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Toxicity to soil macroorganisms except arthropods

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Endpoint:
toxicity to soil macroorganisms except arthropods: short-term
Type of information:
experimental study
Adequacy of study:
key study
Study period:
05 - 19 Nov 2012
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study with acceptable restrictions (no purity, no reference substance)
Qualifier:
according to guideline
Guideline:
OECD Guideline 207 (Earthworm, Acute Toxicity Tests)
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations:
- Sampling method: Samples were collected on Day 2 of dry mixing, Day 6 of hydration equilibration, Day 0, prior to the addition of worms for the control and treatment and at test termination (Day 14). The samples were collected using a stainless steel spatula and weighed into 40 mL VOA vials. Three replicates were collected from the treatment soil and duplicate from the control. The samples collected at termination were from a pooled sample where all four replicates for each treatment group were composited.
- Sample storage conditions before analysis:
Vehicle:
no
Details on preparation and application of test substrate:
- Method of mixing into soil (if used): The treated artificial soil was prepared by spiking 300 grams of peat with the appropriate amount of test material using volumetric pipettes and/or stainless steel and glass syringe and mixed prior to the addition of clay and sand. The treated soil and control soil was mixed on a roller mill for three days. After hydration with distilled water the soils were placed in an environment chamber at test temperature to equilibrate for 8 days.
- Controls: A control soil was prepared without the test substance.
Test organisms (species):
Eisenia fetida
Animal group:
annelids
Details on test organisms:
TEST ORGANISM
- Common name: Earthworm
- Source: Lot W-43, Carolina Biological Supply Co. 2700 York Road, Burlington, NC 27215-3398
- Age at test initiation (mean and range, SD): Worms with clitellum.
- Weight at test initiation: 300 - 600 mg

ACCLIMATION
- Acclimation period: 12 October - 05 November 2012
- Acclimation conditions (same as test or not): Worms were held and evaluated in worm bedding moistened with distilled water from 03 October 2012 until 12 October 2012. All study worms were transferred from worm bedding and conditioned in an artificial soil bed from 12 October 2012 until study initiation on 05 November 2012.
Study type:
laboratory study
Substrate type:
artificial soil
Limit test:
yes
Total exposure duration:
14 d
Test temperature:
19.87°C -20.16°C
pH:
Control: 6.43 (Day 0); 6.41 (Day 14)
1000 mg/kg: 6.31 (Day 0); 6.43 (Day 14)
Moisture:
Control: 27.4 - 30.6% (Day 0)
1000 mg/kg: 24.2 - 29.9% (Day 0)
Details on test conditions:
TEST SYSTEM
- Test container (material, size): 1 L glass jars
- Amount of soil or substrate: 750 g of soil
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 4
- No. of replicates per control: 4
- Other: Each chamber was covered with perforated plastic film during the study to maintain hydration and allow some air circulation.

SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Composition (if artificial substrate): 70% sand, 20% kaolin clay, 10% peat (according to OECD 207)
- Other: Distilled water- UV sterilized, deionized well water is distributed throughout the testing facikity via PVC stainless steel pipes.

OTHER TEST CONDITIONS
- Photoperiod: continuous
- Light intensity: 719 - 728 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Observations for mortality were performed on Days 7 and 14 of the test. Each test chamber was weighed after the addition of hydrated soil and worms on Day 0 to obtain a starting weight for each test chamber. On Day 7 and 14, the chambers were re-weighed to monitor any water weight loss. All surviving worms were pooled per replicate and weighed at the end of the test.
Nominal and measured concentrations:
nominal: 1000 mg/kg dw
measured:
991 mg/kg (average initial concentration prior to soil hydration)
205 mg/kg (final analysis of the soil concentration)
see table 1 under "Any other information on materials and methods" for detailed information
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
>= 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Mortality at end of exposure period: No mortality was observed at test termination in both the control and treatment group.
- Changes in body weigth of live adults (% of initial weight) at end of exposure period: The weight indicate that there were no sublethal effects observed.

Table 2: Worm Percent Survival and Worm Weights

Treatment Group (mg/kg)

Percent Worm Survival

Mean Wet Worm Weight(g)

Day 7*

Day 14*

Day 0**

Day 14**

Control

 

 

 

 

Replicate1

10/10 (100%)

10/10 (100%)

4.2498

3.1220

Replicate2

10/10 (100%)

10/10 (100%)

4.7216

3.6122

Replicate3

10/10 (100%)

10/10 (100%)

4.3836

3.3593

Replicate4

10/10 (100%)

10/10 (100%)

4.9141

4.1418

1000 mg/kg

 

 

 

 

Replicate1

10/10 (100%)

10/10 (100%)

4.7145

3.3925

Replicate2

10/10 (100%)

10/10 (100%)

4.4095

3.5429

Replicate3

10/10 (100%)

10/10 (100%)

4.6580

3.6534

Replicate4

10/10 (100%)

10/10 (100%)

4.5076

3.5073

*Worms were observed, counted and placed back in original soil and chamber
**Worms were carefully rinsed with de-ionized water, bottled dry and weighed by replicate. The mean wet weight was determined an average of the replicate weights for each group.

 

Endpoint:
toxicity to soil macroorganisms except arthropods: short-term
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
05 - 19 Nov 2012
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 207 (Earthworm, Acute Toxicity Tests)
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations:
- Sampling method: Samples were collected on Day 2 of dry mixing, Day 6 of hydration equilibration, Day 0, prior to the addition of worms for the control and treatment and at test termination (Day 14). The samples were collected using a stainless steel spatula and weighed into 40 mL VOA vials. Three replicates were collected from the treatment soil and duplicate from the control. The samples collected at termination were from a pooled sample where all four replicates for each treatment group were composited.
- Sample storage conditions before analysis:
Vehicle:
no
Details on preparation and application of test substrate:
- Method of mixing into soil (if used): The treated artificial soil was prepared by spiking 300 grams of peat with the appropriate amount of test material using volumetric pipettes and/or stainless steel and glass syringe and mixed prior to the addition of clay and sand. The treated soil and control soil was mixed on a roller mill for three days. After hydration with distilled water the soils were placed in an environment chamber at test temperature to equilibrate for 8 days.
- Controls: A control soil was prepared without the test substance.
Test organisms (species):
Eisenia fetida
Animal group:
annelids
Details on test organisms:
TEST ORGANISM
- Common name: Earthworm
- Source: Lot W-43, Carolina Biological Supply Co. 2700 York Road, Burlington, NC 27215-3398
- Age at test initiation (mean and range, SD): Worms with clitellum.
- Weight at test initiation: 300 - 600 mg

ACCLIMATION
- Acclimation period: 12 October - 05 November 2012
- Acclimation conditions (same as test or not): Worms were held and evaluated in worm bedding moistened with distilled water from 03 October 2012 until 12 October 2012. All study worms were transferred from worm bedding and conditioned in an artificial soil bed from 12 October 2012 until study initiation on 05 November 2012.
Study type:
laboratory study
Substrate type:
artificial soil
Limit test:
yes
Total exposure duration:
14 d
Test temperature:
19.87°C -20.16°C
pH:
Control: 6.43 (Day 0); 6.41 (Day 14)
1000 mg/kg: 6.31 (Day 0); 6.43 (Day 14)
Moisture:
Control: 27.4 - 30.6% (Day 0)
1000 mg/kg: 24.2 - 29.9% (Day 0)
Details on test conditions:
TEST SYSTEM
- Test container (material, size): 1 L glass jars
- Amount of soil or substrate: 750 g of soil
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 4
- No. of replicates per control: 4
- Other: Each chamber was covered with perforated plastic film during the study to maintain hydration and allow some air circulation.

SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Composition (if artificial substrate): 70% sand, 20% kaolin clay, 10% peat (according to OECD 207)
- Other: Distilled water- UV sterilized, deionized well water is distributed throughout the testing facikity via PVC stainless steel pipes.

OTHER TEST CONDITIONS
- Photoperiod: continuous
- Light intensity: 719 - 728 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Observations for mortality were performed on Days 7 and 14 of the test. Each test chamber was weighed after the addition of hydrated soil and worms on Day 0 to obtain a starting weight for each test chamber. On Day 7 and 14, the chambers were re-weighed to monitor any water weight loss. All surviving worms were pooled per replicate and weighed at the end of the test.
Nominal and measured concentrations:
nominal: 1000 mg/kg dw
measured:
991 mg/kg (average initial concentration prior to soil hydration)
205 mg/kg (final analysis of the soil concentration)
see table 1 under "Any other information on materials and methods" for detailed information
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
>= 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Mortality at end of exposure period: No mortality was observed at test termination in both the control and treatment group.
- Changes in body weigth of live adults (% of initial weight) at end of exposure period: The weight indicate that there were no sublethal effects observed.

Table 2: Worm Percent Survival and Worm Weights

Treatment Group (mg/kg)

Percent Worm Survival

Mean Wet Worm Weight(g)

Day 7*

Day 14*

Day 0**

Day 14**

Control

 

 

 

 

Replicate1

10/10 (100%)

10/10 (100%)

4.2498

3.1220

Replicate2

10/10 (100%)

10/10 (100%)

4.7216

3.6122

Replicate3

10/10 (100%)

10/10 (100%)

4.3836

3.3593

Replicate4

10/10 (100%)

10/10 (100%)

4.9141

4.1418

1000 mg/kg

 

 

 

 

Replicate1

10/10 (100%)

10/10 (100%)

4.7145

3.3925

Replicate2

10/10 (100%)

10/10 (100%)

4.4095

3.5429

Replicate3

10/10 (100%)

10/10 (100%)

4.6580

3.6534

Replicate4

10/10 (100%)

10/10 (100%)

4.5076

3.5073

*Worms were observed, counted and placed back in original soil and chamber
**Worms were carefully rinsed with de-ionized water, bottled dry and weighed by replicate. The mean wet weight was determined an average of the replicate weights for each group.

 

Description of key information

Key value for chemical safety assessment

Additional information

Since no studies investigating the toxicity of Pentaerythritol, mixed esters with linear and branched fatty acids to soil macroorganisms are available, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read-across to the structurally related source substance Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) was conducted. The target substance is characterized as a tetraester of pentaerythritol and linear and branched fatty acids. Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) is a tetraester of C5/C7/C9/C10 with pentaerythritol. All substances share similar physico-chemical properties, only differ in the distribution of chain lengths of the fatty acid and do not share any functional group which might increase aquatic toxicity the read-across is suitable to investigate the aquatic toxicity using read-across.

This read-across is justified in detail in the overall summary (IUCLID Section 6.1) and within the analogue justification in IUCLID Section 13.

A study with the source substance Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) was conducted according to OECD 207 under GLP conditions (Kelley, 2013). Eisenia fetida was exposed to a test concentration of 1000 mg/kg dw in artificial soil for 14 d. Mortality was recorded at the end of the study. 100% survival was observed in both the control group and treatment group resulting in a NOEC (14 ) for mortality of1000 mg/kg dw.

Based on the available results from structurally related source substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile and comparable structure, it can be concluded that no effects on earthworms are expected for Pentaerythritol, mixed esters with linear and branched fatty acids.


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