Calcium hydrosilicate, reaction product of natural quartz sand and technical lime by a hydrothermal and tribochemical process

Toxicity to soil macroorganisms except arthropods

Administrative data

Endpoint:

toxicity to soil macroorganisms except arthropods: short-term

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2014-04-16 to 2014-04-30

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 207 (Earthworm, Acute Toxicity Tests)

Version / remarks:

and DIN ISO 11268 - 1 (1997)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Calcium hydrosilicate, reaction product of natural quartz sand and technical lime by a hydrothermal and tribochemical process

EC Number:

946-103-2

IUPAC Name:

Calcium hydrosilicate, reaction product of natural quartz sand and technical lime by a hydrothermal and tribochemical process

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): Celitement
- Chemical name: Calcium hydrosilicate
- Physical state: White powder
- pH-value: 10.5
- Expiration date of the lot/batch: 12/2015
- Stability under test conditions: Hydration reaction with water
- Storage condition of test material: Room temperature protected from light, in original container in evacuated desiccator

Sampling and analysis

Analytical monitoring:

no

Details on sampling:

No analytical monitoring

Test substrate

Vehicle:

no

Details on preparation and application of test substrate:

- Method of mixing into soil:
3.2699 g of the test item Celitement was weighed out for the limit test item concentration and mixed thoroughly with 60 g quartz sand (10 g per
replicate). The treated quartz sand was given to the artificial soil. Additional 516 mL demineralised water was added to adjust the humidity of the
artificial soil to a moisture of 40 - 60 % of the maximum water holding capacity. Subsequently, the test medium was thoroughly mixed to ensure a
homogenous distribution and about 555 g soil dry weight was filled into each test vessel.
- Controls: Artificial soil moistened with demineralised water without test or reference item was used as control medium.

Test organisms

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Details on test organisms:

TEST ORGANISM
- Common name: Earthworm Eisenia fetida Savigny 1826
- Source: Own breeding
- Age at test initiation: Adult
- Weight at test initiation (mean and SD): 0.41 +/- 0.05


ACCLIMATION
- Acclimation period: 2 days
- Acclimation conditions (same as test or not): same as test
- Health during acclimation (any mortality observed): No mortality observed

Study design

Study type:

laboratory study

Substrate type:

artificial soil

Limit test:

yes

Total exposure duration:

14 d

Post exposure observation period:

No

Test conditions

Test temperature:

18 - 22 °C

pH:

Test item concentration
[mg/kg soil dry weight]] pH-value
day 0 day 14
Control 5.97 5.89
1000 6.42 5.98

Moisture:

Test item concentration
[mg/kg soil dry weight]] Moisture [%] of dry weight
day 0 day 14
Control 27.2 25.9
1000 27.1 26.3

Details on test conditions:

TEST SYSTEM
- Test container (material, size): Glass dishes, covered with perforated plastic film
- Amount of soil or substrate: 555 g (dry weight)
- No. of organisms per container (treatment): 10 per replicate
- No. of replicates per treatment group: 6
- No. of replicates per control: 6


SOURCE AND PROPERTIES OF SUBSTRATE (if soil)

- Composition (artificial substrate): 10 % peat (air dried and finely ground), 20 % kaolin, 69 % quartzsand (sand with > 50 % particles size of 0.05 to
0.2 mm), 0.40 % calcium carbonate (CaCO3) to adjust the pH to 6.0 ± 0.5
- Maximum water holding capacity (in % dry weigth): 54.4
- Storage (condition, duration): under test conditions for 7 days
- Pretreatment of soil: Two days before earthworm insertion into the test vessels the artificial soil (14 kg) was pre-moistened with 1414 g deionised
water to achieve a moisture of 26 % of the maximum water holding capacity of the artificial soil. Until start of the test evaporation of the artificial soil
was avoided.

OTHER TEST CONDITIONS
- Photoperiod: 24 h
- Light intensity: 529 +/- 117 lx


EFFECT PARAMETERS MEASURED (with observation intervals if applicable)
The live weight of the earthworms was measured individually at the day of application (day 0) and at day 14.
Mortality, behaviour and morphological changes of the earthworms were recorded 7 and 14 days after application.

VEHICLE CONTROL PERFORMED: no

TEST CONCENTRATIONS
- Spacing factor for test concentrations: none, limit test (nominal concentration 1000 mg test material /kg soil dry weight)
- Range finding study: A preliminary non GLP range finding test was performed with four test item concentrations of 1.00, 10.0, 100 and 1000 mg
Celitement/kg soil dry weight. For results see table below.

Range Finding Test (14 days): Mortality and Change of Live Weight

Test item concentration
[mg product/kg soil dry weight] Mortality of adult earthworms [%] Change of live weight [%]
Control 0 2
1.00 0 2
10.0 0 10
100 0 8
1000 0 12

Nominal and measured concentrations:

Nominal: 1000 mg test material/kg soil dry weight

Reference substance (positive control):

yes

Remarks:

2-Chloroacetamide

Results and discussion

Effect concentrations

Effect concentrations 1

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

Remarks:

loss of body weight, behaviour and other symptoms

Effect concentrations 2

Duration:

14 d

Dose descriptor:

LOEC

Effect conc.:

> 1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks:

loss of body weight, other symptoms

Details on results:

- Mortality at end of exposure period:
No mortality was observed in the control as well as in the limit test item concentration of 1000 mg product/kg soil dry weight after 7 and 14 days
of exposure to the test item.
- Changes in body weigth of live adults (% of initial weight) at end of exposure period:
During the test the biomass loss of the earthworms was below 20 % in the control.
There was no statistically or biologically significant difference between earthworm biomass development in the control and in the limit test item
group.
- Morphological or behavioural abnormalities:
No evident pathological symptoms nor changes in the earthworm behaviour were observed in the control as well as in the limit test item
concentration of 1000 mg product/kg soil dry weigh after 7 and 14 days of exposure to the test item. However, one worm showed spontaneous
segmentation and separation in the limit test item concentration.
- Other biological observations: None

Results with reference substance (positive control):

- Results with reference substance valid? Yes
The acute toxicity of 2-Chloroacetamide on the earthworm Eisenia fetida fetida SAVIGNY was determined over a period of two weeks from
2014-03-13 to 2014-03-27. The LC50-value ranged between 20 and 80 mg/kg soil dry weight as recommended by the guideline (see table below).


NOEC and LC-Value after 14 d for the Reference Item 2-Chloroacetamide

LC-Value /NOEC Concentration
[mg product/kg soil dry weight] 95 % - Confidence limits [mg product/kg soil dry weight]
NOEC 30 –
LC50 39.2 31.1 – 55.1

Reported statistics and error estimates:

A t-test was carried out for the determination of statistically significant differences compared to the control.

Any other information on results incl. tables

Earthworm Mortality in [%] after 7 and 14 Days of Exposure

Mortality [%]
Test item concentration [mg product/kg soil dry weight]	Day 7							Day 14
	1	2	3	4	5	6	MV	1	2	3	4	5	6	MV
Control	0	0	0	0	0	0	0	0	0	0	0	0	0	0
1000	0	0	0	0	0	0	0	0	0	0	0	0	0	0

MV = mean value

Earthworm Behaviour and Pathological Symptoms after 7 and 14 Days of Exposure

Test item concentration [mg product/kg soil dry weight]

Effect

Replicate

1

2

3

4

5

6

Day 7

Control

A)

10/10

10/10

10/10

10/10

10/10

10/10

1000

A)

10/10

10/10

10/10

10/10

10/10

10/10

Day 14

Control

A)

10/10

10/10

10/10

10/10

10/10

10/10

1000

A) D)

10/10 -

10/10 -

10/10 -

10/10 -

10/10 -

9/10 1/10

A) no obvious pathological symptoms or behavioural changes   D) spontaneous segmentation and separation

Mean Biomass and Mean Loss of Body Weight

	Mean live weight
Test item concentration [mg product/kg soil dry weight]	Test start MV±SD [g/worm]	Test end MV±SD [g/worm]	Test end CV [%]	Inhibition   [%]	Statistical significance vs. control
Control	0.41 ± 0.04	0.40 ± 0.05	12.3	2	–
1000	0.41 ± 0.05	0.40 ± 0.06	13.9	2	No

MV = mean value           CV = coefficient of variationSD = standard deviation

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Neither mortality, nor evident pathological symptoms or changes in earthworm behaviour were observed in the control and in the limit test item
concentration of 1000 mg product/kg soil dry weight after 7 and 14 days of exposure. However, one worm showed spontaneous segmentation and
separation in the limit test item concentration. Compared to the control, no biologically significant difference of biomass was observed in the limit test item
concentration at test end.

Executive summary:

The acute effects of Celitement (Batch: Not specified) on the earthworm Eisenia fetida were determined according to the OECD Guideline 207 and DIN ISO 11268-1 at Dr.U.Noack-Laboratorienin 31157 Sarstedt, Germany from2014 -04 -16 to 2014 -05 -02 with the definitive exposure phase from 2014-04-16 to 2014-04-30.

 

The study was conducted under static conditions for 14 days with a limit test item concentration of 1000 mg product/kg soil dry weight that was mixed into artificial soil containing 10 % peat. A control using untreated artificial soil was prepared. 60 test organisms, with an individual weight of 0.30 to 0.51 g, were divided into 6 replicate groups with each 10 test organisms.

 

Neither mortality, nor evident pathological symptoms or changes in earthworm behaviour were observed in the control and in the limit test item concentration of 1000 mg product/kg soil dry weight after 7 and 14 days of exposure. However, one worm showed spontaneous segmentation and separationin the limit test item concentration. Compared to the control, no biologically significant difference of biomass was observed in the limit test item concentration at test end.

All validity criteria of the test guidelines were fulfilled.

 

 Summary of all Effects

		Celitement [mg product/kg soil dry weight]
LOEC Mortality, loss of body weight, other symptoms		> 1000
NOEC Mortality, loss of body weight, other symptoms		1000