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Short-term toxicity to fish

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Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
12 November 1990 to 16 November 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test procedure according to national standard
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: German Industrial Standard DIN 38412, part 15
GLP compliance:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): 4,7,10-trioxatridecan-1,13-diamin
- Physical state: Liquid
- Analytical purity: 99%
- Other: - Test substance No.: 89/229
- Homogeneity: Ensured since the test substance is a genuine liquid.
- Solubility in water: Easily soluble
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The product was added to the test water without any pretreatment; subsequently the fish were placed into the aquaria.
Test organisms (species):
Leuciscus idus
Details on test organisms:
TEST ORGANISM
- Common name: Golden orfe (Leuciscus idus L., golden variety)
- Source: Paul Eggers, Hohenwestedt, Germany
- Length at study initiation (length definition, mean, range and SD): 7.0 cm (range: 6.5 - 7.8)
- Weight at study initiation (mean and range, SD): 3.4 g (range: 2.5 - 5.1)
- Feeding during test: none

ACCLIMATION
- Acclimation conditions (same as test or not): Oil-free aerated and charcoal filtered tap water, flow-through system
- Type and amount of food: Growing feed F/B 50, SSNIFF Spezialdiaten GmbH, Soest, Germany
- Feeding frequency: Ad libitum
- Health during acclimation (any mortality observed): No mortality observed
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Test temperature:
23°C - 24°C
pH:
7.5 - 11 (not neutralized test solution)
7.4 - 7.6 (neutralized test solution)
Dissolved oxygen:
4.9 - 7.8 mg/L (not neutralized test solution)
6.4 - 6.6 mg/L (neutralized solution)
Nominal and measured concentrations:
Nominal concentrations: control, 100, 215, 464, 1000; in addition 1000 mg/L was tested after neutralisation with hydrochloric acid.
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass aquaria (30 x 22 x 24 cm)
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 10 L
- Aeration: Continuous aeration with oil-free air
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 3.4 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted freshwater according to DIN 38412, part 11, October 1982
- Intervals of water quality measurement: Oxygen content, pH-value and temperature were measured after 1, 24, 48, 72 and 96 hours of test duration.

OTHER TEST CONDITIONS
- Adjustment of pH: yes
- Photoperiod: 16:8 day-night regime

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality and symptoms of intoxication after 1, 4, 24, 48, 72 and 96 h

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.2
- Range finding study: yes
- Results used to determine the conditions for the definitive study: 96-h LC50 was between 100 and 1000 mg/L
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Remarks on result:
other: neutralized test solution
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Remarks on result:
other: non-neutralized test solution
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Remarks on result:
other: non-neutralized test solution
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 215 - < 464 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Remarks on result:
other: non-neutralized test solution
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
464 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality (fish)
Remarks on result:
other: non-neutralized test solution
Details on results:
- Behavioural abnormalities: Apathy, hyperreflexia, narcotic-like state, restlessness, tumbling
- Other biological observations: Severe mucous secretion from the fish were visible in the aquaria containing 464 and 1000 mg/L test substance,
obviously caused by the high pH.
- After neutralisation, no mortality occurred in the highest test concentration (1000 mg/L).
Sublethal observations / clinical signs:

Mortality

Nominal conc. (mg/L)

Number of fish

Dead fish after

1 h

4 h

24 h

48 h

72 h

96 h

100

10

0

0

0

0

0

0

215

10

0

0

2

2

2

2

464

10

1

2

10

10

10

10

1000

10

10

10

10

10

10

10

 

0

10

0

0

0

0

0

0

1000*

10

0

0

0

0

0

0

* test solution after pH-adjustment

To study the effect of the high pH on the toxicity the concentration 1000 mg/L was tested in parallel after pH-adjustment using hydrochloric acid. No mortality was observed after pH-adjustment. In contrast, after 24 h all fish were dead when a non-neutralized test item solution (464 mg/L) was tested. Hence, observed effects were caused by the pH shift in the test medium.

Symptoms

Nominal conc. (mg/L)

Symptoms

1 h

4 h

24 h

48 h

72 h

96 h

100

 

 

 

 

 

 

215

 

 

(A)

(A)

 

 

464

AN

ANT

 

 

 

 

1000

 

 

 

 

 

 

0

 

 

 

 

 

 

1000*

 

 

(U,H)

(U)

 

 

* test solution after pH-adjustment

A = apathy N = narcotic-like state T = tumbling H = hyperreflexia U = restlessness

Water quality measurement

Nominal

conc.

(mg/L)

pH

1 h

24 h

48 h

72 h

96 h

100

9.9

7.9

7.7

7.7

7.7

215

10.4

9.4

8.2

7.8

7.8

464

10.7

10.4

1000

11.0

 

 

 

 

0

7.8

7.7

7.7

7.5

7.5

1000*

7.6

7.4

7.4

7.5

7.5

*test solution after pH-adjustment

Nominal

conc.

(mg/L)

oxygen content (mg/L)

1 h

24 h

48 h

72 h

96 h

100

7.1

6.0

5.7

5.8

5.7

215

6.6

5.8

4.9

5.4

5.6

464

7.4

7.8

 

 

 

1000

7.5

 

 

 

 

0

7.1

5.2

5.2

5.2

5.1

1000*

6.6

6.6

6.5

6.6

6.4

*test solution after pH-adjustment

Nominal

conc.

(mg/L)

temperature

1 h

24 h

48 h

72 h

96 h

100

24

24

24

24

24

215

24

23

24

24

24

464

24

24

 

 

 

1000

24

 

 

 

 

0

24

24

24

24

24

1000*

24

24

24

24

24

*test solution after pH-adjustment

Validity criteria fulfilled:
not specified
Conclusions:
In conclusion, the 96h-LC50 for Golden orfe (Leuciscus idus L., golden variety) exposed to 3,3'-oxybis(ethyleneoxy)bis(propylamine), has been determined to be > 1000 mg/mL based on mortality in a neutralized test solution.
Executive summary:

The 96h-LC50 for Golden orfe (Leuciscus idus L., golden variety) exposed to 3,3'-oxybis(ethyleneoxy)bis(propylamine), has been investigated in a non-GLP study performed to the guideline German Industrial Standard DIN 38412, part 15 and has been determined to be > 1000 mg/mL based on mortality in a neutralized test solution.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Remarks:
Read across to Maleic Anhydride
Adequacy of study:
weight of evidence
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Maleic anhydride hydrolyzes under test conditions. As a result, maleic acid and its salts are believed to be the test materials investigated in this study.
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: EPA Methods for Acute Toxicity Tests with fish, macroinvertebrates and amphibians (EPA-660/3-75-009)
Deviations:
not specified
GLP compliance:
not specified
Remarks:
GLP-like but predates GLP regulations
Specific details on test material used for the study:
Maleic anhydride hydrolyzes under test conditions. As a result, maleic acid and its salts are believed to be the test materials investigated in this study.
Analytical monitoring:
no
Details on test solutions:
Nominal concentrations (mg/L): 0, 10, 18, 32, 56, 100
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
- Salmo gairdneri (Rainbow Trout) from Trout Lodge, Washington (USA)
- Mean length: 41 mm
- Mean weight: 1.1 g.
- Fish were fed standard commercial fish food daily until 48 hours prior to testing, at which time feeding was discontinued
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
no
Hardness:
The dilution water total hardness was 40 to 45 mg/liter as CaCO3, the total alkalinity was 30 to 35 mg/liter as CaCO3.
Test temperature:
12 °C; maintained via water bath.
pH:
- start: 3.3 (highest concentration) to 7.6
- end: 5.2 to 6.8 (no measurements in the 100 mg/liter vessels were made after initial readings). The pH values decreased with increasing test compound concentrations)
Dissolved oxygen:
start: 8.8 to 9.4 mg/liter
end: 5.8 to 7.2 mg/liter
Salinity:
not applicable
Details on test conditions:
TEST SYSTEM
- Test vessel: 5-gallon glass vessels with 15 liters media
- No. of organisms per vessel: 10 fish per treatment

OTHER TEST CONDITIONS
- Adjustment of pH: no


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality at 24,48 and 96 hours

TEST CONCENTRATIONS
- Spacing factor for test concentrations: ca. 1.8
- Test concentrations: nominal 0, 10, 18, 32, 56, 100 mg/L
Reference substance (positive control):
yes
Remarks:
Antimycin A was used as a reference compound on a separate group of fish with 96-hour LC50 of 0.000042 mg/L which was reported to be within the 95% confidence intervals reported in the literature.
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
75 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% conf. interval = 56 to 100 mg/L
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
75 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% conf. interval = 56 to 100 mg/L
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
75 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% conf. interval = 56 to 100 mg/L
Details on results:
- Behavioural abnormalities: no data
- Observations on body length and weight: Mean length 41 mm, mean weight 1.1 g.
- Other biological observations: no data
- Mortality of control: no martality was observed
- Other adverse effects control: no data
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no data
- Effect concentrations exceeding solubility of substance in test medium: no
Results with reference substance (positive control):
Antimycin A was used as a reference compound on a separate group of fish with 96-hour LC50 of 0.000042 mg/L which was reported to be within the 95% confidence intervals reported in the literature.
Reported statistics and error estimates:
Statistical methods: Stephen et al. calculation of LC50 and 95% confidence limits using the binomial, moving average and probit tests. For confidence intervalls see. Effect concentrations.
Validity criteria fulfilled:
not specified
Conclusions:
Maleic anhydride hydrolyzes under test conditions. As a result, maleic acid and its salts are believed to be the test materials investigated in this study. The derived lethal concentrations are:
24 hr LC50 = 75 mg/L
48 hr LC50 = 75 mg/L
96 hr LC50 = 75 mg/L
Executive summary:

Maleic anhydride hydrolyzes under test conditions. As a result, maleic acid and its salts are believed to be the test materials investigated in this study.

The derived lethal concentrations are:

24 hr LC50 = 75 mg/L;

48 hr LC50 = 75 mg/L;

96 hr LC50 = 75 mg/L.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Remarks:
Read across to Maleic Anhydride
Adequacy of study:
weight of evidence
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
Maleic anhydride hydrolyzes under test conditions. As a result, maleic acid and its salts are believed to be the test materials investigated in this study.
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: EPA Methods for Acute Toxicity Tests with fish, macroinvertebrates and amphibians (EPA-660/3-75-009)
GLP compliance:
not specified
Remarks:
GLP-like but predates GLP regulations
Specific details on test material used for the study:
Maleic anhydride hydrolyzes under test conditions. As a result, maleic acid and its salts are believed to be the test materials investigated in this study.
Analytical monitoring:
no
Test organisms (species):
Lepomis macrochirus
Details on test organisms:
- Lepomis macrochirus (Bluegill Sunfish) from Fattig Fish Hatchery, Brady, Nebraska (USA)
- Mean length: 17 mm
- Mean weight: 0.11 g
- Fish were fed standard commercial fish food daily until 48 hours prior to testing, at which time feeding was discontinued
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
The dilution water total hardness was 40 to 45 mg/liter as CaCO3, the total alkalinity was 30 to 35 mg/liter as CaCO3.
Test temperature:
22 +- 1°C; maintained via water bath.
pH:
- start: 3.3 (highest concentration) to 7.6
- end: 5.2 to 6.8 (no measurements in the 100 mg/liter vessels were made after initial readings). The pH values decreased with increasing test compound concentrations)
Dissolved oxygen:
start: 8.8 to 9.4 mg/liter
end: 5.8 to 7.2 mg/liter
Salinity:
not applicable
Nominal and measured concentrations:
Nominal concentrations (mg/L): 0, 10, 18, 32, 56, 100
Details on test conditions:
TEST SYSTEM
- Test vessel: 5-gallon glass vessels with 15 liters media
- No. of organisms per vessel: 10 fish per treatment

OTHER TEST CONDITIONS
- Adjustment of pH: no

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality at 24,48 and 96 hours

TEST CONCENTRATIONS
- Spacing factor for test concentrations: ca. 1.8
- Test concentrations: nominal 0, 10, 18, 32, 56, 100 mg/L
Reference substance (positive control):
yes
Remarks:
Antimycin A was used as a reference compound on a separate group of fish with 96-hour LC50 of 0.000084 mg/L which was reported to be within the 95% confidence intervals reported in the literature.
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
75 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% conf. interval = 56 to 100 mg/L
Remarks:
Results are the same for 24h and 48h.
Details on results:
- Behavioural abnormalities: no data
- Observations on body length and weight: Mean length: 17 mm, mean weight: 0.11 g.
- Other biological observations: no data
- Mortality of control: no martality was observed
- Other adverse effects control: no data
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no data
- Effect concentrations exceeding solubility of substance in test medium: no
Results with reference substance (positive control):
Antimycin A was used as a reference compound on a separate group of fish with 96-hour LC50 of 0.000084 mg/L which was reported to be within the 95% confidence intervals reported in the literature.
Reported statistics and error estimates:
Statistical methods: Stephen et al. calculation of LC50 and 95% confidence limits using the binomial, moving average and probit tests. For confidence intervalls see. Effect concentrations.
Validity criteria fulfilled:
not specified
Conclusions:
Maleic anhydride hydrolyzes under test conditions. As a result, maleic acid and its salts are believed to be the test materials investigated in this study. The derived lethal concentrations are:
24 hr LC50 = 75 mg/L
48 hr LC50 = 75 mg/L
96 hr LC50 = 75 mg/L
Executive summary:

Maleic anhydride hydrolyzes under test conditions. As a result, maleic acid and its salts are believed to be the test materials investigated in this study.

The derived lethal concentrations are:

24 hr LC50 = 75 mg/L;

48 hr LC50 = 75 mg/L;

96 hr LC50 = 75 mg/L.

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Values determined according to DIN 38412 Part 15
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
other: Deutsche Einheitsverfahren zur Wasser-, Abwasser- und Schlammuntersuchung. L15: Bestimmung der Wirkung von Wasserinhaltsstoffen auf Fische - Fischtest. DIN 38 412 Teil 15.
GLP compliance:
not specified
Test organisms (species):
Leuciscus idus
Details on test organisms:
no data
Water media type:
freshwater
Total exposure duration:
48 h
Post exposure observation period:
no data
Reference substance (positive control):
not specified
Duration:
48 h
Dose descriptor:
LC0
Effect conc.:
100 mg/L
Nominal / measured:
not specified
Conc. based on:
not specified
Basis for effect:
mortality (fish)
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
106 mg/L
Nominal / measured:
estimated
Conc. based on:
not specified
Basis for effect:
not specified
Duration:
48 h
Dose descriptor:
LC100
Effect conc.:
112 mg/L
Nominal / measured:
not specified
Conc. based on:
not specified
Basis for effect:
not specified
Validity criteria fulfilled:
not specified
Conclusions:
LC50 48h = 106 mg/L
Executive summary:

In conclusion, the LC50 48h has been determined to be 106 mg/L.

Endpoint:
short-term toxicity to fish
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
other information
Justification for type of information:
The read-across prediction was based upon the data available on the source substances. The two source substances Maleic Acid and 3,3'-oxybis(ethyleneoxy)bis(propylamine 4,7,10-Trioxatridecan-1,13-diam are mixed together in water in a 2:1 ratio to form the target substance. The only differences are the charged species and that the target substance only exists in an aqueous solution. The source and target substances are all mono-constituent substances. The remaining source substance, Maleic Anhydride was used because this is the substance that can be found in the disseminated ECHA dossier for Maleic Acid, and that Maleic Anhydride hydrolyses under test conditions. As a result, it is believed that Maleic Acid and its salts were the test materials investigated in the studies.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source

Description of key information

Read across values from the most suitable substances (Maleic Acid and 3,3'-oxybis(ethyleneoxy)bis(propylamine) have been used for classification.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
106 mg/L

Additional information