Zeolite, cuboidal, crystalline, synthetic, non-fibrous

Long-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jan. 8-12 and Jan.23-27, 2021

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

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

Test organisms (species):

other: 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.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test temperature:

19.5-20.5 °C

Nominal and measured concentrations:

Test 1: 0, 625, 1250, 2500, 5000, 10000 mg/l
Test 2: 0, 1554, 2020, 2626, 3414, 4438, 5769, 7500, 15000 mg/l

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

1 554 mg/L

Nominal / measured:

nominal

Basis for effect:

growth

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

1 250 mg/L

Nominal / measured:

nominal

Basis for effect:

growth

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

1 554 mg/L

Nominal / measured:

nominal

Basis for effect:

reproduction

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

1 250 mg/L

Nominal / measured:

nominal

Basis for effect:

reproduction

Details on results:

A first test showed that effects of NaY on growth and reproduction mainly occurred between 1,250 mg/l (no significant effect) and 5,000 mg/l (>80% inhibition). Therefore, a second test was performed with more concentration steps in this effect range in order to get a proper dose-response curve and more accurate ECx values.
Compared to the control, first significant inhibitory effect of NaY on nematode growth and reproduction could be observed at nominal concentrations of 1,554 mg/L (p < 0.001; one-way ANOVA [df = 8; growth: F = 58.574; reproduction: 24.651], growth: posthoc Dunnett: p < 0.001; reproduction: posthoc Games-Howell: p < 0.001. Thus, for both toxicity endpoints, a NOEC of 1250 mg/L could be calculated.
If using data of both tests, proper dose-response curves could be established for growth and reproduction, 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 1,755 and 15,437 mg/L, respectively, for growth and 686 and 2303 mg/L, respectively, for reproduction. NOEC and EC10 values matched quite nicely for both toxicity endpoints. The fact that for growth NOEC < EC10 and for reproduction NOEC > EC10, might be explaind by the considerably lower discriminatory power of growth
compared to reproduction.

Validity criteria fulfilled:

yes

Conclusions:

NOECs for growth and reproduction were both 1,250 mg/l.

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 water, NaY inhibited growth or reproduction of C. elegans dose-dependently at concentrations ≥ 1,554 mg/L, with a NOEC at 1,250 mg/L.

Reference 2

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jan. 8-12, 2021

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

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

Test organisms (species):

other: 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.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test temperature:

19.5-20.5 °C

Nominal and measured concentrations:

0, 312.5, 625, 1250, 2500, 5000, 10000 mg/l

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

625 mg/L

Nominal / measured:

nominal

Basis for effect:

growth

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

313 mg/L

Nominal / measured:

nominal

Basis for effect:

growth

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

625 mg/L

Nominal / measured:

nominal

Basis for effect:

reproduction

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

313 mg/L

Nominal / measured:

nominal

Basis for effect:

reproduction

Details on results:

Compared to the control, first significant inhibitory effect of Kt on nematode growth and reproduction could be observed at nominal concentrations of 625 mg/L (p < 0.001; one-way ANOVA [df = 6; growth: F = 88.726; reproduction: 53.376], growth: posthoc Dunnett: p < 0.001;
reproduction: posthoc Games-Howell: p < 0.001). Thus, for both toxicity
endpoints, a NOEC of 313 mg/L could be calculated.
Proper dose-response curves could be established for growth and reproduction, 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 351 and 2,086 mg/L, respectively, for growth and 289 and 777 mg/L, respectively, for reproduction. NOEC and EC10 values matched quite nicely for both toxicity endpoints. Inhibition values at NOEC were very close (growth: 7.4%) or lower (reproduction: 10.5) than the calculated %MDD.

Validity criteria fulfilled:

yes

Conclusions:

NOECs for growth and reproduction were both 313 mg/l.

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 water, Kt inhibited growth or reproduction of C. elegans dose-dependently at concentrations ≥ 625 mg/L, with a NOEC at 313 mg/L.

Reference 3

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jan. 8-12 and Jan. 15-19, 2021

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

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 (Y 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

Test organisms (species):

other: 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.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test temperature:

19.5-20.5 °C

Nominal and measured concentrations:

Test 1: 0, 313, 625, 1250, 2500, 5000 mg/l
Test 2: 0, 62.5, 125, 250, 500, 1000, 2000 mg/l

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

313 mg/L

Nominal / measured:

nominal

Basis for effect:

growth

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

250 mg/L

Nominal / measured:

nominal

Basis for effect:

growth

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

313 mg/L

Nominal / measured:

nominal

Basis for effect:

reproduction

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

250 mg/L

Nominal / measured:

nominal

Basis for effect:

reproduction

Details on results:

A first test showed that strong effects of Zeo on growth and reproduction already occurred at the lowest tested concentration of 313 mg/l (e.g. >70% inhibition of reproduction). Therefore, a second test was performed with lower concentration steps in order to get a proper doseresponse.
Compared to the control, first significant inhibitory effect of Zeo on nematode growth and reproduction could be observed at a nominal concentration of 313 mg/L in the first test (water test 1: p < 0.001; one-way ANOVA [df = 5; growth: F = 92.935; reproduction: 92.739], growth:
posthoc Dunnett: p < 0.001; reproduction: posthoc Games-Howell: p < 0.001) and at a nominal concentration of 500 mg/L in the second test (water test 2: p < 0.001; oneway ANOVA [df = 6; growth: F = 43.102; reproduction: 32.346], growth: posthoc Dunnett: p < 0.001; reproduction: posthoc Games-Howell: p < 0.001). For both toxicity endpoints, a NOEC of 250 mg/L could be calculated (water test 2: growth: posthoc Dunnett: p
= 0.947; reproduction: posthoc Games-Howell: p = 0.846).
If using data of both tests, proper dose-response curves could be established for growth and reproduction. Based on the logistic function that significantly fitted the dose-response curve to the observed toxicity data, EC10 and EC50 values were calculated as 165 and 980 mg/L, respectively, for growth and 142 and 342 mg/L, respectively, for reproduction. NOEC and EC10 values matched quite nicely for both toxicity endpoints. %MDD could properly predict first significant effects of growth and reproduction.

Validity criteria fulfilled:

yes

Conclusions:

NOECs for growth and reproduction were both 250 mg/l.

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 water, Zeo inhibited growth and reproduction of C. elegans dose-dependently at concentrations ≥ 313 mg/L, with a NOEC at 250 mg/L.

Reference 4

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jan. 8-12 and Jan. 15-19, 2021

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

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

Test organisms (species):

other: 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.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test temperature:

19.5-20.5 °C

Nominal and measured concentrations:

Test 1: 0, 313, 625, 1250, 2500, 5000 mg/l
Test 2: 0, 125, 250, 500, 1000, 2000, 4000 mg/l

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

313 mg/L

Nominal / measured:

nominal

Basis for effect:

growth

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

250 mg/L

Nominal / measured:

nominal

Basis for effect:

growth

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

313 mg/L

Nominal / measured:

nominal

Basis for effect:

reproduction

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

250 mg/L

Nominal / measured:

nominal

Basis for effect:

reproduction

Details on results:

A first test showed that strong effects of Syl on growth and reproduction already occurred at the lowest tested concentration of 313 mg/l (e.g. >50% inhibition of reproduction). Therefore, a second test was performed with lower concentration steps in order to get a proper dose-response.
Compared to the control, first significant inhibitory effect of Syl on nematode growth and reproduction could be observed at nominal concentrations of 313 mg/L in the first test (water test 1: p < 0.001; one-way ANOVA [df = 5; growth: F = 121.678; reproduction: 87.683], growth:
posthoc Dunnett: p < 0.001; reproduction: posthoc Games-Howell: p < 0.001) and at a nominal concentration of 500 mg/L in the second test (water test 2: p < 0.001; oneway ANOVA [df = 6; growth: F = 38.116; reproduction: 37.644], growth: posthoc Dunnett: p < 0.001; reproduction: posthoc Games-Howell: p < 0.001). For both toxicity endpoints, a NOEC of 250 mg/L could be calculated (water test 2: growth: posthoc Dunnett: p
= 1.000; reproduction: posthoc Games-Howell: p = 0.532).
If using data of both tests, proper dose-response curves could be established for growth and reproduction. Based on the logistic function that significantly fitted the dose-response curve to the observed toxicity data, an EC10 value was calculated as 215 mg/L for growth and EC10 and EC50 were calculated as 136 and 331 mg/L, respectively, for reproduction. NOEC and EC10 values matched quite nicely for both toxicity endpoints. %MDD could properly predict first significant effects of growth. For reproduction the mean %MDD predicted significant effects already at lower concentrations. However, variance of the reproduction was quite heterogenous between the different treatments (Levene’s test: p = 0.001) leading to a large range range of %MDD values: 7 – 31).

Validity criteria fulfilled:

yes

Conclusions:

NOECs for growth and reproduction were both 250 mg/l.

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 water, Syl inhibited growth and reproduction of C. elegans dose-dependently at concentrations ≥ 313 mg/L, with a NOEC at 250 mg/L.

Reference 5

Endpoint:

long-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Qualifier:

no guideline followed

Principles of method if other than guideline:

21-day test on reproduction, growth and mortality; five concentrations plus control

GLP compliance:

not specified

Specific details on test material used for the study:

Type A Zeolite

Analytical monitoring:

yes

Details on sampling:

Actual test concentrations of zeolite were measured during all partial and full chronic studies with macroinvertebrates and fish by digesting the aluminosilicate to molybdate-reactive silica after APHA.

Test organisms (species):

Daphnia magna

Details on test organisms:

24 ± 12 h old

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

21 d

Hardness:

120 mg/L

pH:

7.3 ± 0.4

Nominal and measured concentrations:

control, 23.6, 36.8, 129.5, 264.3, 415.0 mg/l measured

Reference substance (positive control):

no

Key result

Duration:

21 d

Dose descriptor:

NOEC

Effect conc.:

ca. 130.8 mg/L

Nominal / measured:

meas. (geom. mean)

Basis for effect:

reproduction

Remarks:

also growth, & survival

Remarks on result:

other: calculated form MATC according to Table R.10-1 of the Guidance on information requirements and chemical safety assessment chapter R.10

Key result

Duration:

21 d

Dose descriptor:

other: MATC

Effect conc.:

ca. 185 mg/L

Nominal / measured:

meas. (geom. mean)

Basis for effect:

reproduction

Remarks:

also growth & survival

Remarks on result:

other: geometric mean of 129.5 and 264.3

Duration:

21 d

Dose descriptor:

EC50

Effect conc.:

ca. 214.6 mg/L

Nominal / measured:

meas. (geom. mean)

Basis for effect:

reproduction

Remarks on result:

other: 95% confidence limits: 174.3- 256.2 mg/l

Duration:

96 h

Dose descriptor:

EC50

Effect conc.:

ca. 377.2 mg/L

Nominal / measured:

meas. (geom. mean)

Basis for effect:

reproduction

Remarks on result:

other: 95 % confidence limits: 315.3-464.8 mg/l

Details on results:

The 21-day chronic exposure of the cladoceran, Daphnia magna, was run under continuously mixed conditions to maintain suspensions of zeolite. The results indicated that the compound was essentially nontoxic to this species, normally a highly sensitive indicator of adverse environmental conditions. No effects were observed on survival, growth, or percentage of days reproduction occurred during exposure to suspensions of zeolite less than 129.5 mg/L. The MATC was given as between 129.5 and 264.3 mg/l, with a geometric mean of c. 185 mg/l. According to Table R.10-1 of the Guidance on information requirements and chemical safety assessment chapter R.10 this value has to be divided by the square root of 2 to derive a NOEC, which is c. 130.8 mg/l in the present case.

Probit analyses of the data indicated 50% effect concentrations ranged from 211 mg/L for total young production to 377 mg/ for a 96-h LC50. It is likely that the negative effects on survival and reproduction seen at higher concentrations were due to physical effects of the compound on feeding and motility since these suspensions were extremely turbid.

Validity criteria fulfilled:

not specified

Conclusions:

No effects were observed on survival, growth, or percentage of days reproduction occurred during exposure to suspensions of zeolite less than 129.5 mg/L.

The calculated NOEC is c. 130.8 mg/l.

Executive summary:

A 21-day full chronic test with Daphnia magna was conducted.

Description of key information

No effects were observed on survival, growth, or percentage of days reproduction of daphnia magna occurred during exposure to suspensions of Type A Zeolite less than 129.5 mg/L. The MATC was given as between 129.5 and 264.3 mg/l, with a geometric mean of c. 185 mg/l. According to Table R.10-1 of the Guidance on information requirements and chemical safety assessment chapter R.10 this value was divided by the square root of 2 to derive a NOEC, which is c. 130.8 mg/l.

The lowest NOEC values observed for the reproduction of the nematod C. elegans were 250 mg/l.

No marine water species was tested.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

NOEC

Effect concentration:

ca. 130.8 mg/L