Carbamic acid,N,N'-[1,3-phenylenebis[methyleneiminocarbonylimino(methyl-3,1-phenylene)]]bis-di-C11-14-isoalkylesters, C13-rich

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-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

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on test solutions:

Deionised water with an enrichment of certain minerals (as demanded in the guidelines) is used in the test.
Table 6.4-a Dilution water specification Parameter Concentration in mg/L
CaCl2*2H2O 293.80
MgSO4*7H2O 123.30
NaHCO3 64.80
KCl 5.80
Resulting hardness in mmol/L: 2.50
Resulting hardness in mg CaCO3/L: 250
After preparation, the dilution water is aerated, and the pH is adjusted to 7.8  0.2.

Test organisms (species):

Daphnia magna

Details on test organisms:

Species Daphnia magna
Variety STRAUS
Strain Berlin
Sex female
Age between 0 and 24 hours
Origin Umweltbundesamt Berlin
Arrival of Strain 27. Sep. 2007
Selection of the test system was made following the proposal of the guidelines.

Test type:

static

Water media type:

other: Deionised water with an enrichment of certain minerals (as demanded in the guidelines) is used in the test.

Limit test:

yes

Total exposure duration:

48 h

Test temperature:

26.1 to 27.1 °C
The temperature for the main study lay in a range of 26.1 to 27.1 °C and therefore higher than stated in the guidelines. As no immobility occurred during the test, this deviation was stated as uncritical. The deviation was signed and assessed by the deputy study director on 15. Aug. 2008.  The temperature for the reference study lay in a range of 26.7 to 27.1 °C and therefore higher than stated in the guidelines. As no immobility occurred during the test, this deviation was stated as uncritical. The deviation was signed and assessed by the deputy study director on 01. Aug. 2008.

pH:

7.3 to 7.7

Dissolved oxygen:

above 7.1 mg/L

Details on test conditions:

The following experimental conditions apply to all studies.
Test vessels glass beakers, nominal volume 50 mL, tall shape
Feeding none
Lighting none
Temperature 20 +/- 2 °C

Reference substance (positive control):

yes

Key result

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Key result

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

8 FINDINGS

8.1 Main Study

8.1.1 Immobilities

In the control, none of the daphnia died or showed any signs of abnormal behaviour

throughout the test (see table below).

Table 8.1-a Immobilities

Nominal Concentration in mg/L/ Immobility 24 hours/ Immobility 48 hours

100 / 0 / 0

8.1.2 pH and O2, Temperature

The pH values in the test media and the control ranged from 7.3 to 7.7. The concentration

of dissolved oxygen stayed above 7.1 mg/L throughout the test. Temperature range was

26.1 – 27.1 oC. The details are given in the following tables:

Table 8.1-b pH and O2-values

Nominal Concentration

in

mg/L

pH O2-Concentration in mg/L

0 h 48 h 0 h 48 h

0 7.7 7.6 8.5 7.3

100 7.3 7.5 7.7 7.1

Table 8.1-c Temperature

Temperature in oC

0 h 48 h

26.1 27.1

8.1.3 Analytical Determinations

The measured concentrations for treatment and control are given in the following table:

Table 8.1-d Measured Concentrations

Nominal Conc. Test

Item in mg/L

DOC-Concentration in mg/L

0h 48h

0 0.0 0.0

100 0.13 0.0

The water solubility of the test item is very low. Only in the treatment, a value above the

limit of detection could be measured at t = 0 h. The results are therefore based on the

nominal concentrations.

8.1.4 Biological Results Test Item

The biological results are presented in the following table:

Table 8.1-e Biological Results Test Item

Parameter Value 95%-confidence interval

NOEC 24h 100 mg/L not determinable

24h EC50i > 100 mg/L not determinable

24h EC100i > 100 mg/L not determinable

NOEC 48h 100 mg/L not determinable

48h EC50i > 100 mg/L not determinable

48h EC100i > 100 mg/L not determinable

Validity criteria fulfilled:

yes

Conclusions:

All validity criteria were met. For the estimation of the EC50s of test and reference item, the fits showed sufficient statistical correspondence of the data with the dose-responseequation. The 24h-EC50i of potassium dichromate was determined as 0.77 mg/L, lying within the demanded range of 0.6 – 2.1 mg/L. A further limit test was performed. As the daphnia in one control and one treatment vessel were found immobilised after 24 hours, the test was invalidated. The immobility was probably caused by contaminations in the vessels. The results of this test are not stated in this final report. The raw data is archived together with the other raw data of the study. Due to the physico-chemical properties of the test item (the test item is practically insoluble in water and other relevant solvents) no specific analytical method could be developed. In accordance with the sponsor and the competent authorities (letter of the REACH helpdesk of the German “BAuA” of 22.07.2008, no.: 5.0-720 34/04/2008.1678), the analytical determination of the test item in the test solutions was performed with the sum parameter DOC.
As the test item is very poorly soluble in water, the DOC content of all solutions lay below the limit of detection. For this reason, no correlation between DOC and nominal concentration could be calculated.
As at the saturated solution did not show any toxic effects, it can be stated, that the 24hand 48h-EC50i of ADDUKT TI 65-MXDA is higher than 100 mg/L (nominal) resp. the limit of solubility.

Executive summary:

The main study was performed as a limit test with the concentration 100 mg/L. Twenty daphnia were exposed to the test item for 48 hours in a static test system. After 24 and 48

hours, the immobilised daphnia were counted. The treatment showed no immobilisation. None of the animals were immobilised in the control. The 24h-EC50i of potassium dichromate was tested in a current reference test. The value was determined as 0.77 mg/L, lying within the demanded range of 0.6 – 2.1 mg/L. At the beginning and at the end of the test, the content of the test item in the test solutions was determined using DOC-determination. Only in treatment 100 mg/L, a DOC concentration > 0 mg/L was measured at t = 0 h. All other samples did not contain DOC concentrations above the limit of detection. Therefore, the determination of the biological results was based on the nominal concentration.

The following results were determined for the test item ADDUKT TI 65-MXDA (species: Daphnia magna).

24h-NOEC and 48h-NOEC = 100 mg/L

24h-EC50i and 48h-EC50i > 100 mg/L

Description of key information

As at the saturated solution did not show any toxic effects, it can be stated, that the 24h and 48h-EC50i of ADDUKT TI 65-MXDA is higher than 100 mg/L (nominal) resp. the limit

of solubility.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L