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Toxicity to soil macroorganisms except arthropods

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Endpoint:
toxicity to soil macroorganisms except arthropods: long-term
Type of information:
experimental study
Adequacy of study:
key study
Study period:
05 Dec 2014 - 19 Jun 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 222 (Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei))
Version / remarks:
2004
Deviations:
yes
Remarks:
1) The temperature dropped below 18 °C and was above 22 °C for few and short time periods (14.6 - 23.5 °C). 2) In all treatments tested the soil moisture was more than 10% higher at the end of the test than the initial moisture (26.6% to 41.0%).
Qualifier:
according to
Guideline:
ISO 11268-2 (Effects of Pollutants on Earthworms. 2. Determination of Effects on Reproduction)
Version / remarks:
2012
Deviations:
yes
Remarks:
see deviations for OECD 222
GLP compliance:
yes (incl. certificate)
Remarks:
Hessisches Ministerium für Umwelt, Energie, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
Analytical monitoring:
no
Remarks:
Concentration was only measured in the stock solution before application. HPLC-UV analysis of the test substance in stock solution confirmed the nominal concentration (nominal: 3.56 mg/mL; measured: 3.70 mg/mL).
Details on sampling:
Sample preparation: dilution with acetonitrile
Vehicle:
yes
Remarks:
acetone
Details on preparation and application of test substrate:
- Method of mixing into soil: The test item was dissolved in an amount of acetone sufficient to prepare a stock solution. This stock solution was used to produce the various dosage solutions of the test item. An appropriate amount of the stock and the dosage solutions respectively was used to soak a portion of the quartz sand of the artificial soil by the dosage solution. The solvent was allowed to evaporate at room temperature for 1 h and 15 min under a fume hood. The test item coated fraction of the quartz sand was then incorporated into the remainder of the artificial soil by thoroughly mixing it in for approx. 10 min. Finally, the contaminated artificial soil was filled into the test vessels.
- Controls: yes, artificial soil without application of test item
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): acetone
- Evaporation of vehicle before use: yes
Test organisms (species):
Eisenia fetida
Animal group:
annelids
Details on test organisms:
TEST ORGANISM
- Common name: earthworm
- Source: originally obtained in 1994 from Co. Landenberger, Schömberg, Germany
- Age at test initiation: adults with clitellum; ; at least 2 months old but not older than 1 year (age did not differ by more than 4 weeks)
- Weight at test initiation (mean and range, SD): 250 - 600 mg freshweight
- Feeding during test: Fed with finely ground cow manure (free of pharmaceuticals, growth promotors, provided by Jesus Bruderschaft e.V. Gnadenthal, Hünfelden, Germany). Food was first provided one day after test start. Afterwards, worms were fed every week during the first 4 weeks of exposure. 5 g was moistened with 10 mL deionised water and spread on the soil surface. After removing the adults after 28 d a further 5 g of food was mixed with artificial soil.

ACCLIMATION
- Acclimation period: Earthworms were acclimatised in artificial soil under test conditions for at least 24 h before test start.
- Acclimation conditions (same as test or not): same as test
Study type:
laboratory study
Substrate type:
artificial soil
Limit test:
no
Total exposure duration:
56 d
Test temperature:
14.6 - 23.5 °C (mean 19.9 °C)
pH:
Control - Start: 6.0, End: 6.8
Solvent control - Start: 5.9, End: 6.9
5 mg/kg dw - Start: 5.9, End: 6.8
10 mg/kg dw - Start: 6.0, End: 6.8
20 mg/kg dw - Start: 5.9, End: 6.8
40 mg/kg dw - Start: 5.8, End: 6.9
80 mg/kg dw - Start: 5.8, End: 6.8
Moisture:
Control - Start: 49.0% of WHCmax, End: 69.1% of WHCmax
Solvent control - Start: 49.2% of WHCmax, End: 67.7% of WHCmax
5 mg/kg dw - Start: 51.3% of WHCmax, End: 65.6% of WHCmax
10 mg/kg dw - Start: 54.3% of WHCmax, End: 74.1% of WHCmax
20 mg/kg dw - Start: 50.4% of WHCmax, End: 69.1% of WHCmax
40 mg/kg dw - Start: 53.8% of WHCmax, End: 68.1% of WHCmax
80 mg/kg dw - Start: 48.8% of WHCmax, End: 64.7% of WHCmax
Details on test conditions:
TEST SYSTEM
- Test container (material, size): Bellaplast containers (Company Kastelplast, Mainz, Germany) consisting of inert (non-toxic) plastic (Polystyrol). The test vessels have a base area of 11 x 15.5 cm (=170.5 cm²) and a height of 6 cm. The test vessels were covered with a transparent and perforated lid.
- Amount of soil or substrate: 0.5 kg/container
- No. of organisms per container (treatment): 10 per container
- No. of replicates per treatment group: 4
- No. of replicates per control: 4
- No. of replicates per vehicle control: 8

SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Composition (if artificial substrate): 5% sphagnum peat (5% instead of 10% peat was used considering the influence on bioavailability), 20% kaolin clay (kaolinite content > 30%), ~74% quartz sand (fine sand content with particles between 50 and 200 microns higher than 50%), 0.3 - 1% Calcium carbonate (CaCO3). The pH value was adjusted to 6 ± 0.5 using calcium carbonate. The moisture content was adjusted to 40-60% of WHCmax using deionised water.
- Organic carbon (%): 5%

OTHER TEST CONDITIONS
- Photoperiod: 16 h light/8 h darkness
- Light intensity: 414-580 lux

EFFECT PARAMETERS MEASURED
- Mortality after 28 d
- Biomass after 0 and 28 d
- Reproduction after 56 d

VEHICLE CONTROL PERFORMED: yes

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Range finding study: yes (no details reported)
Nominal and measured concentrations:
Nominal: Water control, solvent control and Nominal concentrations 5, 10, 20, 40 and 80 mg/kg soil dw
Reference substance (positive control):
yes
Remarks:
Boric Acid
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
>= 80 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
28 d
Dose descriptor:
LOEC
Effect conc.:
> 80 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
40 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Biomass
Duration:
28 d
Dose descriptor:
LOEC
Effect conc.:
80 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Biomass
Duration:
56 d
Dose descriptor:
NOEC
Effect conc.:
10 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
56 d
Dose descriptor:
LOEC
Effect conc.:
20 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
56 d
Dose descriptor:
EC50
Effect conc.:
40.9 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Details on results:
- Mortality at end of exposure period: 2.5% at 10, 40 and 80 mg/kg soil dw (after 28 d)
- Changes in body weight of live adults (% of initial weight) at end of exposure period: see "Any other informations on results incl. tables"
- No. of offspring produced: see "Any other informations on results incl. tables"
- Morphological abnormalities: No other effects on behavior or morphology of the adult earthworms were observed.
- Behavioural abnormalities: No other effects on behavior or morphology of the adult earthworms were observed.
- Other biological observations: Almost the whole food was consumed by the earthworms in the test vessels of the control and at the concentrations of 5, 10, 20 and 40 mg test item/kg soil (dw) after 7 and 14 d. After 21 and 28 d of the application the food consumption was reduced compared to the time points before. At the concentration of 80 mg/kg soil dw half or less than half of the food was consumed after 7, 14, 21 and 28 d.
Results with reference substance (positive control):
- Results with reference substance valid? yes
- Relevant effect levels: 2.5% mortality was observed at the control, no mortality at the concentrations of 178, 267, 400 and 900 mg boric acid/kg soil (dw) and 12.5% mortality at a concentration of 600 mg boric acid/kg soil (dw). Concerning reproduction the statistical analysis (Dunnett’s t-test) showed a significant difference between the control and all concentrations of the reference item tested. The EC50 value was calculated by Probit analysis using Linear Max. Likelihood Regression as 259.3 mg boric Acid/kg artificial soil (dw) (95% confidence limits = 235.8 - 284.4 mg boric Acid/kg artificial soil (dw)). The estimated EC50 value in this study (259.3 mg boric acid /kg soil (dw)) is slightly lower than recommended by the guideline. However, since the calculated EC50 is lower by factor of 1.5 than the recommended value of 400 mg boric acid/ kg soil (dw) acceptable sensitivity of the test system is assumed.
Reported statistics and error estimates:
Biomass and reproduction data were checked for normality by R/s test procedure and for homogeneity by Cochran’s test. Solvent control and water control data were compared by the pairwise Student-t test (p ≤ 0.05, two-sided). Concerning biomass and reproduction no statistically significant difference between the solvent control and the water control was determined. Therefore, for further statistical calculations of the biomass and the reproduction data, the water control data have been excluded. Treatment means were compared by ANOVA followed by Dunnett’s test (p ≤ 0.05, two-sided for biomass one-sided for reproduction) and tested for statistically significant differences compared to the solvent control (Sachs 1982). The EC50 was determined using Probit analysis (Finney, 1971). The statistical software package ToxRat Professional 2.10 was used for these calculations.

Table 1: Effect on mortality (28 d), biomass (28 d) and reproduction (56 d)

Concentration [mg/kg soil dw]

Adult mortality [%]

Mean change of initial weight per replicate [%]

Number of juveniles [% of solvent control]

Control

0.0

44.6

92.7

Solvent control

0.0

45.5

100.0

5

0.0

43.1

89.1

10

2.5

45.2

98.6

20

0.0

49.5

79.9**

40

2.5

55.8

61.1**

80

2.5

2.8*

1.5**

* Statistically significant different to solvent control (Dunnett’s test, 2-sided, p ≤0.05)

** Statistically significant different to solvent control (Dunnett’s test, 1-sided, p ≤0.05)

Mortality

0 - 2.5% mortality of adult earthworms was observed within the treatments after 28 d of exposure. Mortality of 2.5% was observed at nominal concentrations of 20, 40 and 80 mg/kg dw, respectively. No mortality was recorded at 5 and 20 mg/kg dw.

Biomass

Biomass increase was between 43.1 - 55.8% at test concentrations of 5 - 40 mg/kg dw after 28 d. Statistical analysis showed a significant difference (only 2.8% increase; Dunnett’s test, 2-sided; p ≤ 0.05) concerning biomass development of individual adults over 28 d between the solvent control and the highest concentration of the test item tested (80 mg/kg soil dw).

Reproduction

Statistical analysis (Dunnett’s test; 1-sided, p ≤ 0.05) showed a significant difference concerning the number of juveniles between the solvent control and the concentrations of 20, 40 and 80 mg/kg dw (79.9, 61.1, 1.5% juveniles compared to the solvent control, respectively). All other concentrations tested did not differ statistically significant from the control.

Food consumption

Almost the whole food was consumed by the earthworms in the test vessels of the control and at the concentrations of 5, 10, 20 and 40 mg test item/kg soil (dw) after 7 and 14 d. After 21 and 28 d of the application the food consumption was reduced compared to the time points before. At the concentration of 80 mg/kg soil dw half or less than half of the food was consumed after 7, 14, 21 and 28 d.

Behavior/Morphology

No other effects on behavior or morphology of the adult earthworms were observed.

Table 2: Validity criteria

Criterion from the guideline to be satisfied in the controls

Outcome

Validity criterion fulfilled

Each replicate (containing 10 adults) to have produced ≥ 30 juveniles by the end of the test.

371.0

yes

The coefficient of variation of reproduction is ≤ 30%.

11.3

yes

Adult mortality over the initial 4 weeks of the test is ≤ 10%.

0 %

yes

Validity criteria fulfilled:
yes
Remarks:
For further details please refer to “Any other information on results incl. tables”.
Conclusions:
NOEC (56 d): 10 mg/kg soil dw based on reproduction
Executive summary:

The present study was performed in accordance with OECD 222 and GLP. Adult earthworms (Eisenia fetida) were exposed to the test substance (5, 10, 20, 40 and 80 mg/kg dw) in artificial soil for a total of 56 d and biomass, reproduction and mortality were assessed. Mortality was assessed additionally after 14 d. The test substance concentrations were prepared using acetone as solvent. However, the solvent was completely evaporated before test initiation. With respect to the properties of the test substance, 5% instead of 10% peat was used. No mortality was observed in the control and in the solvent control and at 0 to 2.5% in all concentrations of the test item tested. Therefore, no statistical analysis was performed and thus the NOEC (14 d) was considered to be ≥ 80 mg/kg soil dw. The NOEC (28 d) based on biomass was 40 mg/kg soil dw whereas the NOEC (56 d) for reproduction was 10 mg/kg soil dw.

Endpoint:
toxicity to soil macroorganisms except arthropods: short-term
Type of information:
experimental study
Adequacy of study:
key study
Study period:
06 Dec 2006 - 21 Dec 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 207 (Earthworm, Acute Toxicity Tests)
Deviations:
no
Qualifier:
according to
Guideline:
ISO 11268-1 (Effects of Pollutants on Earthworms. 1. Determination of Acute Toxicity Using Artificial Soil Substrate)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Hess. Ministerium für Umwelt, ländlichen Raum und Verbraucherschutz, Wiesbaden, Germany
Analytical monitoring:
no
Vehicle:
yes
Details on preparation and application of test substrate:
- Method of mixing into soil (if used): A stock solution was prepared by dissolving 3900 mg of 4-Chloro-3-methylphenol in 20 mL acetone. A sequential 1 :2 dilution series was prepared, starting with the 195.0 mg/mL stock solution by adding 7 mL of acetone to 7 mL of the. stock solution or dilution. Then 5 mL of the stock solution or corresponding dilution were added to 20 g fine quartz sand. The treated saod was left for at least one hour in a fume hood until the solvent had evaporated and was then mixed with a spoon. The artificial soil was then added to test item blended sand.
- Controls: yes, blank control
- Evaporation of vehicle before use: yes
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): acetone
Test organisms (species):
Eisenia fetida
Animal group:
annelids
Details on test organisms:
TEST ORGANISM
- Common name: Earthworm
- Source: Bred by IBACON in a breeding medium of cattle manure, peat, sand and straw, mainly fed with cattle manure, stored at room temperature.
- Age at test initiation (mean and range, SD): 11 to 12 months, with clitellum
- Weight at test initiation (mean and range, SD): 300 - 600 mg
- Feeding during test: none

ACCLIMATION
- Acclimation period: 1 day, in artificial soil
- Acclimation conditions (same as test or not): same as test
Study type:
laboratory study
Substrate type:
artificial soil
Limit test:
no
Total exposure duration:
14 d
Test temperature:
19 °C - 22 °C
pH:
Initial pH: 5.6 - 5.7
End of the study: 5.3 - 5.5
Moisture:
> 50%
Details on test conditions:
TEST SYSTEM
- Test container (material, size): Normal glass bottling jars (1 L)
- Amount of soil or substrate: Approximately 500 g (dry weight equivalent) artificial soil.
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 4
- No. of replicates per control: 4

SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Soil texture: artificial soil according to guideline
- % sand: pproximately 74.8% fine quartz-sand (F34) containing more than 50% by mass of particle size 0.05 mm to 0.2 mm; (Quarzwerke Frechen, Frechen, Germany)
- % chalk: approximately 0.2% chalk (CaCO3) added to adjust pH to 6.0 ± 0.5 (Merck, Darmstadt, Germany)
- % clay: 20% Kaolin clay (Erbslöh, Lohrheim, Germany)
- % peat: 5.0% Sphagnum-peat, air-dried and finely ground (2 mm) (Floragard, Vertriebs GmbH für Gartenbau, Oldenburg, Germany)
- water content: Water content was checked at the start and termination of the experiment in one test unit per treatment group, according to DIN 19683. At experimental start: 21.3 % to 23.0%, corresponding to 53.3% to 57.5% of the max. warer holding capacity. At experimental end: 20.7% to 22.1 % corresponding to 51.8 % to 55.3 % of the max. water holding capacity.

OTHER TEST CONDITIONS
- Photoperiod: continuous light
- Light intensity: 410 - 750 Lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Mortality was recorded after 7 and 14 d after application
- Behavioural abnormalities was recorded after 7 and 14 d
- Mean body weight was determined at day 0 and 14 d

VEHICLE CONTROL PERFORMED: no (solvent was evaporated before application)

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Range finding study
- Test concentrations: control, 1, 10, 100, 500 and 1000 mg/kg artificial soil (dry weight)
- Results used to determine the conditions for the definitive study: 100 % mortality at a concentration of 500 mg/kg
Nominal and measured concentrations:
nominal: control and 15, 30, 60, 120, 240 and 480 mg/kg dw soil
Reference substance (positive control):
yes
Remarks:
2-Chloroacetamide
Duration:
14 d
Dose descriptor:
LC50
Effect conc.:
139.4 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
60 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: After 14 days of exposure no mortality was observed up to and including the concentration of 60.0 mg test item/kg soil. At the concentration of 120 mg test item/kg soil mortality increased to 17.5%.
- Changes in body weight of live adults (% of initial weight) at end of exposure period: The body weight changes of the earthworms were not significantly different compared to the control up to and including the concentration of 60.0 mg test item/kg soil. At the concentration of 120 mg test item/kg soil a statistically significant decrease of body weight was observed.
- Behavioural abnormalities: Worms were fidgety wriggling about at the concentration of 120 mg/kg soil after 7 days of exposure. This effect was not observed after 14 days of exposure. No additional behavioural effects were observed in any other concentration.
Results with reference substance (positive control):
- Results with reference substance valid? yes
- Relevant effect levels: LC50 after 14 days was determined to be 27.0 mg test item/kg soil dry weight (95% confidence limits of 22.6 and 31.1)
Reported statistics and error estimates:
Fisher extract test (mortality), Dunnett test (weight change), Probit Analysis (determination of LC50). The software used to perform the statistical analysis was ToxRatPro, version 2.09 (2005).

Table 1: Results obtained in the study with p-chloro-m-cresol after 7 and 14 days

Concentration
[mg a.i./kg d. wt.s.]

Mortality 7 days [%]

Mortality 14 days [%]

Mean

SD

significance

Mean

SD

significance

Control

0.0

0.0

-

0.0

0.0

-

15.0

0.0

0.0

-

0.0

0.0

-

30.0

0.0

0.0

-

0.0

0.0

-

60.0

0.0

0.0

-

0.0

0.0

-

120

5.0

10.0

n.s.

17.5

35.0

*

240

100.0

0.0

*

100.0

0.0

*

480

100.0

0.0

*

100.0

0.0

*

- not relevant

n.s. not significantly different compared to the control, Fischer exact test, α = 0.05

*significantly different compared to the control, Fischer exact test, α = 0.05

Table 2: Earthworm body weight changes

Concentration
[mg a.i./kg d. wt.s.]

Test start

After 14 days

Mean [mg/worm]

Mean [mg/worm]

Difference %1)

Significance

Control

404.3

370.8

-7.7

-

15.0

397.1

353.5

-10.7

n.s.

30.0

397.5

362.3

-8.7

n.s.

60.0

404.2

375.5

-7.1

n.s.

120

407.1

279.9

-31.2

*

240

411.1

/

-

-

480

417.6

/

-

-

1) % mean of 4 replicates

n.s. not significantly different compared to the control, Dunnett test, α = 0.05

*significantly different compared to the control, Dunnett test, α = 0.05

Table 3: Validity criteria

Criterion from the guideline to be satisfied in the controls

Outcome

Validity criterion fulfilled

Mortality of control animals

< 10%.

0 %

yes

Validity criteria fulfilled:
yes
Remarks:
For further details please refer to “Any other information on results incl. tables”.
Conclusions:
LC50 (14 d) = 139.4 mg/kg dw
NOEC (14 d) = 60 mg/kg dw
Executive summary:

The effect of p-chloro-m-cresol on earthworms was studied on Eisenia fetida (Lührs, 2007). The test was carried out according to OECD Guideline 207 (1984). The test item was mixed with artificial soil and adult earthworms were exposed for 14 days to the test vessels filled with artificial soil of the nominal concentrations of 15.0, 30.0, 60.0, 120 and 480 mg test item/kg dry weight soil. An acetone treated control was run in parallel. Morphological and behavioural changes and the number of surviving worms in each test vessel were recorded after 7 and 14 days. The LC50 value was calculated by probit analysis as 139.4 mg test item/kg dw. The NOECmortality as well as the NOECbiomass was determined to be 60 mg test item/kg dw. Worms were fidgety wriggling about at the concentration of 120 mg/kg soil after 7 days of exposure. This effect was not observed after 14 days of exposure. No additional behavioural effects were observed in any other concentration. The test was performed according to guideline and is considered acceptable since validity criteria are fulfilled (control mortality < 10%).

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:
Refer to analogue justification document provided in IUCLID section 13.
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
>= 80 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: source, CAS 59-50-7, key rel 1, Scheffczyk 2015
Duration:
28 d
Dose descriptor:
LOEC
Effect conc.:
> 80 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: source, CAS 59-50-7, key rel 1, Scheffczyk 2015
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
40 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Biomasss
Remarks on result:
other: source, CAS 59-50-7, key rel 1, Scheffczyk 2015
Duration:
28 d
Dose descriptor:
LOEC
Effect conc.:
80 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Biomass
Remarks on result:
other: source, CAS 59-50-7, key rel 1, Scheffczyk 2015
Duration:
56 d
Dose descriptor:
NOEC
Effect conc.:
10 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other: source, CAS 59-50-7, key rel 1, Scheffczyk 2015
Duration:
56 d
Dose descriptor:
LOEC
Effect conc.:
20 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other:
Remarks:
source, CAS 59-50-7, key rel 1, Scheffczyk 2015
Duration:
56 d
Dose descriptor:
EC50
Effect conc.:
40.9 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other: source, CAS 59-50-7, key rel 1, Scheffczyk 2015
Duration:
14 d
Dose descriptor:
LC50
Effect conc.:
139.4 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: source, CAS 59-50-7, rel 1, Lührs 2007
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
60 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: source, CAS 59-50-7, rel 1, Lührs 2007

Description of key information

NOEC (56 d): 10 mg/kg soil dw based on reproduction, read-across

Key value for chemical safety assessment

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

Additional information

No study investigating the toxicity of sodium p-chloro-m-cresolate (CAS 15733-22-9) to soil macroorganisms is available. Therefore, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read-across to the source substance (p-chloro-m-cresol, CAS 59-50-7) which is the main transformation product of the target substance sodium p-chloro-m-cresolate (CAS 15733-22-9) is applied.

The source substance p-chloro-m-cresol is the common compound in this analogue approach and is solely responsible for the (absence of) effects. Thus, the source substance is considered a suitable representative for the evaluation of the toxicity of the target substance to terrestrial organisms. The read-across approach is justified in detail within the analogue justification in IUCLID section 13.

One key (Scheffczyk 2015) and one supporting study (Lührs 2007) are available investigating the toxicity of the source substance p-chloro-m-cresol (CAS 59-50-7) to earthworms. The key study was performed in accordance with OECD 222 and GLP. Adult earthworms (Eisenia fetida) were exposed to the test substance (5, 10, 20, 40 and 80 mg/kg dw) in artificial soil for a total of 56 d and biomass, reproduction and mortality were assessed. Mortality was assessed additionally after 14 d. The test substance concentrations were prepared using acetone as solvent. However, the solvent was completely evaporated before test initiation. With respect to the properties of the test substance, 5% instead of 10% peat was used. No mortality was observed in the control and in the solvent control and at 0 to 2.5% in all concentrations of the test item tested. Therefore, no statistical analysis was performed and thus the NOEC (14 d) was considered to be ≥ 80 mg/kg soil dw. The NOEC (28 d) based on biomass was 40 mg/kg soil dw whereas the NOEC (56 d) for reproduction was 10 mg/kg soil dw.

The supporting study was carried out according to OECD Guideline 207. The test item was mixed with artificial soil and adult earthworms were exposed for 14 days to the test vessels filled with artificial soil of the nominal concentrations of 15.0, 30.0, 60.0, 120 and 480 mg/kg dry weight soil. An acetone treated control was run in parallel.  Morphological and behavioral changes and the number of surviving worms in each test vessel were recorded after 7 and 14 days. The LC50 value was calculated by probit analysis as 139.4 mg/kg soil dw. The NOECMortality as well as the NOECbiomass was determined to be 60 mg/kg soil dw.

Based on the available results from a structurally similar source substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which is the main transformation product of the target substance and is characterized by a similar ecotoxicological profile and comparable structure, it can be concluded that sodium p-chloro-m-cresolate has effects in the same range as the target substance.