2H-Azepin-2-one, hexahydro-, polymer with 1,6-diisocyanatohexane

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:

2007-10-12 to 2007-12-07

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions: high concentration of solvent, no substance specific analytical monitoring

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Version / remarks:

(1992)

Deviations:

no

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

(1992)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

Measurement of dissolved organic carbon (DOC) after 0, 24, 48, 72 and 96 hours

Vehicle:

no

Details on test solutions:

A stock solution was prepared to give the desired test concentration. To achieve this 500.8 mg of the test item were added to 5 litres of dilution water and treated for 60 seconds at 8000 rpm with an ultra turrax and afterwards stirred for 3 hours on a magnetic stirrer. Finally undissolved particles of the test item were removed by filtration using a folded filter of pore size 7-12 μm. The resulting filtrate was coloured slightly milky white.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

Source: Aqua KloeGer (Germany)
Stock held and acclimatised to test conditions since 2007-09-18
Feeding discontinued 24 hours proir to test start
Mean standard length: 3.4 cm (S.D. = 0.14 cm)
Loading: 0.44 g body weight per litre

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

15.2° dH (=271 mg/l CaCO3)

Test temperature:

21.9-22.8°C

pH:

7.5-7.9

Dissolved oxygen:

above 60% of the air saturation value: 7.4 mg/L to 8.9 mg/L

Nominal and measured concentrations:

nominal: 100 mg/L solution = 72 mg/l oligomer
measured (DOC): 14.4 mg/L (0h), 15.35 mg/L (24h), 14.91 mg/L (48h), 14.61 mg/L (72h), 13.21 mg/L (96h)
For a solution of 28 mg solvent / 100 ml test water a DOC of 15.3 mg/l is expected (54.53 % carbon in molecular formula).

Details on test conditions:

7 animals per test concentration were held in glass aquaria holding 5 L of test media. The aquaria were gently aerated via narrow glass tubes to maintian the dissolved oxygen above 60% of the air saturation value. No feeding took place during the exposure period and the test media were not exchanged (static system). The fish were held in a 16 h light : 8 h dark cycle.

Reference substance (positive control):

no

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:

At a limit test concentration of 100 mg solution/L one out of seven fish died. Typically this would trigger re-testing with several test concentrations. As none of the remaining 6 fish showed any symptoms of toxicity it can be concluded that the LC 50 is > 100 mg solution/L and no re-testing was performed.

Validity criteria fulfilled:

yes

Conclusions:

The test solution showed no toxic effects on fish at a nominal concentration of 100 mg/L, corresponding to 72 mg 2H-Azepin-2-one, hexahydro-, polymer with 1,6-diisocyanatohexane/L.

Executive summary:

A study was performed to assess the acute toxicity of a 72 % solution of 2H-Azepin-2-one, hexahydro-, polymer with 1,6-diisocyanatohexane in 2-methoxy-1-methylethylacetate to Danio rerio under static conditions. The study was conducted in accordance with EEC Methods for Determination of Ecotoxicity in Directive 92/69/EEC (O.J. No. L383A, 1992) Part C, Method 1 'Acute toxicity for Fish' which is in most parts equivalent to the OECD Guideline for Testing of Chemicals No. 203 'Fish, Acute Toxicity Test' (1992). A group of seven fish of mostly the recommended size was exposed to a limit test concentration of nominally 100 mg test item /L test water. Auxiliaries used to prepare the test media were an ultra turrax, a magnetic stirrer and folded filters. Observations were made on the number of dead fish and the incidence of sub-lethal effects after 2, 24, 48, 72 and 96 hours of exposure. At a limit test concentration of 100 mg/L one out of seven fish died. Typically this would trigger re-testing with several test concentrations. As none of the remaining 6 fish showed any symptoms of toxicity it can be concluded that the LC 50 is > 100 mg test item/L (72 mg 2H-Azepin-2-one, hexahydro-, polymer with 1,6-diisocyanatohexane/L) and no re-testing was performed. All results are expressed in terms of nominal concentrations. The determination of the DOC gave results corresponding to the (nominal) 28 mg 2-methoxy-1-methylethylacetate/L while insoluble oligomer was removed before test start.

Description of key information

A study was performed to assess the acute toxicity of a 72 % solution of 2H-Azepin-2-one, hexahydro-, polymer with 1,6-diisocyanatohexane in 2-methoxy-1-methylethylacetate to Danio rerio under static conditions. The study was conducted in accordance with EEC Methods for Determination of Ecotoxicity in Directive 92/69/EEC (O.J. No. L383A, 1992) Part C, Method 1 'Acute toxicity for Fish' which is in most parts equivalent to the OECD Guideline for Testing of Chemicals No. 203 'Fish, Acute Toxicity Test' (1992). A group of seven fish of mostly the recommended size was exposed to a limit test concentration of nominally 100 mg test item /L test water. Auxiliaries used to prepare the test media were an ultra turrax, a magnetic stirrer and folded filters. Observations were made on the number of dead fish and the incidence of sub-lethal effects after 2, 24, 48, 72 and 96 hours of exposure. 

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

> 100 mg/L

Additional information

At a limit test concentration of 100 mg/L one out of seven fish died. Typically this would trigger re-testing with several test concentrations. As none of the remaining 6 fish showed any symptoms of toxicity it can be concluded that the LC 50 is > 100 mg test item/L (72 mg 2H-Azepin-2-one, hexahydro-, polymer with 1,6-diisocyanatohexane/L) and no re-testing was performed. All results are expressed in terms of nominal concentrations. The determination of the DOC gave results corresponding to the (nominal) 28 mg 2-methoxy-1-methylethylacetate/L while insoluble oligomer was removed before test start.