Butanal, reaction products with aniline

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:

2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

yes

Remarks:

, Some test fish had a somewhat larger size than the one recommended in the test guideline for the zebra fish and the temperature fluctuation in the course of the study exceeded 1 °C. Both deviations are not regarded to be relevant to the results.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

, Some test fish had a somewhat larger size than the one recommended in the test guideline for the zebra fish and the temperature fluctuation in the course of the study exceeded 1 °C. Both deviations are not regarded to be relevant to the results.

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

direct weighing

Vehicle:

no

Details on test solutions:

Reconstituted water prepared according to the recommendations of ISO 7346. This freshly prepared standard dilution water was used for the maintenance of the test animals under flow-through conditions and for the preparation of stock and test solutions of the test item.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

- Source : Aqua KlöGer (Germany)
- Date supplied : 2011-04-19
- Acclimatisation : Stock held since 2011-04-19 and acclimatised to the test conditions since then
- Temperature : 20-24 °C
- Dissolved oxygen : > 5 mg/L
- Feeding : Commercial fish food, daily. Feeding discontinued 24 h prior to test start.
- Mortalities during acclimatisation period : < 5 %
- Medication : none
- Mean standard length (n = 35) : 3.6 cm (S.D. = 0.16 cm)

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

13.4°dH (=239mg/L CaCO3)

Test temperature:

21.2 - 22.4°C

pH:

7.6 - 7.8

Dissolved oxygen:

8.1 - 8.4 mg/L (saturation = 94 - 96 %)

Nominal and measured concentrations:

nominal: 12.5, 25.0. 50.0 and 100.0 mg/L

Details on test conditions:

Pre-treatment of test item and preparation of test item concentrations:
To produce the different Water Accommodated Fractions (WAFs) 62.8 mg, 125.2 mg, 250.5 mg and 500.0 mg of the test item were added each to 5 litres of dilution water, treated for 60 seconds at 8000 rpm with an ultra turrax and then stirred for 24 h on a magnetic stirrer. Finally undissolved particles of the test item were removed by filtration using aseptic filters (Sartobran 150 sterile capsule) with a pore size of 0.45 + 0.2 μm. The pH was measured to be 7.8 - 7.9. Finally 7 fish were given to all WAFs and the control.
Exposure conditions:
- Test vessels : glass aquaria holding 5 L of test media covered by glass plates
- Experimental design : 4 test concentrations plus 1 control, 7 fish per test concentration, no feeding during the exposure period, static system
- Method of initiation : fish were placed in prepared media
- Loading : 0.73 g body weight (wet weight) per litre
- Photoperiod : 16 h light: 8 h dark
- Temperature : 21.2 to 22.4 °C
- Aeration : gentle aeration via narrow glass tubes
- Test item concentrations : 12.5, 25, 50 and 100 mg/L
- Method of administration : direct weighing

Duration:

2 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

LL50

Effect conc.:

53.7 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95 % confidence limits: not determined due to mathematical reasons or appropriate data

Duration:

72 h

Dose descriptor:

LL50

Effect conc.:

48.8 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95 % confidence limits: not determined due to mathematical reasons or appropriate data

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

48.8 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95 % confidence limits: not determined due to mathematical reasons or appropriate data

Details on results:

The test item has not a definite or unique structure and consists of several constituents. A suitable selective and sensitive chromatographic method for the determination of the test item in aqueous solutions could not be established and an accompanying analysis by the means of a chromatographic method cannot be performed.
Because aniline seems to have an influence on the toxic effects of Butanal, reaction products with aniline, the aniline content was analysed during the test with the sponsor’s agreement. To record the total amount of dissolved substance the content of the test item during the exposure period was additionally verified by DOC determination.
Water Accommodated Fractions (WAFs) were produced to test the effects at different loading rates and all results are expressed in terms of Lethal Loadings (LL).

Validity criteria fulfilled:

yes

Remarks:

mortality in the controls < 10% by the end of the test; dissolved oxygen concentration above 60% of the air-saturation value throughout the exposure period; pH did not vary by more than 1 unit

Conclusions:

The acute toxicity of the test itm to fish was conducted in a static test according to OECD method 203. After 96 hours of exposure a LL50 of 48.8 mg/L after 96 hours was obtained

Executive summary:

A study was performed to assess the acute toxicity of test item to Danio rerio under static conditions. The study was conducted in accordance with Council Regulation (EC) No 440/2008, Method C.1 'Acute toxicity for Fish' (2008) which is in most parts equivalent to the OECD Guideline for Testing of Chemicals No. 203 'Fish, Acute Toxicity Test' (1992). Groups of seven fish of the recommended size were exposed to a range of concentrations, nominally 12.5, 25.0. 50.0 and 100.0 mg/L of the test item dissolved in dilution water. Auxiliaries used to prepare the test media were an ultra turrax, a magnetic stirrer and aseptic filters. Observations were made on the numbers of dead fish and the incidence of sub-lethal effects after 2, 24, 48, 72 and 96 hours of exposure. After 96 hours of exposure a LL value of 48.8 mg/L was obtained. The tes item has not a definite or unique structure and consists of several constituents. A suitable selective and sensitive chromatographic method for the determination of the test item in aqueous solutions could not be established and an accompanying analysis by the means of a chromatographic method cannot be performed. Because aniline seems to have an influence on the toxic effects of the test item, the aniline content was analysed during the test with the sponsor’s agreement. To record the total amount of dissolved substance the content of the test item during the exposure period was additionally verified by DOC determination. Water Accommodated Fractions (WAFs) were produced to test the effects at different loading rates and all results are expressed in terms of Lethal Loadings (LL).

Description of key information

The acute toxicity of the test itm to fish was conducted in a static test according to OECD method 203. After 96 hours of exposure a LL50 of 48.8 mg/L after 96 hours was obtained

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

48.8 mg/L

Additional information

The test item has not a definite or unique structure and consists of several constituents. A suitable selective and sensitive chromatographic method for the determination of the test item in aqueous solutions could not be established and analytical monitoring by means of a chromatographic method cannot be performed. As aniline seems to have an influence on the toxic effects of the test item, the aniline content was analysed during the test with the sponsor’s agreement. To record the total amount of dissolved substance the content of the test item during the exposure period was additionally verified by DOC determination. Water Accommodated Fractions (WAFs) were produced to test the effects at different loading rates and all results are expressed in terms of Lethal Loadings (LL).