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EC number: 413-550-5 | CAS number: 142068-96-0 H112339
Long-term toxicity to aquatic invertebrates
Administrative data
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 16 June 1999 - 07 July 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to EU & OECD test guidance in complaince with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: EEC GuidelineXI/691/86, Draft 4: "Prolonged toxicity study with Daphnia magna: Effects on reproduction".
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD: Testguideline 202 (Daphnia, acute immobilisation and 14-day reproduction tests) (1981)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Octasodium 2-(8-(4-chloro-6-(3-((4-chloro-6-(3,6-disulfonato-2-(1,5-disulfonatonaphthalen-2-ylazo)-1-hydroxynaphthalen-8-ylamino)-1,3,5-triazin-2-yl)aminomethyl)phenylamino)-1,3,5-triazin-2-ylamino)-3,6-disulfonato-1-hydroxynaphthalen-2-ylazo)naphthalene-1,5-disulfonate
- EC Number:
- 413-550-5
- EC Name:
- Octasodium 2-(8-(4-chloro-6-(3-((4-chloro-6-(3,6-disulfonato-2-(1,5-disulfonatonaphthalen-2-ylazo)-1-hydroxynaphthalen-8-ylamino)-1,3,5-triazin-2-yl)aminomethyl)phenylamino)-1,3,5-triazin-2-ylamino)-3,6-disulfonato-1-hydroxynaphthalen-2-ylazo)naphthalene-1,5-disulfonate
- Cas Number:
- 142068-96-0
- Molecular formula:
- Hill formula: C53H28Cl2N14Na8O26S8
- IUPAC Name:
- octasodium 5-[(4-chloro-6-{[4-({[4-chloro-6-({7-[2-(1,5-disulfonatonaphthalen-2-yl)diazen-1-yl]-8-hydroxy-3,6-disulfonatonaphthalen-1-yl}amino)-1,3,5-triazin-2-yl]amino}methyl)phenyl]amino}-1,3,5-triazin-2-yl)amino]-3-[2-(1,5-disulfonatonaphthalen-2-yl)diazen-1-yl]-4-hydroxynaphthalene-2,7-disulfonate
- Details on test material:
- Name of test substance: H112339
Batch number: 321/18
Date of production: 1. Quarter 1999
Aggregate state: powder
Colour: red
Purity of the test substance [%]: 77.8
Impurities: 10.4% water
Homogeneity: yes
Constituent 1
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
Not applicable.
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Concentration control analyses
The concentration control analyses were performed with test solutions of the following nominal concentrations (mg/l) of the test substance:
Control
100
25
3,13
0,78
Samples for analysis were taken in the 1st, the 2nd and the 3rd week of the test. For each concentration the freshly prepared test solution (unstocked) and the corresponding 48 h or 72 h old test solution (stocked and unstocked with daphnids) were analyzed.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- At the beginning of the test and before changing the test solutions a stock solution of the test substance was freshly prepared. The test substance was stirred in the M4 medium for about 10 min. at 20 ± 2 °C. The nominal concentration of the stock solution was 100 mg/l.
By diluting this stock solution with M4 medium the following nominal concentrations (mg/l) were prepared:
control
25
12,5
6,25
3,13
1,56
0,78
0,39
0,20
0,10
0,05
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- The clone of Daphnia magna STRAUS 1820 used was supplied by the Institut National de Recherche Chimique Appliquee, France, in 1978. From this date on this clone was cultured and bred continuously in the Laboratory of Ecology of BASF AG in Ludwigshafen.
Daphnia magna is geographically widely distributed and is an important part of aquatic food webs where it can be grouped between primary producers and decomposers, on the one hand, and, predators, on the other. Daphnia magna is recommended as a test organism all over the world.
This study investigated the influence of the test substance on the reproduction and the swimming ability (mobility) of Daphnia magna. The test substance was suspended in water. The daphnids were exposed to various concentrations of the test substance and compared to a control.
The daphnid tests are performed under the same environmental conditions as the culture itself. Therefore a phase of adaptation for the young is not necessary.
Feeding
During the test daphnids were fed live green algae (Scenedesmus subspicatus, cultured in a synthetic medium) daily. The algae were separated from culture medium by centrifugation, re suspended in daphnid's medium (M4) and daphnids were fed this concentrate. The algae were stored in a refrigerator (dark, about 4-8°C) for maximum 14 days. Through feeding the concentrate (maximum: 0.3 ml/l/50 ml/l/day) the test solution was diluted in the worst case (Friday-Monday, 3 feedings) by 0.9 ml/I (= 1.8%).
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 21 d
- Post exposure observation period:
- No post exposure period
Test conditions
- Hardness:
- 2,20 - 3,20 mmol/l
- Test temperature:
- 18.4 - 22.6C
- pH:
- 7.8 - 9.0
- Dissolved oxygen:
- 8.0 - 12.1 mg/l
- Salinity:
- Not applicable.
- Nominal and measured concentrations:
- the following nominal concentrations (mg/l) were prepared:
25, 12.5, 6.25, 3.13, 1.56. 0.78, 0.39, 0.20, 0.10, 0.05 - Details on test conditions:
- Duration of the test: 21 days
Test temperature: 18-22°C
Test vessel: numbered glass beakers, nominal volume 100 ml, covered with numbered glass caps
Test volume: 50 ml
Loading (animals/ml): 1 parent animal / 50 ml
Number of animals/vessel: 1
Total number of animals/conc.: 10
Number of replicates/conc.: 10
Number of replicates/control: 10
Number of replicates for the measurement of pH and O2: 1
Age of the animals at the start of the test: 2 - 24 h (starting with the 3rd breed of parent animals)
Age of stock animals: 2 - 4 weeks
Illumination: artificial light, type warm white (e.g. OSRAM L58 W31) day : night rhythm = 16 : 8 h
Light intensity: about 2 - 7 μE/(m2-s) at a wave length of 400 - 700 nm
Change of test solution: each Monday, Wednesday and Friday
Removal of young from test beakers and counting: daily
Check of the study and recording (mortality, embryos, aborted eggs): daily
Feeding: daily, according to feeding schedule
Measurement of temperature: continuously during the whole test period in a separate vessel close to the test vessels
Measurement of pH and oxygen: at the start of the test and at each change of test solution in the 48- or 72-hour-old solution in one parallel at each concentration - Reference substance (positive control):
- not specified
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 12.5 mg/L
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 25 mg/L
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Duration:
- 21 d
- Dose descriptor:
- other: LC0
- Effect conc.:
- 6.25 mg/L
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Details on results:
- Summary of the NOEC and LOEC values for reproduction and LC0 (mortality) after 21 d exposure.
NOEC = 12.5 mg/l
LOEC = 25 mg/l
LC0 = 6.25 mg/l
In the control the first young were observed at day 8. In the highest tested concentration, in which the daphnids produced young (25 mg/l), the first young were observed at day 11.
At a concentration of 1.56 mg/l 20% mortality of the parent animals occurs. Because there was no positive correlated dose response relation this value was not considered by the determination of the LC0 - Results with reference substance (positive control):
- Not applicable.
Any other information on results incl. tables
Total number of living young per surviving parent animal after the 21 day exposure period.Base for the data are the values standardised on the number of surviving parent animals of each of the then parallels.
Concentration [mg/l] |
Par. 1 |
Par. 2 |
Par. 3 |
Par. 4 |
Par. 5 |
Par. 6 |
Par. 7 |
Par. 8 |
Par. 9 |
Par. 10 |
Sum |
Mean |
sd |
vc [%] |
0 |
100 |
105 |
88 |
123 |
88 |
101 |
101 |
99 |
T |
88 |
893 |
99.2 |
10.58 |
10.5 |
0.05 |
104 |
110 |
61 |
100 |
79 |
80 |
73 |
75 |
98 |
116 |
896 |
89.6 |
17.4 |
19.4 |
0.1 |
106 |
T |
93 |
128 |
123 |
117 |
104 |
110 |
134 |
80 |
995 |
110.6 |
16.2 |
14.6 |
0.2 |
97 |
95 |
98 |
126 |
96 |
44 |
135 |
109 |
147 |
141 |
1088 |
108.8 |
28.8 |
26.5 |
0.39 |
105 |
128 |
85 |
86 |
99 |
105 |
132 |
106 |
115 |
T |
961 |
106.8 |
15.4 |
14.4 |
0.78 |
126 |
143 |
115 |
53 |
128 |
150 |
95 |
101 |
125 |
147 |
1183 |
118.3 |
27.8 |
23.5 |
1.56 |
T |
113 |
148 |
114 |
141 |
110 |
132 |
T |
126 |
106 |
990 |
123.8 |
14.5 |
11.7 |
3.13 |
132 |
79 |
104 |
145 |
139 |
91 |
94 |
142 |
175 |
118 |
1219 |
121.9 |
28.4 |
23.3 |
6.25 |
139 |
115 |
96 |
91 |
123 |
121 |
T |
103 |
162 |
162 |
1112 |
123.6 |
24.8 |
20.0 |
12.5 |
T |
87 |
95 |
T |
T |
92 |
T |
74 |
T |
116 |
464 |
92.8 |
13.6 |
14.7 |
25 |
T |
T |
T |
52 |
39 |
T |
T |
59 |
T |
T |
150 |
50.0 |
8.3 |
16.6 |
Total number of dead young per surviving parent animal after the 21 day exposure period.Base for the data are the values standardised on the number of surviving parent animals of each of the ten parallels.
Concentration [mg/l] |
Par. 1 |
Par. 2 |
Par. 3 |
Par. 4 |
Par. 5 |
Par. 6 |
Par. 7 |
Par. 8 |
Par. 9 |
Par. 10 |
Sum |
Mean |
sd |
vc [%] |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
T |
0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.05 |
0 |
3 |
0 |
0 |
4 |
15 |
0 |
5 |
0 |
12 |
39.0 |
3.9 |
5.2 |
132.5 |
0.1 |
0 |
T |
6 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
7.0 |
0.8 |
1.9 |
240.7 |
0.2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.39 |
3 |
0 |
0 |
3 |
0 |
1 |
0 |
4 |
0 |
T |
11.0 |
1.2 |
1.5 |
126.6 |
0.78 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
2.0 |
0.2 |
0.6 |
300.0 |
1.56 |
T |
0 |
0 |
0 |
0 |
0 |
0 |
T |
0 |
0 |
0.0 |
0.0 |
0.0 |
0.0 |
3.13 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
0.0 |
0.0 |
0.0 |
6.25 |
0 |
0 |
0 |
0 |
0 |
0 |
T |
0 |
0 |
0 |
0.0 |
0.0 |
0.0 |
0.0 |
12.5 |
T |
0 |
0 |
T |
T |
0 |
T |
0 |
T |
0 |
0.0 |
0.0 |
0.0 |
0.0 |
25 |
T |
T |
T |
1 |
1 |
T |
T |
0 |
T |
T |
2.0 |
0.7 |
0.5 |
70.7 |
T = Parent animal died during the test period
cv = coefficient of variance
sd = standard deviation
Total number of surviving parent animals at various concentrations of the test substance and all days of the test
Concentration [mg/l] |
Day of the test |
|||||||||||||||||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
16 |
17 |
18 |
19 |
20 |
21 |
|
0 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
9 |
9 |
9 |
9 |
9 |
9 |
9 |
9 |
0.05 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
0.1 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
9 |
9 |
9 |
9 |
9 |
9 |
9 |
9 |
0.2 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
0.39 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
9 |
0.78 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
1.56 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
8 |
8 |
8 |
8 |
8 |
8 |
8 |
8 |
3.13 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
6.25 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
9 |
9 |
9 |
9 |
9 |
12.5 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
10 |
9 |
9 |
9 |
8 |
8 |
7 |
7 |
6 |
6 |
5 |
25 |
10 |
10 |
10 |
10 |
10 |
9 |
9 |
9 |
9 |
9 |
9 |
6 |
6 |
6 |
5 |
5 |
5 |
5 |
4 |
3 |
3 |
3 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Summary of the NOEC and LOEC values for reproduction and LC0 (mortality) after 21 d exposure.
NOEC = 12.5 mg/l
LOEC = 25 mg/l
LC0 = 6.25 mg/l - Executive summary:
Determination of the chronic effect of H 112339 on the reproduction of the water flea Daphnia magna STRAUS was investigated in a 21 day semi static test according to EEC GuidelineXI/691/86, Draft 4: "Prolonged toxicity study with Daphnia magna: Effects on reproduction". Study conducted in compliance to GLP.
The test substance was tested in the range of concentrations between 25 and 0.05 mg/l. The dilution factor was 2.
Summary of the NOEC and LOEC values for reproduction and LC0 (mortality) after 21 d exposure.
NOEC = 12.5 mg/l
LOEC = 25 mg/l
LC0 = 6.25 mg/l
In the control the first young were observed at day 8. In the highest tested concentration, in which the daphnids produced young (25 mg/l), the first young were observed at day 11.
At a concentration of 1.56 mg/l 20% mortality of the parent animals occurs. Because there was no positive correlated dose response relation this value was not considered by the determination of the LC0
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