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 fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jan 8, 2008 - Mar 11, 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Principles of method if other than guideline:

none

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Vehicle:

no

Details on test solutions:

Dechlorinated drinking water (Shanghai Shinan Drinking Water Ltd.) is used in the test. Waters with total hardness of between 10 and 250 mg CaCO3 per liter, and with a pH 6.0 to 8.5 are preferable.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

The test organism, Brachydanio rerio which was obtained from Amazonas Commercial Aquarium, Shanghai were held in our laboratory for 12 days without any medication. Prior to the test start, they were acclimated for one week under conditions of water quality and illumination similar to those used in the test. During holding and acclimatization until one day before the start of the test the fish were fed with a commercial fish diet (SANYUAN Artificial Tropical Fish Food, from Beijing Sanyou Beautification Feed Tech. Co., Ltd.). During holding and acclimatization no fish died in the test fish batch and all fish were healthy.

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

about 250 mg CaCO3

Test temperature:

23+/- 1 °C

pH:

7.49 to 7.62

Dissolved oxygen:

80 % or higher

Nominal and measured concentrations:

loading rate of 100mg/L (mean measured concentration <0.06 mg/L)

Details on test conditions:

none

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

60 µg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

A limit test was performed in accordance with the result of the preliminary test to demonstrate that the test substance at the loading rate of 100mg/L has no acute toxicity effect on the test Brachydanio rerio.

In the controls and the treatments at the loading rate of 100mg/L (mean measured concentration <0.06 mg/L) no fish death was determined during the limit test period of 96 hours. Therefore, the 96h-NOEC and the 96h-LC0 of the test substance to zebra fish were determined to be the loading rate of 100 mg/L (mean measured concentration <0.06 mg/L). The 96h-LOEC, the 96h-LC50 and 96h-LC100 were clearly higher than the loading rate of 100 mg/L (mean measured concentration <0.06 mg/L).

The pH values in the treatments and the controls ranged from 7.49 to 7.62, and water temperature was maintained at 23 °C. During the period of the test, the dissolved oxygen concentration was always 80% or higher, which fulfilled the criteria for a valid test.

Results with reference substance (positive control):

The sensitivity of the Brachydanio rerio and conformity with the procedure were supported by the result of the reference substance, potassium dichromate. The 24h-LC50 of the potassium dichromate was calculated as 348 mg/L which fulfilled the criteria for a valid test that the 24h-LC50 of the potassium dichromate should range 200 mg/L to 400 mg/L.

Conclusions:

Based on these results and the acute toxicity grading criteria in the Guidelines for the Hazard Evaluation of New Chemical Substances (HJ/T 154-2004), the test substance has no acute toxicity effect on zebra fish under the present conditions of the test, and its hazardous level is slight.

Executive summary:

The acute toxicity effect of the test substance to zebra fish (Brachydanio rerio) was determined in a 96-hour semi-static test with a daily test medium renewal. A limit test was performed in accordance with the result of the preliminary test to demonstrate that the test substance at a loading rate of 100 mg/L has no acute toxicity effect on the test organisms. Thus, only the treatments at a loading rate of 100 mg/L and the controls were tested.

Due to the low water solubility of the test substance and shortage of appropriate auxiliary solvents or dispersants, a supersaturated dispersion of the test substance with a loading rate of 100 mg/L was homogenized by continuously stirred over 4 hours prior to each test medium preparation. Then the dispersion was filtered with the 0.45 µm membrane filter. Only the undiluted filtrate with the maximum concentration of dissolved test substance was used as the test medium.

The analytically measured test substance concentrations in the analyzed test medium samples were <0.06 mg/L at both the beginning and the end of the test respectively. The biological results are related to the treatments of 100 mg/L and to the mean measured test substance concentration of <0.06 mg/L (calculated as the average of the test concentration).

In the controls and the treatments at the loading rate of 100 mg/L (mean measured concentration <0.06 mg/L) no fish death was determined during the limit test period of 96 hours. Therefore, the 96h-NOEC and the 96h-LC₀ of the test substance to zebra fish were determined to be the loading rate of 100 mg/L (mean measured concentration <0.06 mg/L). The 96h-LOEC, the 96h-LC50 and 96h-LCroo were clearly higher than the loading rate of 100 mg/L (mean measured concentration <0.06 mg/L).

In conclusion, the test substance had no acute toxic effects on zebra fish under the present conditions of the test. Based on these results and the acute toxicity grading criteria in the Guidelines for the HTiard Evaluation of New Chemical Substances (HJ/T154-2004), the hazardous level of the test substance is slight.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Justification for type of information:

For this endpoint a one-to-one read across was performed to a chemical similar compound of the same chemical class with a comparable phys. chem. profile and similar response in biological assays. The relevant study was performed according to GLP and the methods applied are fully compliant with OECD TG 203. A detailed read across justification is provided in chapter 13 of this dossier.

Reason / purpose for cross-reference:

read-across source

Duration:

96 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Validity criteria fulfilled:

yes

Conclusions:

For this endpoint a one-to-one read across was performed to a chemical similar compound of the same chemical class with a comparable phys. chem. profile and similar response in biological assays. The relevant study was performed according to GLP and the methods applied are fully compliant with OECD TG 203. The EC50 of the structural analogue exceeds 100 mg/L (nominal) A detailed read across justification is provided in chapter 13 of this dossier.

Description of key information

RA OECD 203: EC50 > 100 mg/L (nominal)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L