Rabitle FP-100

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16th July to 20th august 2004

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study report had to be updated in 2006 to correct reporting errors

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Principles of method if other than guideline:

see report

GLP compliance:

yes

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
N/A

Analytical monitoring:

yes

Details on sampling:

The concentration of the test item in the test solution was measured for two sets at the start of the exposure before renewal (after the exposure at 24 hours) and after the renewal (after the exposure 72 hours) the end of the expsoure. The test solution for each test vessel, and then sampled test solutions were mixed.

Vehicle:

yes

Details on test solutions:

Identity and concentration of auxiliary solvent for dispersal: N,N-Dimethylfomamide (DMF).

Test organisms (species):

Oryzias latipes

Details on test organisms:

Medaka (Oryzias latipes), ten fish 2.3 +/- 1.2cm

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

41.2 mg /L

Test temperature:

23.1 to 23.7 degrees centigrade

pH:

7.3 to 7.7

Dissolved oxygen:

6.4 to 8.4mg /L

Salinity:

N/A

Nominal and measured concentrations:

0.0824 mg /L
0.0766 to 0.0956 mg /L

Details on test conditions:

see report

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 0.082 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 0.082 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 0.082 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

%Concentration loss over test: 4.1 ... 18.3

Results with reference substance (positive control):

See report

Reported statistics and error estimates:

No statisical analysis

Validity criteria fulfilled:

yes

Conclusions:

The present study was performed as a limit test to confirm if the test item has no effects on the test organism near 0.100mg/L of the test solution which was expected the expected solubility to dilution in water. The measured concentration at the preapration (twice) of the test solution slightly showed a variation. however, the solubility of the test item to the test media was estimated to be near the concentrations measured after 24 hours in the test solution because these concentrations were almost the same. Therefore, it was considered that the measured concentrationin the test solution was maintained higher than the expected soulbilty of the test item, and the present limit test has no potential for adverse effects on the test organisms near the solubility of the test item to the test medium.

Executive summary:

A 96 hour acute toxicity test of FP-100 with Medaka was conducted.

Ten fish we used in an exposure level of 0.100 mg/L (nominal concentration), a vehicle and a control. The water temperature was maintained within 23 to 25 °C. The test solutions were renewed every 24 hours, as the semi-static method. In preliminary tests the solubility of the test item to dilution water was not reproducible, and the concentration in disperwsed suspension containing the test item was very low and showed variation. So the test concentration was decided from the concentration which was expected to maintain the concentration in the test solution with N,N-dimethyl formamide (DMF) during exposure and be more than the solubility.

The measured concentrations of the test item in the test solution were 80.7 and 96.5% of the nominal concentration at the start of the exposure and the renewal at 72 hours, and 76.6 and 77.3% at the end of the exposure before the renewal at 24 hours. The results were estimated based on the time weighted mean of the measured concentrations, 0.0824 mg/L because the measured values of the test item concentration in the test solution were not kept within the +/- 20% of the nominal concentration.

Consequently, both of the 48 -hour and 96 -hour LC50's (Median Lethal concentration) of FP-100 were > 0.0824 mg/L

The NOEC ( No Observed Effect Concentration) was > 0.0824 mg/L since no mortality was observed in the present test concentration during the exposure.

The measured concentrations at 24 hours after preparation of the test solution were not kept within +/- 20% of the nominal concentration. However, it was considered that the concentration in the test solution was maintained higher than the solubiltiy of the test item to that of the test medium expected from the measured values at 24 hours after the preparation of the test solution. Therefore, it is concluded that the test tiem has no ptoential for adverse effects on the test organism near the solubiltiy of the test item to the test medium.

Description of key information

The NOEC ( No Observed Effect Concentration) was > 0.0824 mg/L since no mortality was observed in the present test concentration during the exposure.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

0.082 mg/L

Additional information

A 96 hour acute toxicity test of FP-100 with Medaka was conducted.

Ten fish we used in an exposure level of 0.0100 mg/L (nominal concentration), a vehicle and a control. The water temperature was maintained within 23 to 25°C. The test solutions were renewed every 24 hours, as the semi-static method. In preliminary tests the solubility of the test item to dilution water was not reproducible, and the concentration in disperwsed suspension containing the test item was very low and showed variation. So the test concentration was decided from the concentration which was expected to maintain the concentration in the test solution with N,N-dimethyl formamide (DMF) during exposure and be more than the solubility.

The measured concentrations of the test item in the test solution were 80.7 and 96.5% of the nominal concentration at the start of the exposure and the renewal at 72 hours, and 76.6 and 77.3% at the end of the exposure before the renewal at 24 hours. The results were estimated based on the time weighted mean of the measured concentrations, 0.0824 mg/L because the measured values of the test item concentration in the test solution were not kept within the +/- 20% of the nominal concentration.

Consequently, both of the 48 -hour and 96 -hour LC50's (Median Lethal concentration) of FP-100 were > 0.0824 mg/L

The NOEC ( No Observed Effect Concentration) was > 0.0824 mg/L since no mortality was observed in the present test concentration during the exposure.

The measured concentrations at 24 hours after preparation of the test solution were not kept within +/- 20% of the nominal concentration. However, it was considered that the concentration in the test solution was maintained higher than the solubiltiy of the test item to that of the test medium expected from the measured values at 24 hours after the preparation of the test solution. Therefore, it is concluded that the test tiem has no potential for adverse effects on the test organism near the solubiltiy of the test item to the test medium.