[No public or meaningful name is available]

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:

Experiment start date - 25 January 2005; Experiment completion date - 09 February 2005; Study completion date - 14 June 2005.

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

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Identity: FAT 40819/A
Description: Red brown powder
Batch number: Red ROE 420 BOP 01/04
Purity: approx. 77 %
Stability of test item: Stable under storage condition
Expiry date: 02 November 2009
Stability of test item dilution: Stable in PEG 300 for at least 7 days at room temperature
Storage conditions: At room temperature.

Analytical monitoring:

yes

Details on sampling:

- For the analysis of the actual test item concentrations the following samples were taken just before test start: duplicate samples from the single test medium and duplicate samples from the control; after 48 and 96 hours: duplicate samples from the single test medium (stability samples) and duplicate samples from the control.
- All samples were taken from the approximate center of the aquaria without mixing of the test media, and were deep-frozen (at about -20 °C) immediately after sampling. Based on pre-experiments for investigation of the storage stability (without GLP) the test item is sufficiently stable in the test water under the storage conditions. The concentration of the test item was analyzed in both test medium samples from the sampling times at 0 and 96 hours. From the control samples only one of the duplicate samples was analyzed from the corresponding sampling times.

Vehicle:

no

Details on test solutions:

The test medium was prepared by dissolving 500.3 mg of test item completely in 5000 mL of test water using ultrasonic treatment for 10 minutes and stirring for 15 minutes at room temperature. The test medium of was freshly prepared just before introduction of the fish (= start of the test).

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

The study was performed with zebra fish (Brachydanio rerio). The test fish were obtained from the commercial fish supplier H. Eggimann, CH-4133 Pratteln, Switzerland. In accordance with the test guidelines the fish were held in the laboratories of RCC for twelve days without any medication. Prior to test start, they were acclimated for one week to the test water and temperature. During holding and acclimatization until one day before the start of the test the fish were fed with a commercial fish diet (Tetra Min Hauptfutter, supplied by TETRA-Werke, D-49304 Melle, Germany). During holding and acclimatization no fish died in the test fish batch and all fish were healthy. From the acclimated test fish batch, 10 fish were measured at the start of the test: The mean body length of the fish was 2.7 ± 0.1 cm (Mean ± SD), the mean body wet weight was 0.17 ± 0.02 g (Mean ± SD).

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

192 mg/L as CaCO3

Test temperature:

21 °C

pH:

7.8-8.6

Dissolved oxygen:

8.1-8.6 mg/L

Nominal and measured concentrations:

- Nominal 0, 100 mg/L.
- Measured: 92 to 96 % of nominal.

Details on test conditions:

One glass aquarium with five liters test medium was used for each treatment (the single test concentration and the control). The test vessels were labeled with the RCC study number and all necessary additional information to ensure unmistakable identification. At the start of the test 7 fish were introduced into each aquarium in a random order. The loading rate was less than 1 g fish wet weight per liter test medium. The test medium and the control were slightly aerated during the test period. The fish were not fed during the test. Light conditions: A 16-hour light to 8-hour dark photoperiod, with a 30-minute transition period (light intensity during the light period was approximately within the range of 60 to 350 Lux).

Reference substance (positive control):

no

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)

Details on results:

- The test item was stable during the test period of 96 hours under the conditions of the test, and the reported biological results are based on the nominal concentration of the test item. No remarkable observations were made concerning the appearance of the test media. The test medium was a clear red - colored solution throughout the whole test duration.
- In the control and in the test medium of 100 mg/L all fish survived until the end of until the test and no visible abnormalities were observed at the test fish. 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 40819/A to zebra fish were determined to be at least 100 mg/L. The 96-hour NOEC and the 96-hour LC0 might even be higher than this concentration, but concentrations in excess of 100 mg/L have not been tested, according to the guidelines. The 96-hour LOEC (lowest concentration with toxic effects), the 96-hour LC50 and the 96-hour LC100 were clearly higher than 100 mg/L. These values could not be quantified due to the absence of toxicity of FAT 40819/A at the tested concentration.

Validity criteria fulfilled:

yes

Conclusions:

The 96 hour LOEC (lowest concentration with toxic effects), the 96 hour LC50 and the 96 hour LC100 were clearly higher than 100 mg/L.

Executive summary:

The acute toxicity of the test item FAT 40819/A to zebra fish (Brachydanio rerio) was determined in a 96-hour static test according to the EL) Commission Directive 92/69/EEC, Part C.1 (1992), and the OECD Guideline for Testing of Chemicals No. 203, (1992). A limit test was performed in accordance with the guidelines to demonstrate that the test item has no toxic effect on the test organisms at the nominal concentration of 100 mg/L. Thus, the only concentration tested was nominal 100 mg/L and a control. The analytically determined test item concentration in the test medium varied in the range from 92 to 96 % of the nominal value. Consequently, the test item was stable during the test period of 96 hours under the conditions of the test, and the reported biological results are based on the nominal concentration of the test item. In the control and at the test concentration of 100 mg/L no mortality or other visible abnormalities were determined at the test fish 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 LC0 of FAT 40819/A to zebra fish were determined to be at least 100 mg/L. The NOEC and the LC0 might even be higher than this concentration, but concentrations in excess of 100 mg/L have not been tested, according to the guidelines. The 96 -hour LOEC (lowest concentration with toxic effects), the 96-hour LC50 and the 96-hour LC100 were clearly higher than 100 mg/L.

Description of key information

The 96-h LC50 is >100 mg/L in zebra fish. 

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

The acute toxicity of the test item FAT 40819/A to zebra fish (Brachydanio rerio) was determined in a 96-hour static test according to the EU Commission Directive 92/69/EEC, Part C.1 (1992), and the OECD Guideline for Testing of Chemicals No. 203, (1992). A limit test was performed in accordance with the guidelines to demonstrate that the test item has no toxic effect on the test organisms at the nominal concentration of 100 mg/L. Thus, the only concentration tested was nominal 100 mg/L and a control. The analytically determined test item concentration in the test medium varied in the range from 92 to 96 % of the nominal value. Consequently, the test item was stable during the test period of 96 hours under the conditions of the test, and the reported biological results are based on the nominal concentration of the test item. In the control and at the test concentration of 100 mg/L no mortality or other visible abnormalities were determined at the test fish 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 LC0 of FAT 40819/A to zebra fish were determined to be at least 100 mg/L. The NOEC and the LC0 might even be higher than this concentration, but concentrations in excess of 100 mg/L have not been tested, according to the guidelines. The 96-hour LOEC (lowest concentration with toxic effects), the 96-hour LC50 and the 96-hour LC100 were clearly higher than 100 mg/L.