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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 700-936-6 | CAS number: -
- 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
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-06-28 to 2013-07-22
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 148559-52-8 (as free acid)
- IUPAC Name:
- 148559-52-8 (as free acid)
- Details on test material:
- - Name of test material (as cited in study report): Reactive Golden Yellow HF-RN 1331
- Molecular formula: C17H11F2Na2O7S2 (as sodium salt) C17H13F2N7O7S2 (as free acid)
- Physical state: Solid, red to orange powder
- Analytical purity: 100 %
- Purity test date: 2012-10-08
- Lot/batch No.: Kilo 10 & 12
- Expiration date of the lot/batch: 2014-01-17
- Stability under test conditions: Not specified
- Storage condition of test material: Room temperature, protected from light, in original container; since 2013-03-01 additionally under nitrogen
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: Limit test with 100 mg/L.
- Sampling method: The limit concentration of 100 mg/L of the test item and the control were analysed by HPLC-DAD at the start of the exposure intervals (0 h) on days 0, 10, 17 and at the end of the exposure intervals (48 or 72 h) on days 3, 12, 19.
For the analyses at the end of the exposure intervals, separate replicates without algae and daphnids were prepared and stored under test conditions until sampling.
- Sample storage conditions before analysis: All original samples were stored at 6 ± 2 °C. Prepared samples were stored at room temperature (autosampler) until analysis, if necessary.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Agitation. The limit concentration (100 mg/L test item were weighed out) was freshly prepared with dilution water at the start of each exposure interval at every water renewal day.
- Eluate: Dilution water
- Differential loading: 100 mg/L
- Controls: 10 replicates of dilution water without test item
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna STRAUS
- Strain/clone: Clone 5
- Justification for species other than prescribed by test guideline: Daphnia magna STRAUS is recommended in the guideline
- Source: Own breeding (Origin: Institut fuer Wasser- Boden- und Lufthygiene)
- Age of parental stock (mean and range, SD): > 14 days
- Feeding during test
- Food type: Mix of Pseudokirchneriella subcapitata and Desmodesmus subspicatus
- Amount: 0.2 mg C/daphnia per day
- Frequency: renewals 3 times per week
ACCLIMATION
- Acclimation period: 2 h in dilution water
- Acclimation conditions (same as test or not): Same as test
- Type and amount of food: During acclimation the daphnids were not fed
- Feeding frequency: None
- Health during acclimation (any mortality observed): Healthy
METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES: The parent animals were removed from the culture medium and the juveniles collected over a sieve and flushed into fresh medium
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 21 d
- Post exposure observation period:
- Not observed
Test conditions
- Hardness:
- Total Hardness [mg/L] as CaCO3
Nominal
test item
concentration
[mg/L] I F I F I F
Day 0 Day 3 Day 10 Day 12 Day 17 Day 19
2013-06-28 2013-07-01 2013-07-08 2013-07-10 2013-07-15 2013-07-17
100 180 169 160 178 164 150
Control 178 142 174 164 174 190 - Test temperature:
- Temperature [°C]
Nominal
test item
concentration
[mg/L] I F I F I F
Day 0 Day 3 Day 10 Day 12 Day 17 Day 19
2013-06-28 2013-07-01 2013-07-08 2013-07-10 2013-07-15 2013-07-17
100 20.8 21.5 21.2 21.5 22.0 21.6
Control 20.6 21.6 21.5 21.7 21.9 21.6 - pH:
- pH-Values
Nominal
test item
concentration
[mg/L] I F I F I F
Day 0 Day 3 Day 10 Day 12 Day 17 Day 19
2013-06-28 2013-07-01 2013-07-08 2013-07-10 2013-07-15 2013-07-17
100 7.84 8.21 7.85 7.64 7.69 7.55
Control 7.75 8.22 8.42 7.69 7.66 7.59 - Dissolved oxygen:
- Dissolved Oxygen Concentration [mg/L]
Nominal
test item
concentration
[mg/L] I F I F I F
Day 0 Day 3 Day 10 Day 12 Day 17 Day 19
2013-06-28 2013-07-01 2013-07-08 2013-07-10 2013-07-15 2013-07-17
100 8.66 9.09 8.47 7.58 7.83 7.41
Control 8.48 9.37 8.20 8.04 8.21 7.56 - Salinity:
- Not measured, freshwater
- Nominal and measured concentrations:
- Please refer to "Any other information on materials and methods"
- Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): closed with parafilm
- Material, size, headspace, fill volume: 100 mL glass beaker, filled with 50 mL test solution
- Aeration: No
- Renewal rate of test solution (frequency): 3 x per week
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Elendt M4, according to ELENDT (1990), modified to a total hardness of 160 to 180 mg CaCO3/L.
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 h light : 8 h dark per day
- Light intensity: Max. 20 µE*m-2*s-1
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Adult mortality: daily
- Number of juveniles: daily
- Stillborn juveniles and aborted eggs: daily
- Appearance of first brood: on days 9 and 10
- Intrinsic rate of natural increase: test end
- Growth (total length and dry weight): test end
RANGE-FINDING STUDY: None
Based on the results of an acute immobilization test conducted at the test facility (Lab-ID: 130215CA/DAI15440) under static conditions over a period of 48 hours, the definitive reproduction test was carried out as a limit test with the limit concentration of 100 mg/L of the test item Reactive Golden Yellow HF-RN 1331.
- Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
Effect concentrations
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Details on results:
- - Mortality of parent animals:
No adult mortality was observed during the test period of 21 days. In the limit concentration of 100 mg/L and in the control, all parental daphnids survived until the end of the test after 21 days.
- No. of offspring produced per day per female:
No stillborn juveniles or aborted egg were observed in the control. At the limit concentration of 100 mg/L, two aborted eggs were observed during the exposure period of 21 days, which corresponds to 0.2 % and is therefore negligible.
- Body length and weight of parent animals:
The mean dry body weight and total body lengths of all parental daphnids of the limit concentration and the control were determined at the end of the study. The mean dry body weight of the parental daphnids was 0.97 mg per daphnid for the control and 0.83 mg per daphnid for the limit concentration of 100 mg/L.
The mean body length of the parental daphnids was 5.08 mm per daphnid for the control and 5.30 mm per daphnid for the limit concentration.
- Type and number of morphological / behavioural abnormalities: please refer to the respective table
- Time to first brood release or time to hatch:
The first brood was released on days 9 and 10 by all parental daphnids of the control and the limit concentration of 100 mg/L.
At the limit concentration of 100 mg/L and the control, 4 broods were produced by all parental daphnids.
- Presence of males: No males were observed in the control or in the test groups during the test.
- Occurrence of Ephippia (Winter Eggs): No ephippia were observed in the control or in the test groups during the test. - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- Relevant effect levels: EC50 (24 h) = 1.92 (CI 1.74 - 2.11) mg/L - Reported statistics and error estimates:
- The NOEC for the reproduction as well as adult survival was deduced directly from the results.
Significant deviations were determined in comparison to the control using statistical standard procedures as normality test, equal variance test and t-test. Prior to running a t-test, a normality test and an equal variance test were performed. P-values of the normality and equal variance tests were set to 0.05. The -value (acceptable probability of incorrectly concluding that there is a difference) was =0.05. For the determination of significant deviations of the reproduction rates and the intrinsic rates of natural increase, t-test (p = 0.05) was used. The coefficients of variation of living offspring produced per parent were calculated for the control and the limit concentration.
Any other information on results incl. tables
Number of Juveniles in the Control and Test Group after 21 Days
Nominal test item conc. [mg/L] |
No. of parents prod. juv. |
Mean no. of juveniles per parent producing juveniles |
Comparison versus control |
||||||||||||||
Number of living juveniles in replicate no. |
Total no. |
CV |
|||||||||||||||
Inc. |
Stat. |
||||||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
å |
N |
MV ± SD |
[%] |
[%] |
|||
100 |
91 |
85 |
83 |
83 |
94 |
96 |
75 |
85 |
91 |
80 |
863 |
10 |
86 ± |
7 |
8 |
3 |
no |
Control |
93 |
80 |
86 |
84 |
85 |
75 |
82 |
77 |
89 |
84 |
835 |
10 |
84 ± |
5 |
6 |
— |
— |
Mortality [%] of the Adult Daphnids after 7, 14 and 21 Days of Exposure
(n = 10)
Nominal Test Item Concentration |
Adult Mortality [%] |
||
7 days |
14 days |
21 days |
|
100 |
0 |
0 |
0 |
Control |
0 |
0 |
0 |
First Appearance of Living Juveniles and Number of Broods in the Individual Groups
Nominal test item concentration [mg/L] |
Day of first appearance of living juveniles |
First |
Mean |
|||||||||
in replicate no. |
appearance |
number |
||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
mean day |
of broods |
|
100 |
9 |
9 |
10 |
9 |
9 |
9 |
9 |
10 |
9 |
9 |
9.2 |
4 |
Control |
9 |
9 |
9 |
9 |
9 |
9 |
10 |
9 |
9 |
9 |
9.1 |
4 |
Total Body Length and Dry Weight of the Parental Daphnids
Nominal test item concentration [mg/L] |
Total length of the parent animals [mm] |
MV |
N |
Dry weight |
||||||||||
Replicate no. |
||||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
[mm] |
S |
MV |
||
100 |
5.25 |
5.50 |
5.00 |
5.50 |
5.50 |
5.50 |
5.25 |
5.00 |
5.25 |
5.25 |
5.30 |
10 |
8.3 |
0.83 |
Control |
5.25 |
5.00 |
4.75 |
5.00 |
5.25 |
5.25 |
5.00 |
5.00 |
5.00 |
5.25 |
5.08 |
10 |
9.7 |
0.97 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- At the limit concentration of 100 mg/L of the test item Reactive Golden Yellow HF-RN 1331, no biologically or statistically significant effects were determined. Based on the nominal concentration, the No Observed Effect Concentration (NOEC) was 100 mg/L.
- Executive summary:
The Daphnia magna Reproduction Test (Semi-Static, 21 d) was conducted as a limit test with the limit concentration of 100 mg/L of the test item Reactive Golden Yellow HF-RN 1331 (batch number: Kilo 10&12) according to OECD 211 (2008) from 2013-06-28 to 2013-07-22, with the definitive exposure phase from 2013-06-28 to 2013-07-19, at Dr.U.Noack-Laboratorien, Käthe-Paulus-Str. 1, 31157 Sarstedt, Germany.
The test species was Daphnia magna STRAUS (Clone 5). Ten daphnids individually held were used for the limit concentration and the control. At the start of the exposure, the daphnids were 2 to 24 h old. The test methodwas semi-static with renewal of the test solutions three times per week. The aim of the Daphnia Reproduction Test over 21 days was to assess effects on the reproduction capacity and other test item-related effects on parameters such as intrinsic rate of natural increase, occurrence of aborted eggs and stillborn juveniles, time of production of the first brood, adult mortality, dry body weight and length of the parental daphnids.
The limit concentration of the test item Reactive Golden Yellow HF-RN 1331 was analytically verified by HPLC-DAD of samples taken at the start of the exposure intervals on days 0, 10, 17 (0 h) and at the end of the exposure intervals on days 3, 12, 19 (48 or 72 h) of the limit concentration and the control.
The recovery of the limit concentration of the test item at the start of the exposure intervals was in the range of 99 to 102 % of the nominal concentration of 100 mg/L. At the end of the exposure intervals (48 or 72 h), the recovery of the limit concentration of the test item was in the range of 101 to 106 % of the nominal concentration. This demonstrates, that the test item concentration was successfully maintained for the duration of the test. The results given are based on the nominal concentration of 100 mg/L of the test item Reactive Golden Yellow HF-RN 1331.
· The average values of living juveniles per parental daphnidwere 84 for the control and 86 for the limit concentration of 100 mg/L after 21 days. The reproductive output of daphnids in the limit concentration was comparable to the reproductive output of daphnids in the control (t-test, p = 0.05).
· The coefficient of variation of the number of living offspring produced per parent was 6 % for the control and 8 % for the limit concentration of 100 mg/L.
· The intrinsic rates of natural increase (IR) of the surviving parental daphnids accounting for generation time and number of offspring were used for calculation of population growth and maintenance. The intrinsic rates of the limit concentration were comparable to those in the control (t-test, p = 0.05).
· No adult mortality was observed during the test period of 21 days. In the limit concentration of 100 mg/L and in the control, all parental daphnids survived until the end of the test after 21 days.
· The first brood was released on days 9 and 10 by all parental daphnids of the control and the limit concentration of 100 mg/L.
At the limit concentration of 100 mg/L and the control, 4 broods were produced by all parental daphnids.
· The mean dry body weight and total body lengths of all parental daphnids of the limit concentration and the control were determined at the end of the study.
The mean dry body weight of the parental daphnids was 0.97 mg per daphnid for the control and 0.83 mg per daphnid for the limit concentration of 100 mg/L.
The mean body length of the parental daphnids was 5.08 mm per daphnid for the control and 5.30 mm per daphnid for the limit concentration.· No stillborn juveniles or aborted eggs were observed in the control. At the limit concentration of 100 mg/L, two aborted eggs were observed during the exposure period of 21 days, which corresponds to 0.2 % and is therefore negligible.
· No males or ephippia (winter eggs) were observed in the control or in the limit concentration of 100 mg/L.
· Water quality parameters (i.e. pH-value, dissolved oxygen concentration, total water hardness and temperature) were within the acceptable limits.
No biologically significant effect could be determined in the limit concentration of 100 mg/L in comparison to the control.
Summary of all Test Item Related Effects
(Based on the nominal test item concentration of 100 mg/L)
Reactive Golden Yellow HF-RN 1331
Effects
Control
Nominal test item
concentration
100 mg/LSignificant
effect
Mean number of juveniles per producing
parent (Reproduction rate ± SD)84 ± 5
86 ± 7
no1)
Coefficient of variation of the mean number
of juveniles per producing parent6
8
—
Intrinsic rate of natural increase (Mean ± SD)
0.42 ± 0.02
0.42 ± 0.02
no1)
Number of stillborn juveniles and aborted eggs
0
2
—
Appearance of first brood (Mean day ± SD)
9.1 ± 0.3
9.2 ± 0.4
—
Number of broods
4
4
—
Adult mortality after 21 days [%]
0
0
no
Parental
daphnids:Mean dry weight [mg]
0.97
0.83
—
Mean body length [mm] ± SD
5.08 ± 0.17
5.30 ± 0.20
—
NOEC
100 mg/L
In order to prove the validity of the test system and test conditions at the test facility, an acute immobilisation test according to DIN 38412 L 11 is monthly carried out with potassium dichromate as reference item.
The EC50 of the reference item was 1.92 mg/L (95% confidence limits: 1.74 - 2.11 mg/L) after 24 hours and is therefore within the prescribed concentration range of 0.6 - 2.4 mg/L of quality criteria according to AQS P 9/2 (02/2000) for daphnids clone 5 cultured in Elendt M4 medium. The EC50-value of the reference item is also within the recommended range of 0.6 - 2.1 mg/L according to OECD-Guideline 202.
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.