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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:
key study
Study period:
7 September 1987 - 11 September 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
No analytical monitoring was performed.
Qualifier:
equivalent or similar to
Guideline:
other: German national standard DIN 38 412, Part 15
Deviations:
yes
Remarks:
Test period 96 h instead of 48 h
GLP compliance:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): 3-Methoxypropylamin
- Analytical purity: 99%
- Other: Test substance nr.: 87/334
Analytical monitoring:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The product was added to the test medium without any pre-treatment.
Test organisms (species):
Leuciscus idus
Details on test organisms:
TEST ORGANISM
- Common name: Golden orfe
- Source: Fischzucht Paul Eggers, Hohenwestedt, Germany
- Length at study initiation (length definition, mean, range and SD): 5.1 cm (range : 4.8 - 5.7 cm)
- Weight at study initiation (mean and range, SD): 1.8 g (range: 1.4 - 2.7 g)
- Feeding during test: withdrawal one day before and during test

ACCLIMATION
- Acclimation period: 3 days
- Type and amount of food: Growing feed F/B50, Ssniff Spezialdiaeten GmbH, Soest, Germany. Ad libitum.
- Feeding frequency: daily
- Health during acclimation (any mortality observed): 0.1% during the last 2 weeks of housing
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
2.5 mmol/L
Test temperature:
20 ± 1 °C
pH:
At t=1h in non-neutralised solutions in control, 46.4, 100, 215, 464 and 1000 mg/L:
pH 8.0, 9.7, 10.0, 10.7, 10.8, 11.1
At t=1h in neutralised solution (1000 mg/L):
pH 7.4
At t=96h in non-neutralised solutions in control, 46.4 and 100 mg/L:
pH 8.0, 8.3, 8.1
At t=96h in neutralised solution (1000 mg/L):
pH 7.6
Dissolved oxygen:
7.1 - 8.6 mg/L
Nominal and measured concentrations:
Nominal concentrations in non-neutralised test medium (mg/L): Control, 46.6, 100, 215, 464, 1000
Nominal concentration in neutralised test medium: 1000
Details on test conditions:
TEST SYSTEM
- Test vessel: glass aquaria (30 cm x 22 cm x 24 cm)
- Fill volume: 10 L
- Aeration: slight
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 1.8 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted freshwater according to DIN 38 412, part 11, draft Sept. 1981
- Conductivity: max. 10 µMHO
- Ca/mg ratio: 4:1

OTHER TEST CONDITIONS
- Photoperiod: 16 h light: 8 h darkness

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

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.2
- Results used to determine the conditions for the definitive study: LC50 (96 h) > 10 < 100 mg/L (non-neutralised test medium)
Reference substance (positive control):
yes
Remarks:
chloroacetamide
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: not neutralised
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: not neutralised
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
146.6 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: not neutralised; geometric mean of LC0 and LC100
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
215 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: not neutralised
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: neutralised
Details on results:
In non-neutralised solutions, a concentration dependent increase in pH was observed, resulting in pH levels outside the recommended range for standard test species (6.0-8.5). The observed mortality was therefore affected by the pH increase. Since no mortality was observed in a neutralised solution of 1000 mg/L, it can be concluded that the observed mortality was due to the pH effect only.
Results with reference substance (positive control):
- Results with reference substance valid? yes
- LC50: ca 32 mg/L after 48 h

Nominal concentration (mg/L)

Cumulative mortality after x hours

 

1

4

24

48

72

96

Control

0

0

0

0

0

0

46.4

0

0

0

0

0

0

100

0

0

0

0

0

0

215

1

10

10

10

10

10

464

10

10

10

10

10

10

1000

10

10

10

10

10

10

1000 neutralised

0

0

0

0

0

0

 

Nominal concentration (mg/L)

Symptoms of intoxication after x hours

 

1

4

24

48

72

96

Control

0

0

0

0

0

0

46.4

0

0

0

0

0

0

100

0

0

0

0

0

0

215

NT

-

-

-

-

-

464

-

-

-

-

-

-

1000

-

-

-

-

-

-

1000 neutralised

0

0

0

0

0

0

Symptoms:

N = narcotic like state

T = tumbling

- = all fish dead

 

For evaluation of the effect of the relatively high pH, the highest substance concentration (1000 mg/L) was investigated after pH adjustment with hydrochloric acid. After pH adjustment 1000 mg/L was tolerated without mortality and symptoms.

Nominal concentration (mg/L)

pH after x hours

 

1

24

48

72

96

Control

8.0

7.0

8.0

7.9

8.0

46.4

9.7

8.2

8.2

8.1

8.3

100

10.0

9.0

8.0

8.1

8.1

215

10.7

-

-

-

-

464

10.8

-

-

-

-

1000

11.1

-

-

-

-

1000 neutralised

7.4

7.5

7.6

7.6

7.6

 

Nominal concentration (mg/L)

Oxygen content after x hours

 

0

24

48

72

96

Control

7.1

7.8

8.1

8.0

8.2

46.4

7.2

8.3

8.4

8.2

8.6

100

7.2

7.8

8.1

7.8

8.1

215

7.4

-

-

-

-

464

7.8

-

-

-

-

1000

7.5

-

-

-

-

1000 neutralised

7.2

8.1

8.3

8.3

8.3

Validity criteria fulfilled:
yes
Conclusions:
The key study, originally performed by BASF (1987) uses Leuciscus idus (golden orfe) as test species. The acute test according to German Industrial Standard DIN 38412 part 15 (similar to OECD TG 203) results in an LC50 of 146.6 mg/L after 96 hours (based on nominal concentrations). The observed mortality was however due to the pH increase caused by the test substance, resulting in initial pH levels outside the recommended range for the test species. Since no mortality was observed in a neutralised test solution at 1000 mg/L, the observed mortality was due to the increased pH only.
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
02 November 1987 - 06 November 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
No analytical monitoring was performed.
Qualifier:
according to
Guideline:
other: German national standard DIN 38 412, part L15
GLP compliance:
no
Specific details on test material used for the study:
- Name of test material (as cited in study report): 2-ethoxyethylamine
- Physical state: liquid
- Analytical purity: >99 %
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 pre-treatment; subsequently the fish were placed into the aquaria.
- Controls: negative control
- Evidence of undissolved material (e.g. precipitate, surface film, etc): The test solutions became cloudy from the concentration 100 mg/L onwards.
Test organisms (species):
Leuciscus idus
Details on test organisms:
TEST ORGANISM
- Common name: Golden orfe
- Strain: Leuciscus idus L. (golden variety)
- Source: Fish farm Paul Eggers, 2354 Hohenwestedt, Germany
- Length at study initiation (length definition, mean, range and SD): 5.3 cm (range 4.7 - 5.7 cm)
- Weight at study initiation (mean and range, SD): 3.7 g (range 2.1 - 4.9 g)
- Feeding during test: no
- Frequency: Withdrawal of food before exposure: 1 day


ACCLIMATION
- Acclimation period: 5 weeks
- Acclimation conditions (same as test or not): oil-free aerated and charcoal filtered tap water, flow-through system
Water temperature: 20 °C
Duration of housing: about 5 weeks
Acclimation to test water and test temperature: 3 days

- Type and amount of food: Growing feed F/B 50
- Feeding frequency: ad libitum.
- Health during acclimation (any mortality observed):
Mortality during the last 2 weeks of housing: 0.03 %
Mortality during the acclimation period: 0 %
Medical treatment: twice with 0.05 mg/L malachite green chloride, once with 10 mg/L tetracycline hydrochloride
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
2.5 mmol/L
Test temperature:
20 - 21 °C
pH:
At t=1h in non-neutralised solutions in control, 21.5, 46.4, 100, 215, 464, 1000 mg/L:
pH 8.1, 9.0, 9.4, 9.7, 10.0, 10.3, 10.6
At t=1h in neutralised solution (1000 mg/L):
pH 8.7
At t=96h in non-neutralised solutions in control, 21.5, 46.4 mg/L:
pH 8.1, 7.8, 7.9
Dissolved oxygen:
7.0 - 8.4 mg/L
Nominal and measured concentrations:
Nominal: Control, 21.5, 46.4, 100, 215, 464, 1000 mg/L (non-neutralised solutions)
Nominal: 1000 mg/L (neutralised solution - pH adjusted with HCl)
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): aquaria open
- Material, size, fill volume: glass, 30 x 22 x 24 cm, 10 L
- Aeration: 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: 3.7 g fish/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted freshwater according to DIN 38412, part 11
- Ca/Mg ratio: 4 : 1

OTHER TEST CONDITIONS
- Adjustment of pH: one test item concentration of 1000 mg/L was pH adjusted
- Photoperiod: 16:8 hour light:dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): mortality, symptoms: 1, 24, 48, 72, and 96 hours

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2

TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: not applicable
- Range finding study
- Test concentrations: range-fiding test: 10, 100, 1000 and 10000 mg/L
- Results used to determine the conditions for the definitive study: LC50 after 96 h between 100 and 1000 mg/L
Reference substance (positive control):
yes
Remarks:
Chloroacetamide
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
68.12 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: geometrical mean value (0% effect: 46.4 mg/L; 100% effect: 100 mg/L); not pH-adjusted
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
46.4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Behavioural abnormalities: apathy, tumbling
- Mortality of control: 0%
- Effect concentrations exceeding solubility of substance in test medium: no
- Other: Mortality was not reduced after neutralisation of the test solution at 1000 mg/L. Mortality was 100% after 96 h in the pH-adjusted and the non-adjusted test solutions at 1000 mg/L.
Results with reference substance (positive control):
- Results with reference substance valid? Yes
- LC50: 26 mg/L after 48 h
Reported statistics and error estimates:
The data obtained were inadequate for the use of standard methods of calculating the LC50, therefore the highest concentration causing no mortality (46.4 mg/L) and the lowest concentration producing 100% mortality (100 mg/L) were used as an approximation for the LC50 (geometric mean of these two concentrations). This method is in accordance with the recent guideline OECD 203.

Cumulative mortality

Nominal conc. (mg/L)

Number of fish

Mortality (cumulated) after

1 h

24 h

48 h

72 h

96 h

0

10

0

0

0

0

0

21.5

10

0

0

0

0

0

46.4

10

0

0

0

0

0

100

10

0

8

10

10

10

215

10

0

10

10

10

10

464

10

10

10

10

10

10

1000

10

10

10

10

10

10

1000*

10

0

10

10

10

10

* = pH adjusted

 

pH values

Nominal conc. (mg/L)

pH values after

1 h

24 h

48 h

72 h

96 h

0

8.1

8.0

8.1

8.0

8.1

21.5

9.0

7.8

7.8

7.9

7.8

46.4

9.4

7.9

7.9

7.9

7.9

100

9.7

8.9

8.2

 

 

215

10.0

9.4

 

 

 

464

10.3

 

 

 

 

1000

10.6

 

 

 

 

1000*

8.7

8.5

 

 

 

* = pH adjusted

Oxygen content

Nominal conc.

(mg/L)

Oxygen content (mg/L)

1 h

24 h

48 h

72 h

96 h

0

8.2

8.1

8.4

8.0

8.7

21.5

7.8

7.5

7.6

7.8

8.3

46.4

8.0

7.2

7.6

7.9

8.4

100

8.2

7.2

7.4

 

 

215

8.1

7.3

 

 

 

464

8.4

 

 

 

 

1000

8.4

 

 

 

 

1000*

8.1

7.0

 

 

 

* = pH adjusted

-The neutralised sample (1000 mg/L) showed compared to the not neutralized sample (1000 mg/L) no other effect on the mortality.

Validity criteria fulfilled:
not specified
Conclusions:
The 96-h LC50 value for Leuciscus idus (golden orfe) was determined to be 68.12 mg/L. There was a concentration dependent increase of pH in the test media, with initial pH levels >= 9, which is outside of the recommended range and may have contributed to fish mortality. However, since mortality was 100% both in a solution of 1000 mg/L in which pH was neutralised and a similar solution without pH adjustment, an intrinsic toxic effect cannot be excluded, although it is not clear if this would also be the case at lower concentrations which are more relevant for classification and hazard assessment purposes (e.g. at 100 mg/L).
Endpoint:
short-term toxicity to fish
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Justification for type of information:
The experimental data from the acute toxicity study in Leuciscus idus with the related substance 2-ethoxyethylamine were included in the read across approach to support the read across justification. The read across justification document is included in IUCLID Section 13.
Reason / purpose:
read-across: supporting information
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
68.12 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: Experimental data on 2-ethoxyethylamine used to support the read across strategy.

Description of key information

Based on the results of the acute toxicity study with Leuciscus idus (golden orfe), 3-methoxy-1-propanamine is not considered to be harmful or toxic to fish.

Key value for chemical safety assessment

LC50 for freshwater fish:
146.6 mg/L

Additional information

The key study, originally performed by BASF (1987), uses Leuciscus idus (golden orfe) as test species. The acute test according to German Industrial Standard DIN 38412 part 15 (similar to OECD TG 203) results in an LC50 of 146.6 mg/L after 96 hours (based on nominal concentrations). The observed mortality was however due to the pH increase caused by the test substance, resulting in initial pH levels outside the recommended range for the test species. Since no mortality was observed in a neutralised test solution at 1000 mg/L, the observed mortality was due to the increased pH only.

To support the read across strategy, acute toxicity data for Leuciscus idus obtained for the related substance 2-ethoxyethylamine are added to the dossier as well. These data as well as the read across strategy are discussed in further detail in the read across justification document attached to IUCLID Section 13.