Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 229-861-2 | CAS number: 6790-58-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
[further information is included as attachment to Iuclid section 13]
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the structural similarity between the source and the target substances. Their environmental properties are expected to be similar because of this structural similarity, on common physico-chemical properties and because they are anticipated to follow the same environmental fate.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Refer to the Test material section of the source and target records.
3. ANALOGUE APPROACH JUSTIFICATION
The results of the available reliable data for the source and target substances are identical for biodegradation in water and short-term toxicity to aquatic invertebrates. No acute effects were observed for both compounds up to the attainable limit of solubility in test medium. The similarity of the structural, physico-chemical properties and ecotoxicity profiles between both substances is pronounced. On this basis, it's considered suitable and scientifically justified to read-across the data between the two substances to fill the long-term toxicity to aquatic invertebrate endpoint in the present dossier.
4. DATA MATRIX
See attached document in Iuclid section 13 - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 0.937 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- > 0.937 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Key result
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- > 0.937 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 0.937 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Conclusions:
- Based on data available on the source substance (no adversed chronic toxic effect on the test Daphnia up to the loading rate of 10 mg test item/ L) The NOEC was determined to be greater or equal than 0.937 mg/L and greater than 0.937 mg/L for the LOEC.
- Executive summary:
A Daphnia magna reproduction test (semi-static, 21 d) of the test item Reaction mass of (3aR,5aS,9aS,9bR)-3a,6,6,9a-tetramethyldodecahydronaphthol[2,1-b]furan and (3aS,5aR,9aR,9bS)-3a,6,6,9a- tetramethyldodecahydronaphthol[2,1-b]furan (batch number: 1005059223) was conducted according to OECD 211 (2012) from 2021-04-06 to 2021-05-12, with the definitive exposure phase from 2021-04-21 to 2021-05-12 at Noack Laboratorien.
Test species was Daphnia magna STRAUS. Ten daphnids, held individually, were used per saturated solution and control. At the start of the exposure the daphnids were less than 24 hours old. The study was carried out under semi-static conditions with a daily renewal of the test solutions. Aim of the test was to assess the effects on the reproduction capacity and other test item-related effects or parameters such as the intrinsic rate of the natural increase, the number of broods with living juveniles, first appearance of living juveniles, occurrence of aborted eggs and stillborn juveniles, adult mortality, body length and dry weight of the parental daphnids.
The test was carried out as a limit test with a saturated solution of the test item (prepared with a nominal concentration of 10 mg test item /L), prepared with the test medium Elendt M4. The test was performed under semi-static conditions with a daily renewal of the test solutions in closed bottles without headspace. A limit test design was chosen because no effects on reproduction were expected at the saturated solution level.
The limit test item concentration and the control were analytically verified via GC-MS five times during the test in the fresh media at the start of an exposure-renewal interval (0 hours; on test days 0, 7, 8, 14 and 15) as well as in the old media at the end of an exposure-renewal interval (24 hours; on test days 1, 8, 9, 15 and 16).
The environmental conditions were within the acceptable limits. The validity criteria of the test guideline were met.
The effects on reproduction were evaluated based on the reproduction per female parent animal inserted at the start of the exposure. The effect values for the cumulative offspring per introduced parent are reported.The overall effect threshold for effects of the test item under the test conditions was ≥ 0.937 mg/L (NOEC) and > 0.937 mg/L (LOEC) based on the time weighted mean measured test item concentration.
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 April 2021 to 25 October 2021
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (incl. QA statement) inspected on 12 - 15 November 2019 / signed on 27 August 2020
- Specific details on test material used for the study:
- Dry area, protected from light, in refrigerator (2 - 8 °C), store under
nitrogen in a closed container after first opening - Analytical monitoring:
- yes
- Remarks:
- GC-MS
- Details on sampling:
- The saturated solution and the control were analyzed via GC-MS at 5 times during the test (at least once within a period of 7 days) in the fresh media at the start of an renewal interval (0 hours) as well as in the old media at the end of an renewal interval (24 hours).
The samples were analyzed under GLP with a GC-MS method which has been implemented under non-GLP and documented finally in the GLP raw data. The GC-MS method was validated according to Annex I. For the analytical methods and the results of the method validation see section 14 and Annex I.
At the start of the renewal intervals, samples of the fresh media monitoring were taken after preparation of the saturated solution and analyzed. At the end of the renewal intervals (24 hours), samples of the old media were taken from the test vessels. - Vehicle:
- no
- Details on test solutions:
- A saturated solution with a nominal concentration of 10 mg/L was prepared 24 ± 1 hours before the start of the exposure and each renewal day.
For the saturated solution an appropriate amount of the test item was weighed out and transferred into a glass bottle with an appropriate amount of dilution water (see Table 2). The dispersion was shaken for 24 ± 1 hours (20 rpm, room temperature). The dispersion was removed by siphoning from the middle of the water column and were centrifuged (17000 g for 20 minutes at 20 ± 1 °C) to separate undissolved test item.
The saturated solution was checked via laser beam (Tyndall effect) . No undissolved test item was observed. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna
- Age at study initiation (mean and range, SD):
Less than 24 hours old daphnids from a healthy stock were used for the study. To achieve this juvenile daphnids were removed from the culture vessels at the latest 24 hours before the start of the exposure and discarded. The juveniles born within the following period were used for the test. No first brood progeny was used for the test.
- Method of breeding:
In glass vessels (2 - 3 L capacity) with approximately 1.8 L culture medium, at 20 +/- 2 °C, in an incubator, 16 hours illumination; light intensity of max. 1500 lx
Culture medium: Elendt M4, according to OECD 211,
- Source: Daphnia magna STRAUS, obtained from continuous laboratory cultures. Origin =
Institut für Wasser-, Boden- und Lufthygiene (WaBoLu), 14195 Berlin, Germany.
- Culture feeding: The culture daphnids are fed at least 5 times per week ad libitum with a mix of unicellular green algae, e.g. Pseudokirchneriella subcapitata and Desmodesmus subspicatus,. The algae are cultured at the test facility.
- Feeding during test: Yes. Daily feeding with unicellular green algae, e.g. Pseudokirchneriella subcapitata and Desmodesmus subspicatus, 0.2 mg C / daphnia and day
ACCLIMATION
Acclimatization was not necessary, because the composition of the dilution water is equivalent to the culture medium - Test type:
- semi-static
- Water media type:
- freshwater
- Remarks:
- edium Elendt M4 according to OECD 211
- Limit test:
- yes
- Total exposure duration:
- 21 d
- Hardness:
- The total hardness was above 140 mg/L as CaCO3.
- Test temperature:
- Measured temperature between 20.1 and 20.8°C. The temperature was within the range of 20 ± 2 °C and not vary by more than 2°C.
- pH:
- The pH in the control was between 7,43 and 8.11
The pH in the tested concentration was between 7.49 and 7.92.
Significant deviations ≥ 1.5 units between the initial and final pH-values were not observed. - Dissolved oxygen:
- The dissolved oxygen in the control was between 8.67 and 8.90 at test start and between 7.33 et 7.88 at test end
The pH in the tested cocnentration was between 8.22 and 8.80 at test start and between 7.00 and 8.25 at test end. The dissolved oxygen concentration was above 3 mg/L. - Salinity:
- not applicable
- Conductivity:
- Not reported
- Nominal and measured concentrations:
- nominal concentration : Saturated solution at 10 mg/L
Time weighted mean measured test item concentration : saturated solution 0.937 mg/l - Details on test conditions:
- TEST SYSTEM :
Sealed glass flasks (4.5 (ID) x 9.5 (H) cm) with screw were used and filled up to the top with the test solutions. A test volume of approximately 130 mL was provided in each test vessel.
Test water : Reconstituted water (Elendt M4 medium), as prescribed by OECD Guideline 211
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
TEST CONDITION :
Test temperature (target) The temperature should be in the range of 18 – 22°C and should not vary by more than 2 °C.
Light intensity (target) Max. 1500 lx
Photoperiod 16/8 hours light/dark cycle
Aeration Test vessels were not aerated during the test.
Feeding Daily feeding with unicellular green algae, e.g. Pseudokirchneriella subcapitata and Desmodesmus subspicatus, max. 0.2 mg C / daphnia and day
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Mortality of parental daphnids: The number of parental daphnids, which were immobilized or dying during the test and the dates of death were observed and recorded once a day at least at the same time as the offspring was counted. Dead daphnids were removed as soon as they were detected. Accidental mortality did not occur.
- Offspring Trials were checked daily for first appearance of juveniles. The number of neonates (alive and dead progeny) was counted and the dates of release were recorded once a day from the first day of production of neonates until the end of the exposure. The neonates (alive and dead) were removed after counting and before addition of algae to prevent them from consuming food intended for the adults. The number of aborted eggs or dead offspring and the dates of
observation were recorded. At the end of the test (21 days), the total number of living offspring was assessed.
- Additional observations / condition of parental daphnids: Abnormalities (e.g. swimming behavior, number of males and winter eggs) were observed and recorded on each day of observation.
- Total body length / Mean dry weight of parental daphnids: At the end of the test, the total body length excluding the anal spine of each survived parental daphnid and the mean dry weight of the
survived parental daphnids of all loading rates and the control were determined. As stated in the OECD protocol, this may be useful additional information but is not used for determination of a NOEC.
- Additional endpoints: The time to first brood, the intrinsic rate of population increase and the number and size of first brood per animal were reported, but not used for endpoint calculations. - Reference substance (positive control):
- no
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 0.937 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- > 0.937 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Key result
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- > 0.937 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 0.937 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Details on results:
- The number of juveniles in all replicates of the control and the test group was counted and recorded every day.
The average number of living juveniles at the end of the test after 21 days per survived parental female daphnid was 159 in the control group and thus the validity criterion for the reproduction of a mean of ≥ 60 living offspring per survived parent animal in the control was met.
Accidental and inadvertent mortality as defined in the OECD test guideline were not observed.
The effects on reproduction were evaluated based on the reproduction per female parent animal inserted at the start of the exposure. The effect values for the cumulative offspring per introduced parent are reported.
No statistically significant reduction of the reproductive output in comparison to the reproductive output in the control was determined at the saturated solution (0.937 mg/L). Therefore, the LOEC was determined to be > 0.937 mg/L and the NOEC ≥ 0.937 mg/L for the cumulative offspring per introduced parent. - Results with reference substance (positive control):
- No data
- Reported statistics and error estimates:
- The NOEC and LOEC for the reproduction were determined with the software ToxRat Professional as specified below. Significant differences of reproduction were determined in comparison to the
control using statistical standard procedures as normality test (Shapiro-Wilk’s test), variance homogeneity test (Levene’s test) and a two sample t-test for reproduction. P-values of the normality and the variance homogeneity test were 0.01.
For the effects on reproduction, the juveniles per introduced parent at the end of the test excluding accidental and inadvertent mortality (reproductive output) were counted. Since no accidental or inadvertent mortality was observed, no parental daphnids were excluded from the evaluation of the reproductive output.
The coefficients of variation around the mean number of living offspring produced per introduced parent and per survived parent in the control and the test groups were evaluated. The NOEC and LOEC for the adult mortality were empirically derived from the observed adult mortality data. - Validity criteria fulfilled:
- yes
- Conclusions:
- The overall effect threshold for effects of the test item under the test conditions was ≥ 0.937 mg/L
(NOEC) and > 0.937 mg/L (LOEC) based on the time weighted mean measured test item
concentration. - Executive summary:
A Daphnia magna reproduction test (semi-static, 21 d) of the test item Reaction mass of (3aR,5aS,9aS,9bR)-3a,6,6,9a-tetramethyldodecahydronaphthol[2,1-b]furan and (3aS,5aR,9aR,9bS)-3a,6,6,9a- tetramethyldodecahydronaphthol[2,1-b]furan (batch number: 1005059223) was conducted according to OECD 211 (2012) from 2021-04-06 to 2021-05-12, with the definitive exposure phase from 2021-04-21 to 2021-05-12 at Noack Laboratorien.
Test species was Daphnia magna STRAUS. Ten daphnids, held individually, were used per saturated solution and control. At the start of the exposure the daphnids were less than 24 hours old. The study was carried out under semi-static conditions with a daily renewal of the test solutions. Aim of the test was to assess the effects on the reproduction capacity and other test item-related effects or parameters such as the intrinsic rate of the natural increase, the number of broods with living juveniles, first appearance of living juveniles, occurrence of aborted eggs and stillborn juveniles, adult mortality, body length and dry weight of the parental daphnids.
The test was carried out as a limit test with a saturated solution of the test item (prepared with a nominal concentration of 10 mg test item /L), prepared with the test medium Elendt M4. The test was performed under semi-static conditions with a daily renewal of the test solutions in closed bottles without headspace. A limit test design was chosen because no effects on reproduction were expected at the saturated solution level.
The limit test item concentration and the control were analytically verified via GC-MS five times during the test in the fresh media at the start of an exposure-renewal interval (0 hours; on test days 0, 7, 8, 14 and 15) as well as in the old media at the end of an exposure-renewal interval (24 hours; on test days 1, 8, 9, 15 and 16).
The environmental conditions were within the acceptable limits. The validity criteria of the test guideline were met.
The effects on reproduction were evaluated based on the reproduction per female parent animal inserted at the start of the exposure. The effect values for the cumulative offspring per introduced parent are reported.The overall effect threshold for effects of the test item under the test conditions was ≥ 0.937 mg/L (NOEC) and > 0.937 mg/L (LOEC) based on the time weighted mean measured test item concentration.
Referenceopen allclose all
Validity criteria :
Mortality of the parent animal in the control group should not exceed 20% at the end of the test. No parent animal in the control group died. Actual mortality of the parent animals in the control group was 0%.
The mean number of living offspring produced per survived parent animal at the end of the test was 159 in the control group (required: at least 60 juveniles per survived parental daphnid).
Water quality :
The measured water quality parameters (i.e. pH-value, dissolved oxygen concentration, total water hardness and water temperature) were within the acceptable limits.
pH-Values
Test group
| Fresh | Old | Fresh | Old | Fresh | Old |
Day 0 | Day 1 | Day 7 | Day 8 | Day 14 | Day 15 | |
0.937 mg/l | 7.51 | 7.91 | 7.49 | 7.91 | 7.63 | 7.92 |
Control | 7.47 | 7.99 | 7.45 | 7.95 | 7.57 | 7.99 |
The pH-values should be in the range of 6 – 9. Significant deviations ≥ 1.5 units between the initial and final pH-values were not observed.
Dissolved Oxygen Concentration [mg/L]
Test group
| Fresh | Old | Fresh | Old | Fresh | Old |
Day 0 | Day 1 | Day 7 | Day 8 | Day 14 | Day 15 | |
0.937 mg/l | 8.62 | 8.17 | 8.80 | 8.25 | 8.22 | 7.00 |
Control | 8.67 | 7.37 | 8.90 | 7.88 | 8.79 | 7.33 |
The dissolved oxygen concentration was above 3 mg/L.
Total Hardness [mg/L] as CaCO3
Test group
| Fresh | Old | Fresh | Old | Fresh | Old |
Day 0 | Day 1 | Day 7 | Day 8 | Day 14 | Day 15 | |
0.937 mg/l | 286 | 253 | 232 | 231 | 247 | 248 |
Control | 267 | 252 | 241 | 234 | 253 | 251 |
The total hardness was above 140 mg/L as CaCO3.
Temperature [°C]
Test group
| Fresh | Old | Fresh | Old | Fresh | Old |
Day 0 | Day 1 | Day 7 | Day 8 | Day 14 | Day 15 | |
0.937 | 20.8 | 20.8 | 20.4 | 20.7 | 20.3 | 20.5 |
Control | 20.8 | 20.7 | 20.1 | 20.6 | 20.5 | 20.6 |
The temperature was within the range of 20 ± 2 °C.
Effects on Adult mortality and Reproduction for Surviving Parents
(based on the nominal loading rates of the test item)
Nominal loading rate of the test item (mg/L) | Mean number of offspring per survived parental daphnid | ||
Mean | SD | CV | |
0.937 | 146 | 9.46 | 6.5 |
control | 159 | 21.5 | 13.6 |
Mortality (%) of the Adult Daphnids after 7, 14 and 21 days of exposure
(control: n = 10; test item loading rates: n = 10)
Nominal loading rate of the test item (mg/L) | Adult mortality (%) | ||
7 days | 14 days | 21 days | |
0.937 | 0 | 0 | 0 |
Control | 0 | 0 | 0 |
Intrinsic rates of natural increase
Nominal loading rate of the test item (mg/L) | Mean IR MV±SD | CV (%) |
0.937 Control | 0.399±0.0177 0.434±0.0330 | 4.4 7.6 |
First appearance of living juveniles at the Survived Parental Daphnids in the Individual Groups
Nominal loading rate of the test item (mg/L) | Day of first appearance of living juveniles at the survived parental daphnids in replicate no. | First appearance mean day | |||||||||
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | ||
0.937 Control | 8 8 | 8 8 | 8 8 | 8 8 | 8 8 | 8 7 | 8 8 | 8 7 | 8 9 | 8 8 | 8.0 7.9 |
Total Body Length and Dry Weight of the Survived Parental Daphnids
Nominal loading rate of the test item (mg/L) | Total length of the survived parent animals (mm) Replicate no. | MV (mm) | N | Dry weight (mg) | ||||||||||
1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | Ʃ | MV | |||
0.937 Control | 4.5 5.0 | 4.5 5.0 | 4.5 5.0 | 4.5 5.0 | 4.5 5.0 | 5.0 4.5 | 5.0 5.0 | 4.5 4.5 | 5.0 4.5 | 4.5 5.0 | 4.65 4.85 | 10 10 | 10.5 11.8 | 1.05 1.18 |
N = number of the survived parental female daphnids
Analytical results :
The limit test item concentration and the control were analytically verified via GC-MS five times
during the test in the fresh media at the start of an exposure-renewal interval (0 hours; on test days 0, 7, 8, 14 and 15) as well as in the old media at the end of an exposure-renewal interval (24 hours; on test days 1, 8, 9, 15 and 16).
Sampling date | Day 0 Fresh medium 0 hours | Day 1 Old medium 24 hours | Day 7 Fresh medium 0 hours | Day 8 Old medium 24 hours | ||
Nominal concentration |
| |||||
of the test item [mg/L] | Meas. conc. [mg/L] | Meas. conc. [mg/L] | % | Meas. conc. [mg/L] | Meas. conc. [mg/L] | % |
10.0 | 1.6 | 1.11 | 69 | 0.866 | 0.745 | 86 |
Control | <LOQ | <LOQ
RR: 106% | <LOQ | <LOQ
RR: 99% | ||
QC | RR: 99% | RR: 94% |
Meas. conc. = measured concentration of the test item, enrichment and dilution factors taken into account
% = percent of the initially measured concentration of the test item
LOQ = limit of quantification (0.005 mg/L of the test item)
QC = Quality control
RR = Recovery rate to nominal concentration of LOQ; mean value 106%
Sampling date | Day 08 Fresh medium 0 hours | Day 09 Old medium 24 hours | Day 14 Fresh medium 0 hours | Day 15 Old medium 24 hours | ||
Nominal concentration |
| |||||
of the test item [mg/L] | Meas. conc. [mg/L] | Meas. conc. [mg/L] | % | Meas. conc. [mg/L] | Meas. conc. [mg/L] | % |
10.0 | 1.01 | 0.821 | 81 | 0.770 | 0.714 | 93 |
Control | <LOQ | <LOQ RR: 96% | <LOQ | <LOQ RR: 96% | ||
QC | RR: 99% | RR: 101% |
Sampling date | Day 15 Fresh medium 0 hours | Day 16 Old medium 24 hours |
|
| ||
Nominal concentration |
| |||||
of the test item [mg/L] | Meas. conc. [mg/L] | Meas. conc. [mg/L] | % | Time weighted mean measured concentration | ||
10.0 | 0.925 | 0.845 | 91 | 0.937 | ||
Control | <LOQ | <LOQ RR: 96% | <LOQ |
| ||
QC | RR: 97% |
|
Description of key information
READ - ACROSS OECD Guideline 211, GLP, key study, validity 1:
NOEC reproduction (Daphnia magna) = ≥ 0.937 mg/L based on time weighted mean measured concentrations
LOEC reproduction (Daphnia magna) = > 0.937 mg/L based on time weighted mean measured concentrations
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Dose descriptor:
- NOEC
- Effect concentration:
- >= 0.937 mg/L
Additional information
To assess the long-term toxicity of the target substance to aquatic invertebrates,one key study is available on the source substance (which is the racemic form of the registered/target substance).
The available data (NOACK, 2021) is assessed as the key study and is an experimental study. In this reproduction test with Daphnia magna, the effects on the reproduction capacity and other sub-lethal effects of a saturated solution of the test item (prepared with a nominal concentration of 10 mg test item/ L) were determined at the test facility according to OECD Guideline 211 with GLP compliance. This study was performed over a period of 21 days under semi-static and closed system without headspace, with a daily renewal of the test solutions. The limit test item concentration and the control were analytically verified via GC-MS five times during the test in the fresh media at the start of an exposure-renewal interval (0 hours; on test days 0, 7, 8, 14 and 15) as well as in the old media at the end of an exposure-renewal interval (24 hours; on test days 1, 8, 9, 15 and 16). The effects on reproduction were evaluated based on the reproduction per female parent animal inserted at the start of the exposure. The effect values for the cumulative offspring per introduced parent are reported. The overall effect threshold for effects of the test item under the test conditions was ≥ 0.937 mg/L (NOEC) and > 0.937 mg/L (LOEC) based on the time weighted mean measured test item concentration.
The results of the available reliable data for the source and target substances are identical for biodegradation in water and short-term toxicity to aquatic invertebrates. No acute effects were observed for both compounds up to the attainable limit of solubility in test medium (see ECHA disseminated dossier of the source substance EC#701-326-2). The similarity of the structural, physico-chemical properties and ecotoxicity profiles between both substances is pronounced. On this basis, it's considered suitable and scientifically justified to read-across the data between the two substances to fill the long-term toxicity to aquatic invertebrate endpoint in the present dossier (see IUCLID section 13 for justification).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.