reaction product of alumina and sulfuric acid

Long-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 211 (Daphnia magna Reproduction Test)

Version / remarks:

Deviations from the Study Plan
The following deviations were documented:
- Temperature during test item storage was partly outside the range stated in the study plan. As this temperature deviation is not estimated to change the test item proper-ties, it is stated as uncritical.
- Temperature during study between 19.7 and 22.6°C and therefore 0.6°C higher than stated in the study plan. Since no relevant mortality occurred in the control and all va-lidity criteria were met, this deviation was stated as uncritical.
- The temperature varied during the study by 2.9°C and varied therefore 0.9°C more than stated in the study plan. Since no relevant mortality occurred in the control and all validity criteria were met, this deviation was stated as uncritical.
- For Sulfur determination QC sample recovery deviations > 15% were accepted and considered in calculation when a calibration was already performed the same day. Since it was a very small deviation and a new calibration was already performed dur-ing the same day, this deviation was stated as uncritical.
The deviations were assessed and signed by the study director on 26. September 2018.

Deviations from the Guideline
The following deviations were documented:
- Temperature during study between 19.7 and 22.6°C and therefore 0.6°C higher than stated in the guideline. Since no relevant mortality occurred in the control and all va-lidity criteria were met, this deviation was stated as uncritical.
- The temperature varied during the study by 2.9°C and varied therefore 0.9°C more than stated in the guideline. Since no relevant mortality occurred in the control and all validity criteria were met, this deviation was stated as uncritical.
The deviations were assessed and signed by the study director on 26. September 2018.

Deviations:

yes

Remarks:

see remarks above

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.20 (Daphnia magna Reproduction Test)

GLP compliance:

yes (incl. QA statement)

Remarks:

(Landesamt für Umwelt-, Wasserwirtschaft und Gewerbeaufsicht, Rheinland-Pfalz)

Test material

Test material information

Constituent 1

Reference substance name:

reaction product of alumina and sulfuric acid

EC Number:

812-508-7

Cas Number:

1093112-19-6

Molecular formula:

unspecified, UVCB substance

IUPAC Name:

reaction product of alumina and sulfuric acid

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

Name Sulfuric acid, reaction product with alumina
Batch no. SSA-SD 0239
Appearance white powder
Composition reaction product of sulfuric acid with alumina, UVCB
CAS No. 1093112-19-6
EINECS-No. 812-508-7
Molecular formula not stated
Molecular weight not stated
Purity 100 %
Homogeneity homogeneous
Vapour pressure not volatile
Stability H2O: not stated; EtOH: not stated; acetone: not stated; CH3CN: not stated; DMSO: not stated
Inorganic substance, stable in light
Solubility H2O: not stated; EtOH: not stated; acetone: not stated; CH3CN: not stated; DMSO: not stated
Production date Dec. 2015
Expiry date Aug. 2018
Storage Room temperature (20 ± 5°C) under dry conditions

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Vehicle:

yes

Details on test solutions:

Deionised water with an enrichment of certain minerals was used in the test. The minerals which are added comply with the composition M4, (full composition see Annex 4, page 25: Composition of Dilution Water (M4-Medium)) derived by ELENDT as stated in the OECD Guideline. As the test item contains metals, M4-Medium without EDTA (Ethylenediaminetetraacetic acid) was prepared.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Species Daphnia magna
Variety STRAUS
Strain Berlin
Arrival of Strain 27. Sep. 2007
Sex female
Age between 0 and 24 hours
The animals which were used in the test did not belong to the first brood of the respective parent animals.

Selection of Daphnia
The adult animals were separated from the young 20 hours and 20 minutes before the start of the test. The following day 50 minutes before test start, the adults were caught with help of a glass tube, and the new-born daphnia, aged between 0 and 19.5 hours, were sieved from the medium and immediately placed into a beaker containing M4 medium without EDTA. After the settling-in period, animals which showed no apparent damage were used for the test.

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

21 d

Test conditions

Test temperature:

17.4 - 21.3°C

pH:

7.3 - 8.6

Dissolved oxygen:

8.2 - 9.1 mg/L

Nominal and measured concentrations:

The content of Aluminium (Al) as a component of the test item in the test solutions was determined using ICP-OES determination. All determined aluminium values were far below the limit of detection (LOD). Therefore, the determination of the biological results was based on the nominal concentrations.

Details on test conditions:

The study was performed as a semi-static test using a limit concentration at 100 mg/L. Ten replicates were prepared for the treatment and the blank control. One daphnia per repli-cate was exposed to the test item or the control, respectively, for 21 days.

Exposure Conditions
Duration 21 days
Loading 80 mL/animal, animals were kept individually
Replicates 10 replicates/treatment
Treatments 100 mg/L (nominal)
Blank Control dilution water (M4 without EDTA)
Lighting 1000 Lux
Aeration none
Feeding 0. 15 - 0.20 mg organic carbon/animal/working day, the amount of carbon is based on photometric measurement (linear correlation between absorption at 440 nm and measured DOC concentration).
Temperature 19.7 - 22.6°C

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Effect concentrations 2

Key result

Duration:

21 d

Dose descriptor:

LOEC

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Effect concentrations 3

Key result

Duration:

21 d

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

reproduction

Details on results:

According to the OECD guideline, the offspring of dead animals must be taken into account if the death is caused by toxicity of the test item. Only inadvertent and/or accidental parental mortality should be excluded from evaluation. Because no test item toxicity could be observed, and only one parent animal died in the blank control, the offspring of the de-ceased parent animal from the control was excluded from the calculation of total offspring per treatment. The mean offspring produced per survived parent animal was 177 in the control and 186 in the treatment.

Reported statistics and error estimates:

The offspring of the animals was counted each working day. One daphnia died in the control by day 16.

Any other information on results incl. tables

Offspring

Replicate         Blank Control      100 mg/L

1                     154                   192

2                     217                   168

3                     167                   176

4                     200                   184

5                     149                   204

6                     178                   207

7                     180                   205

8                     151                   202

9                     193                   151

10                      M                     173

Mean                176.6                186.2

SD                  23.67                18.97

RSD                 13.41                10.19

SD = standard deviation;

RSD = relative standard deviation = coefficient of variation rtality of parent animal

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The following results were determined for the test item Sulfuric acid, reaction product with alumina:
NOEC ≥ 100 mg/L
LOEC > 100 mg/L
EC50 > 100 mg/L

Executive summary:

Significant decrease in the reproduction of the daphnia could not be observed in the treatment when compared to the control.