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

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

key study

Study period:

24 feb - 23 mar 1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Done under GLP and with chemical analyses, however no certificate of analysis.

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 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

During the final test duplicate samples were taken from each vessel containing 1000 mg/l and the control
Sampling:
Frequency: at t=0h (09-03-1992) and t=96h (13-03-1992).
Volume: 10 ml from the approximate centre of the test vessels.
Storage: the samples taken on 09-03-1992 were stored at -20°C until analysis on 13-03-1992.

Additionally, reserve samples of 25 ml were taken. These samples were stored at -20°C for possible analysis. The method of analysis is described in
the appended Analytical Report

Details on test solutions:

Three test solutions containing a nominal concentration of 1000 mg/l were prepared separately. Weighed amounts of test substance
(3006.2, 3002.0 and 3003.3 mg) were added quantitatively to 3000 ml DSW. The final test solutions were all clear and dark red coloured without
precipitation.

Test organisms (species):

Cyprinus carpio

Details on test organisms:

Species: Carp (Cyprinus carpio; Teleostei, Cyprinidae) (Linnaeus, 1758)
Source: Zodiac, proefacc, "De Haar Vissen, L.U. Wageningen, the Netherlands.
Mean length: 2.41 ± 0.18 cm
Mean weight: 0.20 ± 0.05 g
Characteristics: Pathogen-free F1 from a single parent-pair.
Reason for selection: This system has been selected as an internationally accepted species.
Total fish used: 70
Feeding: Daily with Trouvit or Artemia.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

yes, after 96 hour the fish were transferred into fresh DSW to observe other effects. The fish were normal except for discoloration of the skin. This
discoloration was possibly related with the dark red colour of the test solutions.

Hardness:

Dilution water: 210 mg/L CaCO3

Test temperature:

20.5-21.5 ºC

pH:

8.0-8.4

Dissolved oxygen:

9.6-10.7 mg O2/L

Salinity:

no data

Nominal and measured concentrations:

Nominal Concentrations: 1000 mg/L
Analyses confirmed concentration to be between 95-102 % of nominal concentration. (i.e. 952 - 1017 mg/L)

Details on test conditions:

Test duration: 96 hours
Test type: static
Test vessels: 5 litres, all-glass.
Test medium: Dutch standard water (DSW)

Test concentration: The final test was a limit study exposing carp to 1000 mg/l, i.e. the maximum concentration to be tested.
Control: Test medium without test substance or other additives (0 mg/l).
Number of fish: Test concentration: 30 fish, Controls: 10 fish.
Loading: 0.7 g fish/litre, i.e. 10 fish per 3 litres of test medium.
Illumination: 16 hours photoperiod daily
Aeration: The test media were aerated continuously.
Feeding: No feeding from 24 hours prior to the test and during the total test period.
Introduction of fish: Directly after preparation of the test media fish were introduced into the test medium, provided that the temperature of the
medium was within the optimal range.

Reference substance (positive control):

yes

Remarks:

pentachlorophenol

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

1 000 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

no mortality at the highest tested concentration thus 96-h LC50 > 1000 mg/L

Results with reference substance (positive control):

pentachlorophenol LC50 is between 0.32 and 0.56 mg/L

Validity criteria fulfilled:

yes

Conclusions:

The 96-h LC50 is in excess of 1000 mg/L

Executive summary:

96 -hour Acute Toxicity Study in the Carp with FeEDDHMANa.

Analysis of samples from a vessel containing 10 mg/L during the range finding test revealed that FeEDDHMANa was stable under test conditions for at least 96 hours. The final study was a limit test, because no toxicity was observed in the range-finding test. In this limit test 3 x 10 fish were exposed for 96 hours in a static system. Analysis of samples taken at the start of the final test revealed that the initial actual concentrations were in agreement with the nominal concentration of 1000 mg/L. Over a period of 96 hours, the actual concentrations remained constant. Under these conditions, FeEDDHMANa did not induce any significant acute effects in carp at the exposure concentration of 1000 mg/L. Hence, the 96h-LC50 for carp exposed to FeEDDHMANa was greater than 1000 mg/L, the maximum concentration to be tested.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

supporting study

Study period:

3-7 September 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Preliminary test became final GLP test, incl analysis. Conc steps therefore not according to guideline, not all data given (weight of fish), no CoA.

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 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

conc steps not according to guidelines

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

Four test concentrations were chosen for analytical controls.
The analyses were performed prior to the initiation of the test and were repeated every 24 h.
In total, 20 analytical measurements were performed in the test.

Vehicle:

no

Details on test solutions:

Test Medium:
Dechlorinated tap water from the SG dechlorination sytem with a hardness of 14 dH was
used as test water.

Test article:
A stock solution of 10 gil of EDDHMA Fe K was prepared with purified water. For the
concentration levels of 1000 mgll to 1 mg/l the actual test concentrations were achieved by
dilution of the stock solution with dechlorinated tap water.
Additionally, a concentration containing 10 gil was prepared by adding the test article directly
to the test aquaria.
In the preliminary test, test solutions were prepared only once prior to the initiation of the test.

9 liters each of dechlorinated tap water were placed in 12 1 test vessels. For each
concentration level, 11 of a ten-fold concentrated test solution was prepared from the test
article stock solution, using a 1000 ml volumetric. Subsequently, this solution was added to
the test aquaria. To yield the highest concentration of 10 gil, 100 g of the test article were
suspended in 1000 ml of test water and added to the aquaria.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

The fish were obtained from the supplier on the 9th of May, 1990. Prior to the initiation of the test, the fish were acclimatized for a minimum of 14 days in 500 I polypropylene containers with permanent flow through of fresh water and ventilation. Beyond this, the fish were kept
under identical conditions for their entire holding period. Daily controls regarding the temperature, the 02 concentration and the pH-value were
performed. There were no mortalities during this period. The total length of the fish was 3 - 5 cm.

Holding Conditions:
Temperature: 15 C± 1.5 °c
02 - Conc.: at least 60 % of air saturation (ca. 6.0 mg 02/l)
pH- Value: 7.0 - 8.5
Hardness: 14 dH
Exposure to light: 16 h daily
Light intensity: 600 - 800 Lux
Feeding: every 4 hours with trout pellets (BEMO), 0.5 % of their body weight

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

No

Hardness:

Dechlorinated tap water from the SG dechlorination sytem with a hardness of 14 dH was
used as test water.

Test temperature:

15 C± 1.5 C
min -max : 14.8-17.5

pH:

8.0 ± 0.5
min -max : 8.02-8.32

Dissolved oxygen:

> 60% of air saturation (6.0 mg O2/L)
min- max: 7.5-9.9 mg/L

Salinity:

No data

Nominal and measured concentrations:

Nominal: 10, 100, 1000, 10000 mg/L
measured in % compared to nominal: min - max: 84.8% - 102.7%

Details on test conditions:

For each concentration two parallel 12 L test aquaria were prepared and 5 fish were added to each test container, containing 10 L.

Reference substance (positive control):

not specified

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

1 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

behaviour

Details on results:

100% mortality occurred at 10000 mg/L, zero mortality in all other concentration levels. Observation of fish in 100 and 1000 mg/L was not possible due to the deep red color of the test solutions. However, movement of fish in exposed animals seemed restricted to the lower part of the test vessel, fins of the fish showed a slight red colour at 10 mg/L.

Validity criteria fulfilled:

yes

Conclusions:

Although the author concludes a LC50 > 100 mg/L, at 1000 mg/L no mortalities were observed either.
It can thus be concluded that the LC50 is > 1000 mg/L, based on measured concentrations.

Executive summary:

In this study, fish were exposed for 96 h to EDDHMA FeK according to the OECD 203 guideline test, using rainbow trout (salmo gairdneri) as test specieds. 10 fish were used per test concentration (10 -100 -1000 -10000 mg/L), two replicates of 5 fish.

In the preliminary test, a mortality of 100 % was observed for a concentration of 10 000 mg/l. At 1000 mg/l of EDDHMA Fe K no mortalities were noted. Due to these results, the preliminary test could be regarded as a Limit test. At concentration levels of 100 mg/l and 1000 mg/l, no mortalities were observed. Because of the deep red colour of the test article solutions, an observation of the fish in these test aquaria was not possible.

The LC50 is concluded > 1000 mg/L based on measured concentrations, however due to observations on movement of fish being restricted to the lower part of the test vessels and colouration of fins at > 10 mg/L, a NOEC was concluded at 1 mg/L.

Description of key information

The acute toxicity of the structurally related UVCB EDDHMA-Fe to fish was investigated in carp and rainbow  trout. The LC50 for a 96 hour exposure was greater than 1000 mg/L for both species, however from the study with rainbow trout 100% mortality was observed at 10000 mg/L.

Additional information

- Key study by Bogers with EDDHMA-Fe, 1992 with carp:

Over a period of 96 hours, the actual concentrations remained constant. Under these conditions, EDDHMA-FeNa did not induce any significant acute effects in carp at the exposure concentration of 1000 mg/L. Hence, the 96h-LC50 for carp exposed to EDDHMA-FeNa was greater than 1000 mg/L, the maximum concentration tested.

- Additional study by Thun wirh EDDHMA-Fe, 1990 with rainbow trout:

In the preliminary test, a mortality of 100 % was observed for a concentration of 10 000 mg/L. At 1000 mg/l of EDDHMA Fe K no mortalities were noted. At concentration levels of 100 mg/l and 1000 mg/l, no mortalities were observed. Because of the deep red colour of the test article solutions, an observation of the fish in these test aquaria was not possible. The LC50 is concluded > 1000 mg/L based on measured concentrations, however due to observations on movement of fish being restricted to the lower part of the test vessels and colouration of fins at > 10 mg/L, a NOEC was concluded at 1 mg/L.

- Supporting study by Basf 2010 with EDDHA-Fe in zebrafish:

The test substance EDDHA-FeNa was tested at 120 mg/L, which was analytically confirmed. The 96 hour LC50 value for EDDHA-FeNa with the zebrafish (Danio rerio) 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 of analytically detemined concentrations. The 96 hour NOEC was determined to be greater than or equal to 120 mg/L.

- The supporting acute toxicity study by Ciba-Geigy (1978) with EDDHA-Fe to rainbow trout, carp, catfish and bluegill was performed according to the method reported by Bathe et al. (1974). Various concentrations of EDDHA-FeNa were prepared by adding the test material dissolved in aqua dest. (stock solution), at the appropriate amount ensuring that the total volume in each vessel remained the same. The LC50 for a 96 hour exposure was greater than 100 mg/L for Rainbow trout, Carp, Catfish and Bluegill.

- Additionally, a study investigating the acute toxicity of EDDHMA-Na4 to bluegill is given (Engstrom, 1986) as supporting evidence that these similar chelate structures have no high acute toxicity to fish. In this study the LC50 (96h) proved > 1420 mg/L the highest concentration tested, however some mortality was observed at this concentration.