Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and phenol, iron sodium salts

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1995-11-10 to 1996-04-10

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

- Name of test material (as cited in study report): FeEDDHMANa
- Chemical name: N,N'-Bis(2-hydroxy-4-methylphenyl)ethylendiamine diacetic acid, ferric-sodium complex.
- Physical state: Red brown powder
- Analytical purity: 100 % (UVCB)
- Lot/batch No.: 954243
- Storage condition of test material: At room temperature, dry in the dark

Analytical monitoring:

yes

Details on sampling:

During the study samples for analysis were taken as follows:
- Freequency: From all freshly prepared solutions on day 0; from 72-hour old solutions of 0, 10 and 1000 mg/L on day 3; from the freshly prepared solutions of 0, 10 and 1000 mg/L on days 7 and 14; from all freshly prepared solutions on day 19; fromm all 48-hour old solutions on day 21
- Volume: 10 mL
Storage: Samples were stored in a deep-freeze

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
The test media were prepared using freshly prepared stock solutions with a nominal concentration of 1000 mg/L in medium M4. Exact aliquots were taken from these stock solutions for the preparation of the test solutions. the color of the test solutions was increasingly brown with increasing concentration of test substance, There was no indication of precipitation of the test material. Shortly after preparation, the parental daphnids were transferred to the freshly prepared test solutions.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia mgna
- Strain/clone:Crustacea, Cladocera
- Age of parental stock (mean and range, SD): < 24 hrs
- Feeding during test: Daily, a suspension of fresh water algae (Chlorella pyrenoidosa)

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

21 d

Hardness:

250 mg/L as CaCO3

Test temperature:

18.0 to 22 °C

pH:

8.0 +/- 0.2

Dissolved oxygen:

> 7 mg/L

Nominal and measured concentrations:

Nominal: 10, 32, 100, 320 and 1000 mg/L
Measured: >= 85% of nominal (above all treatments and measurements after 0, 3, 7, 14, 19 and 21 days)

Details on test conditions:

TEST SYSTEM
- Test vessel: all-glass covered with a perspex plate
- Material, size, headspace, fill volume: 100 mL
- Renewal rate of test solution (frequency/flow rate): Three times a week (Monday, Wednesday and Friday)
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 20

TEST MEDIUM
M4 medium as described in the OECD Guideline

OTHER TEST CONDITIONS
- Photoperiod: 16 hours photoperiod daily
- Light intensity: 600 lux

Reference substance (positive control):

no

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

320 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks on result:

other: analytically verified

Duration:

21 d

Dose descriptor:

EC50

Effect conc.:

628 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks on result:

other: analytically verified

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Remarks on result:

other: analytically verified

Duration:

21 d

Dose descriptor:

LC50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: analytically verified

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

>= 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: analytically verified

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: analytically verified

Details on results:

- Mortality of parent animals: No mortality or other visible effects were recorded for the parental organisms at any of the test item concentrations tested.
- During the exposure period of 21 days, the mean values for living offspring recorded at test item concentrations up to and including 320 mg/L were within same range as those found in the control group. After the first brood, the parental Daphnia exposed to 1000 mg/L frequently released unhatched eggs instead of living young. Hence, the reproductive capacity of these organisms was substantially lower than those found in the other
groups after 21 days of exposure.

Reported statistics and error estimates:

Statistical analysis of the data for reproduction at the end of the 21-day exposure period showed that significant reduction of the reproductive capacity of Daphnia magna occurred at 320 and 1000 mg/L (Bonferroni t-test, P=0.05). Comparison of the reproduction values between the different gruops showed that the mean value recorded at 1000 mg/L was significantly lower than those of all other groups Tukey test, P=0.05). Only the effect recorded at 1000 mg/L should be considered as a biologically significant effect.

The LC50-values for parental mortality and the EC50 values for reproduction, the lowest observed effect concentrations (LOEC) and the no observed effect concentrations (NOEC) are shown below:

Parameter	Concentration (mg/L)
21-day LC50 for parental mortality	greater than 1000
LOEC for parental mortality	greater than 1000
NOEC for parental mortality	greater or equal to 1000
12-day EC50 for reproduction*1	822
14-day EC50 for reproduction1*1	809
18-day EC50 for reproduction*1	740
21-day EC50 for reproduction*1	628
LOEC for reproduction	1000
NOEC for reproduction	320
Overall LOEC	1000
Overall NOEC	320

*1: Based on linear regression analysis

Validity criteria fulfilled:

yes

Conclusions:

In this reproduction study FeNaEDDHMA had no effect on the survival of Daphnia magna at concentrations up to and including 1000 mg/L. A biologically relevant effect on reproductive capacity of Daphnia magna was noted at 1000 mg/L.

Executive summary:

The effects of the FeNaEDDHMA on survival and reproductive Performance in Daphnia magna during 21 days of exposure were investigated in an OECD guideline No. 211 "Daphnia magna Reproduction Test".

The nominal concentrations tested were 10, 32, 100, 320 and 1000 mg/L. Duration of the study was 21 days and the test solutions were renewed three times a week. 10 neonate daphnia for the test concentrations and 20 neonate daphnia for the control group were investigated. At the start of the test and every workday, the condition of the parental daphnia was recorded and during the reproduction phase the number of living offspring, immobile young and the presence of unhatched eggs were recorded. During the study duplicate samples of 10 ml were taken from freshly prepared solutions on days 0, 7, 14 and 19, from 72-hour old solutions on day 3 and from 48-hour old solutions on day 21. Samples were stored in a deep-freeze until possible anaiysis.

Analysis of the samples showed that the method of preparation of test media provided repeatable recoveries of test substance concentration. Measured concentrations were all in agreement with nominal, except for those measured in the samples taken at 1000 mg/L (85% - 89%) during the 2 -day period after the last renewal. Further, the measured concentrations were stable during the periods between renewals of the test solutions.

No mortality or other visible effects were recorded for the parental organisms at any of the test item concentrations tested.During the total exposure period of 21 days, no significant (greater than 10%) immobilisation (including mortality) of newborn young was observed at any of the test concentrations.

In conclusion the FeNaEDDHMA had no effect on the survival of Daphnia magna at concentrations up to and including 1000 mg/L in this reproduction study. The test item affected the reproductive capacity of Daphnia magna at concentrations of 320 and 1000 mg/L. A biologically relevant effect on reproductive capacity of Daphnia magna was noted at 1000 mg/L.

Reference 2

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:

Read across justification is attached in chapter 13.

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

320 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

>= 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Description of key information

NOEC(21d) = 320 mg/L (measured) for reproductive output of Daphnia magna (OECD 211, read across)

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

320 mg/L

Additional information

Since no studies are available on invertebrate toxicity of Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and phenol, iron sodium salts (CAS No. 84539-55-9), the assessment was based on a study conducted with source substance N,N'-Bis(2-hydroxy-4-methylphenyl)ethylenediamine diacetic acid, ferric-sodium complex (CAS No. 149057-66-9) in a read across approach. This is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. Grouping of substance and read across approach. Further justification for suitability of read across between target and source substance is given in the read across justification document attached to chapter 13.

The key study was performed according to OECD 211 and GLP using Daphnia magna as test organism (Bogers 1995). Concentrations between 10 and 1000 mg/L were tested. Test concentrations were analytically verified. No treatment showed significant differences to the control regarding mortality of parent animals. The substance affected the reproductive capacity at concentrations of 320 and 1000 mg/L. However, only the effect recorded at 1000 mg/L can be considered as a biologically significant effect. Thus, the 21d-NOEC is determined to be 320 mg/L based on nominal concentrations.

Based on the suitability of the read across this can also considered to be true for Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and phenol, iron sodium salts (CAS No. 84539-55-9).