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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

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Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
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.

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
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.

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
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 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.

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
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 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.

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
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 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.

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
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. 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.

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
supporting study
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.

Description of key information

For this endpoint, no data was available for the registered substance. Nevertheless, an experimental study assessing the toxicity of an analogue substance on 2 different aquatic invertebrate species (Daphnia magna and Ceriodaphnia dubia), gave the following results:

- 48h-EC50 = 360 ug/L (Cerodaphnia dubia) and 860 ug/L (Daphnia magna)

- 48h-LC50 = 500 ug/L (Cerodaphnia dubia) and 1220 ug/L (Daphnia magna).

The most conservative value is used as the key ecotoxicity data for this endpoint.

This study was performed according to standard protocol and was of good quality. The extrapolation of the results of this study to the registered substance was considered acceptable.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Effect concentration:
360 µg/L

Additional information

Supporting studies on an analogue substance having the same chemical structure (geometry) were added and gave results in the same order:

- 48h-LC50 between 100 and 800 ug/L (Daphnia magna) and 169 ug/L (Cerodaphnia dubia)

- 48h-EC50 = 670 ug/L (Daphnia magna)