Reaction product of fusion between 1000°C and 2000°C of aluminium oxide and calcium oxide based raw materials with at least CaO+Al2O3+Fe2O3 > 85%, in which aluminium oxide and calcium oxide in varying amounts are combined in various proportions into a multiphase crystalline matrix.

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The reliability is rated Klimish 1

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Cement, alumina, chemicals

EC Number:

266-045-5

EC Name:

Cement, alumina, chemicals

IUPAC Name:

266-045-5

Details on test material:

- Name of test material (as cited in study report): Ciment Fondu®:
- Substance type: mineral
- Physical state: grey fine powder
- Analytical purity: 100%
- Composition of test material, percentage of components: Ciment Fondu® is a mixture of more than 99.5% milled clinker of Ciment Fondu® which is the same substance as the registered substance here, and a grinding agent
- Purity test date: 2010-04-20
- Lot/batch No.: 91478
- Storage condition of test material: at ambient temperature
- Other : It must be kept in mind that the test was carried on with ground product of less than 100 microns diameter. The usual average content in the commercial substance is only less than 15% in weight

Sampling and analysis

Analytical monitoring:

no

Details on sampling:

- Concentrations: 1.0, 1.8, 3.2, 5.6, 10, 18 and 32 mg/l
- Sampling method: dilution water control (DWC)
- Sample storage conditions before analysis:The stock cultures of D. magna were maintained in a reconstituted water medium, identical to the test dilution water, at a temperature of 20 +/- 2°C. The cultures were maintained in 2 l glass vessels with a working volume of 1.6 l. A photoperiod of 16 hours light: 8 hours dark, with 20 minute transition periods was provided

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test solutions were prepared by the addition of the appropriate quantity of Ciment Fondu® directly to 1 litre (for 5.6 10, 18 and 32
mg/l test concentrations), 2 litres (3.2 mg l-1 test concentration) or 5 litres (1.0 and 1.8 mg l-1 test concentrations) of culture medium. The larger volumes were used to aid in the weighing out of small quantities of test substance used to make the test solutions of lower concentrations. 1 litre of the culture medium control was also prepared. All test solutions were stirred overnight using magnetic followers and then allowed to stand for 15 minutes. The test solutions were then filtered through a 0.45 µm membrane filter. All test solutions were clear and colourless. In all cases the final solutions contained nutrients . The appropriate test solution (200 ml volume) was dispensed to each test and blank vessel

- Controls: The control solution was dilution water with no addition of test substance

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Source: Brixham Environmental Laboratory, AstraZeneca UK Limited, Freshwater Quarry, Brixham, Devon, TQ5 8BA, UK
- Age at study initiation (mean and range, SD): < 24 hours old
- Weight at study initiation (mean and range, SD): no data
- Length at study initiation (length definition, mean, range and SD): no data
- Valve height at study initiation, for shell deposition study (mean and range, SD): no data
- Peripheral shell growth removed prior to test initiation: no data
- Method of breeding: ad libitum
- Feeding during test : no


ACCLIMATION
- Acclimation period: The parent animals were 21 +/- 1 days old and had been maintained with a twice weekly renewal of reconstituted water medium since birth
- Acclimation conditions : same as test
- Type and amount of food: mixed algae diet of Chlorella vulgaris, strain CCAP 211/12 and Pseudokirchneriella subcapitata, strain CCAP 278/4, ad libitum
- Feeding frequency: daily
- Health during acclimation : The test organisms and the culture from which they were obtained showed no evidence of disease before the test period

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Hardness:

220.7 mg/l as CaCO3

Test temperature:

20.6°C (0h) - 19.9°C (24h) - 20.1°C (48h)

pH:

7.8 - 8.5

Dissolved oxygen:

6.4 - 9.2 mg/l

Nominal and measured concentrations:

nominal loading concentrations : 1.0, 1.8, 3.2, 5.6 10, 18 and 32 mg/l

Details on test conditions:

TEST SYSTEM
- Test vessel: glass beaker of 250 ml nominal capacity
- Type (delete if not applicable): The beakers were covered with loose fitting glass lids
- Material, size, headspace, fill volume: Each vessel contained 200 ml of test solution providing a depth of approximately 60 mm
- Aeration: no
- Type of flow-through (e.g. peristaltic or proportional diluter): static
- Renewal rate of test solution (frequency/flow rate): no
- No. of organisms per vessel: 25 Daphnia magna
- No. of vessels per concentration (replicates): 4 replicates per test concentration
- No. of vessels per control (replicates): 4 replicates


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Elendt's M4 D. magna medium
- Total organic carbon:
- Particulate matter:
- Metals: < 527 µg/l
- Pesticides: < 0.1 µg/l
- Chlorine: no data
- Alkalinity: 26.6 mg/l as CaCO3
- Conductivity: 667 µS/cm at 25 °C
- Culture medium different from test medium: no
- Intervals of water quality measurement: no data

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light: 8 hours dark, with 20 minute dusk and dawn transition periods
- Light intensity: no data

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8
- Justification for using less concentrations than requested by guideline: no data
- Range finding study : not available
- Test concentrations: 1.0, 1.8, 3.2, 5.6, 10, 18 and 32 mg/l
- Results used to determine the conditions for the definitive study:no data

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

12 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95

Effect concentrations 2

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

6.6 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95

Details on results:

- Behavioural abnormalities: no data
- Observations on body length and weight: no data
- Other biological observations: no data
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: none
- Effect concentrations exceeding solubility of substance in test medium:

Any other information on results incl. tables

An assessment of the response of the D. magnawas made 24 and 48 hours after the commencement of the test. Each D. magnawas viewed by eye and was defined as affected if showing no whole body movement, relative to the water, within a period of 15 seconds even if movement of individual appendages was visible. D. magnaso affected were termed immobile. Any overt symptoms of toxicity were also recorded.

 

The median effect concentration (EC₅₀) was defined as the concentration resulting in 50% immobilisation of theD. magna in the time period specified.  The numbers of Daphnia immobilised in the replicates of thedilution water controland each test concentration were summed for each time period.  The 24 and 48 hour EC50 values, and their 95% confidence intervals, were calculated using Stephan's method

Ciment Fondu^®has low aqueous solubility, therefore the results are based on nominal loading rate, where suspensions of the nominal test concentrations were prepared, stirred overnight, the supernatants separated by filtration, and used as the test solutions.  Some components of the Ciment Fondu^®were solubilised during this procedure, at below their saturation concentrations, as a dose response was observed in the test, with the test organisms being more affected by higher loading concentrations.

Daphnia magna response :

Time	Nominal loading conc of Ciment Fondu^®	Number immobilised per replicate					Total number tested	Total number immobilised	Percentage immobilised
(hour)	(mg l^-1)	A		B	C	D
24	DWC	0		0	0	0	20	0	0
	1.0		0		0		0		0
	1.8	0		0	0	0	20	0	0
	3.2	0		0	0	0	20	0	0
	5.6	0		0	0	0	20	0	0
	10	2		2	3	4	20	11	55
	18	5		3	3	3	20	14	70
	32	5		5	5	5	20	20	100
48	DWC	0		0	0	0	20	0	0
	1.0		0		0		0		0
	1.8	0		0	0	0	20	0	0
	3.2	1		0	0	0	20	1	5
	5.6	1		2	3	1	20	7	35
	10	3		4	4	5	20	16	80
	18	5		5	5	5	20	20	100
	32	5		5	5	5	20	20	100

DWC = Dilution Water Control

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Daphnia magna were exposed under static conditions for 48h to concentrations of 1.0, 1.8, 3.2, 5.6 , 10, 18 and 32 mg/l of Ciment Fondu®. The 48h EC50 value is 6.6 mg/l.

Executive summary:

In order to test acute Ciment Fondu® toxicity to aquatic invertebrates, according to OECD guideline 202, Daphnia magna were exposed to 1.0, 1.8, 3.2, 5.6 ,10, 18 and 32 mg/l of Ciment Fondu® and blank control solution (without test substance or any other additive) for a period of 48 hours under static conditions.

The test solutions were prepared by the addition of the appropriate quantity of Ciment Fondu® directly to 1 litre (for 5.6 10, 18 and 32

mg/l test concentrations), 2 litres (3.2 mg l-1 test concentration) or 5 litres (1.0 and 1.8 mg l-1 test concentrations) of culture medium. All test solutions were stirred overnight using magnetic followers and then allowed to stand for 15 minutes. The test solutions were then filtered through a 0.45 µm membrane filter. All test solutions were clear and colourless.

Immobilisations and viable abnormalities were recorded at 24 and 48 hours.

There was no immobility observed in the dilution water control and no other symptoms of toxicity were observed.

Conclusion : The 48h EC50 is 6.6 mg/l.