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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 701-365-5 | 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
Link to relevant study record(s)
- Endpoint:
- long-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From: 22. Dec. 1997 To: 24. July 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Guideline study Deficiencies: The tested substance is a precursor of Reactive Black 5 bis-vinyl and hydrolyses in aqueous solution from the bis-ester to the bis-vinyl form. The study was performed by the MOE with test substance of unknown origin. The EC50 in this study was found to be 15.7 mg/L, which is not in accordance with the data from studies with Reactive Black 5 performed with our own test compound. From comparative data for acute toxicity studies with Daphnia magna with Reactive Black 5 from Hoechst and from Aldrich, we know that the EC50 is strongly dependent on the supplier of the material. Whereas with the Hoechst substance the EC50 was >800 mg/L, the EC50 was between 25 and 50 mg/L with the Aldrich substance, and the immobile daphnids were found on the surface of the test vessels. This is most likely due to the surface active properties of the test substance. In addition, in the MOE study, the control group showed a mortality rate of 20 %, which raised doubts on the validity of the study. The NOEC of 1.25 mg/L is due to an effect on reproduction. The study was performed at concentrations of 20.0, 10.0, 5.00, 2.50 and 1.25 mg/L. At 5 and 2.5 mg/L, the reproduction rate was statistically significantly increased, therefore, the NOEC was set to 1.25 mg/L. However, this effect could be caused by the same surface active effect as the higher mortality rate with the Aldrich substance.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 211 (Daphnia magna Reproduction Test)
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 20.0, 10.0, 5.00, 2.50 and 1.25 mg/L
- Sampling days: 0, 1, 11, 12, 18 and 19
- Sampling: from one replicate per concentration: three times before and three times after water exchange
- Sample storage conditions before analysis: - - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
The necessary amount of the test substance was added and stirred in the dilution water, and a stock solution at a concentration of 200 mg/L was prepared. The test solutions were prepared by mixing the necessary amount of the stock solution with the dilution water for respective concentration areas, and then divided into each test vessel. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Water fleas (Daphnia magna)
- Strain/clone: -
- Justification for species other than prescribed by test guideline: -
- Source: Sheffield University in United Kingdom (Sheffield S10 2UQ, United Kingdom)
- Age of parental stock: 2 - 4 weeks
- Feeding during test
- Food type: Chlorella vulgaris
- Amount: 0.1 - 0.2 mgC (organic carbon content)/day per flea
- Frequency: daily
REARING METHOD of Daphnia magna to obtain the juvenile daphnia for this study
Subcultured fleas at 2 - 4 weeks of age were used as the parents for the test organisms. The juvenile fleas were removed at least the previous day of the study when the fleas were matured to give birth. Batches with high mortality, with resting eggs or in which males were observed were not used.
- Water for rearing: Diluted water
- Rearing density: 10 – 30 fleas/800 mL of rearing water
- Water temperature: 19 to 21 °C
- Lighting: Room light, 16-hour lighting/8-hour darkness
- Feed: Single cell green algae (Chlorella vulgaris); Green algae culture solution was centrifuged, followed by substitution to diluted water to feed the fleas.
- Feeding amount: Chlorella vulgaris at 0.1 - 0.2 mgC (organic carbon content)/day per flea was given. According to the growth stages of fleas, the feed amount was changed within this range. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 21 d
- Remarks on exposure duration:
- June 18, 1998 - July 9, 1998
- Post exposure observation period:
- -
- Hardness:
- 27.6 - 38.2 mgCaCO3/L
- Test temperature:
- 20.3 - 20.7 °C
- pH:
- 7.4 - 7.8
- Dissolved oxygen:
- 7.6 - 8.7 mg/L
- Salinity:
- NA
- Nominal and measured concentrations:
- Nominal: 20.0, 10.0, 5.00, 2.50 and 1.25 mg/L (common ratio: 2.0) and a control area
At the time of preparation of the test solution, the ratio of the measured concentrations of the test substance to nominal values accounted for 85.2 - 95.7 % whereas the counterpart one day later (before water exchange) was 58.3 - 76.0 %. - Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Type: 100 mL beaker
- Fill volume: 80.0 mL per vessel
- Renewal rate of test solution (frequency/flow rate): daily
- No. of organisms per vessel: 1
- No. of vessels per concentration (replicates): 10
- No. of vessels per control (replicates): 10
TEST MEDIUM / WATER PARAMETERS (see attachment)
- Source/preparation of dilution water: Dechlorinated tap water (Kurume city water treated with active carbon to remove residual chlorine, etc with sufficient aeration) was used. When the dilution water was employed, it was confirmed that the residual chlorine concentration was not more than 0.02 mg/L by the ortho-tolidine method
- Metals: see attachment "Dilution water parameters"
- Pesticides: see attachment "Dilution water parameters"
- Chlorine: < 0.01
- Alkalinity: 28.5 mg/L
- Conductivity: 142 µs/cm
- Culture medium different from test medium: -
- Water quality measurement: The water temperature, dissolved oxygen concentration, pH and hardness were determined in all the test areas (per test vessel) six times (three times before and after water exchange) during the exposure period.
OTHER TEST CONDITIONS
- Adjustment of pH: -
- Photoperiod: 16-hour lighting/8-hour darkness
- Light intensity: not more than 1,200 lux
- Temperature of the test water: 19 to 21 °C
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Observation of Daphnia:
- Parent Daphnia: The survival numbers, the immobilization numbers, the size and the conditions were macroscopically observed compared to the control area every day. The dead parent Daphnia was removed after counting.
- Reproduced juvenile: The number of live or dead juvenile as well as the occurrence of dormant eggs were observed every day. After counting, the juvenile was removed. The date of the first reproduction of juvenile was recorded.
ESTABLISHMENT OF THE TEST CONCENTRATION
Based on the 48-hour EiC50 (>1,000 mg/L) obtained by the acute immobilization test and the result of preliminary test conducted prior to this study, the test concentration was determined to be 20.0 mg/L as the maximum concentration, with 5 concentration areas (20.0, 10.0, 5.00, 2.50 and 1.25 mg/L) with the common ratio of 2.0. For the control, a control area with use of only the dilution water was prepared. - Reference substance (positive control):
- not specified
- Duration:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 1.25 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: based on increased number of juveniles
- Duration:
- 21 d
- Dose descriptor:
- LC50
- Effect conc.:
- 15.7 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- immobilisation
- Remarks on result:
- other: 10.5 - 38.9 mg/L
- Duration:
- 21 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 2.5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: based on increased number of juveniles
- Duration:
- 21 d
- Dose descriptor:
- EC50
- Effect conc.:
- > 20 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Details on results:
- - Mortality of parent animals (cummulative): no statistically significant difference from control
- control: 20 %
- 1.25 and 2.50 mg/L: no deaths
- 5.00 mg/L: 10%
- 10.0 mg/L: 30%
- 20.0 mg/L: 60%
- Mean cumulative number of juveniles:
- control: 176
- 1.25 mg/L: 204
- 2.50 mg/L: 231 - statistically significant difference
- 5.00 mg/L: 234 - statistically significant difference
- 10.0 mg/L: 180
- 20.0 mg/L: 175
- Size and conditions of parent Daphnia:
- 10.0 and 20.0 mg/L: reproduction inhibition
- 20 mg/L: immobilization, attachment of materials on the fleas
- Date of initial deliver:
- Control, 1.25 - 5.00 mg/L: Day 8
- 10.0 mg/L: Day 8.2
- 20.0 mg/L: Day 8.7 - statistically significant difference
- Other biological observations:
- no dormant egg was noted
- dropped eggs were observed in all test areas
- Effect concentrations exceeding solubility of substance in test medium: no - Results with reference substance (positive control):
- NA
- Reported statistics and error estimates:
- Number of dead parent Daphnia and the mortality: Kruskal-Wallis rank sum test and Dunnett multiple comparison test
Date of initial delivery: Kruskal-Wallis rank-sum test and Scheffé’s multiple comparison test: p=0.05
Mean cumulative number of juvenile: One-way layout ANOVA and Scheffé’s multiple comparison test: p = 0.01
Effect concentrations: One-way layout ANOVA and Scheffé’s multiple comparison test): p = 0.01 - Validity criteria fulfilled:
- yes
- Conclusions:
- 1) 50 % lethal concentration for adult daphnids for 21 days (LC50) = 15.7 mg/L (95 % confidence limit: 10.5 - 38.9 mg/L)
2) 50 % reproduction inhibition concentration for 21 days (ErC50) > 20.0 mg/L
3) Maximum no observed effect concentration (NOECr) = 1.25 mg/L
4) Lowest observed effect concentration (LOECr) = 2.50 mg/L - Executive summary:
This test was conducted in accordance with the OECD guideline for testing of chemicals No. 211 “Daphnia magnaReproduction Test” (proposed in April 1997) which is a revised edition of the same guidelines No.202 “Daphnia magna, acute immobilization test and reproduction test” (adopted in April, 1984).
The following results were obtained:
1) 50 % lethal concentration for adult daphnids for 21 days (LC50) = 15.7 mg/L (95 % confidence limit: 10.5 - 38.9 mg/L)
2) 50 % reproduction inhibition concentration for 21 days (ErC50) > 20.0 mg/L
3) Maximum no observed effect concentration (NOECr) = 1.25 mg/L
4) Lowest observed effect concentration (LOECr) = 2.50 mg/L
Reference
Description of key information
50% lethal concentration for adult daphnids for 21 days (LC50) = 15.7 mg/L. 50 % reproduction inhibition concentration for 21 days (EC50) >20.0 mg/L. Maximum no observed effect concentration (NOEC) = 1.25 mg/L. Lowest observed effect concentration (LOEC) = 2.50 mg/L
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 1.25 mg/L
Additional information
In a GLP-compliant Daphnia magna reproduction test, the test substance was assessed according to OECD Guideline 211 (publication from The Environmental Agency of Japan). Daphnia magna were exposed for 21 days to 20.0, 10.0, 5.00, 2.50 and 1.25 mg/L concentration of the test material. The results observed after 21 days were as follows:
1) 50 % lethal concentration for adult daphnids for 21 days (LC50) = 15.7 mg/L
2) 50 % reproduction inhibition concentration for 21 days (EC50) >20.0 mg/L
3) Maximum no observed effect concentration (NOEC) = 1.25 mg/L
4) Lowest observed effect concentration (LOEC) = 2.50 mg/L
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.