Zinc hexafluorosilicate

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:

other: evidence from degradation product

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

study not according to standard protocol but good quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Study used for that purpose in the EU risk assessment process on zinc (ECB 2008). Culture medium, test water conditions well described and relevant the purpose of classification.

Qualifier:

no guideline followed

Principles of method if other than guideline:

lab designed flow-through test system for testing acute toxicity to daphnia magna.

GLP compliance:

not specified

Analytical monitoring:

yes

Details on sampling:

samples for metal dosage were taken daily

Vehicle:

no

Details on test solutions:

Bristol's algae medium prepared in dechlorinated Montreal city water

Test organisms (species):

Daphnia magna

Details on test organisms:

D. magna culture was obtained from the Arbor Scientific Supply house, Port credit, Ontario.

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Hardness:

100 mg CaCO3

Test temperature:

20°C

pH:

6.95

Nominal and measured concentrations:

nominal concentrations ranging between 10.6 and 450.9 µg/l

Details on test conditions:

flow-through design

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

800 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mortality

Details on results:

results after 48 hrs exposure are reported

Reported statistics and error estimates:

dosage-mortality curves at 48 hrs were used to define the LC50. goodness-of fit was tested with chi-square test.

Validity criteria fulfilled:

yes

Conclusions:

good quality study for use in derivation of the reference acute aquatic toxicity

Executive summary:

Tests done to check the effects of different metals and their combinations on Daphnia magna. Only results on zinc were used for this analysisi. Tests not done according to standard protocol, (lab-designed flow-through test), but of good quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Study used for that purpose in the EU risk assessment process on zinc (ECB 2008). Culture medium, test water conditions well described and relevant the purpose of classification. LC50 values: see “results” section.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

other: evidence from degradation product

Adequacy of study:

other information

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Tests done according to standard protocol. Good quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Study used for that purpose in the EU risk assessment process on zinc (ECB 2008). Culture medium, test water conditions well described and relevant the purpose of classification.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

Remarks:

tests run over 96 hrs; results after 48 hrs are reported. Tests carried out at different hardnesses, see results.

GLP compliance:

not specified

Analytical monitoring:

yes

Details on sampling:

duplicate samples were taken at the start and the end of the experiment, and acidified with HNO3

Vehicle:

no

Details on test solutions:

synthetic inorganic medium and varying hardness (see below)

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnids were fed daily with Chlorella vulgaris

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

soft water: 46 mg CaCO3/l
moderately hard water: 91 mg CaCO3/l
hard water: 179 mg CaCO3/l

Test temperature:

20+/-0.5 °C

pH:

softw ater: 7.2
moderately hard water: 7.7
hard water: 8.1

Nominal and measured concentrations:

results expressed as measured concentrations

Details on test conditions:

tests at different hardnesses

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

259 µg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: Clone C; low hardness

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

1 060 µg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: Clone C; moderate hardness

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

962 µg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: Clone C; high hardness

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

131 µg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: Clone A; low hardness

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

457 µg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: Clone A; moderate hardness

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

601 µg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: Clone A; high hardness

Reported statistics and error estimates:

LC50 values were determined using probit analysis with a maximum likelihood procedure. Only LC50 values with 95% CI <50% of the mean were used.

Validity criteria fulfilled:

yes

Conclusions:

high quality study, results considered useful for derivation of the aquatic toxicity reference value for classification

Executive summary:

Study on the effect of genetic variability on zinc toxicity response in standard testing. Tests done according to standard protocol. Good quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Culture medium, test water conditions well described and relevant the purpose of classification. Study not considered in the EU risk assessment. LC50 values: see results section.

Reference 3

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

other: evidence from degradation product

Adequacy of study:

disregarded due to major methodological deficiencies

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

study not according to standard protocol but good quality . Study used for PNEC derivation (NOEC values) in the EU risk assessment process on zinc (ECB 2008). Culture medium, test water conditions well described but not relevant the purpose of classification.However, Results of the Belanger and Cherry 1990 study were obtained in natural waters, so, in accordance to the approach taken in the riks assessment zinc (ECB 2008), not considered useful for setting the reference value for acute aquatic toxicity.

Qualifier:

no guideline followed

Principles of method if other than guideline:

lab-designed dose response test

GLP compliance:

not specified

Analytical monitoring:

yes

Details on sampling:

no details given

Vehicle:

no

Details on test solutions:

tests performed in water from 3 different rivers: New river (Virginia), Amy Bayou river (Louisiana) and Clinch river (Virginia), water 11-µm filtered before use). Background zinc concentration in all three water were less than 20 µg/l (detection limit; Zn measured as acid soluble metal). According to Shiller & Boyle, (1985), the natural dissolved-Zn concentrations in New river, is very low: in the order 0.4 µg/l; of the other rivers, the zinc background is also very low, based on very detailed analysis of similar small rivers in the same area.

Test organisms (species):

Ceriodaphnia dubia

Details on test organisms:

neonates were used, <24, >12 hrs old

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

new river water: 98 mg CaCO3/l
Clinch river: 182 mg CaCO3/l
Amy bayou water: 114 mg CaCO3/l

Test temperature:

no data

pH:

new river water: 8.1
Clinch river: 8.3
Amy bayou water: 8.3

Nominal and measured concentrations:

Measured zinc concentrations not reported separately for each test, but according to the authors measured zinc concentrations were within 15% of nominal concentrations.

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

101 µg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

dissolved

Basis for effect:

mortality

Remarks on result:

other: in new river water pH 8, hardness 98 mg CaCO3/l

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

120 µg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

dissolved

Basis for effect:

mortality

Remarks on result:

other: in Amy Bayou water, pH 8, hardness 114 mg CaCO3/l

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

123 µg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

dissolved

Basis for effect:

mortality

Remarks on result:

other: clinch river water, pH 8, hardness 182 mg CaCO3/l

Details on results:

only the tests done at pH 8.0 are reported;

Reported statistics and error estimates:

Duncan's multiple range test was empoyed to determine significantly different groups with significance inferred for all tests at a=0.05

Validity criteria fulfilled:

yes

Conclusions:

Tests done according to standard protocol. Good quality but not considered useful for setting the reference value for acute aquatic ecotoxicity, since obtained in natural waters, according to the zinc risk assessment (ECB 2008).

Executive summary:

Tests not done according to standard protocol, but of good quality. Results not considered useful for setting the reference value for acute aquatic ecotoxicity, in accordance to the approach, followed in the risk assessment zinc. Study was used for the purpose of PNEC setting (NOECs) in the EU risk assessment process on zinc (ECB 2008). Culture medium, test water conditions well described but not relevant the purpose of classification. LC50 values: see “results” section.

Reference 4

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

other: evidence from degradation product

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

study not according to standard protocol but good quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Study used for that purpose in the EU risk assessment process on zinc (ECB 2008). Culture medium, test water conditions well described and relevant the purpose of classification.

Principles of method if other than guideline:

dose response test with Daphnia magna in beakers, similar to the later developed standard D. magna chronic test. linear series of concentrations were used for delineating reproductive impairment levels.

GLP compliance:

not specified

Analytical monitoring:

yes

Details on sampling:

sampling at beginning

Vehicle:

no

Details on test solutions:

unfiltered lake Superior water strained through #20 bolting cloth

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnids were 12 +/- 12 hrs old. They originated from a laboratory clone from the university of Michigan.

Test type:

static

Water media type:

freshwater

Limit test:

no

Hardness:

45.3 mg CaCO3/l

Test temperature:

not reported for acute test but chronic test performed at 18°C

pH:

7.7

Dissolved oxygen:

near saturation at all times

Nominal and measured concentrations:

nominal concnetrations: 25,50,100,125,200 µg/l;
corresponding measured concnetrations: 35,52,105,125,208 µg/l

Details on test conditions:

tests were run both with and without food additions. Both results were considered.

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

100 µg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

dissolved

Basis for effect:

mortality

Remarks on result:

other: result obtained without food

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

280 µg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

dissolved

Basis for effect:

mortality

Remarks on result:

other: result obtained with food

Details on results:

Two different results, obtained without and with food, respectively

Reported statistics and error estimates:

results were said to be statistically evaluated but no information was further reported

Validity criteria fulfilled:

yes

Conclusions:

results considered useful for derivation of the aquatic toxicty reference value for classification

Executive summary:

Study on the short term and long trem toxicity of zinc to daphnia magna. Tests not done according to standard protocol, but of good quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Study result (without food) used for that purpose in the EU risk assessment process on zinc (ECB 2008). Culture medium, test water conditions well described and relevant the purpose of classification. LC50 values: see “results” section.

Reference 5

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

other: evidence from degradation product

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Tests done according to standard protocol. Good quality and considered useful for assessing acute aquatic ecotoxicity. Culture medium, test water conditions well described and relevant.

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

Remarks:

Daphtoxkit T

GLP compliance:

not specified

Analytical monitoring:

yes

Details on test solutions:

tests were done in artificial water and 6 natural river waters.

Test organisms (species):

Daphnia magna

Details on test organisms:

origin: Daphtoxkit T

Test type:

static

Water media type:

freshwater

Total exposure duration:

48 h

Hardness:

Ca++ in natural waters varied between 124 and 58 mg/l; artificial medium CaCl2.2H20: 294mg/l

Test temperature:

20°C

pH:

pH of natural waters varied between 7.5 and 8.2, artificial water: 7.8

Nominal and measured concentrations:

Zn background of natural waters baried between 1.4 and 3.1 mg (total)/l

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

1.4 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: artificial water

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

1.8 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: river 1

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

2 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: river 2

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

1.6 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: river 3

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

2.5 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: river 4

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

1.4 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: river 5

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

1.7 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: river 6

Validity criteria fulfilled:

yes

Conclusions:

Tests done according to standard protocol. Good quality and considered useful for assessing acute aquatic ecotoxicity.

Executive summary:

Standard Daphnia magna testing to check the effect of ZnO nanoparticles. This study record contains the results on the ZnSO4 control (see results table)

Reference 6

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

other: evidence from degradation product

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Tests done with standardised toxkit. Good quality and considered useful for assessing acute aquatic ecotoxicity. Culture medium, test water conditions well described and relevant.

Qualifier:

no guideline available

Principles of method if other than guideline:

test according to standardised "Protoxkit F"

GLP compliance:

not specified

Analytical monitoring:

yes

Details on test solutions:

tests were done in artificial water and 6 natural river waters.

Test organisms (species):

other aquatic crustacea: Tetrahymena thermophila

Details on test organisms:

Protoxkit F, 2 replicates

Test type:

static

Water media type:

freshwater

Total exposure duration:

24 h

Hardness:

Ca++ in natural waters varied between 124 and 58 mg/l; artificial medium CaCl2.2H20: 294mg/l

Test temperature:

30°C

pH:

pH of natural waters varied between 7.5 and 8.2, artificial water: 7.8

Nominal and measured concentrations:

Zn background of natural waters baried between 1.4 and 3.1 mg (total)/l

Details on test conditions:

The substance was added to the food substrate suspension in the test medium. While a normal proliferating protozoan culture clears the substrate suspension in 24hrs, inhibition of growth is reflected by residual turbidity measured by optical density at 440nm.

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

7.1 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

dissolved

Basis for effect:

other: growth inhibition

Remarks on result:

other: artificial water

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

21.1 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

dissolved

Basis for effect:

other: growth inhibition

Remarks on result:

other: river 2

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

18.6 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

dissolved

Basis for effect:

other: growth inhibition

Remarks on result:

other: river 4

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 22 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

dissolved

Basis for effect:

other: growth inhibition

Remarks on result:

other: river 5

Validity criteria fulfilled:

yes

Conclusions:

Tests done on standardised toxkit.Good quality and considered useful for assessing acute aquatic ecotoxicity.

Executive summary:

Standardised toxkit test on Tetrahymena thermophila to check the effect of ZnO nanoparticles. This study record contains the results on ZnSO4 control (see results table)

Reference 7

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

other: evidence from degradation product

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Tests done on standardised toxkit. Good quality and considered useful for assessing acute aquatic ecotoxicity. Culture medium, test water conditions well described and relevant.

Qualifier:

no guideline available

Principles of method if other than guideline:

test done with "Thamnotoxkit F"

GLP compliance:

not specified

Analytical monitoring:

yes

Details on test solutions:

tests were done in artificial water and 6 natural river waters.

Test organisms (species):

other aquatic crustacea: Thamnocephalus platyurus

Details on test organisms:

origin: Thamnotoxkit T

Test type:

static

Water media type:

freshwater

Total exposure duration:

24 h

Hardness:

Ca++ in natural waters varied between 124 and 58 mg/l; artificial medium CaCl2.2H20: 294mg/l

Test temperature:

25°C

pH:

pH of natural waters varied between 7.5 and 8.2, artificial water: 7.8

Nominal and measured concentrations:

Zn background of natural waters baried between 1.4 and 3.1 mg (total)/l

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

0.22 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

dissolved

Basis for effect:

mortality

Remarks on result:

other: artificial water

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

0.92 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

dissolved

Basis for effect:

mortality

Remarks on result:

other: river 1

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

1.6 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

dissolved

Basis for effect:

mortality

Remarks on result:

other: river 2

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

0.61 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

dissolved

Basis for effect:

mortality

Remarks on result:

other: river 3

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

0.75 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

dissolved

Basis for effect:

mortality

Remarks on result:

other: river 4

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

1.1 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

dissolved

Basis for effect:

mortality

Remarks on result:

other: river 5

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

1.7 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

dissolved

Basis for effect:

mortality

Remarks on result:

other: river 6

Validity criteria fulfilled:

yes

Conclusions:

Tests done according to standard protocol. Good quality and considered useful for assessing acute aquatic ecotoxicity.

Executive summary:

Standardised thamnotoxkit test on Thanocephalus platyurus to check the effect of ZnO nanoparticles. This study record contains the results on the ZnSO4 control (see results table)

Reference 8

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

other: evidence from degradation product

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

study not according to standard protocol but good quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Study used for that purpose in the EU risk assessment process on zinc (ECB 2008). Culture medium, test water conditions well described and relevant the purpose of classification.

Qualifier:

no guideline followed

Principles of method if other than guideline:

lab-designed dose -response test along the lines of later developed standard test protocols

GLP compliance:

not specified

Analytical monitoring:

not specified

Vehicle:

no

Details on test solutions:

dechlorinated tap water

Test organisms (species):

Daphnia pulex

Details on test organisms:

Daphnia were fed 5 to 10 ml of a fine suspension of trout chow at the start of the 48 hrs period.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

45 mg CaCO3/l

Test temperature:

different test temperatures were used: 5,10,15,20,25°C
results from 20°C were used, as in the risk assessment analysis (ECB 2008)

pH:

7.5

Dissolved oxygen:

6mg/l

Nominal and measured concentrations:

no data

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

500 µg/L

Nominal / measured:

nominal

Conc. based on:

dissolved

Basis for effect:

mortality

Details on results:

According to OECD guidelines, and in accordance with the data used in the EU risk assessment (ECB 2008), results obtained at 20°C are reported. tests were also performed at other temperatures;

Reported statistics and error estimates:

LC50 values were obtained by probit analysis using the statistical analysis system

Validity criteria fulfilled:

yes

Conclusions:

results considered useful for derivation of the aquatic toxicity reference value for classification

Executive summary:

Tests not done according to standard protocol, but along the lines of later developed standard test protocols. Test of good quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Study used for that purpose in the EU risk assessment process on zinc (ECB 2008). Culture medium, test water conditions well described and relevant the purpose of classification. LC50 values: see “results” section.

Reference 9

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

other: evidence from degradation product

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

study not according to standard protocol but good quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Study used for that purpose in the EU risk assessment process on zinc (ECB 2008). Culture medium, test water conditions well described and relevant the purpose of classification.

Qualifier:

no guideline followed

Principles of method if other than guideline:

lab-designed dose -response test along the lines of later developed standard test protocols

GLP compliance:

not specified

Analytical monitoring:

not specified

Vehicle:

no

Details on test solutions:

dechlorinated tap water

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnia were fed 5 to 10 ml of a fine suspension of trout chow at the start of the 48 hrs period.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

45 mg CaCO3/l

Test temperature:

different test temperatures were used: 5,10,15,20,25°C
results from 20°C were used, as in the risk assessment analysis (ECB 2008)

pH:

7.5

Dissolved oxygen:

6mg/l

Nominal and measured concentrations:

no data

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

280 µg/L

Nominal / measured:

nominal

Conc. based on:

dissolved

Basis for effect:

mortality

Details on results:

According to OECD guidelines, and in accordance with the data used in the EU risk assessment (ECB 2008), results obtained at 20°C are reported. tests were also performed at other temperatures;

Reported statistics and error estimates:

LC50 values were obtained by probit analysis using the statistical analysis system

Validity criteria fulfilled:

yes

Conclusions:

results considered useful for derivation of the aquatic toxicity reference value for classification

Executive summary:

Tests not done according to standard protocol, but along the lines of later developed standard test protocols. Tests of good quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Study used for that purpose in the EU risk assessment process on zinc (ECB 2008). Culture medium, test water conditions well described and relevant the purpose of classification. LC50 values: see “results” section.

Reference 10

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

other: evidence from degradation product

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

study not according to standard protocol but good quality and data obtained in contyrol water considered useful for setting the reference value for acute aquatic ecotoxicity. Culture medium, control test water conditions well described and relevant the purpose of classification.

Qualifier:

no guideline followed

Principles of method if other than guideline:

lab-designed dose response test along the lines of later standard cladoceran test protocols

GLP compliance:

not specified

Analytical monitoring:

yes

Details on sampling:

US EPA approved procedures were used for sampling (not further detailed)

Vehicle:

no

Details on test solutions:

tests were performed in
a) lake superior water (control) and
b) different natural waters taken from Naugatuck river (US). only the results obtained in synthetic waters were used
Zinc background: (total concentration)

Test organisms (species):

Ceriodaphnia dubia

Details on test organisms:

laboratory stock C. dubia were used from the US EPA environmental research mlab, Duluth, Minnesota culture unit (maintained in lake superior water). organisms were <4hrs old

Test type:

static

Water media type:

freshwater

Limit test:

no

Hardness:

(as CaCO3/l): reference water: 52
water 1: 36
water 5: 68

Test temperature:

22-28°C

pH:

ref water: 7.7
water 1: 7.5
water 5: 7.5

Nominal and measured concentrations:

not detailed

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

169 µg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

dissolved

Basis for effect:

mortality

Remarks on result:

other: results obtained in control water

Details on results:

Only results obtained in water with non-increased ambient zinc background are reported. For the acute toxicity reference database, only the result in control water (Lake Superior) is used, according to the approach followed in the RA (ECB 2008). The data obtained in natural waters are not used. they are:
Duration Endpoint Effect conc. Nominal/Measured Conc. based on Basis for effect Remarks (e.g. 95% CL)

48 h LC50 165 µg/L meas. (not specified) dissolved mortality result on water 1, test 1
48 h LC50 145 µg/L meas. (not specified) dissolved mortality result on water 1, test 2
48 h LC50 194 µg/L meas. (not specified) dissolved mortality result on water 5

Reported statistics and error estimates:

the trimmed Spearman-Karber method was used for estimating median LC50.one way analysis of variance and Dunett's procedure was used for comparing all treatments with a control (p=0.95) to identify significant differences.

Validity criteria fulfilled:

yes

Conclusions:

Tests done according to standard protocol. Good quality and result obtained in Lake superior water considered useful for setting the reference value for acute aquatic ecotoxicity.

Executive summary:

Tests not done according to standard protocol, but along the lines of later standard cladoceran test protocols. Tests of good quality and data obtained in control water (Lake Superior) considered useful for setting the reference value for acute aquatic ecotoxicity, in accordance to the approach followed in the EU risk assessement (ECB 2008). Culture medium, test water conditions well described and relevant the purpose of classification. LC50 values: see “results” section.

Reference 11

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

other: evidence from degradation product

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Tests done according to standard protocol. Good quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Study used for PNEC derivation in the EU risk assessment process on zinc (ECB 2008). Culture medium, test water conditions well described and relevant the purpose of classification.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

Remarks:

different hardnesses were applied within acceptable boundaries

Principles of method if other than guideline:

lab-designed dose response test

GLP compliance:

not specified

Analytical monitoring:

yes

Details on sampling:

2 samples for metal analysis were taken at the start and the end of the test. One sample was filtered over a 0.45µm mesh

Vehicle:

no

Details on test solutions:

Culture and test medium: well water with parent (ambient) hardness of 22-60 mg/l (as CaCO3), adjusted to nominal hardness of 100 and 200 by adding CaSO4, MgCl2.2H2O, NaHCO3, and KHCO3, to achieve medium-hard and hard water with an average ionic composition as medium hard and hard types of natural (North American) waters. these conditions are also relevant for EU waters.

Test organisms (species):

Daphnia magna

Details on test organisms:

Separate cultures were maintained at each water hardness, so it appears that the animals were acclimated to the hardness of the water before testing

Test type:

static

Water media type:

freshwater

Limit test:

no

Hardness:

variable, as indicated in results section

Test temperature:

19.5°C at 54 hardness
19.8°C at 105 hardness
20.4 at 196 hardness

pH:

variable, as indicated in results section

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

330 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: at hardness 54 mg CaCO3/l, pH 7.6

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

530 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: at hardness 105 mg CaCO3/l, pH 8.1

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

660 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: at hardness 196 mg CaCO3/l, pH 8.2

Reported statistics and error estimates:

no statistics reported

Validity criteria fulfilled:

yes

Conclusions:

Tests not done according to standard protocol., but good quality and considered useful for setting the reference value for acute aquatic ecotoxicity.

Executive summary:

Tests not done according to standard protocol, but following protocol similar of OECD 202. Tests of good quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Study used for the purpose of PNEC setting (NOEC values) in the EU risk assessment process on zinc (ECB 2008). Culture medium, test water conditions well described and relevant the purpose of classification. LC50 values: see “results” section. Results show decreasing sensitivity when increasing pH and hardness at the same time.

Reference 12

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

other: evidence from degradation product

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Tests done according to standard protocol, but not GLP (article was submitted for publication on 28 April 2008, so tests were done before June 1st 2008, when GLP requirement starts). Good quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Culture medium, test water conditions well described and relevant the purpose of classification.

Qualifier:

according to guideline

Guideline:

other: Environment Canada EPS/RM/11 test guideline for "Biological test method: acute lethality test using Daphnia spp.

Deviations:

yes

Remarks:

physicochemical parameters of the test medium were varied

GLP compliance:

not specified

Analytical monitoring:

yes

Details on sampling:

samples taken prior to testing and after 48hrs.

Vehicle:

no

Details on test solutions:

key parameters from the test solution (pH, hardness, DOC) was varied to check the effect on acute zinc toxicity.

Test organisms (species):

Daphnia pulex

Details on test organisms:

D. pulex originating from Aquatic research Organisms Inc (Hampton, NH) were used. adults were transferred daily to fresh medium and fed a mixture of algae and YTC (yeast, cerrophyl and trout feed). algal food was mixture of 70% Pseudokircherniella subcapitata and 30% Chlorella vulgaris.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

varying between 51 and 241 (as CaCO3 +MgCO3) in mg/l (see results)

Test temperature:

21°C

pH:

varying between 6.32 and 8.01 (see results)

Nominal and measured concentrations:

nominal added varied between 98 and 2943 µg/l. all the zinc in solution was found to be dissolved (mean dissolved was 96.3%). measured total zinc concentrations are reported and considered equal to measured dissolved.

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

105 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: at hardness 51

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

190 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: at hardness 69

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

399 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: at hardness 86

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

321 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: at hardness 104

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

556 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: at hardness 131

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

1 014 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: at hardness 241

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

268 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: at hardness 46

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

399 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: at hardness 81

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

432 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: at hardness 122

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

353 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: at hardness 163

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

615 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: at hardness 224

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

425 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: at pH 6.32

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

765 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: at pH 7.28

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

687 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: at pH 8.01

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

523 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: at Na+ 0.1mM

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

399 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: at Na+ 0.56mM

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

706 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: at Na+1.17mM

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

399 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: at K+0.01mM

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

477 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: at K+ 0.12mM

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

392 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: at K+ 1.39mM

Details on results:

All hardness dependent results were obtained at pH 7.85.
All pH dependent results were obtained at hardness 84
Only results obtained under test conditions within the criteria of pH and hardness set out in the EU risk assessment (ECB 2008) are reported and used.
3 additional EC50 were reported for varying Na+ and K+ conditions, resp., and at constant pH (7.85) and hardness (84).
Results obtained on test waters with natural DOC are not used and reported.

Reported statistics and error estimates:

EC50 values werecalculated using the software programme PROBIT. Lower and upper 95% CI are reported and generally within +/- 40% of mean LC50.

Validity criteria fulfilled:

yes

Conclusions:

Tests done according to standard protocol. Good quality and considered useful for setting the reference value for acute aquatic ecotoxicity.

Executive summary:

Study to develop a biotic ligand model for zonc bioavailability in Daphnia pulex in soft water. Tests done according to standard protocol. Good quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Culture medium, test water conditions well described and relevant the purpose of classification. LC50 values: see “results” section.

Reference 13

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

other: evidence from degradation product

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Tests done according to standard protocol, but not GLP (article was received for publication October 1st 2008). Good quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Culture medium, test water conditions well described and relevant the purpose of classification.

Qualifier:

according to guideline

Guideline:

other: US EPA -821-R-02-012: Methods for measuring the acute toxicity of effluents and receiving waters to freshwater and marine organisms (2002)

Deviations:

no

GLP compliance:

not specified

Analytical monitoring:

yes

Details on sampling:

samples were taken on day 1

Vehicle:

no

Test organisms (species):

other aquatic crustacea: Daphnia carinata

Details on test organisms:

D. carinata originated from the department of environment and conservation, New South Wales, Australia

Test type:

static

Water media type:

freshwater

Limit test:

no

Hardness:

82 mg CaCO2/l

Test temperature:

25.3+/-0.5°C

pH:

7.5+/-0.3

Nominal and measured concentrations:

nominal and measured dissolved concentrations are very similar: nominal added: 0, 12.5, 25, 50, 100, 200, 400, 800 µg Zn/l; average measured: 2, 13.2, 25.5, 52.5, 102,5, 219, 417, 832 µg Zn/l.

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

340 µg/L

Nominal / measured:

meas. (initial)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: 95% C.I. are 263-439 µg Zn/l

Reported statistics and error estimates:

median LC50 values are calculated using the trimmed Spearman-Karber method.

Validity criteria fulfilled:

yes

Conclusions:

Tests done according to standard protocol. Good quality and considered useful for setting the reference value for acute aquatic ecotoxicity.

Executive summary:

Study on the effect of metal mixtures on different daphnids. Te

sts done according to standard protocol. Good quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Culture medium, test water conditions well described and relevant the purpose of classification. Study on effects of mixtures of metals, but result reported is obtained on zinc only. LC50 value: see “results” section.

Reference 14

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

other: evidence from degradation product

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Tests done according to standard protocol, but not GLP (article was received for publication October 1st 2008). Good quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Culture medium, test water conditions well described and relevant the purpose of classification.

Qualifier:

according to guideline

Guideline:

other: US EPA -821-R-02-012: Methods for measuring the acute toxicity of effluents and receiving waters to freshwater and marine organisms (2002)

Deviations:

no

GLP compliance:

not specified

Analytical monitoring:

yes

Details on sampling:

samples were taken on day 1

Vehicle:

no

Test organisms (species):

Ceriodaphnia dubia

Details on test organisms:

C. dubia originated from the Center for ecotoxicology, environment protection authority, New South Wales, Australia

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

82 mg CaCO2/l

Test temperature:

25.3+/-0.5°C

pH:

7.5+/-0.3

Nominal and measured concentrations:

nominal and measured dissolved concentrations are very similar: nominal added: 0, 12.5, 25, 50, 100, 200, 400, 800 µg Zn/l; measured: 2, 13.2, 25.5, 52.5, 102,5, 219, 417, 832 µg Zn/l.

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

174 µg/L

Nominal / measured:

meas. (initial)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: 95% C.I. are 131-232 µg Zn/l

Reported statistics and error estimates:

median LC50 values are calculated using the trimmed Spearman-Karber method.

Validity criteria fulfilled:

yes

Conclusions:

Tests done according to standard protocol. Good quality and considered useful for setting the reference value for acute aquatic ecotoxicity.

Executive summary:

Study on the effect of metal mixtures on different daphnids; Tests done according to standard protocol. Good quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Culture medium, test water conditions well described and relevant the purpose of classification. Study on effects of mixtures of metals, but result reported is obtained on zinc only. LC50 value: see “results” section.

Reference 15

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

other: evidence from degradation product

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Tests done according to standard protocol. Good quality and result obtained under control conditions considered useful for setting the reference value for acute aquatic ecotoxicity. Culture medium, test water conditions well described but natural testwaters considered not relevant for the purpose of classification.

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

Remarks:

tests performed in different natural waters. This is allowed by the OECD 202 protocol

GLP compliance:

not specified

Analytical monitoring:

yes

Details on sampling:

sampling was done at start and end of test

Vehicle:

no

Details on test solutions:

Tests performed in control (synthetic) medium and natural waters from The Netherlands, Belgium and France

Test organisms (species):

Daphnia magna

Details on test organisms:

<24hrs old. Feeding: 8, 16, 24 x 10 to 6th cells /d in week 1

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

variable, as indicated in results section.

Test temperature:

20°C

pH:

variable, as indicated in results

Dissolved oxygen:

no aeration

Nominal and measured concentrations:

control +6 concentrations

Details on test conditions:

10 animals /replicate, 3 replicates

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

2 140 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: in synthetic medium, pH 7.2, hardness 242 CaCO3+MgCO3/l

Details on results:

In accordance with the approach followed in the RA zinc (ECB 2008), only the value obtained in synthetic water is used. Results obtained in natural waters (containing e.g. DOC at different levels) were not used for the final database for setting the reference value for acute ecotoxicity. These data are:

Duration Endpoint Effect conc. Nominal/Measured Conc. based on Basis for effect Remarks (e.g. 95% CL)

48 h EC50 354 µg/L meas. (arithm. mean) dissolved mobility In Brisy water, pH 7.3, hardness 24.3 mg CaCO3+MgCO3/l
48 h EC50 3290 µg/L meas. (arithm. mean) dissolved mobility In Markermeer water, pH 8.0, hardness 180 mg CaCO3+MgCO3/l
48 h EC50 2580 µg/L meas. (arithm. mean) dissolved mobility in Rhine water, pH 8.2, hardness 189 mg CaCO3+MgCO3/l
48 h EC50 1670 µg/L meas. (arithm. mean) dissolved mobility in Voyon water, pH 8.4, hardness 117 mg CaCO3+MgCO3/l

Results obtained under conditions deviating from the relevancy range for OECD 202 are not reported.

Reported statistics and error estimates:

EC50 values were calculated using logistic regression

Validity criteria fulfilled:

yes

Conclusions:

Tests done according to standard protocol. Good quality and result obtained in synthetic control water considered useful for setting the reference value for acute aquatic ecotoxicity.

Executive summary:

Tests done according to standard protocol. Good quality and result obtained in synthtic medium considered useful for setting the reference value for acute aquatic ecotoxicity. Culture medium, test water conditions of control well described and relevant the purpose of classification. LC50 value: see “results” section.

Reference 16

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

other: evidence from degradation product

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Tests done according to standard protocol. Good quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Culture medium, test water conditions well described and relevant the purpose of classification.

Qualifier:

according to guideline

Guideline:

other: US EPA EPA 821-R-02-012. Methods for measuring the acute toxicity of effluents and receiving waters to freshwater and marine organisms, 5th Ed. (2002)

Deviations:

yes

Remarks:

tests were done under varying conditions of pH, hardness, DOC

GLP compliance:

not specified

Analytical monitoring:

yes

Details on sampling:

samples taken at beginning and end of test (48hrs).

Vehicle:

no

Details on test solutions:

US EPA synthetic soft water at pH 7.5-7.7 was used as control for tests at different pH; pH was modified with 2mM MES buffer or 1mM MOPS buffer.

Test organisms (species):

Ceriodaphnia dubia

Details on test organisms:

Ceridaphnia cultures were kept in the center for Ecotoxicology (NSW Australia) laboratories. Cladocerans were fed with Ankistrodesmus sp. and Pseudokircherniella subcapitata (50.000 cells/ml of each species).
tests done on neonates <24hrs old. organisms were not fed during the test.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

tests done at varying hardness; only the tests at low hardness (44 mg CaCO3/l) are considered relevant and reported (other hardness: 374 mg CaCO3/l)

Test temperature:

25+/-1°C

pH:

tests performed at pH 6.5 and 7.5 are relevant for the purpose of classification and reported;

Nominal and measured concentrations:

5 metal concentrations were used + control

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

413 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: 95% C.I. are 388-437 µg/l; test at pH 6.5, hardness 44mgCaCO3/l

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

200 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: 95% C.I. are 186-214 µg/l; test at pH 7.5, hardness 44mg CaCO3/l

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

155 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: 95% C.I. 130-185; test at pH 7.5, hardness 44mg CaCO3/l

Reported statistics and error estimates:

EC50 values calculated with the Trimmed-Spearman-Karber method. Differences between EC50 values determined with a procedure based on the F ratio of Litchfield and Wilcoxon.

tests not considered relevant when performed

-at pH 5.5

-at very high alkalinity/high hardness at pH 8.4

-in presence of DOC

Validity criteria fulfilled:

yes

Conclusions:

Tests done according to standard protocol. Good quality and considered useful for setting the reference value for acute aquatic ecotoxicity.

Executive summary:

Study determined the influence of key water parameters on the acute toxicity of zinc to Ceriodaphnia dubia. Tests done according to standard protocol. Good quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Culture medium, test water conditions well described and relevant the purpose of classification. LC50 values: see “results” section.LC50 of 413 µg Zn/l observed at pH 6.5 is the reference value for classification at this pH.

Reference 17

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

other: evidence from degradation product

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Tests done according to standard protocol. Good quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Study used for that purpose in the EU risk assessment process on zinc (ECB 2008). Culture medium, test water conditions well described and relevant the purpose of classification.

Qualifier:

according to guideline

Guideline:

other: US EPA/600/4-85/013: methods for measuring the acute toxicity of effluents to freshwaterand marine organisms

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

samples taken at beginning and end of the test

Vehicle:

no

Details on test solutions:

charcoal-filtered city of Syracuse tap water, hardness adjusted to 180-200mg CaCO3/l

Test organisms (species):

Ceriodaphnia dubia

Details on test organisms:

no data

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

180-200mg CaCO3/L

Test temperature:

25°C

pH:

8.5

Nominal and measured concentrations:

nominal concentrations 0,0.12,0.22,0.39,0.7,1.22,2.1 mg Zn/l
corresponding measured concentrations: <0.1, <0.1, 0.10, 0.18, 0.53, 0.77, 1.3 mg Zn/l

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

500 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mortality

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

360 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

other: effect parameter not explicitly mentioned

Reported statistics and error estimates:

LC50 and EC50 estimated by computerised versions of the non-parametric Spearman-Karber procedure

Validity criteria fulfilled:

yes

Conclusions:

Tests done according to standard protocol. Good quality and considered useful for setting the reference value for acute aquatic ecotoxicity.

Executive summary:

Tests done according to standard protocol. Good quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Study used for that purpose in the EU risk assessment process on zinc (ECB 2008). Culture medium, test water conditions well described and relevant the purpose of classification. LC50 and EC50 values: see “results” section.

Reference 18

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

other: evidence from degradation product

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Tests done according to standard protocol. Good quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Study used for that purpose in the EU risk assessment process on zinc (ECB 2008). Culture medium, test water conditions well described and relevant the purpose of classification.

Qualifier:

according to guideline

Guideline:

other: US EPA/600/4-85/013: methods for measuring the acute toxicity of effluents to freshwaterand marine organisms

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

samples taken at beginning and end of the test

Vehicle:

no

Details on test solutions:

charcoal-filtered city of Syracuse tap water, hardness adjusted to 180-200mg CaCO3/l

Test organisms (species):

Daphnia magna

Details on test organisms:

no data

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

180-200mg CaCO3/L

Test temperature:

20°C

pH:

8.5

Nominal and measured concentrations:

nominal concentrations 0,0.22,0.34,0.54,0.84,1.26 1.95 mg Zn/l
corresponding measured concentrations: 0.08, 0.22,0.36,0.52,0.82,0.96,1.3 mg Zn/l

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

1 220 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mortality

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

860 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

other: effect parameter not explicitly mentioned

Reported statistics and error estimates:

LC50 and EC50 estimated by computerised versions of the non-parametric Spearman-Karber procedure

Validity criteria fulfilled:

yes

Conclusions:

Tests done according to standard protocol. Good quality and considered useful for setting the reference value for acute aquatic ecotoxicity.

Executive summary:

Tests done according to standard protocol. Good quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Study used for that purpose in the EU risk assessment process on zinc (ECB 2008). Culture medium, test water conditions well described and relevant the purpose of classification. LC50 and EC50 values: see “results” section.

Reference 19

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

other: evidence from degradation product

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

study not according to standard protocol but sufficient quality to be considered useful for setting the reference value for acute aquatic ecotoxicity. Study used for that purpose in the EU risk assessment process on zinc (ECB 2008). Test water conditions sufficiently well described and relevant the purpose of classification. culture conditions of the organisms unknown. Species originally reported as Ceriodaphnia reticulata, but was Ceriodaphnia dubia.

Qualifier:

no guideline followed

Principles of method if other than guideline:

lab-designed dose-response test

GLP compliance:

not specified

Analytical monitoring:

not specified

Details on sampling:

no data

Vehicle:

no

Details on test solutions:

lake Superior water containing 50000-100000 bacterial cells /ml as a food source for the cladoceran

Test organisms (species):

Ceriodaphnia dubia

Details on test organisms:

test organisms were <4 h old
results originally reported for Ceriodaphnia reticulata, but afterwards it was corrected that the species was Ceriodaphnia dubia (EPA 1986)

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

45 mg CaCO3/l

Test temperature:

no data

pH:

7.2-7.4

Dissolved oxygen:

no data

Nominal and measured concentrations:

no data

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

76 µg/L

Nominal / measured:

nominal

Conc. based on:

dissolved

Basis for effect:

not specified

Reported statistics and error estimates:

no data

Validity criteria fulfilled:

yes

Remarks:

with reservation

Conclusions:

Tests not done according to standard protocol. Impossible to assess quality and relevancy because of lack of data. In general very limited information. However, test results were considered useful for setting the reference value for acute aquatic ecotoxicity in the RA process (ECB 2008). For this reason, study is also used in the present analysis, with reservation.

Executive summary:

This paper discusses the development of a chronic Ceriodaphnia test.

The acute tests are only given in the margin and poorly described. Results are listed for 13 substances. Tests not done according to standard protocol. Description of test set up and test conditions minimal. Culture medium not given, so impossible to assess relevancy of the medium for the purpose of classification. Species identification was changed from Ceriodaphnia reticulata to C. dubia. Test however considered as useful for setting the reference value for acute aquatic ecotoxicity in the EU RA (ECB 2008). Test water conditions sufficiently described and relevant the purpose of classification. LC50 values: see “results” section. Acute LC50 also reported in the paper for other cladoceran species, showing no difference in sensitivity to zinc.

Reference 20

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

other: evidence from degradation product

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

study not according to standard protocol but sufficient quality to be considered useful for setting the reference value for acute aquatic ecotoxicity. Study used for that purpose in the EU risk assessment process on zinc (ECB 2008). Test water conditions sufficiently well described and relevant the purpose of classification. However, culture conditions of the organisms unknown.

Qualifier:

no guideline followed

Principles of method if other than guideline:

lab-designed dose-response test

GLP compliance:

not specified

Analytical monitoring:

not specified

Details on sampling:

no data

Vehicle:

no

Details on test solutions:

lake Superior water containing 50000-100000 bacterial cells /ml as a food source for the cladoceran

Test organisms (species):

Daphnia magna

Details on test organisms:

test organisms were <24 h old

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

45 mg CaCO3/l

Test temperature:

no data

pH:

7.2-7.4

Dissolved oxygen:

no data

Nominal and measured concentrations:

no data

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

68 µg/L

Nominal / measured:

nominal

Conc. based on:

dissolved

Basis for effect:

not specified

Reported statistics and error estimates:

no data

Validity criteria fulfilled:

yes

Remarks:

with reservation

Conclusions:

Tests not done according to standard protocol. Impossible to assess quality and relevancy because of lack of data. In general very limited information. However, test results were considered useful for setting the reference value for acute aquatic ecotoxicity in the RA process (ECB 2008). For this reason, study is also used in the present analysis, with reservation.

Executive summary:

This paper discusses the development of a chronic Ceriodaphnia test.

The acute tests are only given in the margin and poorly described. Results are listed for 13 substances. Tests not done according to standard protocol. Description of test set up and test conditions minimal. Culture medium not given, so impossible to assess relevancy of the medium for the purpose of classification. Test however considered as useful for setting the reference value for acute aquatic ecotoxicity in the EU RA (ECB 2008). Test water conditions sufficiently described and relevant the purpose of classification. LC50 values: see “results” section. Acute LC50 also reported in the paper for other cladoceran species, showing no difference in sensitivity to zinc.

Reference 21

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

other: evidence from degradation product

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

study not according to standard protocol but sufficient quality to be considered useful for setting the reference value for acute aquatic ecotoxicity. Study used for that purpose in the EU risk assessment process on zinc (ECB 2008). Test water conditions sufficiently well described and relevant the purpose of classification. culture conditions of the organisms unknown.

Qualifier:

no guideline followed

Principles of method if other than guideline:

lab-designed dose-response test

GLP compliance:

not specified

Analytical monitoring:

not specified

Details on sampling:

no data

Vehicle:

no

Details on test solutions:

lake Superior water containing 50000-100000 bacterial cells /ml as a food source for the cladoceran

Test organisms (species):

Daphnia pulex

Details on test organisms:

test organisms were <24 h old

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

45 mg CaCO3/l

Test temperature:

no data

pH:

7.2-7.4

Dissolved oxygen:

no data

Nominal and measured concentrations:

no data

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

107 µg/L

Nominal / measured:

nominal

Conc. based on:

dissolved

Basis for effect:

not specified

Reported statistics and error estimates:

no data

Validity criteria fulfilled:

yes

Remarks:

with reservation

Conclusions:

Tests not done according to standard protocol. Imossible to assess quality and relevancy because of lack of data. In general very limited information. However, test results were considered useful for setting the reference value for acute aquatic ecotoxicity in the RA process (ECB 2008). For this reason, study is also used in the present analysis, with reservation.

Executive summary:

This paper discusses the development of a chronic Ceriodaphnia test.

The acute tests are only given in the margin and poorly described. Results are listed for 13 substances. Tests not done according to standard protocol. Description of test set up and test conditions minimal. Culture medium not given, so impossible to assess relevancy of the medium for the purpose of classification. Test however considered as useful for setting the reference value for acute aquatic ecotoxicity in the EU RA (ECB 2008). Test water conditions sufficiently described and relevant the purpose of classification. LC50 values: see “results” section. Acute LC50 also reported in the paper for other cladoceran species, showing no difference in sensitivity to zinc.

Reference 22

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

other: evidence from degradation product

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Tests done according to standard protocol. Good quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Culture medium, test water conditions well described and relevant the purpose of classification.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

not specified

Analytical monitoring:

yes

Details on sampling:

no details given

Vehicle:

no

Details on test solutions:

M-4 Elendt medium was used for testing

Test organisms (species):

Ceriodaphnia dubia

Details on test organisms:

lab clone of Ceriodaphnia dubia was used that had been successfully cultured in the lab for 5 years. the paper describes the effect of acclimatisation to higher zinc concnetrations before testing; only the results of the non-acclimatised organisms are reported and used.
organisms were fed daily a mixture of (3:1 ratio) the algae Raphidocelis subcapitata and Chlamydomonas Rheinhardtii at a concnetration of 2,5 x 10 to the 6th algal cells/ml

Test type:

static

Water media type:

freshwater

Limit test:

no

Hardness:

280mgCaCO3/l

Test temperature:

24+/-1°C

pH:

7.8

Nominal and measured concentrations:

not mentioned, all results expressed as measured dissolved Zn-concentrations

Details on test conditions:

Elendt M-4 medium

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

670 µg/L

Nominal / measured:

meas. (initial)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: result from the non-acclimatised clone

Details on results:

only the result from the non-acclimatised control clone are reported and used.

Reported statistics and error estimates:

statements of significance were based on accepting p<0.05

Validity criteria fulfilled:

yes

Conclusions:

Tests done according to standard protocol. Good quality and considered useful for setting the reference value for acute aquatic ecotoxicity.

Executive summary:

Study into the development of acclimation to zinc in Ceriodaphnia dubia. Tests done according to standard protocol. Good quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Culture medium, test water conditions well described and relevant the purpose of classification. LC50 values: see “results” section.

Reference 23

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

other: evidence from degradation product

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Tests done according to standard protocol. Good quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Study used for that purpose in the EU risk assessment process on zinc (ECB 2008). Culture medium, test water conditions well described and relevant the purpose of classification.

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

Remarks:

daphnids of different origin (lab-clones and organisms isolated from natural waters) were used. the age of the test organisms from the natural waters was <48hrs.

GLP compliance:

not specified

Analytical monitoring:

yes

Details on sampling:

sampling at end of test. samples were filtered over 0.45µm mesh and acidified with 14N HNO3

Vehicle:

no

Details on test solutions:

standard ISO / TC 147/SC 5 medium

Test organisms (species):

Daphnia magna

Details on test organisms:

Daphnia magna were collected from six pristine natural waters with different physicochemical characteristics in the EU. the organisms from these waters were collected by filtering in the field through a zooplakton net with a maze widht of 80µm. Organisms were identified in the lab using cladoceran keys , and cultured in the lab in their original water conditions.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

250mgCaCO3/l

Test temperature:

20+/-1°C

pH:

7.8

Nominal and measured concentrations:

not indicated

Details on test conditions:

all tests were done under the same standard test conditions.

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

1 833 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: result obtained on the laboratory clone

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

2 909 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: result obtained on D magna isolated from "Markermeer" water

Details on results:

results were also reported for organisms isolated from the "Leuven" water. The zinc background of the reported "Leuven" water was however not determined, therefore the results were not used, to avoid possible effects of acclimatisation to high zinc background.

Reported statistics and error estimates:

statements on significant differences were based on acccepting p<0.05

Validity criteria fulfilled:

yes

Conclusions:

Tests done according to standard protocol. Good quality and considered useful for setting the reference value for acute aquatic ecotoxicity.

Executive summary:

Tests done according to standard protocol. Good quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Culture medium, test water conditions well described and relevant the purpose of classification. EC50 values: see “results” section.

Reference 24

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

other: evidence from degradation product

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Tests done according to standard protocol for D. magna. Good quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Study used for that purpose in the EU risk assessment process on zinc (ECB 2008). Culture medium, test water conditions well described and relevant the purpose of classification.

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

Remarks:

daphnids of different origin (lab-clones and organisms isolated from natural waters) were used. the age of the test organisms from the natural waters was <48hrs.

GLP compliance:

not specified

Analytical monitoring:

yes

Details on sampling:

sampling at end of test. samples were filtered over 0.45µm mesh and acidified with 14N HNO3

Vehicle:

no

Details on test solutions:

standard ISO / TC 147/SC 5 medium

Test organisms (species):

Ceriodaphnia dubia

Details on test organisms:

Ceriodaphnia dubia were collected from six pristine natural waters with different physicochemical characteristics in the EU. the organisms from these waters were collected by filtering in the field through a zzoplacton net with a maze width of 80µm. Organisms were identified in the lab using cladoceran keys , and cultured in the lab in their original water conditions.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

250mgCaCO3/l

Test temperature:

20+/-1°C

pH:

7.8

Nominal and measured concentrations:

not indicated

Details on test conditions:

all tests were done under the same standard test conditions.

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

416 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: result obtained on the laboratory clone

Reported statistics and error estimates:

statements on significant differences were based on acccepting p<0.05

Validity criteria fulfilled:

yes

Conclusions:

Tests done according to standard protocol. Good quality and considered useful for setting the reference value for acute aquatic ecotoxicity.

Executive summary:

Tests done according to standard protocol. Good quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Culture medium, test water conditions well described and relevant the purpose of classification. EC50 values: see “results” section.

Reference 25

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

other: evidence from degradation product

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Tests done according to standard protocol. Good quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Study used for that purpose in the EU risk assessment process on zinc (ECB 2008). Culture medium, test water conditions well described and relevant the purpose of classification.

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

Remarks:

daphnids of different origin (lab-clones and organisms isolated from natural waters) were used. the age of the test organisms from the natural waters was <48hrs.

GLP compliance:

not specified

Analytical monitoring:

yes

Details on sampling:

sampling at end of test. samples were filtered over 0.45µm mesh and acidified with 14N HNO3

Vehicle:

no

Details on test solutions:

standard ISO / TC 147/SC 5 medium

Test organisms (species):

other aquatic crustacea: Ceriodaphnia reticulata

Details on test organisms:

Ceriodaphnia reticulata were collected from six pristine natural waters with different physicochemical characteristics in the EU. the organisms from these waters were collected by filtering in the field through a zooplakton net with a maze width of 80µm. Organisms were identified in the lab using cladoceran keys , and cultured in the lab in their original water conditions.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

250mgCaCO3/l

Test temperature:

20+/-1°C

pH:

7.8

Nominal and measured concentrations:

not indicated

Details on test conditions:

all tests were done under the same standard test conditions.

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

937 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

dissolved

Basis for effect:

mobility

Remarks on result:

other: result obtained on the "Ankeveen" clone

Details on results:

The zinc background of the reported "Leuven" water was within the range accepted for the EU risk assessment (<25µg/l)

Reported statistics and error estimates:

statements on significant differences were based on acccepting p<0.05

Validity criteria fulfilled:

yes

Conclusions:

Tests done according to standard protocol. Good quality and considered useful for setting the reference value for acute aquatic ecotoxicity.

Executive summary:

Tests done according to standard protocol. Good quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Culture medium, test water conditions well described and relevant the purpose of classification. EC50 values: see “results” section.

Reference 26

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

other: evidence from degradation product

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

study not according to standard protocol but sufficient quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Study used for that purpose in the EU risk assessment process on zinc (ECB 2008). Culture medium, critical test water conditions well described, and although having too high hardness,considered relevant the purpose of classification.

Qualifier:

no guideline followed

Principles of method if other than guideline:

lab-designed dose-response test at varying pH and at relatively high hardness conditions.

GLP compliance:

not specified

Analytical monitoring:

yes

Details on sampling:

no data

Vehicle:

no

Details on test solutions:

tests done in very hard reconstituted water at varying pH.

Test organisms (species):

Ceriodaphnia dubia

Details on test organisms:

C. dubia was cultured at at the US EPA laboratory in Duluth (Minnesota. organisms were <48hrs old at start test. Organisms were fed 100µl of yeast-cerophyl (Agri-tech, Kansas city) fermented Purina brand (St. Louis MO) trout chow solution (6mg/l solids).

Test type:

not specified

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

280-300mg CaCO3/l

Test temperature:

25°C

pH:

6-6.5
7-7.5
8-8.5

Dissolved oxygen:

dissolved O2 was never below 5mg/l (60% saturation)

Nominal and measured concentrations:

nominal concentrations and measured concentrations never deviating >10 % from each other

Details on test conditions:

varying pH; tests done in relatively hard water

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 530 µg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

dissolved

Basis for effect:

mortality

Remarks on result:

other: at pH 6-6.5

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

360 µg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

dissolved

Basis for effect:

mortality

Remarks on result:

other: at pH 7-7.5

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

95 µg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

dissolved

Basis for effect:

mortality

Remarks on result:

other: at pH 8-8.5

Reported statistics and error estimates:

median LC50s and corresponding 95%CI were calculated using the trimmed Spearman-karber method.

Validity criteria fulfilled:

yes

Conclusions:

results considered useful for derivation of the aquatic toxicty reference value for classification

Executive summary:

Study on the effects of pH on the zinc toxicity to different aquatic organisms. Tests not done according to standard protocol, but of good quality and considered useful for setting the reference value for acute aquatic ecotoxicity. Study used for that purpose in the EU risk assessment process on zinc (ECB 2008). Culture medium, test water conditions well described and relevant the purpose of classification. LC50 values: see “results” section.

Description of key information

Key data (lowest EC50 values) are: 
-for Ceriodapnia dubia: 0.413 mg Zn/l (single value) at low pH and low hardness
-for Ceriodapnia dubia: >0.53 mg Zn/l (single value) at low pH and high hardness
-for Ceriodapnia dubia: 0.147 mg Zn/l (geomean value) at neutral/high pH and low hardness
-for Ceriodapnia dubia: 0.228 mg Zn/l (geomean value) at neutral/high pH and high hardness

Additional information

The following robust study summary is based on the data presented in the environmental sections of this dossier and adresses solely zinc, zinc oxide and zinc chloride. The environmental hazards of zinc hexafluorosilicate originate exclusively from the zinc ion. Refer to read-across justification for details.

Many good quality and relevant data for 5 standard species. Tests were done according to standard protocol or equivalent.

Data are grouped per species according to

-pH: low (6 -<7) - neutral/high (7 -8.5)

-and hardness: low/medium (<100mg CaCO3/l) and medium/high (>100 mg CaCO3/l).

Ceriodaphnia dubia is for all test conditions the most sensitive species.