Reaction products of ricinoleic acid with 2-aminoethanol and maleic acid and sodium hydrogensulfite

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

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 Survival^1	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). ^3There 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.