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EC number: 619-372-6 | CAS number: 98730-04-2
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- Initiation date: 24 August 1988, Termination date: 10 October 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
- Objective of study:
- other: assessment of radioactive residues in ruminant tissues, organs and milk following daily dosing of 14C-CGA154281 to dairy goats
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: EPA Pesticide Assessment Guidelines, Subdivision O: series 171-4
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,2-dichloro-1-[(3R)-3-methyl-3,4-dihydro-2H-1,4-benzoxazin-4-yl]ethan-1-one; 2,2-dichloro-1-[(3S)-3-methyl-3,4-dihydro-2H-1,4-benzoxazin-4-yl]ethan-1-one
- EC Number:
- 619-372-6
- Cas Number:
- 98730-04-2
- Molecular formula:
- C11H11Cl2NO2
- IUPAC Name:
- 2,2-dichloro-1-[(3R)-3-methyl-3,4-dihydro-2H-1,4-benzoxazin-4-yl]ethan-1-one; 2,2-dichloro-1-[(3S)-3-methyl-3,4-dihydro-2H-1,4-benzoxazin-4-yl]ethan-1-one
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- other: goat
- Strain:
- not specified
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: At least 2 years
- Weight at study initiation: 34-44 kg
- Fasting period before study: No
- Housing: Individually
- Individual metabolism cages: yes
- Diet: Daily ration of 1.0 kg hay and 1.0 kg of Sweet Goat Feed "B" divided into two and half given at each milking (am and pm)
- Water: Water ad libitum
- Acclimation period: 6 days (acclimatised to metabolism cages and the balling gun 2 days prior to dosing)
ENVIRONMENTAL CONDITIONS
- Temperature: 60-80°F
- Humidity: 54-100%
- Air changes (per hr): Not reported
- Photoperiod: Natural light/dark cycles
IN-LIFE DATES: Not reported
Administration / exposure
- Route of administration:
- oral: capsule
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- PREPARATION OF DOSING CAPSULES: The phenyl 14C-CGA154281 was already contained within the gelatin capsules when supplied
HOMOGENEITY AND STABILITY OF TEST MATERIAL: Characterisation and stability of the test material was the responsibility of the sponsor and is not reported. - Duration and frequency of treatment / exposure:
- up to 28 days (+ 3 day recovery)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.09 mg (equivalent to 0.045 ppm in the feed (2 kg/day).
- No. of animals per sex per dose / concentration:
- 1
- Control animals:
- no
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: Milk, tissues (tenderloin, round muscle, peripheral fat, omental fat, liver, kidneys), blood.
- Time and frequency of sampling: Milk twice daily (am and pm), blood and tissues at sacrifice
- Limits of detection and quantification: <0.0001 ppm (milk), <0.002 ppm (tissues) - Statistics:
- Not applicable
Results and discussion
Main ADME results
- Type:
- other: radiocarbon residues
- Results:
- Residue levels in milk were below detection limit of <0.0001 ppm except day 5 and 7 samples from the goat dosed for 7 days. No radiocarbon residues were measured in any of the tissues sampled post mortem.
Toxicokinetic / pharmacokinetic studies
- Details on distribution in tissues:
- Radiocarbon residue levels in milk were all below the detection limit of <0.0001 ppm except day 5 and 7 samples from the goat dosed for 7 days (0.0002 ppm each). These very low residue levels represented an average of 19 dpm/mL. No radiocarbon residues were measured in any of the tissue or organ samples collected post mortem, as measured at <0.002 ppm detection limit.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
Residue levels in milk were below detection limit of <0.0001 ppm except day 5 and 7 samples from the goat dosed for 7 days (where residues of 0.0002 ppm were detected). No radiocarbon residues were measured in any of the tissues sampled post mortem. - Executive summary:
This study was performed to assess the radiocarbon residues in ruminant tissues organs, and milk resulting from the daily administration of 14C-CGA154281 to dairy goats.
Five lactating goats received a daily radiocarbon dose of 0.09 mg 14C-CGA154218 (equivalent to 0.045 ppm in feed) for up to 28 days. The 14C-CGA154281 dose corresponded to 2.33 µg/kg body weight. The animals were killed approximately 20 h after the final dose. One animal each was dosed for 7, 14, 21, and 28 days, and one animal was dosed for 28 days followed by a 3 day withdrawal from dosing. At necropsy, representative samples of round muscle, tenderloin muscle, liver, kidneys, omental fat, peripheral fat, and blood were collected and frozen.
Milk was collected twice daily (am and pm) and measured. Milk samples were taken pre-dose and on days 1, 3, 5, 7, 14, 21, and 28 and on days 1 and 3 of withdrawal from 28 days dosing. The pm milk was mixed with the following am milk for each sample period.
All tissue samples were homogenized with dry ice, combusted and quantitated by liquid scintillation counting. Milk samples were homogenized by shaking and were quantitated directly in liquid scintillation cocktail. The blood was homogenized by repetitive hand inversion of the bottle, combusted and quantitated.
Residue levels in milk were below detection limit of <0.0001 ppm except day 5 and 7 samples from the goat dosed for 7 days (where residues of 0.0002 ppm were detected). No radiocarbon residues were measured in any of the tissues sampled post mortem.
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