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Long-term toxicity to aquatic invertebrates

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Reference
Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
other: OECD 2002, Part 2; Daphnia Reproduction Test
Principles of method if other than guideline:
GLP guideline study. However, according to OECD TG 202 the exposure concentration selection should be based on the EC50 (24 h) for immobilization, starting at about the 24 h EC50 and ending at about 1/100 of the 24 h EC50. The effects of the test concentrations were far lower.
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
Regarding the entire test area (1 sample/ 1 test area made by mixing the extracts from the contents of the 4 test containers), after removing the feed by centrifugal separation (at 3000 rpm for 10 minutes) on the exposure start date (0th day), 7th day, 14th day and the exposure end day (21st day), it was analysed by GC by diluting as well as by keeping as-is.
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Stock Solutions Preparations and Stability: A proportional diluter system was used for intermittent introduction of test material solution (0.1 wt% of test chemical with solubilizer hydrogenated caster oil HCO-40 5000mg/L) and dilution and water into the test chambers.
- Controls: water and vehicle controls included
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): hydrogenated caster oil HCO-40
- Concentration of vehicle in test medium (stock solution and final test solution(s) including control(s)): 25 mg/L
- Evidence of undissolved material (e.g. precipitate, surface film, etc): no data
Test organisms (species):
Daphnia magna
Details on test organisms:
Age at study initiation: < 24 hours after hatching
Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Post exposure observation period:
none
Hardness:
55.6mg/L as CaCO3
Test temperature:
19-21 °C
pH:
7.7
Dissolved oxygen:
> 60% of saturation
Nominal and measured concentrations:
Nominal: 0, 0.128. 0.32, 0.8, 2.0, 5.0 mg/L
Measured: 0, 0.904, 0.2298, 0.641, 1.46, 3.87 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): no data whether open / closed
- Material, size, headspace, fill volume: 1.8 L test solution in 3.0L glass vessel (diameter = 16 cm, depth = 17 cm )
- Aeration: no data
- Type of flow-through (e.g. peristaltic or proportional diluter): proportional diluter
- Renewal rate of test solution (frequency/flow rate): flow rate 50 mL/min
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): 4
- Biomass loading rate: 180 mL/animal


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: dechlorinated tap water
- Chlorine: <0.02 mg/L
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod: 16h:8h light-dark cycle
- Light intensity: room light


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality of parental animals


VEHICLE CONTROL PERFORMED: yes


Duration:
21 d
Dose descriptor:
LC50
Effect conc.:
> 3.87 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
21 d
Dose descriptor:
other: ErC50 (reproduction)
Effect conc.:
2.09 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other: 95% CL: 1.94-2.25 mg/L

Nominal/measured Concentration:

Measured concentration (mg/L)

(percentage of nominal)

Nominal

concentration

(mg/L)

0-day

7-day

14-day

21-day

Mean*

control

n.d.

n.d.

n.d.

n.d.

-

Solvent control

n.d.

n.d.

n.d.

n.d.

-

0.128

0.103

(80.1)

0.0854

(66.7)

0.0878

(68.6)

0.0860

(67.2)

0.0904

(70.7)

0.320

0.273

(85.4)

0.230

(71.9)

0.231

(66.5)

0.200

(62.5)

0.229

(71.5)

0.800

0.703

(87.9)

0.622

(77.7)

0.785

(98.1)

0.454

(56.8)

0.641

(80.1)

2.00

1.62

(80.8)

1.54

(76.8)

1.51

(75.3)

1.19

(59.3)

1.46

(73.0)

5.00

4.08

(81.6)

4.06

(81.2)

3.67

(73.5)

3.67

(73.5)

3.87

(77.4)

n.d. : <0.100 mg

*The values are express as arithmetic means calculated

Water Temperature: 19.9-20.3 degree C

Water Chemistry in test: pH 7.3-7.6; Disooved oxygen = 8.3-8.9 mg/L(Oxygen saturation level >=60%)

Effect Data

Mortality: 21 day LC50 > 3.87 mg/L

Reproduction: 21 day ErC50 = 2.09 mg/L (95% c.i.: 1.94 - 2.25 mg/L); NOECr = 1.46 mg/L; LOECr = 3.87 mg/L

Cumulative number of dead parental Daphnia:

Cumulative number of dead parental Daphnia

Exposure time (day)

Measured

conc.

(mg/L)

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

control

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

1

(2.5)

2

(5.0)

4

(10.0)

5

(12.5)

6

(15.0)

Solvent control

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

1

(2.5)

2

(5.0)

5

(12.5)

7

(17.5)

7

(17.5)

0.0904

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

1

(2.5)

1

(2.5)

1

(2.5)

2

(5.0)

2

(5.0)

4

(10.0)

0.229

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

1

(2.5)

3

(7.5)

3

(7.5)

8

(20.0)

12

(30.0)

13

(32.5)

0.641

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

1

(2.5)

1

(2.5)

2

(5.0)

5

(12.5)

1.46

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

1

(2.5)

1

(2.5)

1

(2.5)

1

(2.5)

2

(5.0)

3

(7.5)

4

(10.0)

5

(12.5)

3.87

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

3

(7.5)

3

(7.5)

3

(7.5)

3

(7.5)

3

(7.5)

3

(7.5)

3

(7.5)

4

(10.0)

5

(12.5)

The value in parentheses express mortality (%) of Daphnia

Time (days) required to first brood production during exposure

Vessel No.

Measured

concentration

(mg/L)

1

2

3

4

Mean*

control

7

7

7

7

7.0

0.0904

7

7

7

7

7.0

0.229

7

7

7

7

7.0

0.641

7

7

7

7

7.0

1.46

7

7

7

7

7.0

3.87

10

10

10

10

10.0

Mean cumulative number of Juvenile produced per adult during exposure:

Exposure time (day)

Measured

conc.

(mg/L)

1

2

3

4

5

6

7

8

9

10

11

12

control

0

0

0

0

0

0

4.4

4.4

4.4

38.0

38.0

42.6

Solvent control

0

0

0

0

0

0

5.3

5.3

5.3

38.0

38.0

41.0

0.0904

0

0

0

0

0

0

9.4

9.4

9.4

45.7

45.7

52.0

0.229

0

0

0

0

0

0

7.4

7.4

7.4

40.7

40.7

47.7

0.641

0

0

0

0

0

0

7.6

7.6

7.6

46.9

46.9

53.3

1.46

0

0

0

0

0

0

5.8

5.8

5.8

34.3

34.3

40.1

3.87

0

0

0

0

0

0

0

0

0

3.0

3.0

6.0

Exposure time (day)

Measured

conc.

(mg/L)

13

14

15

16

17

18

19

20

21

control

42.6

85.0

85.0

85.0

138

138

188

188

197

Solvent control

41.0

76.4

76.4

76.4

129

129

171

171

185

0.0904

52.0

90.4

90.4

90.4

143

143

188

188

208

0.229

47.7

89.8

89.8

89.8

133

133

176

176

206

0.641

53.3

88.8

88.8

88.8

149

149

174

174

193

1.46

40.1

60.0

60.0

60.0

108

108

128

128

135

3.87

6.0

15.2

15.2

15.2

17.4

17.4

17.5

17.5

23.1

Validity criteria fulfilled:
yes
Conclusions:
According to OECVDT TG 202 the exposure concentration selection should be based on the EC50 (24 h) for immobilization, starting at about the 24 h EC50 and ending at about 1/100 of the 24 h EC50. The effects of the test concentrations were far lower. As to reproduction, the effect values were:
Reproduction: 21 day EC50 = 2.09 mg/L (95% c.i.: 1.94 - 2.25 mg/L); NOECr = 1.46 mg/L; LOECr = 3.87 mg/L
Executive summary:

3, 5,5 -trimethylhexan-1-ol was tested in a Daphnia reproduction test according to OECD TG 202, Part 2, under GLP for 21 days at concentrations up to nominal 5 mg/L (measured 3.87 mg/L). The effect data are as follows:

Mortality: 21 day LC50 > 3.87 mg/L

Reproduction: 21 day ErC50 = 2.09 mg/L (95% c.i.: 1.94 - 2.25 mg/L); NOECr = 1.46 mg/L; LOECr = 3.87 mg/L

According to OECD TG 202 the exposure concentration selection should be based on the EC50 (24 h) for immobilization, starting at about the 24 h EC50 and ending at about 1/100 of the 24 h EC50. The effects of the test concentrations were far lower (CITI, 1997).

Description of key information

3,5,5-trimethylhexan-1-ol was tested in a Daphnia reproduction test according to OECD TG 202, Part. The NOECr was 1.46 mg/L.

Key value for chemical safety assessment

EC10, LC10 or NOEC for freshwater invertebrates:
1.46 mg/L

Additional information

3, 5,5 -trimethylhexan-1 -ol was tested in a Daphnia reproduction test according to OECD TG 202, Part 2, under GLP for 21 days at concentrations up to nominal 5 mg/L (measured 3.87 mg/L). The effect data are as follows:

Mortality: 21 day LC50> 3.87 mg/L

Reproduction: 21 day ErC50= 2.09 mg/L (95% c.i.: 1.94 - 2.25 mg/L); NOECr= 1.46 mg/L; LOECr= 3.87 mg/L