Trans-2-[4'-[Difluor(3,4,5-trifluorphenoxy)methyl]-3',5'-difluor[1,1'-biphenyl]-4-yl]-5-propyl-tetrahydro-2H-pyran

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007-11-23 to 2008-02-15

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Reason / purpose for cross-reference:

reference to other study

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

92/69/EC

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

2004-04-13

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

no

Details on sampling:

NA

Vehicle:

no

Details on test solutions:

Reconstituted water according to ELENDT (1990):
Macro nutrients (mg/L):
CaCI2 x 7 H20 293.80
MgSO4 x 7 H20 123.30
NaHCO3 64.80
KCI 5.80
Na2SiO3 x 9H20 10.00
NaNO3 0.27
KH2PO4 0.14
K2HPO4 0.18

Trace elements (mg/L):
B 0.5000
Fe 0.2000
Mn 0.1000
Li, Rb and Sr 0.0500
Mo 0.0250
Br 0.0125
Cu and Zn 0.0063
Co and I 0.0025
Se 0.0010
V 0.0003

Macro nutrients (mg/L):
Na2EDTA x 2H20 2.50

Vitamins (µg/L):
Thiamine 75.00
B12 1.00
Biotin 0.75


After preparation, the reconstituded water was aerated for 24 hours.

- Hardness: about 14° dH (about 250 mg/L CaCO3)
- pH: 7.9 ± 0.3, after an aeration for 24 hours.



References:

ELENDT, B.-P. Selenium deficiency in Crustacea. An ultrastructural approach to antennal damage in Daphnia magna Straus.
Protoplasma 154, 25-33, 1990

Test organisms (species):

Daphnia magna

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

about 14 ° dH (about 250 mg/L CaCO3)

Test temperature:

18 - 22°C

pH:

ca. 7.9 +/- 0.3

Dissolved oxygen:

between 95.2 - 98.6 %

Nominal and measured concentrations:

Nominal concentration of 100 mg/L (limit test); due to the low water solubility and the fact that the study was a limit test, no further analysis was initiated.

Details on test conditions:

Concentration: 100 mg/L (limit test)
Static Test

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

A nominal test concentration of 100 mg/L revealed no aquatic toxicity in this test system.

Daphnia magna exposed to a nominal concentration of 100 mg/L (limit test) for 48 hours in an open static system were not affected. The test material concentration in the aqueous medium was not quantified at the start and at the end of this study as a very low water solubility was calculated for this test item (ca. 0.059 µg/L). Therefore, the development of an analytical method with a sufficiently low detection and quantification limit would be very time and cost intensive. Due to the absence of any adverse effects at the saturation concentration, the study was performed without analytical concentration verification. For the test material, the following EC50 values for Daphnia magna were determined: 24h-EC50: > 100 mg/L nominal, 48h-EC50: > 100 mg/L nominal.

Validity criteria fulfilled:

yes

Conclusions:

Under the given experimental conditions, the test material showed a 24 hand 48h EC50 value > 100 mg/L nominal.

Executive summary:

Daphnia magna exposed to a nominal concentration of 100 mg/L (limit test) for 48 hours in an open static system were not affected. The test material concentration in the aqueous medium was not quantified at the start and at the end of this study as a very low water solubility was calculated for this test item (ca. 0.059 µg/L). Therefore, the development of an analytical method with a sufficiently low detection and quantification limit would be very time and cost intensive. Due to the absence of any adverse effects at the saturation concentration, the study was performed without analytical concentration verification. For the test material, the following EC50 values for Daphnia magna were determined: 24h-EC50: > 100 mg/L nominal, 48h-EC50: > 100 mg/L nominal.

Reference 2

Endpoint:

short-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:

For this endpoint information from structural similar compounds is available. The studies for these similar compounds were performed according to GLP and the methods applied are fully compliant with OECD TG 202. See chapter 13 report for a more detailed justification.

Reason / purpose for cross-reference:

read-across source

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: Read across substance

Description of key information

RA OECD 202: EC50 > 100 mg/L (nominal)

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L