Formaldehyde, oligomeric reaction products with diethylenetriamine and phenol

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

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

GLP compliance:

yes

Analytical monitoring:

yes

Vehicle:

yes

Details on test solutions:

A nominal amount of test item (50 mg) was dissolved in 1000 mL of test water to give a 50 mg/L stock solution. The stock solution was inverted several times to ensure adequate mixing and homogeneity. A dilution was made from this stock solution to give the test concentration of 0.20 mg/L.
The test preparation was mixed with a flat bladed stirrer for approximately 1 minute to ensure adequate mixing and homogeneity.
The concentration and stability of the test item in the test preparations were verified by chemical analysis of the fresh media at 0 and 72 hours and of the old media at 24 and 96 hours.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test temperature:

14 degrees Celcius

pH:

7.3-7.7

Dissolved oxygen:

9.6-11.6

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 0.14 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity of the test item to the freshwater fish rainbow trout (Oncorhynchus mykiss) has been investigated and, based on the average geometric mean measured test concentration, gave a 96-Hour LC50 of greater than 0.14 mg/L. The No Observed Effect Concentration was 0.14 mg/L.

Executive summary:

Introduction

A study was performed to assess the acute toxicity of the test item to rainbow trout (Oncorhynchus mykiss). The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (1992) No 203, "Fish, Acute Toxicity Test" referenced as Method C.1 of Commission Regulation (EC) No. 440/2008.

Methods

In accordance with the recommendations of REACh, the test was conducted according to the threshold approach recommended by ECHA. Using this approach the lowest EC50 value from either the Algal Growth Inhibition study or Acute Toxicity to Daphnia magna study (Envigo Study Numbers HH45BX and WY27VT) is set as the threshold concentration and a “Limit test” is conducted at this threshold concentration. If no mortalities are observed this indicates that fish are not the most sensitive species and that the LC50 is greater than the threshold concentration. The EC50 value obtained from the Algal Growth Inhibition study was the lower of these two EC50 values and hence the test was conducted at a single concentration of 0.20 mg/L.

Seven fish were exposed to an aqueous solution of the test item, at a single concentration of 0.20 mg/L for a period of 96 hours at a temperature of approximately 14 ºC under semi-static test conditions. The number of mortalities and any sub-lethal effects of exposure in each test and control vessel were determined 1, 3 and 6 hours after the start of exposure and then daily throughout the test until termination after 96 hours.

Results

Analysis of the fresh test preparations at 0 and 72 hours showed measured test concentrations of 0.134 and 0.151 mg/L, respectively. The measured concentrations of the aged test preparations at 24 and 96 hours were 0.154 and 0.122 mg/L, respectively.

Given that the measured test concentrations of the fresh test preparations were not near nominal, it was considered justifiable to base the results on the average geometric mean measured test concentration to give a "worst case" analysis of the data. The geometric mean measured concentration was determined to be 0.14 mg/L.

Exposure of rainbow trout (Oncorhynchus mykiss) to the test item gave LC50 values based on the average geometric mean measured test concentration of greater than 0.14 mg/L. The No Observed Effect Concentration was 0.14 mg/L.

Description of key information

The acute toxicity of the test item to the freshwater fish rainbow trout (Oncorhynchus mykiss) has been investigated and, based on the average geometric mean measured test concentration, gave a 96-Hour LC50 of greater than 0.14 mg/L. The No Observed Effect Concentration was 0.14 mg/L.