Reaction mass of aluminium hydroxide and aluminium nitrate and aluminium sulphate

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

weight of evidence

Study period:

06-05-2003 to 08-08-2003

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with restrictions, method of determining endpoints is questionable

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

At test start water phase samples were taken from the test solution before filling the
individual beakers and at test end after 48 h after decanting and pooling the water per
concentration by using a plastic syringe and transferred into disposable 20 mL-polyethylene
vials. One subsample of 20 mL was acidified with 0.2 mL 14 M nitric acid,
thoroughly mixed and analyzed without further treatment. The added amount of nitric
acid was sufficient to reduce the pH below 2. This fraction is designated as “unfiltered
sample” and is assumed to contain the “total aluminium”. A second subsample was
passed through a Sartorius 0.45 μm-membrane filter (type Minisart NML, diameter 26
mm). In order to rinse the filter approx. 2 - 3 mL of the sample water was processed
at first. The filtrate from this rinsing was discarded. Then, further 20 mL of the sample
water was processed. This filtrate was acidified as described above (20 mL sample plus 0.2 mL 14 M nitric acid; resulting pH below 2). In aquatic chemistry, 0.45 μmmembrane
filtered samples generally are assumed to contain the “dissolved metal” fractions

Vehicle:

no

Details on test solutions:

For each test item concentration, adequate amounts of the test item were mixed
thoroughly with reconstituted water in volumetric glass ware. The prepared test liquid
was sampled for chemical analysis and filled into the test beakers. The daphnids
were introduced directly thereafter. The nominal test concentrations were 10, 20, 40,
80, and 160 mg/L. Reconstituted water was tested as control.

Test organisms (species):

Daphnia magna

Details on test organisms:

Specification:
Species: Daphnia magna STRAUS, Crustacea, Cladocera (clone V).
Age: 4 - 24 hours old.
Origin: Umweltbundesamt, Institut für Wasser-, Boden- und Lufthygiene,
bred in the laboratory of the Fraunhofer-IME.
Breeding and holding conditions:
Adult Daphnia, at least 3 weeks old, were separated from the stock population by
sieving. Batches of 30 to 50 animals were held at room temperature in approx. 1800
mL purified drinking water. During the week the daphnids are fed daily with an algal
suspension (Scenedesmus subspicatus) and LiquizellR (HOBBY) according to the
EEC-Guideline. Algae growing in the log-phase, are centrifuged and the pellet
is resuspended in a few mL of medium. 30 mL of this suspension is given to 1 L
Daphnia medium. The water was changed once per week. Newborn daphnids were
separated by sieving, the first generation was discarded.
Sensitivity
The sensitivity of the test clone was checked by using K2Cr2O7 as reference substance.
Between 04.04.2003 and 13.05.2003 the EC50 ranged from 1.0 to 1.3 mg/L.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

Calcium chloride solution
Dissolve 11.76 g CaCl2*2H2O in deionised water;
make up to 1 litre with deionised water
Magnesium sulphate solution
Dissolve 4.93 g MgSO4*7H2O in deionised water;
make up to 1 litre with deionised water
Sodium bicarbonate solution
Dissolve 2.59 g NaHCO3 in deionised water; make up to 1 litre with deionised water
Potassium chloride solution
Dissolve 0.23 g KCl in deionised water; make up to 1 litre with deionised water
All chemicals must be of analytical grade.
The conductivity of the distilled or deionised water should not exceed 10 μScm-1.
25 mL each of solutions (a) to (d) are mixed and the total volume made up to 1 litre
with deionised water. The sum of the calcium and magnesium ions in this solution is
2.5 mmol/L. The proportion Ca:Mg ions is 4:1 and Na:K ions 10:1. The acid capacity
KS4.3 of this solution is 0.8 mmol/L.

Test temperature:

20.0-20.1 C

pH:

4.6-8.0 decreasing pH with increasing Al concentration

Dissolved oxygen:

91-97% of saturation

Nominal and measured concentrations:

nominal testsubstance: 10.0, 20.0, 40.0, 80.0, 160 mg/L
nominal aluminium: 0.900, 1.80, 3.60, 7.20, 14.4 mg/L
measured aluminium in test solution begin: 0.078, 0.039, 0.029, 0.468, 5.00

Reference substance (positive control):

yes

Remarks:

Pottasium dichromate

Duration:

48 h

Dose descriptor:

EC10

Effect conc.:

30.8 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

47.5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 40.5-55.6 mg/L

Duration:

48 h

Dose descriptor:

EC10

Effect conc.:

2.8 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

other: total aluminium

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

4.3 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

other: total aluminium

Basis for effect:

mobility

Remarks on result:

other: 3.6-5.0

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

0.33 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

dissolved

Remarks:

aluminium

Basis for effect:

mobility

Results with reference substance (positive control):

EC50 from reference substance test was 1.0 -1.3 mg/L

Reported statistics and error estimates:

The evaluation of the effect concentrations was based on initially nominal test item
concentrations, since the initial test item concentrations, calculated from the initially
measured total aluminium concentrations, deviated by < 20 % from the nominal concentrations.
The evaluation of the concentration-effect-relationships and the calculations of effect
concentrations of dissolved aluminium were based on the initially measured concentrations.
EC10 and EC50 values were determined together with 95% confidence intervals using
Probit-analysis assuming log-normal distribution of the values by using the ToxRat
programme

Nominal concentration (mg/L)	24h				48h
	No. 1	2	3	4	1	2	3	4
Control	0	0	0	0	0	0	0	0
10	0	0	0	0	0	0	0	0
20	0	0	0	0	0	0	1	0
40	0	0	0	0	0	0	3	0
80	1	2	4	3	5	5	5	5
160	5	5	5	5	5	5	5	5

Validity criteria fulfilled:

yes

Conclusions:

The EC50 of the test item was determined to be 48 mg test item /L (95 % confidence limits: 41 – 56 mg/L) nominal. and 0.33 mg/L bioavailable aluminium. the EC10 was determined to be 30.8 mg/L nominal. Endpoint determinations are questionable, therefore NOEC/LOEC data are not to be used. EC50 of the bioavailable concentration of aluminium was calculated in a very questionable way but adaptations would lead to minor differenes in EC50. Therefore this value still seems valid.

Executive summary:

A study sponsored by the Aluminium Salts Subgroup of the Cefic Incopa Sector Group was performed at the Fraunhofer-Institute for Molecular Biology and Applied Ecology to evaluate the acute toxicity of aluminium sulphate-14-hydrate to Daphnia magna relevant for an accidental exposure. Aluminium sulphate-14-hydrate was tested at nominal concentrations of 10, 20, 40, 80, and 160 mg/L under static conditions for 48 hours. Test water was reconstituted water according to OECD TG 203, without pH adjustment. The initially measured concentrations based on total aluminium differed by less than 20 % from nominal values. The mean measured dissolved aluminium concentrations strongly depended on pH which was influenced by the test item. The EC50 of the test item was determined to be - 48 mg test item /L (95 % confidence limits: 41 – 56 mg/L). The concentration-effect relationship for the test item integrates the enhanced solubility of aluminium at the pH caused by the test item concentration: 48 mg/L of aluminium sulphate-14-hydrate reduced the pH of reconstituted water (OECD 203) to a level which enabled 0.33 mg Al/L to be dissolved, causing 50 % immobility after 48 h.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented publication which meets basic scientific principles.

Qualifier:

no guideline followed

Principles of method if other than guideline:

In semi-static tests on the acute toxicity of metals salts to freshwater peracarids, including Crangonyx pseudogracilis, 48 and 96 hours LC50 values are determined for Al(III).

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

Stoch solutions were prepared by dissolving Al2(SO4)3 x 16H2O in deonized water in 1L glass volumetric flasks which had previously been washed in 10 % nitric acid and rinsed with deionized water. Stocks were stored in the dark at 6 °C and none were prepared earlier than two days prior to testing.

Test organisms (species):

other: Crangonyx pseudogracilis

Details on test organisms:

TEST ORGANISM
- Common name: amphipod
- Source: obtained from self-maintaining cultures in open-air concrete stock tanks (2.5 m long x 1.2 m wide x 0.8 m deep) used to house fresh-water crayfish. Original source was Nottingham Canal, a disused and clean static water body north-west of Nottingham
- Weight at study initiation (mean and range, SD): approx. 0.2 mg dry wt
- Length at study initiation (length definition, mean, range and SD): mean size 4 mm
- feeding during study: no

ACCLIMATION
- Acclimation period: 1 week prior to tests
- Acclimation conditions (same as test or not): not the same
- Type and amount of food: ad libitum upon trout-fry pellets
- aeration: no aeration

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

50 ppm (as CaCO3)

Test temperature:

13 °C

pH:

6.75

Dissolved oxygen:

9.6 (mean after 24 h)

Nominal and measured concentrations:

minimum of eight concentrations; not specified

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 200 cm3 polystyrene beakers
- Aeration: no
- No. of organisms per vessel: 20-30
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2



TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: tap water : deionized water 1:3
- Conductivity: 325 uS/cm
- Intervals of water quality measurement: 24 h


OTHER TEST CONDITIONS
- Adjustment of pH: adjusted to 6.75 with 0.1 molar sodium hydroxide and 0.1 molar hydrchloric acid
- Photoperiod: 12:12 (dark:light)


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality, every 24 h

TEST CONCENTRATIONS
- Range finding study conducted; no details

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

12.8 mg/L

Nominal / measured:

nominal

Conc. based on:

element

Remarks:

Al

Basis for effect:

mortality

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

9.19 mg/L

Nominal / measured:

nominal

Conc. based on:

element

Remarks:

Al

Basis for effect:

mortality

Reported statistics and error estimates:

LC50 and 95 % confidence limits derived from weighted regression of log metal concentration (as ppm of metal added)/ probit mortality. Goodness of fit of the regression model was verified by Chi-square statistic.

Reference 3

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented publication which meets basic scientific principles.

Reason / purpose for cross-reference:

reference to same study

Qualifier:

no guideline followed

Principles of method if other than guideline:

Acute toxicity tests were conducted as static tests in constant temperature water baths for 48 hr. Each beaker held 10 neonate daphnia that were 12 ± 12 hr old at the start of the test. Two of the four replicates were not fed. Survival was observed daily.

GLP compliance:

no

Analytical monitoring:

yes

Details on sampling:

- Concentrations: all concentrations
- Sampling method: samples were taken at the beginning and end of each test. Samples were drawn into 15 ml tubes and acidified with 1 drop of 1.0 N HNO3.

Vehicle:

no

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: daphnid
- Source: commercially available source, Aquatic Life Company, Minneapolis, MN.
- Age at study initiation: neonates 12 ± 12 hrs old
- Method of breeding: used a series of 250 ml beakers containing 200 ml water with food at a concentration of 30 mg/L in each beaker. Water was totally renewed three times per week with approximately 5 adult daphnia per beaker transferred to the new solution.
- Feeding during test
- Amount: 30 mg/l with an eye dropper

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

Hard, value not reported

Test temperature:

20.1 °C (mean)

pH:

7.05 (mean)

Dissolved oxygen:

8.08 mg/L (mean)

Nominal and measured concentrations:

Range of treatment means (mg/L): 4.0-43.0 total, 1.5-3.0 supernatant

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: 250 ml beakers containing 200 ml solution
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: well water tapping the Jordan sandstone stratum underlying the Minneapolis-St. Paul metropolitan area, with iron catalytically removed
- Culture medium different from test medium: no
- Intervals of water quality measurement: beginning and end of experiments

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

38.2 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

element

Remarks:

Al

Basis for effect:

mortality

Reported statistics and error estimates:

LC50 values were derived by a computer program that calculates LC50 values by four methods. The method that gave the tightest confidence interval was used. An LC50 could not be calculated at 96 hr.

Reference 4

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented publication which meets basic scientific principles.

Qualifier:

no guideline followed

Principles of method if other than guideline:

In semi-static tests on the acute toxicity of metals salts to freshwater peracarids, including Asellus aquaticus, 48 and 96 hours LC50 values are determined for Al(III).

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

Stock solutions were prepared by dissolving Al2(SO4)3 x 16H2O in deonized water in 1L glass volumetric flasks which had previously been washed in 10 % nitric acid and rinsed with deionized water. Stocks were stored in the dark at 6 °C and none were prepared earlier than two days prior to testing.

Test organisms (species):

other: Asellus aquaticus

Details on test organisms:

TEST ORGANISM
- Common name: isopod
- Source: obtained from self-maintaining cultures in open-air concrete stock tanks (2.5 m long x 1.2 m wide x 0.8 m deep) used to house fresh-water crayfish. More than one wild original source for stock population; the captive population has been established for more than a year prior to tests
- Weight at study initiation (mean and range, SD): approx. 1.5 mg dry wt
- Length at study initiation (length definition, mean, range and SD): mean size 7 mm
- feeding during study: no


ACCLIMATION
- Acclimation period: 1 week prior to tests
- Acclimation conditions (same as test or not): not the same
- Type and amount of food: ad libitum upon trout-fry pellets
- aeration: no aeration

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

72 h

Hardness:

50 ppm (as CaCO3)

Test temperature:

13 °C

pH:

6.75

Dissolved oxygen:

9.6 (mean after 24 h)

Nominal and measured concentrations:

minimum of eight concentrations; not specified

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: 200 cm3 polystyrene beakers
- Aeration: no
- No. of organisms per vessel: 20-30
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2



TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: tap water : deionized water 1:3
- Conductivity: 325 uS/cm
- Intervals of water quality measurement: 24 h


OTHER TEST CONDITIONS
- Adjustment of pH: adjusted to 6.75 with 0.1 molar sodium hydroxide and 0.1 molar hydrchloric acid
- Photoperiod: 12:12 (dark:light)


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality, every 24 h

TEST CONCENTRATIONS
- Range finding study conducted; no details

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

6.75 mg/L

Nominal / measured:

nominal

Conc. based on:

element

Remarks:

Al

Basis for effect:

mortality

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

4.37 mg/L

Nominal / measured:

nominal

Conc. based on:

element

Remarks:

Al

Basis for effect:

mortality

Reported statistics and error estimates:

LC50 and 95 % confidence limits derived from weighted regression of log metal concentration (as ppm of metal added)/ probit mortality. Goodness of fit of the regression model was verified by Chi-square statistic.

Reference 5

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Study period:

02-12-1997

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: No reference substance used, no substance identity, to little information is provided, to conclude the reliability.

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

not specified

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

A solution with 10 g/L concentration was prepared and pH was adjested to 7.8. The solution was settled and the transparant phase was used as stck solution for the test.

Test organisms (species):

Daphnia magna

Details on test organisms:

6-24 h old, the test animals were taken from Toxicons stock

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test temperature:

21.0 C

pH:

7.6-8.0

Dissolved oxygen:

>90% of saturation

Nominal and measured concentrations:

nominal: 0, 100, 250, 500, 750, 1000 mg/L

Details on test conditions:

The animals were incubated in glass petridishes with 50 ml test solution. Two replicateswere used for each test concentration, including the controls, with ten animals in each. The dishes were incubated in a thermoconstant room at 21.0 Cand with light rhytm of 16h light and 8h darkness.

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

750 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

870 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Reported statistics and error estimates:

The percentage immobolised animals in each testconcentration were plotted against the contrastion. The EC50 and the LOEC were calculated by graphic interpolation as well as by probit analysis.

Validity criteria fulfilled:

not specified

Conclusions:

The LOEC was determined to be 750 mg/L ALS (nominal) to Daphnia magna, The EC50 was determined to be 870 mg/L. No reference test was used, as prescribed by the guideline

Executive summary:

In the acute immobilisation test with Daphnia, the LOEC was determined to be 750 mg/L ALS to Daphnia magna, The EC50 was determined to be 870 mg/L ALS. No reference test was used, as prescribed by the guideline. The test was performed according to the OECD 202 guideline. Most validity criteria have been met.

Reference 6

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

weight of evidence

Study period:

06-05-2003 tom 08-02-2003

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was conducted according to an appropriate OECD test guideline, and in compliance with GLP. The study is considered to be reliability 1 (reliable without restrictions); the read across of the result is considered to be reliability 2 (reliable with restrictions).

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

Remarks:

reconstitution water according to the OECD 203 guideline

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

Water phase samples were taken from the freshly prepared test solutions before filling
the individual beakers and from old media after decanting and pooling the water
per concentration by using a plastic syringe and transferred into disposable 20 mLpolyethylene
vials. One subsample of 20 mL was acidified with 0.2 mL 14 M nitric
acid, thoroughly mixed and analyzed without further treatment. The added amount of
nitric acid was sufficient to reduce the pH below 2. This fraction is designated as “unfiltered
sample” and is assumed to contain the “total aluminium”. A second subsample
was passed through a Sartorius 0.45 μm-membrane filter (type Minisart NML, diameter 26 mm).
In order to rinse the filter approx. 2 - 3 mL of the sample water was processed at first.
The filtrate from this rinsing was discarded. Then, further 20 mL of
the sample water was processed. This filtrate was acidified as described above
(20 mL sample plus 0.2 mL 14 M nitric acid; resulting pH below 2). In aquatic chemistry,
0.45 μm-membrane filtered samples generally are assumed to contain the “dissolved
metal” fractions.

Vehicle:

no

Test organisms (species):

Daphnia magna

Details on test organisms:

Justification for the use of the test organism:
Daphnia magna (Crustacea, Phyllopoda, Cladocera) was chosen by OECD-experts (ref 1)
as test organism representing aquatic invertebrates.
8.1.2 Specification:
Species: Daphnia magna STRAUS, Crustacea, Cladocera (clone V).
Age: 4 - 24 hours old.
Origin: Umweltbundesamt, Institut für Wasser-, Boden- und Lufthygiene,
bred in the laboratory of the Fraunhofer-IME.
8.1.3 Breeding and holding conditions:
Adult Daphnia, at least 3 weeks old, were separated from the stock population by
sieving. Batches of 30 to 50 animals were held at room temperature in ca. 1800 mL
purified drinking water. During the week the daphnids are fed daily with an algal suspension
(Scenedesmus subspicatus) and LiquizellR (HOBBY) according to the EECGuideline
(ref 2). Algae growing in the log-phase, are centrifuged and the pellet is resuspended
in a few mL of medium. 30 mL of this suspension is given to 1 L Daphnia
medium. The water was changed once per week. Newborn daphnids were separated
by sieving, the first generation was discarded.
8.1.4 Sensitivity
The sensitivity of the test clone was checked by using K2Cr2O7 as reference substance.
Between 04.04.2003 and 13.05.2003 the EC50 ranged from 1.0 to 1.3 mg/L.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test temperature:

20.0-20.1 C

pH:

7.5-8.0

Dissolved oxygen:

94-100% saturation

Nominal and measured concentrations:

nominal: 10, 20, 40, 80, 160 mg/L
nominal AL: 0.9, 1.8, 3.6, 7.2, 14.4 mg/L
measured Al: 1.11, 1.89, 4.02, 7.38, 14.1 mg/L (geomean)
measured AL (dissolved):0.172, 0.176, 0.166, 0.107, 0.115 mg/L (geomean)

Details on test conditions:

Daphnids (Daphnia magna) were exposed to 5 concentrations of the test item in 4
replicates under semi-static conditions for a period of 48 hours. 60 mL glass beakers
were used as test vessels. To each beaker 50 mL test solution and 5 daphnids, not
older than 24 hours, were added. They were transferred to freshly prepared test liquids
in new test vessels after 24 h. No feeding and no aeration occurred throughout
the test. The controls were kept under the same conditions in reconstituted water.
Immobility and abnormal behaviour were recorded after 24 h and 48 h. Immobile
animals were eliminated from the vessels as soon as they were discovered. The
daphnids were considered to be immobile if they were not able to swim within 15
seconds after gentle agitation of the test vessels. The temperature during the test was
20.0 ± 0.1 °C. The beakers were covered with glass panes and subjected to a
light/dark cycle of 16/8 h with light intensities of less than 1000 Lux.
In the freshly prepared test liquids at test start and after 24 h (before adding the
daphnids), and in the old liquids after 24 h and at test end pH-values (WTW Microprocessor
pH-Meter pH 196) and oxygen concentrations (WTW Microprocessor Oximeter
OXI 196) of the decanted and pooled test solutions and control water were
measured.

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

> 160 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

measured concentrations appeared to be very pH dependent and reached maximum solubility. therefore the nominal and measured (dissolved) concentration) are very diffrent. The result therefore is that the NOEC exceeds the water solubility at the tested pH's.

Validity criteria fulfilled:

yes

Conclusions:

No signs of immobility wre observed during the 48h test period nor other signs of intoxication could be observed. the conclusion is that the NOEC >= 160 mg/L nominal and the NOEC exceeds the water solubility at the tested pH levels.

Executive summary:

A study sponsored by the Aluminium Salts Subgroup of the Cefic Incopa Sector Group was performed at the Fraunhofer-Institute for Molecular Biology and Applied Ecology to evaluate the acute toxicity of aluminium sulphate-14-hydrate to Daphnia magna. Aluminium sulphate-14-hydrate was tested at nominal concentrations of 10, 20, 40, 80, and 160 mg/L under semi-static conditions (daily renewal of the test medium) for 48 hours. Test water was reconstituted water according to OECD TG 203, with pH adjusted to 7.5 at each renewal. The mean measured concentrations based on total aluminium differed by less than 20 % from nominal values for all concentrations except the lowest one. The concentrations of dissolved aluminium were measured between 0.1 and 0.2 mg/L, irrespective of the applied amount of total aluminium. Up to the highest test concentration, no immobility could be observed after 48 h. Thus, the NOEC of aluminium sulphate-14-hydrate under the described study conditions was determined as follows:

NOEC ≥ 160 mg aluminium sulphate-14-hydrate / L and exceed the water solubility at the tested pH levels.

Reference 7

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented publication which meets basic scientific principles.

Reason / purpose for cross-reference:

reference to same study

Qualifier:

no guideline followed

Principles of method if other than guideline:

Static, acute short-term toxicity test with Daphnia magna

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

Unfiltered lake water strained through #20 bolting cloth was used for all rearing and testing, thus including some nutrients from bacteria, algae, and detritus in the water.
Stock solutions was aged for at least 4 days to allow them to become chemically equilibrated before being used for testing animals.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Source: laboratory clone originally obtained from the University of Michigan
- Age at study initiation: 12 ± 12 hrs
- Method of breeding:
- Type and amount of food: 1 mL/L suspension of food (prepared by adding 0.5 g of powdered dried grass and 10 g of enriched trout-fry granules to 250 mL of Lake Superior water and mixing vigorously in a blender for 5 min; suspension was strained through #20 bolting cloth; the blender was rinsed with an additonal 50 mL of lake water, and the rinse water was added to the suspension)
- Feeding frequency: twice weekly
- Feeding during test: both, with and without food addition
- Food type: suspension of food (prepared by adding 0.5 g of powdered dried grass and 10 g of enriched trout-fry granules to 250 mL of Lake Superior water and mixing vigorously in a blender for 5 min; suspension was strained through #20 bolting cloth; the blender was rinsed with an additonal 50 mL of lake water, and the rinse water was added to the suspension)
- Amount: 1 mL/L
- Frequency: once weekly

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 d

Hardness:

Total hardness: 44,000 - 53,000 (mean 45,300) µg/

Test temperature:

18 ± 1 °C

pH:

7.4 - 8.2 (mean 7.74)

Dissolved oxygen:

Near saturation at all times. At dawn, before the lights came on, the concentration was ~9 mg/L; late in the day oxygen sometimes slightly exceeded saturation because of photosynthesis by algae.

Details on test conditions:

TEST SYSTEM
- Test vessel:
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- Chloride: 1170 - 1340 (mean 1217) ug/L
- Alkalinity: 41,000 - 50,000 (mean 42,300) ug/L

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

3.9 mg/L

Nominal / measured:

nominal

Conc. based on:

element

Remarks:

Al

Basis for effect:

mobility

Additional information

No reliable studies on the acute toxicity of reaction mass of aluminium hydroxide and aluminium nitrate and aluminium sulphate to invertebrates are available.Therefore, a weight of evidence approach is applied and data are read-across to various aluminium compounds based on an analogue approach.

 

Two guideline studies with Daphnia magna are available (Schäfers, 2003) for aluminium sulfate. One test was static without pH adjustment. In this test an EC50 was found of 0.33 mg/l (dissolved Al) at a pH of approximately 6.5 -7.5. The second test was semi-static with pH adjustment. The test substance concentrations were in a range of 10 to 160 mg/l (nominal), this resulted in dissolved aluminum concentrations of 0.107 to 0.176 mg/l. The pH was between 7.5 and 8.0. No effects were found in this test, therefore, EC50 is greater than 0.176 mg/l (dissolved Al and > 160 mg/L nominal), which was the maximum soluble concentration under the test conditions.

 

Further data from non-guideline studies (RL2) conducted Kimball (1978), Biesinger & Christensen (1972), and Martin & Holdich (1986) are available. All these studies report LC50/EC50 values based on total Al well above 1 mg/L, ranging from 3.9 to 38.2 mg/L.