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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- 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 oral 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 - 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 / concentrations
- Remarks:
- Doses / Concentrations:
0, 250, 1250 and 5000 ppm (males); 0, 250, 1250 and 2500 ppm (females)
Basis:
nominal in diet
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent no treatment
Examinations
- Observations and examinations performed and frequency:
- 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
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 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)
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: prior to the start of the administration period and on day 90
- Dose groups that were examined: control and high dose groups
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at the termination of the experiment
- Anaesthetic used for blood collection: Yes (isoflurane)
- Animals fasted: Yes
- How many animals: all
- Parameters checked: Leukocyte count (WBC), Erythrocyte count (RBC), Hemoglobin (HGB), Hematocrit (HCT), Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), Platelet count (PLT), Differential blood count, Reticulocytes and Prothrombin time.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at the termination of the experiment
- Animals fasted: Yes
- How many animals: all
- Parameters checked: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP), γ-Glutamyltransferase (GGT), Sodium (NA), Potassium (K), Chloride (CL), Inorganic phosphate (INP), Calcium (CA), Urea (UREA), Creatinine (CREA), Glucose, Total bilirubin, Total protein, Albumin, Globulins, Triglycerides, Cholesterol, Magnesium
URINALYSIS: Yes
- Time schedule for collection of urine: during 13th week
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Yes
- Parameters checked: pH, protein, Glucose, Ketones, Urobilinogen, Bilirubin, Blood, Specific gravity, Sediment, color, turbidity, volume
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: at the end of the administration period
- Dose groups that were examined: all
- Battery of functions tested: sensory activity [approach response, touch response, vision ("visual placing response"), pupillary reflex, pinna reflex, audition ("startle response"), coordination of movements ("righting response"), behavior during "handling", vocalization, pain perception ("tail pinch"), grip strength of forelimbs, grip strength of hindlimbs, landing foot-splay test] / grip strength / motor activity (examinations were performed using the TSE Labmaster System) / other: home cage observations [Attention was paid to posture, tremor, convulsions, abnormal movements, impairment of gait]; Open field observations [behavior when removed from cage, fur, skin, salivation, nose discharge, lacrimation, eyes/pupil size, posture, palpebral closure, respiration, tremors, convulsions, abnormal movements, impairment of gait, activity/arousal level, feces (number of fecal pellets/appearance/consistency) within two minutes, urine (appearance/quantity) within two minutes, number of rearings within two minutes]. - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
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 - Other examinations:
- Organ weights were determined from anesthetized animals, Liver, Kidneys, Adrenal glands, Testes, Epididymides, Cauda epididymides, Ovaries, Uterus, Prostate, Seminal vesicles including coagulation glands, Spleen, Brain, Heart, Thymus, Thyroid glands.
- Statistics:
- - Body weight, body weight change: A comparison of each group with the control group was performed using DUNNETT's test (two-sided) for the hypothesis of equal means.
- feces, rearing, grip strength forelimbs, grip strength hindlimbs, footsplay test, motor activity, Clinical pathology parameters, urine volume, urine specific gravity: Non-parametric oneway analysis using KRUSKAL-WALLIS test (two-sided)
- Urinalysis, except color, turbidity, volume and specific gravity- Pairwise comparison of each test group with the control group using FISHER's exact test for the hypothesis of equal proportions
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS AND MORTALITY: no mortality or clinical signs were observed.
BODY WEIGHT AND WEIGHT GAIN: 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.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No substance-related changes in food consumption were observed. 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.
FOOD EFFICIENCY: Significant changes in food efficiency were measured on some isolated days in all treated animals over the whole study period. Due to the lack of a dose-response relationship, no clear substance related influence was observed.
WATER CONSUMPTION: No substance-related changes in water consumption were observed
OPHTHALMOSCOPIC EXAMINATION: All findings were incidental in nature, due to the occurrence in single animals, only, and/or the lack of a dose-response relationship
HAEMATOLOGY: At the study end in male rats of the 5000 ppm test group the hemoglobin concentrations and the hematocrit values were higher compared to the controls. No other substance-related findings were observed.
CLINICAL CHEMISTRY: No treatment-related adverse effects were observed concerning the clinical chemistry parameters.
URINALYSIS: No treatment-related adverse effects were observed
NEUROBEHAVIOUR: No substance-related findings were observed.
REPRODUCTIVE FUNCTION: ESTROUS CYCLE: No substance-related effects were observed.
REPRODUCTIVE FUNCTION: SPERM MEASURES: There were no treatment-related changes in the sperm parameters measured.
ORGAN WEIGHTS: 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: incidentally as single cases were reported which were not substance-related findings.
HISTOPATHOLOGY: NON-NEOPLASTIC: no substance-related findings were observed
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 77.6 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: reduced body weight and body weight change, and increased hemoglobin and hematocrit values
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 191.3 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: no effects
Target system / organ toxicity
- Critical 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 signs of general systemic toxicity only in male animals of the 5000 ppm group as indicated by a reduced body weight and body weight change as well as increased hemoglobin and hematocrit values. No other substance-related adverse findings were observed, neither in mid and low dose males nor in females throughout all concentrations tested. Therefore, the no observed adverse effect level (NOAEL) under the conditions of this study was 1250 ppm in male (about 77.6 mg/kg bw/day) and 2500 ppm in female (about 191.3 mg/kg bw/day) Wistar rats.
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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