Glycine, N,N'-1,2-ethanediylbis-, reaction products with formaldehyde, iron chloride (FeCl3) and phenol, potassium salts

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

3-27 September 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No CoA and some rather large differences at the start of the test with regard to temperature and O2. No analytical confirmation of control exposure, but analysis of test concentrations.

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
See chapter 13 for read across justification

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

Only three nominal concentrations were analysed prior to the initiation of the test (10, 1 and 0.1 g/L) and main test (10, 5.1 and 1.0 g/L).

Vehicle:

no

Details on test solutions:

Test medium:
Synthetic water prepared according to OECD Guideline 203
Test article:
For the preliminary test, two concentration levels of EDDHMA Fe K (10 g/l and 1 g/l) were prepared directly. The concentrations of 100 mg/l and 10 mg/l were prepared by dilution of the stock solution containing 1 g/l. The preliminary test was performed with 4 concentrations of the test aticle.
For the main test, a stock solution of 10 g/l EDDHMA Fe K was prepared with synthetic water. The concentration levels were achieved by dilution of the stock solution. The serial dilution factor was 1.4. The main test was performed with 8 concentrations of the test article.

Test organisms (species):

Daphnia magna

Details on test organisms:

The daphnia were kept at 1000 ml glass vessels with synthetic water. Every 24 h the daphnia were fed with unicellular green algae and a substitute medium (extract of fish pellets). The renewal of the holding water was done every 48 h.

Temperature: 18C - 20C
02 - Conc.: at least 80 % of air saturation
pH - Value: 7.0 - 8.5
Exposure to light: 16 h daily
Light intensity: ca.1000 Lux
Feeding: once daily
Treatment: none

In the preliminary and main test 4 groups of 5 daphnids were used per concentration.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Remarks on exposure duration:

Only one observation on effects was performed after 48 h

Hardness:

?

Test temperature:

20±2 C, 19.9 - 21.9 C

pH:

7.75 - 8.16

Dissolved oxygen:

> 60 % of air saturation (ca. 6.0 mg O2/L), 5.9 - 8.5 mg/L

Salinity:

?

Nominal and measured concentrations:

Main test:
Nominal: 10 , 7.1 , 5.1, 3.6, 2.6, 1.9, 1.4, 1.0 g/L,
measured conc: 9.6 (10), 4.7 (5.1), 0.99 (1.0) g/L prior to the initiation of the test.

Details on test conditions:

The test was performed in a RUMED cooled incubator under standardized conditions.
20 daphnia at each concentration, 4 groups of 5 animals, age 6- 24h
10 ml for 5 daphnia, in a 25 ml volumetric cylinder, 16h light regime at 1000 lux, no feeding during the test

Reference substance (positive control):

yes

Remarks:

K2Cr2O7, two concentrations (nominal 0.4, 1.4 g/L)

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

4.6 g/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 4.1- 6.0 g/L

Details on results:

From the preliminary test it was shown that one 1 daphnid was immobilised at 1 g/L, while at 10 g/L all daphnids were immobilised.
The main test was therefore carried out with conc in between, which clearly confirmed the data from the preliminary test.

Number of mobile daphnids
Conc substance Test vessel
in mg/l number 0 hours 48 hours
1 5 5
2 5 5
3 5 5
control 4 5 5
total 20 20
1 5 5
2 5 5
1.0 3 5 5
4 5 5
total 20 20
1 5 5
2 5 5
1.4 3 5 5
4 5 5
total 20 20
1 5 5
2 5 5
1.9 3 5 5
4 5 5
total 20 20
1 5 5
2 5 5
2.6 3 5 5
4 5 5
total 20 20
1 5 5
2 5 4
3.6 3 5 5
4 5 4
total 20 18
1 5 3
2 5 1
5.1 3 5 1
4 5 1
total 20 6
1 5 0
2 5 0
7.1 3 5 0
4 5 0
total 20 0
1 5 0
2 5 0
10 3 5 0
4 5 0
total 20 0

Results with reference substance (positive control):

Reference substance K2Cr2O7:

0.4 mg/L 18 daphnids alive (10% effect), 1.4 mg/L 0 daphnids alive (100% effect),
Thus an EC50 is in line with Techn Corrigendum to ISO 6341, stating EC50 between 0.6-2.1 mg/l after 24 hours

Validity criteria fulfilled:

yes

Conclusions:

In a valid OECD 202 test, the acute toxicity of EDDHMA FeK to daphnia was tested. The 48 hour EC50 was determined at 4.6 g/L test substance. Analytical measurements indicate actual concentrations were close to nominal (92-99%).

Executive summary:

In a valid OECD 202 test, the acute toxicity of EDDHMA FeK to waterfleas, Daphnia magna was tested. In a static test using 20 daphnids per concentration, 8 concentrations were used to determine the EC50. Concentrations tested were 1.0, 1.4, 1.9, 2.6, 3.6, 5.1, 7.1 and 10 g/L based on a preliminary test. The reference substance K2Cr2O7 was also included in two concentrations. Anaytical verification of concentrations was performed using a HPLC method. The 48 hour EC50 was determined at 4.6 g/L test substance, with 95% confidence intervals between 4.12 and 6.0 g/L. Analytical measurements indicate actual concentrations were close to nominal (92-99%). Due to strong coloration by the test substance only a 48h assessment was done.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Study period:

29 Jan - 24 Feb 1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Done under GLP, no chemical analyses and no certificate of analysis. Because no effect was observed in the test (and in anothor test (fish acute 96h) under almost identical conditions, analyses proved the substance to be stable for 96h), a reliability of 2 is applicable.

Justification for type of information:

REPORTING FORMAT FOR THE ANALOGUE APPROACH
See chapter 13 for read across justification

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

Principles of method if other than guideline:

no chemical analyses
temperature out of range (i.e. 1ºC) : this is considered not to have influenced the final results

GLP compliance:

yes

Analytical monitoring:

no

Details on sampling:

no chemical analyses

Details on test solutions:

The test media were prepared using a stock solution of 1000 mg/l by adding quantitatively 1004.6 mg of test substance to 1000 ml ISO-medium.
The final test solutions were all clear and red coloured without precipitation. Analysis of samples taken during the fish toxicity test with
FeEDDHMANa (RCC NOTOX Project 069503) showed that the procedure of preparation of exposure media resulted in actual concentrations of
95 to 101% relative to nominal. Furthermore, under these test conditions, FeEDDHMANa concentrations remained constant during at least 96 hours.

ISO medium:
CaCl2* 2H20 = 293.8 mg/L
MgS04* 7H20 = 123.3 mg/L
NaHC03 = 64.8 mg/L
KCl= 5.8 mg/L

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnia magna (Crustacea, Cladocera) (Straus, 1820) For the test selection of young daphnia with an age of <24 hours were selected.

Maximum age of the cultures: 4 weeks
Renewal of the cultures: After 7 days of cultivation half of the medium twice a week.
Temperature of medium: 18-22ºC, constant within ± 1°C
Feeding: Daily, a suspension of fresh water algae.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Post exposure observation period:

no

Hardness:

Dilution water: 250 mg/L CaCO3

Test temperature:

20.0 -23.0 ºC

pH:

8.1-8.2

Dissolved oxygen:

> 8.0 mg O2/L

Salinity:

no data

Nominal and measured concentrations:

nominal concentrations: 0 - 560 and 1000 mg/L

Details on test conditions:

Test type: Static
Test duration: 48 hours
Test vessels: 250 ml , all-glass
Medium: IS0
Number of daphnia: 20 per concentration
Loading: 10 per vessel containing 100 ml medium
Light: 16 hours photoperiod daily
Feeding: No feeding during the test
Test concentrations: Based on the results of the range-finding test: 560 and 1000 mg/l.
Control: Test medium without test substance or other additives (0 mg/l).
Introduction of young: The daphnia were introduced into the test daphnia medium directly after preparation of the test media.

Reference substance (positive control):

yes

Remarks:

potassium dichromate (K2Cr2O7)

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

>= 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

no chemical analyses performed, however in other study (i.e. LC50 fish acute) analyses showed substance to be stable for 96 hours under almost
identical conditions

Results with reference substance (positive control):

48h EC50 = 0.75 mg/L is within the expected range of 0.6 - 1.9 mg/L (n=60)

No immobile daphnia's in the test.

Validity criteria fulfilled:

yes

Conclusions:

Good quality study under GLP, however no chemical analyses and no certificate of analyses. The report states that the substance is 52% pure. Even
though there is absolutely no effect at the highest tested concentration, it is necessary to know what the remaining impurity’s are. Therefore
a certificate of analysis is necessary which covers 99.9% of the chemicals composition.

Executive summary:

Acute Toxicity Study in Daphnia magna with FeEDDHMANa.

Daphnia were exposed for a maximum of 48 hours to nominal concentrations of 560 and 1000 mg/L. The test was performed in duplicate with 10 daphnia per vessel. Under the conditions of the present study FeEDDHMANa did not induce significant acute immobilization of Daphnia magna at or below 1000 mg/L after 48 hours of exposure. Hence, the 48h-EC50 was greater than 1000 mg/L, being the No Observed Effect Level (NOEC) for mobility of Daphnia magna.

Description of key information

The acute toxic effects of the structurally related UVCB EDDHMA-Fe to Daphnia magna were investigated according to the principles of OECD-Guideline 202 and EU method C.2. The EC50 for a 48 hour exposure was 4.6 g/L based on the study with EDDHMA-Fe which provides a true EC50 value (Thun, 1990).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

4.6 g/L

Additional information

- Key study by Thun, 1990 with EDDHMA-Fe :

Concentrations tested were 1.0, 1.4, 1.9, 2.6, 3.6, 5.1, 7.1 and 10 g/L EDDHMA-FeK based on a preliminary test. The 48 hour EC50 was determined at 4.6 g/L test substance, with 95% confidence intervals between 4.12 and 6.0 g/L. Due to strong coloration by the test substance only a 48h assessment was done.

Since this study provides a true EC50 and is of equal or highest reliability, it is preferred over the other studies to be considered key.

- Supporting study by Bogers, 1992 with EDDHMA-Fe :

Under the conditions of the study EDDHMA-FeNa did not induce significant acute immobilization of Daphnia magna at or below 1000 mg/L after 48 hours of exposure. Hence, the 48h-EC50 was greater than 1000 mg/L, being the No Observed Effect Level (NOEC) for mobility of Daphnia magna.

- Supporting study by BASF, 2010 with EDDHA-Fe:

In the study the acute toxic effects of EDDHA-FeNa to Daphnia magna were determined according to the principles of OECD-Guideline 202 and EU method C.2. A limit test with a nominal concentration of 120 mg/L was carried out at a static system. The EC50 for a 48 hour exposure was greater than 120 mg/L based on the nominal concentration of the test substance and greater than 122 mg/L based on the mean measured concentrations.

- Additionally, a study investigating the acute toxicity of EDDHMA-Na4 is given (Engstrom, 1986) as supporting evidence that these similar chelate structures have no high acute toxicity to daphnids. In this study the EC50 (96h) proved > 1200, but < 2400 mg/L the highest concentration tested at which 100% mortality was observed. No clear EC50 could be determined.