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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 613-953-8 | CAS number: 66603-10-9
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- Version / remarks:
- adopted September 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.1300 (Daphnid Chronic Toxicity Test)
- Version / remarks:
- April 1996
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Cyclohexylhydroxydiazene 1-oxide, potassium salt
- EC Number:
- 613-953-8
- Cas Number:
- 66603-10-9
- Molecular formula:
- C6H11KN2O2
- IUPAC Name:
- Cyclohexylhydroxydiazene 1-oxide, potassium salt
- Test material form:
- liquid
- Details on test material:
- Xyligen 30F is a 30% aqueous solution of K-HDO.
Constituent 1
- Specific details on test material used for the study:
- Name: Xyligen K 30 F
Batch No.: U8456
Purity: 31.4 % in water
Certificate of Analysis Date: July 17, 2001
Aggregate State at RT: liquid
Colour: yellowish-brown
Solubility: in water: miscible up to 10 g/L
Stability: stability during the test period was guaranteed
Storage: in original container, at room temperature, in the dark
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- SAMPLING:
One sample from the freshly prepared stock solutions and duplicate samples from the freshly prepared test media of all test concentrations and the control were taken at the first treatment period (day 0) and at a treatment period in the second and third week (days 10 and 17).
For the determination of the stability of the test item under test conditions respectively the maintenance of the test item concentrations during the test period at three dates (days 3, 12 and 19) a sufficient volume from the freshly prepared test media of all test concentrations and the control were incubated under the same conditions as the test itself, however without food and Daphnia.
One of these three stability control treatments last for 72 hours (weekend), two for 48 hours, corresponding to the different test medium renewal periods.
STORAGE OF THE SAMPLES:
All samples of the nominal test concentrations of 0.39, 3.13 and 50.0 mg/L were analysed directly after sampling. All other test concentrations were stored in a refrigerator. After delivery of the final test report all samples will be discarded.
ANALYSES:
The concentrations of the test item were measured in all duplicate test medium samples from the lowest (0.39 mg/L), a middle (3.13 mg/L) and the highest test concentration (50.0 mg/L). From the control samples, only one of the duplicate samples was analysed from each sampling date.
Test solutions
- Vehicle:
- yes
- Remarks:
- water
- Details on test solutions:
- Test Concentrations: 0.39, 0.78, 1.56, 3.13, 6.25, 12.5, 25.0 and 50.0 mg test item/L, and a control
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
Species: Daphnia magna (Straus), clone 5
Age at Test Start: 6.5 - 20.5 hours old
Sex: Female
Origin: supplied 1997 by the "Umweltbundesamt, lnstitut für Wasser-,Boden-, und Lufthygiene", Berlin, Germany.
Breeding Conditions: The Daphnia are bred in the laboratories of IBACON under similar temperature and light conditions as in the test, and in the same kind of reconstituted water used in the test. The test organisms were not first brood progeny.
Acclimatisation: under test conditions
TEST UNITS
Type and Size: 100 mL glass beakers containing 80 mL test medium
Identification: Each test unit was uniquely identified with study number, treatment and replicate number.
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 21 d
- Post exposure observation period:
- not required
Test conditions
- Hardness:
- Hardness: 2.5 mmol/L (= 250 mg/L) as CaCO3
Alkalinity: 0.9 mmol/L - Test temperature:
- 21 °C
- pH:
- pH 7.7 to 8.5
- Dissolved oxygen:
- at least 8.1 mg/L or higher
- Salinity:
- not mentioned in the test report
- Conductivity:
- not mentioned in the test report
- Nominal and measured concentrations:
- During the test period at the test item concentrations of nominal 3.13 mg/L and 50 mg/L concentrations were measured in the range from 73 % to 108 % of the nominal values. In the mean 94 % and 103 % of nominal were determined. At the lowest test concentration of 0.39 mg/L in the mean 65 % of nominal was determined. However, this test concentration is below the limit of quantification. Under the test conditions the test item was sufficiently stable during the test medium renewal periods of 48 and 72 hours. Since the determined concentrations at the nominal test concentrations of 3.13 and 50 mg/L were well within the range of 80 % to 120 %, all reported results are related to nominal concentrations of the test item.
- Details on test conditions:
- TEST SYSTEM
- Type and Size: 100 mL glass beakers containing 80 mL test medium
- Identification: Each test unit was uniquely identified with study number, treatment and replicate number.
- Type of flow-through (e.g. peristaltic or proportional diluter): semi-static test
- Renewal rate of test solution (frequency/flow rate): the test media of all test concentrations and of the control were renewed on days 3, 5, 7, 9, 12, 14, 16 and 19 of the exposure period (every Monday, Wednesday and Friday). By that, a total of 9 treatments were performed. At these dates the test animals were carefully transferred by glass tubes from the old test vessels into the freshly prepared test media of the corresponding concentrations.
- No. of organisms per vessel: 10 Daphnia per control and test concentration, each in 80 mL test medium
TEST CONDITIONS
Surrounding Type: controlled environment room
pH-Value of Test Water: pH 7.7 - 8.5
Light Intensity: between 390 and 450 lux
Light Regime: 16 h light: 8 h dark
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted Water (Elendt "M4")
- Alkalinity: 0.9 mmol/L
- Culture medium different from test medium: no
- Water Hardness: 2.5 mmol/L (= 250 mg/L) as CaCO3
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Mortality of Adults and Number of Young: The mortality of the test animals and the number of young were recorded each day. Dead animals and offspring were removed at the same times.
- Measurements of pH, Dissolved Oxygen and Water Temperature: The pH-values and dissolved oxygen concentration in the control and all test concentrations were measured at the start and end of each treatment period. The water temperature was measured in one control beaker at the start and end of each treatment period.
- Behaviour of the Test Item in Test Water: The behaviour of the test item in test water was determined at each test medium renewal period in the freshly prepared and old test media of all test concentrations.
TEST CONCENTRATIONS
- Spacing factor for test concentrations:
- Test concentrations: 0.39, 0.78, 1.56, 3.13, 6.25, 12.5, 25.0 and 50.0 mg test item/L. Additionally, a control was tested in parallel (test water without addition of the test item).
- Reference substance (positive control):
- not required
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 1.56 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Key result
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 3.13 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Key result
- Duration:
- 21 d
- Dose descriptor:
- EC50
- Effect conc.:
- 9.7 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Details on results:
- see tables below
- Results with reference substance (positive control):
- not applicable
Any other information on results incl. tables
Number of surviving adult daphnia exposed to test item on day 21:
|
Nominal concentration of Xyligen 30 F (mg/L) |
|||||||
Control |
0.39 |
0.78 |
1.56 |
3.13 |
6.25 |
12.5 |
25.0 |
50.0 |
100 % |
90 % |
80 % |
90 % |
100 % |
100 % |
100 % |
50 % |
10 % |
Total number of alive, young daphnia reproduced by all adults (cumulative values) in % of control on day 21
|
Nominal concentration of Xyligen 30 F (mg/L) |
|||||||
Control |
0.39 |
0.78 |
1.56 |
3.13 |
6.25 |
12.5 |
25.0 |
50.0 |
100 % |
93.7 % |
81.6 % |
89.6 % |
86.4 % |
82.4 % |
50.0 % |
2.4 % |
0.0 % |
Number of alive offspring reproduced per surviving adult within 21 days of exposure (mean reproduction rate)
|
Nominal concentration of Xyligen 30 F (mg/L) |
|||||||
Control |
0.39 |
0.78 |
1.56 |
3.13 |
6.25 |
12.5 |
25.0 |
50.0 |
106.0 |
104.3 |
96.0 |
102.1 |
91.6 |
87.3 |
52.0 |
3.0 |
0.0 |
Toxic Effects: At the LOEC the mean reproduction rate of the surviving test animals was statistically significant lower than in the control. The survival rate of Daphnia magna after 21 days was significantly reduced first at the nominal test concentration of 25 mg test item/L.
Other effects: With the exception of the reported mortality and the reduced reproduction rates, no particular signs of intoxication were observed at the test animals during the test.
Results of controls: In the control, all the daphnia survived until the end of the test. The first young daphnia released from their parent animals were recorded in the control group at the observation on day 8. The mean reproduction rate for each individual daphnia, which survived until the end of the test in the control group was 106 + 13.3 (mean + SD).
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Taking into account the survival rates and the reproduction rates of the test animals, the highest concentration of Xyligen 30 F tested without toxic effects after the exposure period of 21 days (21-days NOEC) was 1.56 mg test item/L. The lowest concentration tested with toxic effects (21-days LOEC) was determined to be 3.13 mg test item/L due to the statistically significantly reduced mean reproduction rate of Daphnia magna at this test concentration.
- Executive summary:
Survival of Adults:
In the control, all Daphnia survived until the end of the test. At the test concentrations of nominal 0.39 and 1.56 mg test item/L 90 % of the Daphnia survived and at the test concentration of 0.78 mg test item/L a survival rate of 80 % was determined. At the three next higher test concentrations of nominal 3.13 to 12.5 mg/L all Daphnia survived until the end of the test. At the nominal concentration of 25 mg test item/L the mortality rate increased to 50 % and at the highest test concentration of nominal 50 mg test item/L, one Daphnia survived until test end.
Thus, the survival rate of Daphnia magna after 21 days was significantly (> 20 %) reduced first at the nominal test concentration of 25 mg test item/L.
Reproduction Rate:
The first young Daphnia released from their parent animals were recorded in the control and the nominal test concentrations up to 6.25 mg/Lat the observation on day 8. At the test concentration of 12.5 mg test item/L first offspring was observed on day 10 and at the test concentration of 25 mg/L on day 14 the first offspring was determined. At the highest concentration tested (50 mg test item/L), no offspring was reproduced.
Reproduction rates were calculated for each individual Daphnia, which survived until the end of the test. The mean reproduction rate of those Daphnia in the control was 106.0 ± 13.3 (mean ± SD) alive offspring per adult. According to the results of a Williams-test (one-sided, a.= 0.05) no significant toxic effect of the test item on the mean reproduction rate was determined up to and including the nominal test concentration of 1.56 mg test item/L. First at the nominal concentration of 3.13 mg test item/L, the mean reproduction rate of surviving Daphnia was statistically significantly reduced to in the mean 86.4 % alive offspring compared to the control. The EC50of the reproduction rate was determined to be 9.7 mg test item/L, with 95 % confidence limits from 4.3 to 54.1 mg/L.
Signs of Intoxication: With exception of the reported mortality and the reduced reproduction rates, no particular signs of intoxication were observed at the test animals during the test.
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.