)

± Std. Dev.1,3

Mean No. Neonates

Per Adult at Start

(# Surviving Adults)

± Std. Dev.2

 

Mean Length

± Std. Dev.

(mm)1

 

Mean Dry Weight

± Std. Dev.

(mg)1

C12

C14

Negative

Control

Negative

Control

Negative

Control

90

 

169 ± 25.1 (n=18)

(CV = 14.9%)

155 ± 48.4

 

5.1 ± 0.14

 

1.06 ± 0.21

 

0.13

0.092

0.091

60

160 ± 22.0 (n=6)

145 ± 50.0

5.0 ± 0.16

1.03 ± 0.17

0.42

0.18

0.18

80

176 ± 14.4 (n=8)

152 ± 52.2

5.0 ± 0.14

0.95 ± 0.19

1.3

0.42

0.40

70

180 ± 28.4 (n=7)

137 ± 76.9

5.0 ± 0.22

0.97 ± 0.27

3.8

1.4

0.97

90

167 ± 17.7 (n=9)

163 ± 21.1

4.9 ± 0.17

1.09 ± 0.21

12

5.1

3.6

70

166 ± 31.9 (n=7)

128 ± 69.9

4.9 ± 0.16

1.06 ± 0.11

1  There were no statistically significant differences from the control (Fisher Exact test, p> 0.05 for survival and Dunnett’s one-tailed test, p > 0.05 for mean number of neonates per surviving adult and growth).

2  There were no statistically significant differences from the control (Jonckheere-Terpstra step down trend test, p > 0.05).

3   There were total of 15, 8, 6, 8, 6 and 7 immobile neonates produced and total of 14, 28, 11, 10, 6 and 9 aborted/shed eggs produced by surviving adults in the negative control, 0.13, 0.42, 1.3, 3.8 and 12 mg a.i./L nominal test concentrations, respectively. These were production of immobile neonates and aborted/shed eggs not considered to be treatment related effect.

The results for the source substance are considered to be relevant for the target substance as well and no additional factor is needed.

Validity criteria fulfilled:
yes
Conclusions:
The overall NOEC and EC10 were > 3.6 mg a.i./L and 3.6 mg/L respectively.
Executive summary:

 In the Klimisch 1 study from Minderhout (2018) the cladoceran,Daphnia magna,was exposed to the aqueous solution of butanedioic acid, 2 (or 3)-sulfo-, 4-[2-[(1-oxo (C12-C18 (Even Numbered) and C18 unsaturated)alkyl))amino]ethyl]esters, disodium salts,at time-weighted mean measured concentrations of 0.092, 0.18, 0.42, 1.4 and 5.1 mg a.i/L based on C12 component and from 0.091, 0.18, 0.40, 0.97 and 3.6 mg a.i./L based on C14 component under semi-static conditions for 21 days. There were no statistically significant treatment-related effects on survival, reproduction or growth at concentrations ≤5.1 mg a.i./L based on C12 component or ≤3.6 mg a.i./L based on C14 component of the test item. 

As worst case, the concentrations based on the measured C14 constituent were used for the risk assessment., i.e., the overall NOEC and EC10 were > 3.6 mg a.i./L and 3.6 mg/L respectively.

The results for the source substance are considered to be relevant for the target substance as well and no additional factor is needed.

The results of this study are considered relevant and reliable for the risk assessment.

Description of key information

The overall NOEC and EC10 were > 3.6 mg a.i./L and 3.6 mg/L respectively.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
3.6 mg/L

Additional information

In the Klimisch 1 study from Minderhout (2018) the cladoceran,Daphnia magna,was exposed to the aqueous solution of butanedioic acid, 2 (or 3)-sulfo-, 4-[2-[(1-oxo (C12-C18 (Even Numbered) and C18 unsaturated)alkyl))amino]ethyl]esters, disodium salts,at time-weighted mean measured concentrations of 0.092, 0.18, 0.42, 1.4 and 5.1 mg a.i/L based on C12 component and from 0.091, 0.18, 0.40, 0.97 and 3.6 mg a.i./L based on C14 component under semi-static conditions for 21 days. There were no statistically significant treatment-related effects on survival, reproduction or growth at concentrations ≤5.1 mg a.i./L based on C12 component or ≤3.6 mg a.i./L based on C14 component of the test item.  As worst case, the concentrations based on the measured C14 constituent were used for the risk assessment., i.e., the overall NOEC and EC10 were > 3.6 mg a.i./L and 3.6 mg/L respectively. The results for the source substance are considered to be relevant for the target substance as well and no additional factor is needed. The results of this study are considered relevant and reliable for the risk assessment.

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