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Ecotoxicological information

Toxicity to soil macroorganisms except arthropods

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Reference
Endpoint:
toxicity to soil macroorganisms except arthropods: long-term
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
The read across is justified since the the target substance has a lower ecotoxicity (about a factor of 2) than the source substance. Therefore, one to one read across is considered conservative. Further information is provided in the read across justification documents.
Reason / purpose:
read-across source
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
>= 104 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
>= 104 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
growth
Key result
Duration:
56 d
Dose descriptor:
NOEC
Effect conc.:
>= 104 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
reproduction
Key result
Duration:
56 d
Dose descriptor:
NOEC
Effect conc.:
>= 104 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
food consumption
Details on results:
- Mortality at end of exposure period: none
- Total mass of adults at beginning of test: about 420 mg/worm
- Changes in body weigth of live adults (% of initial weight) at end of exposure period:Control weight after 4 weeks: on average 506.0 mg/worm
- No. of offspring produced: control: 190 worms per container
- No. of unhatched cocoons:not reported
- Morphological abnormalities: none reported
- Behavioural abnormalities: none reported
- Other biological observations: none

The read across is justified since the the target substance has a lower ecotoxicity (about a factor of 2) than the source substance. Therefore, one to one read across is considered conservative.
Results with reference substance (positive control):
- Results with reference substance valid? yes
- Relevant effect levels: Carbendazim 600 g/L SC NOEC reproduction 1.44 mg/kg dw
Reported statistics and error estimates:
Dunnetts t-test, alpha = 0.05, one-sided smaller
Validity criteria fulfilled:
yes
Conclusions:
earthworm reproduction: NOEC >= 104 mg/kg dw
Executive summary:

In the Klimisch 1 GLP study from Straube (2016) the chronic toxicity of Butanedioic acid, sulfo-, 1,4-diisodecyl ester, sodium salt on earthworms (Eisenia fetida) reproduction and growth in artificial soil was determined in an 56 day test according to OECD 222. The test was performed with Control, 1.3, 13, 26, 52 and 104 mg a.i./kg soil dry weight. The biological results are based on nominal concentrations since the analysis of the stock solution confirmed correct preparation of this solution and the preparation and application of the application solutions was checked and documented by weighing.

Eight replicates with 10 worms each were set up for the control and 4 replicates for each test group. After 28 days 0, 0, 0, 0, 0, 0 and 0% mortality was observed in the control and at nominal test concentrations of 1.3, 13, 26, 52 and 104 mg a.i./kg soil dry weight, respectively.

The reproduction per pre replicate container with 10 adult worms was 190, 165, 171, 150, 170, and 170 living offspring per container (10 worms) control and at nominal test concentrations of 1.3, 13, 26, 52 and 104 mg a.i./kg soil dry weight, respectively.

 

The overall NOEC for reproduction, mortality, growth and food consumption was equal or greater than the highest test concentration, i.e. >= 104 mg/ kg dw.

The read across is justified since the the target substance has a lower ecotoxicity (about a factor of 2) than the source substance. Therefore, one to one read across is considered conservative. Further information is provided in the read across justification documents.

 

The result is considered relevant and reliable for the risk assessment.

Description of key information

NOEC chronic earthworm >= 104 mg/kg dw

Key value for chemical safety assessment

Long-term EC10, LC10 or NOEC for soil macroorganisms:
104 mg/kg soil dw

Additional information

The Guidance on information requirements and chemical safety assessment, Chapter R.7C: Endpoint specific guidance (November 2014), section R. 7.11.6.3, Table R.7.11-2, page 145, specifies the information needed to waive the terrestrial studies based on soil hazard categories.

The log Pow of the registered substance is <3. Therefore, accumulation and persistence of the registered substance in soil and organisms is very unlikely. Based on these characteristics, the registered substance is not expected to cause adverse effects on terrestrial organisms and consequently terrestrial toxicity tests are not needed.

Nevertheless, in the Klimisch 1 GLP study from Straube (2016) the chronic toxicity of Butanedioic acid, sulfo-, 1,4-diisodecyl ester, sodium salt on earthworms (Eisenia fetida) reproduction and growth in artificial soil was determined in an 56 day test according to OECD 222. The test was performed with Control, 1.3, 13, 26, 52 and 104 mg a.i./kg soil dry weight. The biological results are based on nominal concentrations since the analysis of the stock solution confirmed correct preparation of this solution and the preparation and application of the application solutions was checked and documented by weighing.

Eight replicates with 10 worms each were set up for the control and 4 replicates for each test group. After 28 days 0, 0, 0, 0, 0, 0 and 0% mortality was observed in the control and at nominal test concentrations of 1.3, 13, 26, 52 and 104 mg a.i./kg soil dry weight, respectively.

The reproduction per pre replicate container with 10 adult worms was 190, 165, 171, 150, 170, and 170 living offspring per container (10 worms) control and at nominal test concentrations of 1.3, 13, 26, 52 and 104 mg a.i./kg soil dry weight, respectively.

 

The overall NOEC for reproduction, mortality, growth and food consumption was equal or greater than the highest test concentration, i.e. >= 104 mg/ kg dw.

The read across is justified since the the target substance has a lower ecotoxicity (about a factor of 2) than the source substance. Therefore, one to one read across is considered conservative. Further information is provided in the read across justification documents.

 

The result is considered relevant and reliable for the risk assessment.