Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 December - 19 December 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: EPA OCSPP 850.1010
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Batch/Lot number: 0008282300
Description: Clear liquid
Purity: 40.9 % in water
Expiry date: 13 July 2021
Storage conditions: Controlled room temperature (15-25 °C, ≤70% relative humidity)
Analytical monitoring:
yes
Details on sampling:
Analytical measurements were performed from the control and at the applied test concentration level at the beginning and at the end of the experiment.
Test samples were kept below -15 °C
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A stock solution with a nominal concentration of 100.0 mg a.i./L was prepared with direct addition of the test item, mixed into the test medium (ISO Medium). As a Limit test was carried out, further dilution of stock solution was not performed.
- Controls: The dilution water (ISO-medium) was used without addition of the test item.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna
- Age at study initiation: < 24 h old at the beginning of the test
- Method of breeding: The Daphnia are bred in Ecotoxicological Laboratory of Charles River Laboratories Hungary Kft. The health of the stock animals is continuously monitored by visual daily checking. Abnormal behaviour or significant decrease of population is recorded.
- Source: István Szent University, 2100 Gödöllő, Páter Károly u. 1, Hungary
- Age of parental stock (mean and range, SD):
- Feeding during test : No

ACCLIMATION
- Acclimation period: There was no acclimatization because the water used was similar to the culture water.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
The reconstituted water (ISO medium) had a total hardness of 248 mg/L (as CaCO3).
Test temperature:
The test temperature was in the range of 20.7 – 20.9°C measured in the test vessels.
pH:
The pH was measured at the start and at the end of the experiment in one test vessel at all concentration levels and was in the range of 7.21 – 7.29.
Dissolved oxygen:
The dissolved oxygen concentration was measured in one test vessel at all concentration levels at the start and at the end of the test and was in the range of 8.2 – 8.5 mg/L.
Salinity:
Not reported
Conductivity:
Not reported
Nominal and measured concentrations:
100 mg a.i./L (nominal)
Details on test conditions:
TEST SYSTEM
- Test vessel: Beaker
- Material: Glass, 50 mL
- Volume of solution: 40 mL test solution/flask
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Biomass loading rate: 8 mL test solution /animal

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water (ISO medium, according to OECD 202) was used as dilution water for both the range finding and definitive tests. The same composition of reconstituted water was used for the tests and for breeding the test animals.

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16-hour light and 8-hour dark cycle
- Light intensity: Not reported

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : The immobility or mortality of the Daphnia was determined by visual observation 24 and 48 hours after the start of the test. Those animals not able to swim within 15 seconds after gentle agitation of the test beaker are considered to be immobile.

VEHICLE CONTROL PERFORMED: no

RANGE-FINDING STUDY
- Test concentrations: 0.1, 1, 10, 100 mg a.i./L
- Results used to determine the conditions for the definitive study: No deaths or immobility were observed at any test concentration in the range-finding study.
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
LOEC
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mobility
Details on results:
- Behavioural abnormalities: none
- Mortality of control: none
- Immobilisation of control: none
- Abnormal responses: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: no
Results with reference substance (positive control):
For the evaluation of the quality of the Daphnia clone and the experimental conditions, Potassium dichromate is tested at least twice a year to demonstrate satisfactory test conditions.
The date of the last study (Study Code: 19/238-023DA) with reference item Potassium dichromate (batch no.: A0345704) is: 05 - 06 September 2019.
The 24h EC50: 0.82 mg/L, (95 % confidence limits: 0.66 – 0.93 mg/L)
Reported statistics and error estimates:
No statistical analysis was performed because of the lack of toxic effects.
The EC50, NOEC, LOEC and EC100 values were determined directly from the raw data.

Measured concentration was 98.53 mg a.i./L at the start and 105.27 mg a.i./L at the end of the experiment.

As the measured concentrations deviated not more than 20 per cent from the nominal, the biological results are based on the nominal concentration.

There were no immobilised animals at 24 or 48 hours in either the control or 100 mg a.i./L test group. In addition to immobility, no abnormal behaviour or appearance of test animals was detected.

Validity criteria fulfilled:
yes
Executive summary:

Acute toxicity of the test item on Daphnia magna was assessed in an acute immobilisation test performed according to OECD TG 202 over an exposure period of 48 hours in a static test system.

Because no toxic response was observed during the preliminary range-finding test, a Limit Test was carried out using only one test concentration (100.0 mg a.i./L) and one control group in the definitive test.

The test concentration was analytically determined at the start and at the end of the experiment. Measured concentration was 98.53 mg a.i./L at the start and 105.27 mg a.i./L at the end of the experiment. As the measured concentration deviated not more than 20 per cent from the nominal, biological results are based on the nominal test item concentration.

Twenty animals, divided into four groups (glass beaker) of five animals each were used at the test concentration and for the control.

All validity criteria were met during this study.

Under the conditions of this Daphnia magna acute immobilisation study the observed endpoints for the effect of the test item were the following:

The 24h and 48h EC50 value: > 100.0 mg a.i./L (nominal)

The 48h EC100 value: > 100.0 mg a.i./L (nominal)

The 48h No-Observed Effect Concentration (NOEC): 100.0 mg a.i./L (nominal)

The 48h Lowest Observed Effect Concentration (LOEC): > 100.0 mg a.i./L (nominal)

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
21 July - 12 August, 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
- Name of test material (as cited in study report): Bio-terge PAS-8S
- Lot/batch No.: 7252329
- Expiration date of the lot/batch: May 2009
- Storage condition of test material: ambient conditions
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
Primary stock solution prepared at 500 mg/L using well water. Mixed by inversion. Aliquots proportionally diluted with well water to give the test solutions. Mixed by inversion.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna
- Source:Wildlife International, Ltd. Cultures, Easton, Maryland 21601, USA
- Method of breeding: 3 adult daphnids used to supply neonates for the test. Held for at least 14 days prior to collection of juveniles for testing and had each produced at least one previous brood. Adults produced an average of at least 3 young/adult/day over the 7-day period prior to the test.
- Feeding during test: no

ACCLIMATION
- Acclimation period: < 24 h
- Acclimation conditions: Neonates cultured in water from same source and at approximately the same temperature as used during the test.

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Post exposure observation period:
not applicable
Hardness:
138 mg/L as CaCO3
Test temperature:
20 +/- 1 deg C
pH:
8.2 - 8.5
Dissolved oxygen:
>= 7.5 mg/L (>= 83 % of saturation)
Salinity:
not applicable
Nominal and measured concentrations:
Nominal: 0, 65, 108, 180, 300, or 500 mg/L, equivalent to 0, 22.75, 37.8, 63, 105, 175 mg AS/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 250 mL glass beakers
- fill volume: 250 mL
- Aeration: No
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Well water. Sand-filteres and aerated. Prior to use, filtered to 0.45 micron and passed through a UV sterilizer to remove fine particles and microrganisms.
- Total organic carbon: < 1 mg C/L
- Alkalinity: 180 mg/L as CaCO3
- Conductivity: 368 uS/cm
- Culture medium different from test medium: no
- Intervals of water quality measurement: no data

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 h light/ 8 h dark
- Light intensity: 310 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mobility - 5, 24 and 48 h

TEST CONCENTRATIONS
- Spacing factor for test concentrations:x1.667
Reference substance (positive control):
no
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
421 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
147.4 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mobility
Details on results:
- Behavioural abnormalities:108 and 180 mg/L - 2 lethargic daphnids in each group at test temination.
- Mortality of control:None
- Other adverse effects control: None
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: no
Results with reference substance (positive control):
not applicable
Reported statistics and error estimates:
Mortality/immobility data analysed using the computer porgram of CE Stephan. Calculated EC50 and 95% confidence interval by probit analysis.
Validity criteria fulfilled:
yes

Description of key information

Acute toxicity to aquatic invertebrates: 48-h EC50 > 100 mg/L (Daphnia magna; OECD TG 202)

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Dose descriptor:
EC50
Effect concentration:
> 100 mg/L

Additional information

Acute toxicity of the test item on Daphnia magna was assessed in an acute immobilisation test performed according to OECD TG 202 over an exposure period of 48 hours in a static test system.

Because no toxic response was observed during the preliminary range-finding test, a Limit Test was carried out using only one test concentration (100.0 mg a.i./L) and one control group in the definitive test.

The test concentration was analytically determined at the start and at the end of the experiment. Measured concentration was 98.53 mg a.i./L at the start and 105.27 mg a.i./L at the end of the experiment. As the measured concentration deviated not more than 20 per cent from the nominal, biological results are based on the nominal test item concentration.

Twenty animals, divided into four groups (glass beaker) of five animals each were used at the test concentration and for the control.

All validity criteria were met during this study.

Under the conditions of this Daphnia magna acute immobilisation study the observed endpoints for the effect of the test item were the following:

The 24h and 48h EC50 value: > 100.0 mg a.i./L (nominal)

The 48h EC100 value: > 100.0 mg a.i./L (nominal)

The 48h No-Observed Effect Concentration (NOEC): 100.0 mg a.i./L (nominal)

The 48h Lowest Observed Effect Concentration (LOEC): > 100.0 mg a.i./L (nominal)