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EC number: 602-997-3 | CAS number: 124495-18-7
- 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
Neurotoxicity
Administrative data
Description of key information
Acute Neurotox Study Rat Gavage NOAEL: >2000 mg/kg; not neurotoxic. OECD 424; Reliability = 1
90-Day Study Rat Diet Systemic NOAEL: 20 mg/kg, Neurotox NOEL: 80 mg/kg (highest dose tested); not neurotoxic. EPA 83-1; Reliability = 1
Key value for chemical safety assessment
Effect on neurotoxicity: via oral route
Link to relevant study records
- Endpoint:
- neurotoxicity: chronic oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 83-1 (Chronic Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
- Specific details on test material used for the study:
- - Substance ID: TSN 100097
- Name of substance: XDE-795
- Purity: 97.4% - Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Route of administration:
- oral: feed
- Vehicle:
- other: diet
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 12 months for neurotoxicity study
- Frequency of treatment:
- daily
- Dose / conc.:
- 5 mg/kg bw/day
- Dose / conc.:
- 20 mg/kg bw/day
- Dose / conc.:
- 80 mg/kg bw/day
- No. of animals per sex per dose:
- 10 for neurotoxicity study
- Control animals:
- yes
- Details on study design:
- The study was conducted concurrently with the first year portion of a two-year chronic toxicity/oncogenicity study in Fischer 344 rats. The neurotoxicity and concurrent chronic toxicity studies with the test substance were carried out at dose levels of 0, 5, 20 and 80 mg/kg/day of test substance via the diet of the rats. Ten male and ten female Fischer 344 rats per dose level were assigned to the neurotoxicity study. The neurotoxicity subset of rats were evaluated pre-exposure, and at months 3, 6, 9 and 12 by a functional observational battery (FOB), forelimb and hindlimb grip performance, landing foot splay, and an automated test of motor activity. After completion of 12 months of exposure, neuropathologic examination of perfusion fixed central and peripheral nervous tissues was conducted on 5 rats/sex from the control and high-dose groups.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Repeated-Measure analysis of monthly body weight data revealed that the test substance did not significantly alter pre-existent differences in body weights over time. Body weight summary histograms and descriptive statistics show a slight decrease in body weights in the high-dose group compared to controls. This decrease persisted from month 3 to month 12 and was more apparent in females. This decrease attained toxicological significance when body weights were evaluated as body weight gains.
Compared to controls, the body weight gain was 10.2% less in the high-dose (80 mg/kg/day) females at month 3 and was 11% less in the same group at month 12. This decreased gain attained toxicological significance going by EPA guidance for toxicity considerations for subchronic and chronic studies (10% change in weight gain). The high-dose females gained lesser at the 6-month (~8% less than controls) and 9-month (~9% less than controls) time points also. The high-dose males had slightly lower body weight gains than controls (never exceeding 4%) although not enough to be considered significant. - Behaviour (functional findings):
- effects observed, non-treatment-related
- Description (incidence and severity):
- Hand-held and Open field Observations: The distribution of FOB observations (non-ranked and ranked) suggested a low incidence of random differences; there were no patterns of effects that suggested treatment-related differences. The FOB composite scores provided an overall summary of the magnitude or intensity of ranked observations. Only a few composite scores were sufficiently disparate between groups as to merit further attention, but did not suggest an effect of treatment. Ranked FOB observations were evaluated statistically, treatment vs. control, by the test of proportions. There potentially were 360 pairwise comparisons, only two of which were significant. Like composite scores, the statistical findings reflected a random pattern of differences between sexes and dose groups. The lack of any kind of dose response relationship supports an absence of treatment-related effects.
Hindlimb and forelimb grip performance and landing foot splay: There were no treatment related differences at any test period in either males or females. There were no sex differences at any test period in how males and females responded to treatment.
Hand-held clinical evaluation: There were no treatment related differences at any test period in either males or females seen in the clinical evaluations. Some perineal soiling was seen in high-dose females. However, whenever the soiling occurred (generally, occurred at different times for different rats) it never lasted more than a few days in any of 4 rats that were diagnosed with perineal soiling.
Motor activity: The overall treatment-by-month interaction was not significant (p = 0.491),i.e., total motor activity counts of males and females were not affected by treatment at any test period. The treatment-by-month-by-sex interaction was not significant (p = 0.761), i.e., motor activity was not significantly different in males and females as a consequence of treatment at any test period. The treatment-by-month-by-epoch interaction was not significant (p = 0.343), i.e., the count distribution across epochs did not change as a consequence of treatment at any test period. Thus, there was no evidence of a treatment effect on habituation. - Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Only mild treatment-related effects were noted. Liver weights of high-dose males and females were increased, and kidney weights of high-dose male rats were increased. There were no treatment-related histopathologic findings in the liver or kidneys at one year of exposure. After two years of exposure, high-dose male rats had an increased incidence of chronic progressive glomerulonephropathy.
- Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no gross pathologic observations attributable to dosage with the test substance in the animals from the chronic neurotoxicity study. All gross pathologic observations were interpreted to be spontaneous findings, unassociated with dietary administration of the test substance.
- Neuropathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no histopathologic observations attributable to dosage with test substance in the animals from the chronic neurotoxicity study. All histopathologic observations were interpreted to be spontaneous findings, unassociated with dietary administration of the test substance.
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 20 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- body weight and weight gain
- organ weights and organ / body weight ratios
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 80 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: no treatment related neurotoxicological effects were observed
- Remarks on result:
- other: highest dose tested
- Conclusions:
- Neurotoxicological NOEL: 20 mg/kg/day for female rats (based on body weight gain findings) and 80 mg/kg/day for male rats
- Executive summary:
This one-year chronic neurotoxicity study was conducted according to EPA-FIFRA Guideline No. 83-1. The study was conducted concurrently with the first year portion of a two-year chronic toxicity/oncogenicity study in Fischer 344 rats.
The neurotoxicity and concurrent chronic toxicity studies with the test substance were carried out at dose levels of 0, 5, 20 and 80 mg/kg/day of test substance via the diet of the rats. Ten male and ten female Fischer 344 rats per dose level were assigned to the neurotoxicity study. The neurotoxicity subset of rats were evaluated pre-exposure, and at months 3, 6, 9 and 12 by a functional observational battery (FOB), forelimb and hindlimb grip performance, landing foot splay, and an automated test of motor activity. After completion of 12 months of exposure, neuropathologic examination of perfusion fixed central and peripheral nervous tissues was conducted on 5 rats/sex from the control and high-dose groups.
Rats in the chronic neurotoxicity study showed treatment-related effects at the 3-month time point (80 mg/kg/day group females) and at the end of 12 months of treatment on body weight gains (80 mg/kg/day group females). All other neurotoxicological parameters showed no treatment-related effects. The neurotoxicological NOEL was greater than 20 mg/kg day for female rats (based on body weight gain findings) and 80 mg/kg/day for male rats.
Only mild treatment-related effects were noted in the concurrent one-year portion of the 2-year toxicity study. Liver weights of high-dose males and females were increased, and kidney weights of high-dose male rats were increased. There were no treatment-related histopathologic findings in the liver or kidneys at one year of exposure. After two years of exposure, high-dose male rats had an increased incidence of chronic progressive glomerulonephropathy.
- Endpoint:
- neurotoxicity: acute oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 424 (Neurotoxicity Study in Rodents)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.6200 (Neurotoxicity Screening Battery)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
- Specific details on test material used for the study:
- - Substance ID: TSN 100097
- Name of substance: XDE-795
- Lot number: DECO-97-152-1
- Purity: 97.4% - Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% w/v solution of methyl cellulose in Milli-Q water
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- Single dose
- Frequency of treatment:
- Single dose
- Dose / conc.:
- 200 mg/kg bw (total dose)
- Dose / conc.:
- 632 mg/kg bw (total dose)
- Dose / conc.:
- 2 000 mg/kg bw (total dose)
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Details on study design:
- Body weights were taken and a functional observational battery and test for motor activity were both conducted during the week of pre-exposure, and on the day of dosing (i.e., Day 1), Day 8 and Day 15. Functional observational battery included hand-held and open-field observations as well as measurements of rectal temperature, grip performance and landing foot splay. Clinical observations were conducted on Days 2, 3 and 4. Five rats/sex/dose level were perfused for neurohistopathology on Day 16.
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Ophthalmological findings:
- no effects observed
- Behaviour (functional findings):
- effects observed, non-treatment-related
- Description (incidence and severity):
- Hand-held and Open field Observations: Only 4 average rank values were 0.5 greater or lesser than control average ranks. These occurred at low-dose and at mid-dose and were randomly distributed among time periods (three at pre-exposure and one at Day 8) and among observations (resistance to removal and level of activity). These data showed no pattern indicating a treatment-related effect. Between average ranks and z-scores, all findings were at pre-exposure except for one significant finding that occurred on Day 8 - the middle dose males had a higher level of activity than control males. To summarize, there were no FOB observations related to treatment.
Grip performance: No treatment-related effects were seen in hindlimb or forelimb grip performance at any time during the study. Sexes did not react differently to treatment at any time.
Landing foot splay: No treatment-related effects were seen in landing foot splay at any time during the study. Sexes did not react differently to treatment at any time.
Rectal temperature: No treatment-related effects were seen in rectal temperature at any time during the study. Rectal temperature data analysis resulted in a significant interaction of Treatment by Day (p = 0.0494). Mean rectal temperatures, overall, did not differ much from each other. Sexes did not react differently to treatment at any time. Stepdown analysis was performed to follow up on the significant Treatment x Day interaction. The only significant contrast was control vs low dose at p = 0.0133. The significance seen was deemed to be unrelated to treatment.
Motor activity: No treatment-related effects were seen in motor activity at any time during the study. Sexes did not react differently to treatment at any time. The test substance did not affect the distribution of motor activity counts at any time point, i.e., no change in habituation occurred due to test substance treatment. - Gross pathological findings:
- no effects observed
- Neuropathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were no treatment-related histopathologic observations in the central or peripheral nervous systems of rats administered quinoxyfen. All histopathologic observations were interpreted to be spontaneous findings, unassociated with oral administration of the test substance.
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- > 2 000 mg/kg bw (total dose)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No neurotoxicological effects
- Remarks on result:
- other: highest dose tested
- Conclusions:
- Rat NOEL (male/female): >2000 mg/kg bw (highest dose tested)
- Executive summary:
The study was conducted following OECD guideline 424 and US EPA guideline 870.6200. Ten male and ten female Fischer 344 rats per group were dosed by oral gavage with 0, 200, 632 or 2000 mg/kg bw to evaluate the potential for acute neurotoxicity. Body weights were taken and a functional observational battery and test for motor activity were both conducted during the week of pre-exposure, and on the day of dosing (i.e., Day 1), Day 8 and Day 15. Functional observational battery included hand-held and open-field observations as well as measurements of rectal temperature, grip performance and landing foot splay. Clinical observations were conducted on Days 2, 3 and 4. Five rats/sex/dose level were perfused for neurohistopathology on Day 16.
There were no treatment-related effects seen on body weights, clinical observations, functional observations and measurements, motor activity or neuropathology at any time. Based on the absence of neurotoxicological effects, the neurotoxicological no-observed-effect level (NOEL) for Fischer 344 rats of either sex was greater than the highest dose of test substance tested (i.e., greater than 2000 mg/kg) under the exposure conditions of this study.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Effect on neurotoxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Effect on neurotoxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Ten male and ten female Fischer 344 rats per group were dosed by oral gavage with 0, 200, 632 or 2000 mg/kg bw to evaluate the potential for acute neurotoxicity. Body weights were taken and a functional observational battery and test for motor activity were both conducted during the week of pre-exposure, and on the day of dosing (i.e., Day 1), Day 8 and Day 15. Functional observational battery included hand-held and open-field observations as well as measurements of rectal temperature, grip performance and landing foot splay. Clinical observations were conducted on Days 2, 3 and 4. Five rats/sex/dose level were perfused for neurohistopathology on Day 16. There were no treatment-related effects seen on body weights, clinical observations, functional observations and measurements, motor activity or neuropathology at any time. Based on the absence of neurotoxicological effects, the neurotoxicological no-observed-effect level (NOEL) for Fischer 344 rats of either sex was greater than the highest dose of test substance tested (i.e., greater than 2000 mg/kg) under the exposure conditions of this study.
The neurotoxicity and concurrent chronic toxicity studies with the test substance were carried out at dose levels of 0, 5, 20 and 80 mg/kg/day of test substance via the diet of the rats. Ten male and ten female Fischer 344 rats per dose level were assigned to the neurotoxicity study. The neurotoxicity subset of rats were evaluated pre-exposure, and at months 3, 6, 9 and 12 by a functional observational battery (FOB), forelimb and hindlimb grip performance, landing foot splay, and an automated test of motor activity. After completion of 12 months of exposure, neuropathologic examination of perfusion fixed central and peripheral nervous tissues was conducted on 5 rats/sex from the control and high-dose groups. Rats in the chronic neurotoxicity study showed treatment-related effects at the 3-month time point (80 mg/kg/day group females) and at the end of 12 months of treatment on body weight gains (80 mg/kg/day group females). All other neurotoxicological parameters showed no treatment-related effects. The neurotoxicological NOEL was greater than 20 mg/kg day for female rats (based on body weight gain findings) and 80 mg/kg/day for male rats.
Justification for classification or non-classification
The test substance was negative for neurotoxicity in an acute and a 90-day rat neurotoxicity study. Therefore, the substance does not need to be classified for neurotoxicity according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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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