Reaction mass of 5-[(Disubstituted-dihydrocarbopolycyclyl)diazenyl]-6-hydroxy-4-methyl-2-substituted-1-propyl-1,2-dihydropyridine-3-carbonitrile and 1-Butyl-5-[(disubstituted-dihydrocarbopolycyclyl)diazenyl]-6-hydroxy-4-methyl-2-substituted-1,2-dihydropyridine-3-carbonitrile

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

key study

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: no mortality found

Remarks:

The test item FAT 41039/A had no acute toxic effects on zebra fish up to the loading rate of 100 mg/L

Details on results:

No remarkable observations were made concerning the appearance of the test medium. The test medium was a clear solution throughout the whole test duration.

The pH values in the test medium and the control ranged from 7.9 to 8.7.
The oxygen concentration was always 8.1 mg/L or higher, and thus higher than 60% oxygen saturation.
The water temperature was 22 °C during the test.

In the control and at the loading rate of 100 mg/L, no mortality or other visible abnormalities were determined during the test period of 96 hours

The analytically measured test item concentration in the WAF with the loading rate of 100 mg/L was determined to be between < 0.08 µg/L (limit of quantification of the analytical method) and 0.91 µg/L at the start and the end of the test medium renewal periods. The biological results were based on the loading rate of the WAF of 100 mg/L.

Results with reference substance (positive control):

None

Reported statistics and error estimates:

No required

Sublethal observations / clinical signs:

The 96-hour NOEC (highest concentration tested without toxic effects after the exposure period of 96 hours) and the 96-hour LC0 of FAT 41039/A to zebra fish were determined to be the loading rate of at least 100 mg/L. The 96-hour NOEC and the 96-hour LC0 might even be higher but loading rates above 100 mg/L were not tested, in accordance with the test guidelines. The 96-hour LOEC (lowest concentration with toxic effects), the 96-hour LC50 and the 96-hour LC100 were clearly higher than the loading rate of 100 mg/L.

These values could not be quantified due to the absence of toxicity of FAT 41039/A up to the tested loading rate.

Validity criteria fulfilled:

yes

Conclusions:

FAT 41039/A, structural analogue of FAT 41048, had no acute toxic effects on zebra fish up to the loading rate of 100 mg/L. The 96 hour LC50 and NOEC values were determined to be greater than 100 mg/L, respectively.

Executive summary:

Currently, no study to assess the acute toxicity potential of FAT 41048 to fish is available. However, the acute toxicity of FAT 41039/A, structural analogue to FAT 41048, to zebra fish (Brachydanio rerio) was determined in a 96-hour semi-static test with a daily test medium renewal according to the EU Commission Directive 92/69/EEC, Part C.1 (1992) and the OECD Guideline for Testing of Chemicals No. 203 (1992).

In order to assess the toxicity of the test item FAT 41039/A containing different components to zebra fish, a water accommodated fraction (WAF) was prepared. The method is based on the Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures (2000).

A limit test was performed in accordance the test guidelines to demonstrate that WAFs of the test item has no toxic effect on the test fish up the loading rate of 100 mg/L. Before to the start of the test and prior to each test medium renewal, the test medium was prepared as follows:

A dispersion of the test item with the loading rate of 100 mg/L was prepared using ultrasonic treatment and intense stirring. The dispersion was stirred at room temperature in the dark over 96 hours to dissolve a maximum amount of the different components of the test item in the test water. After the stirring period, the dispersion was filtered (0.45 µm membrane filter) and the filtrate was tested on the test fish as WAF. Additionally, a control was tested in parallel.

The analytically measured test item concentration in the WAF with the loading rate of 100 mg/L was determined to be between < 0.08 µg/L (limit of quantification of the analytical method) and 0.91 u,g/L at the start and the end of the test medium renewal periods. The biological results were based on the loading rate of the WAF of 100 mg/L.

In the control and at the loading rate of 100 mg/L, no mortality or other visible abnormalities were determined during the test period of 96 hours.

Therefore, the 96-hour NOEC (highest concentration tested without toxic effects after the exposure period of 96 hours) and the 96-hour LCO of FAT 41039/A to zebra fish were determined to be the loading rate of at least 100 mg/L. The 96-hour NOEC and the 96-hour LCO might even be higher but loading rates above 100 mg/L were not tested in accordance with the test guidelines. The 96-hour LOEC (lowest concentration with toxic effects), the 96-hour LC50 and the 96-hour LC100 were clearly higher than the loading rate of 100 mg/L.

In conclusion, the test item FAT 41039/A had no acute toxic effects on zebra fish up to the loading rate of 100 mg/L under the present conditions of the test.

Description of key information

FAT 41039/A, structural analogue of FAT 41048, had no acute toxic effects on zebra fish up to the loading rate of 100 mg/L. The 96 hour LC50 and NOEC values were determined to be greater than 100 mg/L, respectively.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

Currently, no study to assess the acute toxicity potential of FAT 41048 to fish is available. However, the acute toxicity of FAT41039/A, structural analogue of FAT 41048, to zebra fish (Brachydanio rerio) was determined in a 96-hour semi-static test with a daily test medium renewal according to the EU Commission Directive 92/69/EEC, Part C.1 (1992) and the OECD Guideline for Testing of Chemicals No. 203(1992). In order to assess the toxicity of the test item FAT 41039/A containing different components to zebra fish, a water accommodated fraction (WAF) was prepared. The method is based on the Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures (2000).

In the control and at the loading rate of 100 mg/L, no mortality or other visible abnormalities were determined during the test period of 96 hours. In conclusion, the test item FAT 41039/A had no acute toxic effects on zebra fish up to the loading rate of 100 mg/L under the present conditions of the test.