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Short-term toxicity to fish

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Endpoint:
short-term toxicity to fish
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study with acceptable restrictions (no analytical verification)
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: SSA has an extremely low solubility in water. The test material was offered as 1.15% dispersion in water. The test concentrations were prepared by direct dilution from the 1.15% dispersion.
In the range - finding test 10, 100 and 1000 mg SSA/L were tested. In these dispersions SSA particles were available in suspension and on the bottom of the test vessels. In the definitive tests, a dispersion of 1000 mg/L was tested.
- Evidence of undissolved material: yes, small particles in dispersion
Test organisms (species):
Poecilia reticulata
Details on test organisms:
TEST ORGANISM
- Common name: Guppy
- Source: own breeding; Akzo Research Laboratories Arnhem, dept. CRL
- Age at study initiation: 4 -6 weeks
- Length at study initiation: 2 cm

Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
5.1 - 19.2 °dH
Test temperature:
23.5 -24.8°C
pH:
7.2 - 8.4
Dissolved oxygen:
6.5 - 9.0 mg/L
Nominal and measured concentrations:
Main test: Nominal concentration: 1000 mg/L (repeated due to problems in the fish population)

Range finding test with: 0, 1, 10, 100 , 1000 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type: open
- fill volume: 1 L
- Renewal rate of test solution (frequency): after 48 h
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.6 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline
The dilution water was a natural water front the aquarium in which the fish were kept. This aquarium was purified by a biological filtration system (including a mechanical filter, an aerobic sprinkling filter and an anaerobic nitrate removal (Minireef System)).
- Culture medium different from test medium: No
- Intervals of water quality measurement: after 48 and 96 hours

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 12 hours ambient light per day.
- Light intensity: not stated

EFFECT PARAMETERS MEASURED: mortality
Reference substance (positive control):
no
Duration:
96 h
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: undissolved test material in test medium

In the range finding test, no mortality occurred in the control and in the highest test concentration, In the definitive tests starting on 10.10.1988 and 5.12.1988, due to poor conditions in the fish culture, mortalities in the controls exceeded 10%, implying that the conditions for the validity of the test were not fulfilled. However, mortality in 1 g SSA/L was not significantly higher than in the control. After major improvement of the fish quality during December, the test was repeated in January. This time the quality criteria for the test have been fulfilled: the mortality in the control was <10% and the oxygen concentration were >60% of the air saturation value throughout the test. SSA was present in the test medium in an over—saturated suspension; the test confirmed that SSA is not acutely toxic to fish.

Results of acute toxicity on guppy:

 

Nominal concentrations

(mg/L)

number of animals surviving

% survival after 96 h

Date of test

0 h

24 h

48 h

72 h

96 h

0

1

10

100

1000

5

5

5

5

5

5

5

5

5

5

5

4

5

4

5

5

4

5

4

5

5

4

5

4

5

100

80

100

80

100

10.10.88

0

0

1000

1000

10

10

10

10

8

10

8

10

7

10

8

10

7

10

8

10

6

8

8

10

}70

 

}90

11.10.88

0

1000

10

10

 

10

9

10

8

10

7

10

7

80

70

05.12.88

0

1000

10

10

10

10

10

10

10

10

10

10

100

100

02.01.89

 

total survival:   in control: 37 out of 45 (82%)

in 1 g/L : 40 out of 45 (88%)

Endpoint:
short-term toxicity to fish
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please refer to the analogue justification attached to IUCLID section 13.
Reason / purpose:
read-across source
Duration:
96 h
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: undissolved test material in test medium
Conclusions:
LC50 (96 h) > 1000 mg/L for Poecilia reticulata (EU Method C.1)
Executive summary:

No data are available for the toxicity of (Z)-N-Octadec-9-enylhexadecan-1-amide (CAS No. 16260-09-6) towards fish. Therefore data from the analogue substanceN-octadecylstearamide (stearyl stearamide, CAS 13276-08-9)were used as read across. This read-across is in accordance with Regulation (EC) No. 1907/2006 Annex XI, 1.5 and justified in detail in the overall summary (IUCLID Chapter 6.1) and within the analogue justification attached in IUCLID Section 13.

The short-term toxicity ofN-octadecylstearamide (stearyl stearamide, CAS 13276-08-9)to fish was investigated in one study according to EU Method C.1 and following GLP principles (Balk, 1989). In this limit test, guppies (Poecilia reticulata) were exposed to a nominal concentration of 1000 mg/L under semi-static conditions.

Description of key information

LC50 (96 h) > 1000 mg/L for Poecilia reticulata (EU Method C.1)

Key value for chemical safety assessment

LC50 for freshwater fish:
1 000 mg/L

Additional information

No data are available for the toxicity of (Z)-N-Octadec-9-enylhexadecan-1-amide (CAS No. 16260-09-6) towards fish. Therefore data from the analogue substanceN-octadecylstearamide (stearyl stearamide, CAS 13276-08-9) were used as read across. This read-across is in accordance with Regulation (EC) No. 1907/2006 Annex XI, 1.5 and justified in detail in the overall summary (IUCLID Chapter 6.1) and within the analogue justification attached in IUCLID Section 13.

The short-term toxicity of N-octadecylstearamide (stearyl stearamide, CAS 13276-08-9) to fish was investigated in one study according to EU Method C.1 and following GLP principles (Balk, 1989). In this limit test, guppies (Poecilia reticulata) were exposed to a nominal concentration of 1000 mg/L under semi-static conditions.