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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 262-765-9 | CAS number: 61397-56-6
- 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
Short-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-02-03 to 2017-02-2017
- 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
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Analytical purity: impurities: R036844 3.30%, unknown <0.10%
- Source and lot/batch No.of test material:
* batch: I15DB1648
* test item: 207556/A
- Expiration date of the lot/batch: 2020-04-19 (retest date)
- Purity test date: 2015-05-27 (certificate of analysis release date)
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: solubility in water: <0.05 g/L - Analytical monitoring:
- yes
- Details on sampling:
- - Sampling method: samples for possible analysis were taken form all test concentrations and the control at t=0 and t=48h. 2.0 mL of volume was taken from the approximate centre of the test vessels. At the end of the exposure period, the replicates were pooled at each concentration before sampling
- Sample storage conditions before analysis: the samples were stored in a freezer. Additionally, reserve samples of 2.0 mL were taken for possible analysis - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Due to an expected low water solubility of the test substance saturated solutions (SS) were prepared. The preparation of test solutions started with a loading rate of 100 mg/L applying three days of magnetic stirring at room temperature to ensure maximum dissolution of the test item in the test medium. This resulted in a hazy dispersion that contained undissolved material. The obtained dispersion was filtered through a 0.45 µm membrane filter (Whatman; RC55). The filter was pre-conditioned with a small volume of test solution that was discarded. The resulted Saturated Solution (SS) was used as the highest test concentration. The lower test concentrations were prepared by subsequent dilutions in test medium.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): final test solutions were clear and colourless - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Water-flea
- Source: in-house laboratory culture with a known history
- Age at study initiation (mean and range, SD): <24h (from parental daphnids of more than 2 weeks old)
- Method of breeding: 250 newborn daphnids (i.e. less than 3 days old) are placed into 5 litres of medium in an all-glass culture vessel. Medium is M7. After 7 days of cultivation half of the medium is renewed twice a week.
- Feeding during test: no
- Feeding during cultivation: fresh water algae, daily
ACCLIMATION
- Acclimation period: not relevant - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Hardness:
- 180 mg/L as CaCO3
- Test temperature:
- 19-20°C
- pH:
- At t= 0h: 7.8 - 8.0
At t= 48h: 7.8-7.9 - Dissolved oxygen:
- At t= 0h: 8.6-8.7
At t= 48h: 9.2 - Salinity:
- not relevant
- Conductivity:
- not relevant
- Nominal and measured concentrations:
- Final test
Nominal concentrations: control, 1.0, 10 and 100% of a SS prepared at a loading rate of 100 mg/L
Measured concentrations (mg/L) at t=0h: n.d., 0.018*
Measured concentrations (mg/L) at t=48h: n.d., 0,0040* (22% relative to initial)
* only 0 and 100% SS were analysed. - Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: 100 mL, all-glass filled with 80mL
- Aeration: not during the test
- Type of flow-through (e.g. peristaltic or proportional diluter): no flow-through
- Renewal rate of test solution (frequency/flow rate):no renewal, static system
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
OTHER TEST CONDITIONS
- Photoperiod: 16h light daily
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Immobility was defined as those organisms which are not able to swim within 15 seconds after gentle agitation of the test container and was monitored after 24 and 48 hours of continuous treatment with the test substance.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 10
- Range finding study
- Test concentrations: Twenty daphnids per group (5 per replicate, quadruplicate) were exposed to an untreated control and to the undiluted SS (100 mg/L) in the limit test. In addition, ten daphnids per group (5 per replicate, duplicate) were exposed to solutions containing 1.0 and 10% of the SS prepared at 100 mg/L in the combined range-finding.
- Results used to determine the conditions for the definitive study: Study was a limit test - Reference substance (positive control):
- yes
- Remarks:
- Potassium Dichromate
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% C.L.: not determined
- Details on results:
- - Mortality of control: none
- Other adverse effects control: no
- Abnormal responses: none
Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- EC50/LC50: 48-h EC50 = 0.58 mg/L (with a 95% confidence interval ranging from 0.49 to 0.67 mg/L). The sensitivity of the daphnia was within the range determined with the historical data collected at Charles River Den Bosch. - Reported statistics and error estimates:
- The 24 and 48-h EC50 could not be calculated because no effect was observed at any of the tested concentrations
- Validity criteria fulfilled:
- yes
- Conclusions:
- The acute toxicity of JNJ-16479671-AAA (T001095) to Daphnia magna was determined in a 48-hour static test according to the OECD guideline 202.
The 48-h EC50 exceeded 0.0085 mg/L, being the geometric mean measured concentration in a saturated solution prepared at a loading rate of 100 mg/L. This concentration was considered the maximum soluble concentration in test medium.
In conclusion, the test item T001095 clearly had no toxic effect to Daphnia magna up to the maximum solubility in medium obtained with a loading rate of 100 mg/L. The results of the test can be considered reliable without restriction.
Reference
Description of key information
Based on the guideline study (Tobor-Kaplon, 2016), it is concluded that the 48-h EC50 for the test item, JNJ-16479671 -AAA (T001095) based on geometric mean measured test concentrations, exceeded an average exposure concentration of 0.0085 mg T001095/L (95% CL could not be determined) being the geometric mean measured concentration in a saturated solution prepared at a loading rate of 100 mg/L. In conclusion, the test item T001095 clearly had no toxic effect to Daphnia magna up to the maximum solubility in medium obtained with a loading rate of 100 mg/L. The results of the test can be considered reliable without restriction.
Key value for chemical safety assessment
Additional information
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.