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Long-term toxicity to aquatic invertebrates

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Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Refer to read across justification provided in IUCLID section 13.
Reason / purpose for cross-reference:
read-across source
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
>= 1 mg/L
Nominal / measured:
nominal
Conc. based on:
other: filtered test solution
Basis for effect:
mortality
Remarks on result:
other:
Remarks:
Source: CAS 26399-02-0, BASF, 1995, D. magna, 21 d
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
>= 1 mg/L
Nominal / measured:
nominal
Conc. based on:
other: filtered test solution
Basis for effect:
reproduction
Remarks:
number of offspring
Remarks on result:
other:
Remarks:
Source: CAS 26399-02-0, BASF, 1995, D. magna, 21 d
Conclusions:
No long-term effects on aquatic invertebrates were recorded up to the limit of water solubility (OECD 211, D. magna, RA CAS 26399-02-0).
Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06 Oct - 28 Oct 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: OECD 202, part 2 (1993)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations: Eluate of 1 and 100 mg/L at 0, 24, 48 and 72 hours
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Stock solutions of 1 and 100 mg/L in test medium (M4) were prepared and stirred for 16 h up to 5 d. The suspension was filtered via glass fibre filter, the water phase, supposedly satisfied with test substance to the limit of solubility, was used without further dilution
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water flea
- Source: in-house culture, originally obtained from BGA Berlin (May 1994)
- Feeding during test: yes
- Food type: Scenedesmus subspicatus
- Amount: 2.5*10E6 cells/daphnid/day for 0-7 day old animals; 5.0*10E6 cells/daphnid/day for >7 day old animals
- Frequency: daily

ACCLIMATION
- Acclimation conditions (same as test or not): same

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Test temperature:
20.9 - 22.1 °C
pH:
7.8 - 8.2
Dissolved oxygen:
89 - 100 % (air saturation)
Nominal and measured concentrations:
Nominal: 1 and 100 mg/L
Measured: <0.01 and <0.01 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: Erlenmeyer flask
- Type: closed by hourglass
- Size: 100 mL; Fill volume: 50 mL
- Renewal rate of test solution: every 2 to 3 days
- No. of organisms per vessel: 1
- No. of vessels per concentration: 10
- No. of vessels per control: 10

TEST MEDIUM / WATER PARAMETERS
- Culture medium different from test medium: same, M4-Elendt

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light, 8 hours dark
- Light intensity: 300 Lux

EFFECT PARAMETERS MEASURED: The number of offspring and mortality of parental animals were recorded daily.
Reference substance (positive control):
no
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
>= 1 mg/L
Nominal / measured:
nominal
Conc. based on:
other: filtered test solution
Basis for effect:
mortality
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
>= 1 mg/L
Nominal / measured:
nominal
Conc. based on:
other: filtered test solution
Basis for effect:
reproduction
Remarks:
number of offspring
Details on results:
- Measured concentration of test substance: < 0.01 mg/L in the 1 mg/L as well as in the 100 mg/L sample at all sampling times.
- Mortality of parent animals: 0% in control and 1 mg/L (nominal) at the end of the test, 90% died on day 19 in 100 mg/L (nominal);
- No. of offspring produced per day per female: 5.8 offspring/daphnid/day in control over 21 days; 6.0 offspring/daphnid/day in 1 mg/L (nominal) over 21 days and 6.7 offspring/daphnid/day in 100 mg/L (nominal) over first 17 days as well as 4.5 offspring/daphnid/day in 100 mg/L (nominal) over full 21 days (23% reduced due to mortality of parent animals);
- other: limit of solubility of test substance <0.01 mg/L.
- The authors state, that the deaths of 90% of parent animals on day 19 in the 100 mg/L (nominal) sample could have resulted from sample contamination. Another course to explain the given results would be an error in eluate preparation. Either way, it is safe to say that a NOEC > 1 mg/L (nominal) is given for reproduction (number of offspring) and mortality (parent animals).

The analytic shows a similarly small concentration of test substance (< 0.01 mg/L) in the 1 mg/L as well as in the 100 mg/L sample at all sampling times.

Detailed information on offspring numbers and mortality is presented in Table 1.1 to 1.3.

Table 1.1: Number of offspring and average offspring per daphnid per day in the control:

Control

Daphnid no.

Day 10

Day 12

Day 14

Day 17

Day 19

Day 21

Σoffspring in 21 days per animal

Average offspring/

daphnid/d

1

8

23

0

20

20

13

84

6.5

2

7

0

24

18

21

0

70

5.4

3

6

0

28

19

18

0

71

5.5

4

12

0

21

21

19

11

84

6.5

5

5

13

19

0

12

18

67

5.2

6

5

19

0

21

24

12

81

6.2

7

10

0

21

18

19

15

83

6.4

8

7

0

22

19

25

0

73

5.6

9

6

0

16

18

18

17

75

5.8

10

4

20

0

22

10

13

69

5.3

Average

75.7

5.8

Table 1.2: Number of offspring and average offspring per daphnid per day in the 1 mg/L concentration:

Nominal 1 mg/L (analytically <0.01 mg/L)

Daphnid no.

Day 10

Day 12

Day 14

Day 17

Day 19

Day 21

Σoffspring in 21 days per animal

Average offspring/

daphnid/d

1

11

19

0

15

19

16

80

6.2

2

0

12

17

10

0

33

72

5.5

3

11

0

21

16

20

0

68

5.2

4

8

17

0

21

29

16

91

7.0

5

7

19

0

21

13

16

76

5.8

6

10

0

23

19

26

0

78

6.0

7

10

0

20

18

21

15

84

6.5

8

9

18

0

18

18

20

83

6.4

9

5

17

0

18

22

18

81

6.2

10

8

0

14

18

29

0

67

6.2

Average

78.0

6.0

Table 1.3: Number of offspring and average offspring per daphnid per day in the 100 mg/L concentration up to day 17. On day 19 parent animals started dying, so this values were excluded. T=animal found dead.

Nominal 100 mg/L (analytically <0.01 mg/L)

Daphnid no.

Day 10

Day 12

Day 14

Day 17

Day 19

Day 21

Σoffspring in 17 days per animal

Average offspring in/

daphnid/d

1

10

19

0

21

T

 

50

6.3

2

13

25

0

25

T

 

63

7.9

3

5

21

26

0

0

T/9

52

6.5

4

8

20

0

23

6

T

51

6.4

5

7

26

0

25

T

 

58

7.3

6

9

0

24

16

T

 

49

6.1

7

6

20

27

11

0

12

64

8.0

8

8

23

0

23

T/8

 

54

6.8

9

3

15

23

0

9

T

41

5.1

10

10

5

23

17

T

 

55

6.9

Average

53.7

6.7

Description of key information

No long-term effects on aquatic invertebrates up to the limit of water solubility (OECD 211, D. magna); read-across

Key value for chemical safety assessment

Additional information

There is no study available assessing the long-term toxicity of the target substance Fatty acids, C16-18, isononyl esters (CAS 91031-57-1) to aquatic invertebrates. Therefore, read-across to the structurally related source substance 2-ethylhexyl oleate (CAS 26399-02-0) was conducted in accordance with Regulation (EC) No 1907/2006 Annex XI, 1.5. The source substance is characterized by a similar fatty acid chain length as well as alcohol component and is therefore considered a suitable representative for the assessment of the chronic toxicity of the target substance to aquatic invertebrates. A detailed read-across justification is provided in IUCLID section 13.

The available study was performed according to OECD 202, part 2 (1993, equivalent to OECD 211 for reproduction) and GLP with the freshwater invertebrate D. magna. In a semi-static test, the test item was applied as filtered test solutions of nominal loading rates of 1 and 100 mg/L test item. The analytically determined concentrations were < 0.01 mg/L in both test concentrations. After 21 d, no effects on D. magna were observed at 1 mg/L and 90% mortality was observed at 100 mg/L (on day 19). The authors state that the mortality in the higher concentration could be attributed to sample contamination. Therefore, a NOEC (21 d, mortality) > 1 mg/L (nominal) was reported. Similarly, a 23% reduction in reproduction (number of offspring) in the 100 mg/L sample occurred after 21 days and no effect on reproduction occurred in the 1 mg/L treatment, resulting in a NOEC (21 d, reproduction) > 1 mg/L. Comparing the reproduction up to day 17 in the 100 mg/L sample to the reproduction in the control, no reduction of reproduction was stated.

Based on the structural and chemical similarity of the target and source substance, the target substance is expected to exhibit a similar ecotoxicological profile. Therefore, it can be concluded that Fatty acids, C16-18, isononyl esters (CAS 91031-57-1) will not exhibit long-term effects to aquatic invertebrates up to the limit of water solubility.