Reaction mass of 2-ethyl-2-(methoxymethyl)-propane-1,3-diol and 2-ethylpropane-1,3-diol

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:

2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

The test fish were received in November 2008 from import quarantine and were kept in internal quarantine for 14 days before the start of the study.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Post exposure observation period:

No

Hardness:

250±25 mg/L calcium carbonate

Test temperature:

24±1°C

pH:

7.8±0.2

Dissolved oxygen:

>90% saturation

Salinity:

Not applicable

Conductivity:

Not applicable

Nominal and measured concentrations:

Nominal exposure concentrations: 0 (control), 400, 800, 1600, 3200 and 6400 mg/L.

Details on test conditions:

Fish were incubated under semi-static conditions with exchange of test and control solutions every 24 hours.

Dilution water was aerated ot oxygen saturation exceeding 90% with a pH of 7.8 +- 0.2. This fish were tested in 5L glass vessels. With normal laboratory illumination and a light dary cycle of 16:8. The following loading rates were used with 7 fish per rate: 0 (control), 400, 800, 1600, 3200, 6400 mg/L nominal.

Reference substance (positive control):

yes

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

2 400 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

800 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

behaviour

Details on results:

Mortality after 96 hours exposure was 0% in the control, 400, 800 and 1600 mg/L, 100% mortality was observed at 3200 and 6400 mg/L. Visible abnormalities (eg darker pigmentation, loss of equilibrium, disturbance in swimming behaviour or increased respiration rate) were observed in all fish at the nomi9nal 1600 mg/L concentration.

Results with reference substance (positive control):

Disodium heptachromate was used a reference material. The 24 h LC50 fulfilled the acceptance criterion of 200 - 400 mg/L.

Reported statistics and error estimates:

Not applicable

Sublethal observations / clinical signs:

The test substance demonstrated low toxicity to fish in this acute study. The nominal 96 hour LC50 was found to be 2400 mg/L with a NOEC of 800 mg/L.

Validity criteria fulfilled:

yes

Conclusions:

96 hour LC50 was found to be 2400 mg/L

Executive summary:

In a 96-h acute toxicity study, zebrafish (Danio rerio) were exposed to DMP-Tech (Reaction mass of 2-ethyl-2-(methoxymethyl)-propane-1,3-diol and 2-ethylpropane-1,3-diol) at nominal concentrations of 0 (control), 400, 800, 1600, 3200 and 6400 mg/L under semi-static conditions. The 96-h LC50 was 2400 mg/L. The NOEC value based on behavioural differences was observed to be 800 mg/L. Sublethal effects of visible abnormalities (e.g. darker pigmentation, loss of equilibrium, disturbance in swimming behaviour or increased respiration rate) were observed in the groups exposed to 1600 mg/L of DMP-Tech. Based on the results of this study, DMP-Tech would be classified as not hazardous to the aquatic environment in accordance with the classification system of the U.S. EPA.

This toxicity study is classified as acceptable and satisfies the guideline requirement for short-term toxicity study to fish.

Description of key information

In an OECD 203 study the 96-hour LC50 was determined to be 2400 mg/L, and the NOEC 800 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

2 400 mg/L

Additional information

A semi-static GLP study to OECD 203 was carried out to determine the toxicity to fish. The test substance demonstrated low toxicity to fish in this acute study. The nominal 96 hour LC50 was found to be 2400 mg/L with a NOEC of 800 mg/L. The test substance should be considered non toxic to fish.