Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
9 September 2004
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N'-[dithiobis[2-(2-hydroxyethyl)-1-methylvinylene]]bis[N-[(4-amino-2-methyl-5-pyrimidinyl)methyl]formamide
EC Number:
200-644-4
EC Name:
N,N'-[dithiobis[2-(2-hydroxyethyl)-1-methylvinylene]]bis[N-[(4-amino-2-methyl-5-pyrimidinyl)methyl]formamide
Cas Number:
67-16-3
Molecular formula:
C24H34N8O4S2
IUPAC Name:
N-[(4-amino-2-methylpyrimidin-5-yl)methyl]-N-[(2E)-3-{[(2E)-2-{N-[(4-amino-2-methylpyrimidin-5-yl)methyl]formamido}-5-hydroxypent-2-en-3-yl]disulfanyl}-5-hydroxypent-2-en-2-yl]formamide
Test material form:
solid: particulate/powder

Sampling and analysis

Analytical monitoring:
not specified
Details on sampling:
Not specified

Test solutions

Vehicle:
no
Details on test solutions:
To prepare the stock solution, the test item was dissolved or dispersed directly in M4 reconstituted water. The pH of this solution (M4) is 8.0 ± 0.5 and the sum of Ca and Mg ions in the solution is 2.5 mmol/L with a molar ratio of Ca to Mg ions of approximately 4:1, and of Na to K of 10:1. The obtained preparation was agitated mechanically for up to 24 hours in an attempt to completely dissolve or disperse the test item.

Test solutions was prepared by further dilution of the stock solution with M4 or directly from the test item. A solution containing a maximum of 100 mg/L of the test item plus two other range-finding concentrations was prepared. Test vessels was filled directly from the test solution containers immediately after preparation. The pH range considered as appropriate for a normal life of test organisms is circa 6 to 9.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
Daphnia magna STRAUS, clone 5.
Reason for this choice: most sensitive clone of the species recommended in OECD and EEC guidelines.

Study design

Test type:
static
Water media type:
freshwater
Total exposure duration:
48 h
Post exposure observation period:
Animals were inspected for immobilization at TO, T24 and T48 hours.

Test conditions

Hardness:
272 mg/L at T0 and 289 mg/L at T48 on the control flask
Test temperature:
19,7°C mini
20.2°C maxi
pH:
pH = between 8.13 & 8.20 at T0
ph = between 8.35 & 8.37 at T48
Dissolved oxygen:
between 8.6 & 8.7 mg/L at T0
between 8.7 & 8.8 mg/L at T48
Salinity:
Not specified
Conductivity:
Not specified
Nominal and measured concentrations:
Nominal concentration of 1, 10 and 100 mg/L

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
No immobilisation was observed at tested concentrations.

Any other information on results incl. tables

Table I :physicochemical parameters

Control

Time

Hardness

(mg/L)

Oxygen levels %

Oxygen levels (mg/l)          pH

T 0 hours

T 48 hours

272

289

98

98

8,7

8,8

8,20

8,37

Highest tested concentration 

Time                   Oxygen level %

Oxygen level (mg/L)

pH

Nominal charge rate (mg (L)

T 0 hours

T 48 hours                   97

8,6

8,7

8,13

8,35

100

100

Temperature measured in water between T2 hours and TO time: 19.8°C.

Temperature recorded in a beaker of water dilution placed in the conditions of the study: minimum 19.7°C / maximum 20.2°C.

Table 2:Summary table of mortality

Immobilization (n on 5 daphnia) at each nominal rate (mg/L)

 

 

0

1

10

100

 

Replicat

1 2 3 4

Replicat

1 2 3 4

Replicat

1 2 3 4

Replicat

1 2 3 4

T 0 hour

0 0 0 0

0 0 0 0

0 0 0 0

0 0 0 0

T 24 hours

0 0 0 0

0 0 0 0

0 0 0 0

0 0 0 0

T 48 hours

0 0 0 0

0 0 0 0

0 0 0 0

0 0 0 0

 

Applicant's summary and conclusion

Conclusions:
The highest rate of charge without immobilisation at T48h was > 100 mg/L.
The lowest charge rate with 100% of immobilisation at T48h was > 100 mg / L.
Executive summary:

The highest rate of charge without immobilisation at T48h was > 100 mg/L.

The lowest charge rate with 100% of immobilisation at T48h was > 100 mg / L.

EC50s at 24 h and 48 h were > 100 mg/L (charge rate).