Zeolite, cuboidal, crystalline, synthetic, non-fibrous

Sediment toxicity

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

sediment toxicity: long-term

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jan. 23-27, 2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

other: ISO 10872

Version / remarks:

2020

Deviations:

no

Remarks:

All validity criteria were met in the controls of all tests.

GLP compliance:

no

Remarks:

As these data are not used to assess extrapolation to humans, a study according to GLP was not regarded as necessary.

Specific details on test material used for the study:

• Chemical name: Aluminosilicate
• Trade name: Sylosiv A4 (A Zeolite)
• Acronym in Report: Syl
• Batch number: 1000361205
• Composition: Aluminosilicate (Al/Si ~ 1)
• CAS No.: 1318-02-1
• Purity: 100 %
• Specific Surface Area (BET): not stated
• Grain size (diameter): 8.687 μm

Vehicle:

yes

Remarks:

M9 medium

Details on sediment and application:

Artificial sediment was prepared according to ISO 10872 (20.1.21). All components were stored at room temperature.
Composition:
- 40% (w/w) Quartz sand (0.1-0.4 mm; BayWa; Munich, Germany)
- 30% (w/w) Quartz powder (Millisil W4; Quarzwerke Frechen, Germany)
- 20% (w/w) Al2O3 (purum, p.a.; Fluka; Batch: 437451/1)
- 4.5% (w/w) Fe2O3 (puriss. p.a. ≥99%; Fluka; Batch: 428807/1)
- 0.5% (w/w) Dolomite (Dolomitwerk Jettenberg; Germany)
- 1% (w/w) CaCO3 (Ph Eur; USP; BP, precipitated; Carl-Roth; batch: 14245877)
- 4% (w/w) Peat (untreated, highly decomposed black peat, R.H.P. quality; Klasmann-Deilmann, Geeste, Germany)
The dry components were thoroughly mixed to result in a total amount of 50 g (dry wt) artificial sediment. Analysis of grain size distribution and TOC revealed 41% sand (>63 μm), 54.5% silt (2-63 μm), 4.5% clay (<2 μm) and 2.1% TOC.

0.1 ml M9-medium (ISO 10872; 6 g Na2HPO4 /L, 3 g KH2PO4 /L, 5 g NaCl, 0.25 g MgSO4 7H2O /L) were added to 0.15 g dry sediment to moisten the sediment and to achieve a sediment wet weight of 0.25 g and a water content of 40%.

Test organisms (species):

Caenorhabditis elegans

Details on test organisms:

Strain: N2
Genotype: C. elegans wild type
Source: Caenorhabditis Genetic Centre; University of Minnesota; Minneapolis; MN 55455; USA.
Cultivation: C. elegans were cultivated according to ISO 10872.

Study type:

laboratory study

Test type:

static

Water media type:

freshwater

Type of sediment:

artificial sediment

Limit test:

no

Duration:

96 h

Exposure phase:

total exposure duration

Test temperature:

19.5-20.5 °C

Nominal and measured concentrations:

0, 1563, 3125, 6250, 12500, 25000, 50000 mg/kg d.w.

Details on test conditions:

formulated sediment (ISO 10872)

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

50 000 mg/kg sediment dw

Nominal / measured:

nominal

Basis for effect:

growth rate

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

6 250 mg/kg sediment dw

Nominal / measured:

nominal

Basis for effect:

reproduction

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

3 125 mg/kg sediment dw

Nominal / measured:

nominal

Basis for effect:

reproduction

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

25 000 mg/kg sediment dw

Nominal / measured:

nominal

Basis for effect:

growth rate

Details on results:

For growth, first inhibitory effects compared to the control occurred at a concentration of 50,000 mg/kg dry sediment (p < 0.014; one-way ANOVA [df = 6; F = 3.535], posthoc Dunnett: p = 0.008). Thus, a NOEC of 25,000 mg/kg dry sediment could be calculated.
For reproduction, first inhibitory effects compared to the control occurred at a concentration of 6,250 mg/kg dry sediment (p < 0.001; one-way ANOVA [df = 6; F = 13.805], posthoc Games-Howell: p = 0.049). Thus, a NOEC of 3,125 mg/kg dry sediment could be calculated.
For growth a partial dose-response curve could be set up, however including effect > 50%. Based on the logistic function that significantly fitted the dose-response curve to the observed toxicity data, EC10 and EC50 values of 14,518 and 42.701 mg/kg dry sediment has been
determined. For reproduction a proper dose-response curve could be established, as effect. Based on the logistic function that significantly fitted the dose-response curve to the observed toxicity data, EC10 and EC50 values were calculated as 1,490 and 7979 mg/L, respectively.
For growth and reproduction, EC10 values were considerably lower than the NOECs. One reason might be the generally high data variance within some treatments leading to high MDDvalues (up to 31% and 45% for growth and reproduction, respectively).

Validity criteria fulfilled:

yes

Conclusions:

NOECs for growth and reproduction were 25,000 and 3,125 mg/kg dry soil, respectively.

Executive summary:

The toxicity of the zeolite Sylosiv via spiked water, sediment and soil was tested with the nematode Caenorhabditis elegans, using the ISO guideline 10872. In spiked sediment, C. elegans’s growth was first affected at a concentration of 50,000 (NOEC 25,000 mg/kg dry sediment). First effects on reproduction occurred at 6,250 mg/kg dry sediment (NOEC: 3,125 mg/kg dry sediment).

Reference 2

Endpoint:

sediment toxicity: long-term

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jan. 23-27, 2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

other: ISO 10872

Version / remarks:

2020

Deviations:

no

Remarks:

All validity criteria were met in the controls of all tests.

GLP compliance:

no

Remarks:

As these data are not used to assess extrapolation to humans, a study according to GLP was not regarded as necessary.

Specific details on test material used for the study:

• Chemical name: Aluminosilicate
• Trade name: Zeocros (P Zeolite)
• Acronym in Report: Zeo
• Batch number: 2020-531
• Composition: Aluminosilicate (Al/Si ~ 0.8)
• CAS No.: 1318-02-1
• Purity: 100 %
• Specific Surface Area (BET): not stated
• Grain size (diameter): 1.115 μm

Vehicle:

yes

Remarks:

M9 medium

Details on sediment and application:

Artificial sediment was prepared according to ISO 10872 (20.1.21). All components were stored at room temperature.
Composition:
- 40% (w/w) Quartz sand (0.1-0.4 mm; BayWa; Munich, Germany)
- 30% (w/w) Quartz powder (Millisil W4; Quarzwerke Frechen, Germany)
- 20% (w/w) Al2O3 (purum, p.a.; Fluka; Batch: 437451/1)
- 4.5% (w/w) Fe2O3 (puriss. p.a. ≥99%; Fluka; Batch: 428807/1)
- 0.5% (w/w) Dolomite (Dolomitwerk Jettenberg; Germany)
- 1% (w/w) CaCO3 (Ph Eur; USP; BP, precipitated; Carl-Roth; batch: 14245877)
- 4% (w/w) Peat (untreated, highly decomposed black peat, R.H.P. quality; Klasmann-Deilmann, Geeste, Germany)
The dry components were thoroughly mixed to result in a total amount of 50 g (dry wt) artificial sediment. Analysis of grain size distribution and TOC revealed 41% sand (>63 μm), 54.5% silt (2-63 μm), 4.5% clay (<2 μm) and 2.1% TOC.

0.1 ml M9-medium (ISO 10872; 6 g Na2HPO4 /L, 3 g KH2PO4 /L, 5 g NaCl, 0.25 g MgSO4 7H2O /L) were added to 0.15 g dry sediment to moisten the sediment and to achieve a sediment wet weight of 0.25 g and a water content of 40%.

Test organisms (species):

Caenorhabditis elegans

Details on test organisms:

Strain: N2
Genotype: C. elegans wild type
Source: Caenorhabditis Genetic Centre; University of Minnesota; Minneapolis; MN 55455; USA.
Cultivation: C. elegans were cultivated according to ISO 10872.

Study type:

laboratory study

Test type:

static

Water media type:

freshwater

Type of sediment:

artificial sediment

Limit test:

no

Duration:

96 h

Exposure phase:

total exposure duration

Test temperature:

19.5-20.5 °C

Nominal and measured concentrations:

0, 1563, 3125, 6250, 12500, 25000, 50000 mg/kg d.w.

Details on test conditions:

formulated sediment (ISO 10872)

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

25 000 mg/kg sediment dw

Nominal / measured:

nominal

Basis for effect:

growth rate

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

3 125 mg/kg sediment dw

Nominal / measured:

nominal

Basis for effect:

reproduction

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

1 563 mg/kg sediment dw

Nominal / measured:

nominal

Basis for effect:

reproduction

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

12 500 mg/kg sediment dw

Nominal / measured:

nominal

Basis for effect:

growth rate

Details on results:

For growth, first inhibitory effects compared to the control occurred at a concentration of 25,000 mg/kg dry sediment (p < 0.001; one-way ANOVA [df = 6; F = 6.901], posthoc Dunnett: p = 0.002). Thus, a NOEC of 12,500 mg/kg dry sediment could be calculated.
For reproduction, first inhibitory effects compared to the control occurred at a concentration of 3,125 mg/kg dry sediment (p < 0.001; one-way ANOVA [df = 6; F = 30.971], posthoc Dunnett: p = 0.008). Thus, a NOEC of 1,563 mg/kg dry sediment could be calculated.
For growth a partial dose-response curve could be set up (highest effect < 50%). Based on the logistic function that significantly fitted the dose-response curve to the observed toxicity data, an EC10 of 4,746 mg/kg dry sediment has been determined. For reproduction a proper dose-response curve could be established, as effects of > 50% inhibition were observed. Based on the logistic function that significantly fitted the dose-response curve to the observed toxicity data, EC10 and EC50 values were calculated as 1,370 and 6835 mg/L, respectively.
NOEC and EC10 values matched quite nicely for reproduction and %MDD could properly predict first significant effects of growth and reproduction. For growth, EC10 was considerably lower than the NOEC. However, as the dose-response curve is not complete, the EC10 value for growth should be regarded with caution.

Validity criteria fulfilled:

yes

Conclusions:

NOECs for growth and reproduction were 12,500 and 1,563 mg/kg dry soil, respectively.

Executive summary:

The toxicity of the zeolite Zeocros (Zeo) via spiked water, sediment and soil was tested with the nematode Caenorhabditis elegans, using the ISO guideline 10872. In spiked sediment, C. elegans’s growth was first affected at a concentration of 25,000 (NOEC 12,500 mg/kg dry sediment). First effects on reproduction occurred at 3,125 mg/kg dry sediment (NOEC: 1,563 mg/kg dry sediment).

Reference 3

Endpoint:

sediment toxicity: long-term

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Feb. 9-13, 2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

other: ISO 10872

Version / remarks:

2020

Deviations:

no

Remarks:

All validity criteria were met in the controls of all tests.

GLP compliance:

no

Remarks:

As these data are not used to assess extrapolation to humans, a study according to GLP was not regarded as necessary.

Specific details on test material used for the study:

• Chemical name: Aluminium Magnesium Vanadium Oxide
• Trade name: Na Y (Y Zeolite)
• Acronym in Report: NaY
• Batch number: RZ200094/1
• Composition: Aluminosilicate (Al/Si ~ 0.3)
• CAS No.: 1318-02-1
• Purity: 100 %
• Specific Surface Area (BET): not stated
• Grain size (diameter): 5.723

Vehicle:

yes

Remarks:

M9 medium

Details on sediment and application:

Artificial sediment was prepared according to ISO 10872 (20.1.21). All components were stored at room temperature.
Composition:
- 40% (w/w) Quartz sand (0.1-0.4 mm; BayWa; Munich, Germany)
- 30% (w/w) Quartz powder (Millisil W4; Quarzwerke Frechen, Germany)
- 20% (w/w) Al2O3 (purum, p.a.; Fluka; Batch: 437451/1)
- 4.5% (w/w) Fe2O3 (puriss. p.a. ≥99%; Fluka; Batch: 428807/1)
- 0.5% (w/w) Dolomite (Dolomitwerk Jettenberg; Germany)
- 1% (w/w) CaCO3 (Ph Eur; USP; BP, precipitated; Carl-Roth; batch: 14245877)
- 4% (w/w) Peat (untreated, highly decomposed black peat, R.H.P. quality; Klasmann-Deilmann, Geeste, Germany)
The dry components were thoroughly mixed to result in a total amount of 50 g (dry wt) artificial sediment. Analysis of grain size distribution and TOC revealed 41% sand (>63 μm), 54.5% silt (2-63 μm), 4.5% clay (<2 μm) and 2.1% TOC.

0.1 ml M9-medium (ISO 10872; 6 g Na2HPO4 /L, 3 g KH2PO4 /L, 5 g NaCl, 0.25 g MgSO4 7H2O /L) were added to 0.15 g dry sediment to moisten the sediment and to achieve a sediment wet weight of 0.25 g and a water content of 40%.

Test organisms (species):

Caenorhabditis elegans

Details on test organisms:

Strain: N2
Genotype: C. elegans wild type
Source: Caenorhabditis Genetic Centre; University of Minnesota; Minneapolis; MN 55455; USA.
Cultivation: C. elegans were cultivated according to ISO 10872.

Study type:

laboratory study

Test type:

static

Water media type:

freshwater

Type of sediment:

artificial sediment

Limit test:

no

Duration:

96 h

Exposure phase:

total exposure duration

Test temperature:

19.5-20.5 °C

Nominal and measured concentrations:

0, 3125, 6250, 12500, 25000, 50000 mg/kg d.w.

Details on test conditions:

formulated sediment (ISO 10872)

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

12 500 mg/kg sediment dw

Nominal / measured:

nominal

Basis for effect:

reproduction

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

6 250 mg/kg sediment dw

Nominal / measured:

nominal

Basis for effect:

reproduction

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 50 000 mg/kg sediment dw

Nominal / measured:

nominal

Basis for effect:

growth rate

Details on results:

Compared to the control (artificial sediment without test item), no inhibitory effect of NaY on growth could be observed up to the highest tested nominal concentration of 50,000 mg/kg dry sediment. Although one-way ANOVA showed a significant difference between the treatments
(p < 0.001; one-way ANOVA [df = 5, F = 7.644]), Games-Howell posthoc test showed no significant different of any treatment to the control (p > 0.05). Thus, for growth the NOEC was calculated as ≥ 50,000 mg/kg dry sediment.
For reproduction, first inhibitory effects compared to the control occurred at a concentration of 12,500 mg/kg dry sediment (p < 0.001; one-way ANOVA [df = 5; F = 7.498], posthoc Dunnett: p < 0.001). Thus, a NOEC of 6,250 mg/kg dry sediment could be calculated.
It fits to the calculated discriminatory power for growth and reproduction (%MDD) that (1) no significant effects on growth occurred at % inhibition values ≤ 5%, (2) significant effects on reproduction occurred at % inhibition values ≥ 14%.
No significant dose-response curve could be fitted to the toxicity data.

Validity criteria fulfilled:

yes

Conclusions:

NOECs for growth and reproduction were >= 50,000 and 6,250 mg/kg dry soil, respectively.

Executive summary:

The toxicity of the Alumininosilicate (NaY Zeolite; NaY) via spiked water, sediment and soil was tested with the nematode Caenorhabditis elegans, using the ISO guideline 10872. In spiked sediment, C. elegans’s growth was not affected till the highest concentration (NOEC ≥ 50,000 mg/kg dry sediment), while first effects on reproduction occurred at 12,500 mg/kg dry sediment (NOEC: 6,250 mg/kg dry sediment). ECx-values could not be determined in sediment.

Reference 4

Endpoint:

sediment toxicity: long-term

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Feb. 9-13, 2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Reason / purpose for cross-reference:

reference to same study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

other: ISO 10872

Version / remarks:

2020

Deviations:

no

Remarks:

All validity criteria were met in the controls of all tests.

GLP compliance:

no

Remarks:

As these data are not used to assess extrapolation to humans, a study according to GLP was not regarded as necessary.

Specific details on test material used for the study:

• Chemical name: Alumininosilicate
• Trade name: Köstrolith (X Zeolite)
• Acronym in Report: Kt
• Batch number: 2006090001
• Composition: Aluminosilicate (Al/Si ~ 0.7)
• CAS No.: 1318-02-1
• Purity: 100 %
• Specific Surface Area (BET): not stated
• Grain size (diameter): 3.432 μm

Vehicle:

yes

Remarks:

M9 medium

Details on sediment and application:

Artificial sediment was prepared according to ISO 10872 (20.1.21). All components were stored at room temperature.
Composition:
- 40% (w/w) Quartz sand (0.1-0.4 mm; BayWa; Munich, Germany)
- 30% (w/w) Quartz powder (Millisil W4; Quarzwerke Frechen, Germany)
- 20% (w/w) Al2O3 (purum, p.a.; Fluka; Batch: 437451/1)
- 4.5% (w/w) Fe2O3 (puriss. p.a. ≥99%; Fluka; Batch: 428807/1)
- 0.5% (w/w) Dolomite (Dolomitwerk Jettenberg; Germany)
- 1% (w/w) CaCO3 (Ph Eur; USP; BP, precipitated; Carl-Roth; batch: 14245877)
- 4% (w/w) Peat (untreated, highly decomposed black peat, R.H.P. quality; Klasmann-Deilmann, Geeste, Germany)
The dry components were thoroughly mixed to result in a total amount of 50 g (dry wt) artificial sediment. Analysis of grain size distribution and TOC revealed 41% sand (>63 μm), 54.5% silt (2-63 μm), 4.5% clay (<2 μm) and 2.1% TOC.

0.1 ml M9-medium (ISO 10872; 6 g Na2HPO4 /L, 3 g KH2PO4 /L, 5 g NaCl, 0.25 g MgSO4 7H2O /L) were added to 0.15 g dry sediment to moisten the sediment and to achieve a sediment wet weight of 0.25 g and a water content of 40%.

Test organisms (species):

Caenorhabditis elegans

Details on test organisms:

Strain: N2
Genotype: C. elegans wild type
Source: Caenorhabditis Genetic Centre; University of Minnesota; Minneapolis; MN 55455; USA.
Cultivation: C. elegans were cultivated according to ISO 10872.

Study type:

laboratory study

Test type:

static

Water media type:

freshwater

Type of sediment:

artificial sediment

Limit test:

no

Duration:

96 h

Exposure phase:

total exposure duration

Test temperature:

19.5-20.5 °C

Nominal and measured concentrations:

0, 1563, 3125, 6250, 12500, 25000, 50000 mg/kg d.w.

Details on test conditions:

formulated sediment (ISO 10872)

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

50 000 mg/kg sediment dw

Nominal / measured:

nominal

Basis for effect:

reproduction

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

25 000 mg/kg sediment dw

Nominal / measured:

nominal

Basis for effect:

reproduction

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 50 000 mg/kg sediment dw

Nominal / measured:

nominal

Basis for effect:

growth rate

Details on results:

Compared to the control (artificial sediment without test item), no inhibitory effect of Kt on growth could be observed up to the highest tested nominal concentration of 50,000 mg/kg dry sediment (p > 0.05; one-way ANOVA; df = 6, F = 0.444). Thus, for growth the NOEC was calculated as ≥ 50,000 mg/kg dry sediment.
For reproduction, first inhibitory effects compared to the control occurred at a concentration of 50,000 mg/kg dry sediment (p < 0.05; one-way ANOVA [df = 6; F = 3.481], posthoc Dunnett: p = 0.003). Thus, a NOEC of 25,000 mg/kg dry sediment could be calculated.
It fits to the calculated discriminatory power for growth (%MDD) that no significant effects on growth occurred at % inhibition values ≤ 5%. For reproduction only at the highest concentration, % inhibition clearly exceeded the calculated %MDD values (16 ± 5; max: 23.5). No significant dose-response curve could be fitted to the toxicity data.

Validity criteria fulfilled:

yes

Conclusions:

NOECs for growth and reproduction were >= 50,000 and 25,000 mg/kg dry soil, respectively.

Executive summary:

The toxicity of the zeolite Köstrolith (Kt) via spiked water, sediment and soil was tested with the nematode Caenorhabditis elegans, using the ISO guideline 10872. In spiked sediment, C. elegans’s growth was not affected till the highest concentration (NOEC ≥ 50,000 mg/kg dry sediment), while first effects on reproduction occurred at 50,000 mg/kg dry sediment (NOEC: 25,000 mg/kg dry sediment).

Description of key information

Tests in sediment were conducted with the nematode Caenorhabditis elegans. The NOECs for growth and reproduction ranged between 12500 (type P Zeolite) to >= 50000 (type Y Zeolite, type X Zeolite) and 1563 (type P zeolite) to 25000 (type X zeolite) mg/kg dry sediment, respectively.

No marine water species were tested.

Key value for chemical safety assessment

EC10, LC10 or NOEC for freshwater sediment:

1 563 mg/kg sediment dw

Additional information

Also, a supporting study in two full life-cycles of the Dipteran midge, Paratanytarsus parthenogenica, exposed to concentrations of calcium-exchanged zeolite, indicated minimal effects on hatchability, survival, growth, and reproduction. The NOEC was between 100 and 200 mg/l (NOEC: >= 100 mg/l).