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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 844-009-5 | CAS number: 167173-85-5
- 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
Toxicity to terrestrial arthropods
Administrative data
- Endpoint:
- toxicity to bees: acute oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 213 (Honeybees, Acute Oral Toxicity Test)
- Deviations:
- yes
- Remarks:
- A limit test was conducted in which 48% mortality occurred. The study was terminated and no further full dose-response test was carried out due to inconsistencies related to the solvent.
- GLP compliance:
- yes
- Application method:
- oral
Test material
- Reference substance name:
- (3S,6S,7R,8R)-8-benzyl-3-(3-hydroxy-4-methoxypyridine-2-amido)-6-methyl-4,9-dioxo-1,5-dioxonan-7-yl 2-methylpropanoate
- Cas Number:
- 167173-85-5
- Molecular formula:
- C26H30N2O9
- IUPAC Name:
- (3S,6S,7R,8R)-8-benzyl-3-(3-hydroxy-4-methoxypyridine-2-amido)-6-methyl-4,9-dioxo-1,5-dioxonan-7-yl 2-methylpropanoate
Constituent 1
- Specific details on test material used for the study:
- Substance name: X642188 (a metabolite of XDE-777)
Lot No.: SYN-FS08353-048 (TSN303567)
Purity: 99%
Sampling and analysis
- Analytical monitoring:
- no
Test substrate
- Vehicle:
- yes
- Remarks:
- Sucrose solution and DMSO
Test organisms
- Test organisms (species):
- Apis mellifera
- Animal group:
- Hymenoptera (honeybees)
Study design
- Study type:
- laboratory study
- Limit test:
- yes
- Total exposure duration:
- 48 h
Test conditions
- Test temperature:
- 25°С
- Humidity:
- 40-63%
- Photoperiod and lighting:
- 24 h darkness
- Nominal and measured concentrations:
- 15.0 μg a.i./bee.
- Reference substance (positive control):
- yes
- Remarks:
- dimethoate
Results and discussion
Effect concentrations
- Key result
- Duration:
- 48 h
- Dose descriptor:
- LD50
- Remarks:
- Oral
- Effect conc.:
- > 15 µg per animal
- Nominal / measured:
- nominal
- Conc. based on:
- act. ingr.
- Basis for effect:
- mortality
- Results with reference substance (positive control):
- The LD50 values obtained with the reference item (dimethoate), were within the required ranges. The oral LD50 (24 h) value of the reference item (dimethoate) was calculated to be 0.15 μg a.i./bee.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The LD50 (48 h) was >15.0 μg a.i./bee in the oral toxicity test.
- Executive summary:
In the oral toxicity test the maximum nominal test level of the test substance (15.0 μg a.i./bee) corresponded to an actual intake of exact 15.0 μg a.i./bee. This dose level led to 48 % mortality after 48 hours. 6.0 % mortality occurred in the water control group (50 % w/v sucrose solution = 500 g sucrose/L tap water). 2.0 % mortality occurred in the solvent control group (2.5 % DMSO in 50 % w/v sucrose solution).
Test item induced behavioural effects of a few bees (bees were moribund or affected, apathetic) were observed at all assessments in the oral test.
This study was terminated after the limit test recorded unexpectedly high mortality at the functional solubility maximum. Another study conducted by IBACON (IBACON Project 73133035; DAS Project 120379; completion date: November 29, 2012) shows no mortality at a dose level of 101.9 μg/bee when acetone was used as the solvent (5% acetone, 45% water, 50% sugar). Taken together, this suggests that the enhanced toxicity was attributable to the DMSO.
The oral LD50 (24 h) value of the reference item (dimethoate) was calculated to be 0.15 μg a.i./bee.
The toxicity of the test substance was tested in an acute oral toxicity test on honeybees. The LD50 (48 h) was > 15.0 μg a.i./bee in the oral toxicity 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.