Zeolite, cuboidal, crystalline, synthetic, non-fibrous

Additional information on environmental fate and behaviour

Administrative data

Endpoint:

additional information on environmental fate and behaviour

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Aug. 29, 2021 - Mar. 7, 2022; experimental phase: Sep. 1 - Oct. 7, 2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Remarks:

The study documented in this endpoint (performed on blank soil) is a validation of the cross-referenced one.

Reference

Endpoint:

transformation / dissolution of metals and inorganic metal compounds

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jul. 27 - Dec. 9, 2021; experimental phase: Jul. 27 - Aug. 26, 2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Series on Testing and Assessment No. 29 (23-Jul-2001): Guidance document on transformation/dissolution of metals and metal compounds in aqueous media

Version / remarks:

Jul. 23, 2001

Deviations:

yes

Remarks:

The pH screening and the reproducibility tests were not performed as the suitable buffer solution with the highest measured Si concentration was determined during the previous study of the similar test item.

GLP compliance:

yes (incl. QA statement)

Type of method:

flask method

Remarks:

measurement of Silicon and Aluminium per ICP-OES in aqueous media

Specific details on test material used for the study:

Name: SYLOSIV A4 (A Zeolite)
Batch no.: 1000361205
CAS no.: 1318-02-1
Composition: Zeolite (crystalline Aluminium silicate) 95-100 %
Storage: room temperature (20 ± 5 °C)
Expiry date: 31. Jan. 2022
Stability: stable under storage conditions
Appearance: off-white powder
Purity: not applicable, UVCB
Homogeneity: homogeneous
Production date: 01. Dec. 2020
EC no.: 215-283-8 (930-915-9)
Molecular formula: not stated
Molecular weight: not stated
Vapour pressure: 0 hPa

Key result

Type of test:

full transformation/dissolution test - metals and sparingly soluble metal compounds

Mean dissolved conc.:

< 10 µg/L

Element analysed:

silicon

Loading of aqueous phase:

1 mg/L

Incubation duration:

28 d

Key result

Type of test:

full transformation/dissolution test - metals and sparingly soluble metal compounds

Mean dissolved conc.:

4.5 µg/L

Element analysed:

aluminium

Loading of aqueous phase:

1 mg/L

Incubation duration:

28 d

Details on results:

In this study, the maximum concentration of total dissolved Si and Al was determined in order to identify compounds of SYLOSIV A4 which undergo either dissolution or rapid transformation.
The calibration was performed using the certified Si and Al stock solutions (1000 mg/L nominal each). All validation conditions for the range of 10 – 250 µg/L Si and 3 – 50 µg/L Al in pH 8.5 buffer solution were fulfilled. The correlation coefficient r was > 0.99 and the back calculated concentrations of the calibration standards lay in the demanded ranges 100 ± 15 % and 100 ± 20 % (low concentration) of the nominal values.
The accuracy was in the range of 100 ± 5 % with the mean value of 95.3 % for Si and 100.6 % for Al. Therefore, no recovery rates were used for calculation in the study. The condition “RSD ≤ 20 % per level” was fulfilled for both elements.
The pH screening test and reproducibility test were not performed as the suitable buffer solution with the highest measured Si concentration was determined during the previous study of the similar test item.
The full test was performed with 1 mg/L (three replicates) over a period of 28 days with samplings after 2 h, 6 h, 1 d, 4 d, 7 d, 14 d, 21 d and 28 d. Two flasks were prepared as blanks without addition of test item.
The concentration of Si in the test item solutions was in the similar range as in the blank solutions. During the full test the concentration of Si has continuously increased in all flasks (inclusive blank solutions). Some parts of the aeration system made of glass may be a reason for this result. Therefore, the value below the LOQ of Si was stated as the result of the dissolution test.
The concentration of Al was below the LOQ on days 0 – 21 (< 3 µg/L). Therefore, the calculation of the kinetic was not possible. On day 28, the concentration of Al was stated as 4.5 µg/L with the relative standard deviation of 20 %.

Conclusions:

The following concentrations of Al and Si were stated at 20.1 – 21.1 °C and pH 8.5 ± 0.2 for 1 mg/L nominal load on day 28:
4.5 µg/L Al and < 10 µg/L Si.

Executive summary:

This study was performed in order to determine the transformation and/or dissolution of SYLOSIV A4 via measurement of Silicon (Si) and Aluminium (Al) per ICP-OES in aqueous media. The full test was performed with 1 mg/L (three replicates) over a period of 28 days. The concentration of Si in the test item solutions was in the similar range as in the blank solutions. During the full test the concentration of Si has continuously increased in all flasks (inclusive blank solutions).  Therefore, the value below the LOQ of Si was stated as the result of the dissolution test. The concentration of Al was below the LOQ on days 0 – 21 (< 3 µg/L). Therefore, the calculation of the kinetic was not possible. On day 28, the concentration of Al was stated as 4.5 µg/L with the relative standard deviation of 20 %.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2022

Report date:

2022

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD guidance document 29

Version / remarks:

Jul. 23, 2001

Deviations:

yes

Remarks:

The mass balance was not performed for 1 mg/L as the determination is not precise.

GLP compliance:

yes (incl. QA statement)

Type of study / information:

This study was performed in order to determine the transformation and/or dissolution of Soil Type 2.2 via measurement of Silicon (Si), Aluminium (Al) and Titanium (Ti) per ICP-OES in aqueous media.

Test material

Specific details on test material used for the study:

Name: Soil Type 2.2
Batch no.: Sp 2.2 2121
CAS no.: not applicable, mixture
Composition: loamy sand (IS) accroding to DIN respectively sandy loam according to ASDA
Storage: room temperature (20 ± 5 °C)
Expiry date: not stated
Stability: stable under storage conditions
Appearance: brown solid, sandy soil
Purity: not applicable, mixture
Homogeneity: not stated
Production date: 26. May 2021

Results and discussion

Any other information on results incl. tables

The following concentrations of Si, Al and Ti were stated at 20.2 – 21.1 °C and pH 8.5 ± 0.2 (8.31 – 8.52) for 1 mg/L nominal load on day 28:

< 10 µg/L Si
< 3 µg/L Al
< 1 µg/L Ti

Applicant's summary and conclusion

Conclusions:

The following concentrations of Si, Al and Ti were stated at 20.2 – 21.1 °C and pH 8.5 ± 0.2 (8.31 – 8.52) for 1 mg/L nominal load on day 28:

< 10 µg/L Si
< 3 µg/L Al
< 1 µg/L Ti

Executive summary:

This study was performed in order to determine the transformation and/or dissolution of Soil Type 2.2 via measurement of Silicon (Si), Aluminium (Al) and Titanium (Ti) per ICP-OES in aqueous media.

For the determination of the concentration of Si, Al and Ti in the samples, a method validation was performed. The method validation of Si and Al was performed during the study 20120305G989.