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EC number: 464-520-3 | CAS number: 189813-45-4
- 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 reproduction
Administrative data
- Endpoint:
- fertility, other
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable study report which meets basic scientific principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
- Principles of method if other than guideline:
- see details in remarks on amterial and methods
- GLP compliance:
- yes
- Remarks:
- BASF AG, Experimental Toxicology and Ecology
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): 520 F-Chlormethyloximether
- Physical state: solid/ dark green
- Analytical purity: 96.8%
- Lot/batch No.: 31196-182
- Storage condition of test material: room temperature
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH
- Age at study initiation: 42 ± 1 days
- Weight at study initiation:
- Housing: 5 per cage
- Diet (e.g. ad libitum): Kliba maintenance diet
- Water (e.g. ad libitum): drinking water (from water bottles)
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: feed
- Details on exposure:
- DIET PREPARATION
- For each concentration, the test substance was weighed out and mixed with a small amount of food. Then corresponding amounts of food, depending on test group, were added to this premix in order to obtain the desired concentrations. Mixing was carried out for about 10 minutes in a laboratory mixer.
- Rate of preparation of diet (frequency): every 4 weeks - Details on mating procedure:
- not done
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Mean values of 520 F-Chlormethyloximether in Kliba lab diet were found to be in the range of 97.7 – 108.2% of the nominal concentration.
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- continously, 7 days/week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 250, 1250 and 5000 ppm (males); 0, 250, 1250 and 2500 ppm (females)
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
16.2, 77.6 and 326.3 mg/kg bw/d (males); 18.3, 93.4 and 191.3 mg/kg bw/d (females)
Basis:
actual ingested
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent no treatment
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- A check for moribund and dead animals was made twice daily on working days and once daily on Saturdays, Sundays and public holidays. If animals were in a moribund state, they were sacrificed and necropsied. All animals were checked daily for any clinically abnormal signs.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: prior to the administration period (day 0) and thereafter at weekly intervals
- The following parameters were examined: abnormal behavior during “handling”, fur, skin, posture, salivation, respiration, activity/arousal level, tremors, convulsions, abnormal movements, impairment of gait, lacrimation, palpebral closure, exophthalmus,feces (appearance/consistency), urine, pupil size
BODY WEIGHT: Yes
- Time schedule for examinations: day 0 (start of the administration period) and thereafter at weekly intervals
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: daily (Group water consumption) - Oestrous cyclicity (parental animals):
- Vaginal smears were prepared for cycle determination in the morning and evaluated according to the timetable. The differentiation was conducted according to the Table 1.
- Sperm parameters (parental animals):
- Parameters examined in [P] male parental generations:
[testis weight, epididymis weight, sperm count in testes, sperm count in epididymides, sperm motility, sperm morphology] - Litter observations:
- not done
- Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals
- Maternal animals: All surviving animals
GROSS NECROPSY
- Gross necropsy consisted of [external and internal examinations including the cervical, thoracic, and abdominal viscera.]
HISTOPATHOLOGY / ORGAN WEIGHTS
The tissues weighed were: Liver, Kidneys, Adrenal glands, Testes, Epididymides, Cauda epididymides, Ovaries, Uterus, Prostate, Seminal vesicles including coagulation glands, Spleen, Brain, Heart, Thymus, Thyroid glands. The following organs or tissues were fixed in 4% formaldehyde solution: All gross lesions, Brain, Pituitary gland, Thyroid glands, Parathyroid glands, Oesophagus, Salivary glands (mandibular and sublingual glands), Trachea, Lungs, Pharynx, Larynx, Nose (nasal cavity), Thymus, Aorta, Heart, Liver, Pancreas, Spleen, Kidneys, Adrenal glands, Oviducts, uterus and vagina, Prostate and seminal vesicles including coagulation glands, Stomach (forestomach and glandular stomach), Duodenum, jejunum and ileum, Cecum, colon and rectum, Urinary bladder, Lymph nodes (mesenteric and axillary lymph nodes), Sciatic nerve, Bone marrow (femur), Eyes, Extraorbital lacrimal glands, Skin, Female mammary gland, Spinal cord (cervical, thoracic and lumbar cords), Sternum with marrow, Femur with knee joint, Skeletal muscle - Postmortem examinations (offspring):
- not done
Results and discussion
Results: P0 (first parental generation)
Details on results (P0)
BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS): body weight (-11.7% on day 91) as well as body weight change (-20.5% on day 91) were significantly impaired only in the male animals of high dose group (5000 ppm) throughout the whole study period. No substance-related changes in food consumption were observed.
TEST SUBSTANCE INTAKE (PARENTAL ANIMALS): The approximate mean daily test-substance intake in mg/kg bw/day in males of the 250, 1250 and 5000 ppm dose groups were 16.2, 77.6 and 326.3, respectively. The approximate mean daily test-substance intake in mg/kg bw/day in females of the 250, 1250 and 2500 ppm dose groups were 18.3, 93.4 and 191.3, respectively.
REPRODUCTIVE FUNCTION: ESTROUS CYCLE (PARENTAL ANIMALS): No substance-related effects were observed.
REPRODUCTIVE FUNCTION: SPERM MEASURES (PARENTAL ANIMALS): There were no treatment-related changes in the sperm parameters measured.
ORGAN WEIGHTS (PARENTAL ANIMALS): The only treatment-related effect observed was decrease of the terminal body weight in the 5000 ppm group males (88 % in comparison to controls)
GROSS PATHOLOGY (PARENTAL ANIMALS): incidentally as single cases were reported which were not substance-related findings.
HISTOPATHOLOGY (PARENTAL ANIMALS): no substance-related findings were observed
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 191.3 mg/kg bw/day (actual dose received)
- Sex:
- female
- Basis for effect level:
- other: no effects
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 326.3 mg/kg bw/day (actual dose received)
- Sex:
- male
- Basis for effect level:
- other: no effects
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
The oral administration of 520 F-Chlormethyloximether via the diet over a period of 3 months caused no adverse effects on the fertility parameters in both males and females up to be the highest dose tested.
Applicant's summary and conclusion
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.
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