2,5-Furandione, dihydro-, mono-C15-20-alkenyl derivs.

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Remarks:

read-across to similar substance

Adequacy of study:

key study

Study period:

19-08-1996 to 23-08-1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP study, method is clear and all criteria are met so the study with the test substance CAS 28777-98-2 is valid. However data is missing on the stability of the testsubstance and since no analysis has been performed the actual exposure remains uncertain.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes (incl. QA statement)

Remarks:

UK GLP Monitoring Authority, Dep. Health UK, 1996

Analytical monitoring:

no

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: For the purpose of the definitive study the test material was prepared using a preliminary solution in dimethylsulphoxide.
An amount of test material (200 mg) was dissolved in 2.0 mL of solvent prior to dispersal in approximately 15 mL of reverse osmosis water with the aid of ultrasonic disruption for about 30 minutes. This mixture was then dispersed in approximately 4 litres of dechlorinated tap water with the aid of ultrasonic disruption for about 1 hour prior to adjusting the volume to 20 litres to give a 10 mg/L test concentration. The test vessels were furnished with shielded propeller stirrers in order to maintain a homogenous dispersion of the test material.

Test organisms (species):

Leuciscus idus

Details on test organisms:

TEST ORGANISM
- Common name: Golden orfe
- Strain: Leuciscus idus
- Source: Xotic Fish Centre, Alfreton, Derbyshire, UK
- Length at study initiation (length definition, mean, range and SD): Mean standard length of 5.4 cm (s.d. = 0.2)
- Weight at study initiation (mean and range, SD): Mean weight of 1.66 g (s.d. = 0.17) at the end of the definitive study


ACCLIMATION
- Acclimation period: From 12 August 1996 to 19 August 1996. The lighting cycle was controlled to give a 16 hours light and
8 hours darkness cycle.
- Acclimation conditions (same as test or not): Yes
- Type and amount of food: commercial Tetramin® flake food
- Feeding frequency: Daily, but discontinued 48 hours prior to the start of the definitive study
- Health during acclimation (any mortality observed): No mortality

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

100 mg/L CaCO3

Test temperature:

21 °C

pH:

7.6-8.0

Dissolved oxygen:

8.0-8.5 mg/L

Nominal and measured concentrations:

nominal: 10 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 20 litre glass exposure vessels
- Type: closed
- Aeration: shielded propeller stirrers
- Renewal rate of test solution (frequency/flow rate): daily
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: 0.83 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Laboratory tap water dechlorinated by passage through an activated carbon filter

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light and 8 hours darkness

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Any mortalities and sub-lethal effects of exposure were recorded at 3, 6, 24, 48, 72 and 96 hours after the start of exposure. The criteria of death were taken to be the absence of both respiratory movement and response to physical stimulation.

TEST CONCENTRATIONS
- Range finding study: In the range-finding study 3 fish were exposed to a series of nominal test concentrations of 1.0 and 10 mg/L.
- Results used to determine the conditions for the definitive study: The results showed no mortalities at the test concentrations of 1.0 and 1 O mg/L. However, during the preliminary solubility work performed precipitation of the test material was observed at concentrations in excess of 10 mg/L indicating this to be the maximum limit of water solubility of the test material under these test conditions.

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

There were no mortalities in 20 fish exposed to a test concentration of 10 mg/L for a period of 96 hours.

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity of Pentasize 68 to the freshwater fish golden orfe (Leuciscus idus) has been investigated and gave a 96-Hour LC50 of greater than 10 mg/L nominal. Correspondingly the No Observed Effect Concentration was greater than or equal to 10 mg/L nominal. All criteria are met so the study is valid. However data is missing on the stability of the testsubstance and since no analysis has been performed the actual exposure remains uncertain.

Executive summary:

A study was performed to assess the acute toxicity of the test material, Pentasize 68, to golden orfe (Leuciscus idus) in accordance with OECD Guidelines for Testing of Chemicals (1992) No 203, "Fish, Acute Toxicity Test" referenced as Method C.1 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC) and the Guidelines of the German Water Hazard Classification Scheme (Bewertung Wassergefahrdender Stoffe LTWS - Nr 10). Following a preliminary range-finding study two groups of ten fish were exposed to an aqueous dispersion of the test material at a concentration of 10 mg/L for a period of 96 hours under semi-static test conditions. The number of mortalities and any sub-lethal effects of exposure in each test and control vessel were determined 3 and 6 hours after the start of exposure and then daily throughout the study until termination after 96 hours. As a result, the 96-Hour LC50 based on nominal test concentrations was greater than 10 mg/L and correspondingly the No Observed Effect Concentration was greater than or equal to 10 mg/L. The test concentration of 10 mg/L was the highest attainable test concentration due to the limited solubility of the test material in water and auxiliary solvent, and having due regard for the amount of auxiliary solvent permitted in the test under the OECD Guidelines.

Given that the LC50 can only be estimated as greater than 10 mg/I (> 10 ppm = 1 x 10-s) the evaluation number (Bewertungszahl, BWZ) for the German Water Hazard Classification Scheme can only be estimated as being less than 5.

Description of key information

Short-term toxicity as determined by read-across: LC50 (96 h) > 10 mg/L, NOEC (96 h) >= 10 mg/L (CAS 28777-98-2)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

10 mg/L

Additional information

Because no test with 2,5-Furandione, dihydro-, mono-C15-20-alkenyl derivs on acute toxicity in fish is available, a test with the main constituent C18 ASA is assessed.

In a limited test performed in accordance with OECD 203, no mortalities have been among 20 freshwater fishes Leuciscus idus exposed for 96 hours to the nominal concentration 10 mg/L of C18 ASA. Consequently, the LC50 and NOEL after 96 were determined to be >10 mg/L.

Since the tested substance C18-ASA is a main constituent of 2,5-Furandione, dihydro-, mono-C15-20-alkenyl derivs, the same outcome of the tests would be expected for 2,5-Furandione, dihydro-, mono-C15-20-alkenyl derivs .