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EC number: 203-118-2 | CAS number: 103-50-4
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Scientifically acceptable and well documented
Data source
Reference
- Reference Type:
- publication
- Title:
- Safety evaluation of dibenzyl ether
- Author:
- Burdock GA and Ford RA
- Year:
- 1 992
- Bibliographic source:
- Food Chem Toxicol 30, 7, 559-566 (1992)
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Principles of method if other than guideline:
- Dibenzyl ether (FEMA No. 2371, CAS No. 103-50-4) was given in the diet to rats at a rate of 62, 196 or 620 mg/kg/day for 91 consecutive days. Body weights and food consumption were measured weekly; haematological, clinical chemistry and urinalysis values were obtained at wk 6 and 12. Gross and microscopic pathological changes were examined and organ weights recorded.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Dibenzyl ether
- EC Number:
- 203-118-2
- EC Name:
- Dibenzyl ether
- Cas Number:
- 103-50-4
- Molecular formula:
- C14H14O
- IUPAC Name:
- [(benzyloxy)methyl]benzene
- Details on test material:
- purity: 99% (supplied by McCormick and Company Inc.; Hunt valley, MD, USA)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CD-Cal:(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: diet
- Details on oral exposure:
- No data
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 91 days
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
62 , 196 or 620 mg/kg/day
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
196 mg/Kg/day
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
620 mg/Kg/day
Basis:
nominal in diet
- No. of animals per sex per dose:
- dose of dibenzylether:
0 mg/kg/day: 24 males and 24 females
62 mg/kg bw: 16 males and 16 females
196 mg/kg bw: 12 males and 12 females
620 mg/kg bw: 10 males and 10 females - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data
- Positive control:
- No data
Examinations
- Observations and examinations performed and frequency:
- No data
- Sacrifice and pathology:
- No data
- Other examinations:
- No data
- Statistics:
- No data
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No clinical signs of toxicity were observed during the course of the study.
- Mortality:
- no mortality observed
- Description (incidence):
- There were no deaths.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No significant changes of the mean body weights were observed throughout the study.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Sporadic changes in food consumption occurred during the course of study, but were not attributable to test substance administration.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- There was a decrease in erythrocyte count, haemoglobin and haematocrit in mid- and high-dose females at the 6-wk interval, which appeared to be resolving at the 12-wk interval, with the exception of the haematocrit in the mid- and high-dose females and erythrocyte counts in the mid-dose females. As some of the decreases appeared to resolve during the intervening 6 wk, and since the erythrocyte count and haematocrit were significantly elevated in males and the values were within normal limits for the laboratory for this strain, these and other effects in the haemograms were considered to be transient and not toxicologically significant.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- At the 6-wk interval, serum aspartate aminotransferase (AsT) and alanine aminotransferase (AlT) were significantly increased in mid- and high-dose males and AsT was elevated in the high-dose females. These increases were no longer apparent at the 12-wk interval and the values for these groups were, in fact, slightly lower than those of the controls. The changes in liver enzymes and other changes occurring sporadicalIy throughout the groups were not considered to be toxicologically significant.
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- Urinalyses (data not presented) were unremarkable.
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- There was a statisticalIy significant increase in absolute and relative liver weight in high-dose females at study termination. Other increases occurred sporadically throughout the groups of females in one or another of the paired organs and were not considered to be biologically significant.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No macroscopic or microscopic abnormalities were seen that could be attributed to treatment with the test substance.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No macroscopic or microscopic abnormalities were seen that could be attributed to treatment with the test substance.
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- no effects observed
- Details on results:
- The high-dose females had increased absolute and relative liver weights; this was considered to be related to dose. Other statistically significant events that occurred sporadically within the test groups were unrelated to dose and were considered to be normal adaptive change. No toxicological or pathological effects were noted at any of the dose levels after 91 consecutive days of feeding dibenzyl ether. A no-effect level was achieved at 196 mg/kg/day
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 620 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Any other information on results incl. tables
No clinical signs of toxicity were observed during the course of the study; there were no deaths. No significant changes of the mean body weights were observed throughout the study for Sporadic changes in food consumption occurred during the course of study, but were not attributable to test substance administration.
There was a decrease in erythrocyte count, haemoglobin and haematocrit in mid- and high-dose females at the 6-wk interval, which appeared to be resolving at the 12-wk interval, with the exception of the haematocrit in the mid- and high-dose females and erythrocyte counts in the mid-dose females. As some of the decreases appeared to resolve during the intervening 6 wk, and since the erythrocyte count and haematocrit were significantly elevated in males and the values were within normal limits for the laboratory for this strain, these and other effects in the haemograms were considered to be transient and not toxicologically significant.
At the 6-wk interval, serum aspartate aminotransferase (AsT) and alanine aminotransferase (AlT) were significantly increased in mid- and high-dose males and AsT was elevated in the high-dose females. These increases were no longer apparent at the 12-wk interval and the values for these groups were, in fact, slightly lower than those of the controls. The changes in liver enzymes and other changes occurring sporadicalIy throughout the groups were not considered to be toxicologically significant.
Urinalyses (data not presented) were unremarkable.
There was a statisticalIy significant increase in absolute and relative liver weight in high-dose females at study termination. Other increases occurred sporadically throughout the groups of females in one or another of the paired organs and were not considered to be biologically significant.
No macroscopic or microscopic abnormalities were seen that could be attributed to treatment with the test substance.
Applicant's summary and conclusion
- Executive summary:
Dibenzyl ether was given in the diet to rats at a rate of 62, 196 or 620 mg/kg/day for 91 consecutive days. Body weights and food consumption were measured weekly; haematological, clinical chemistry and urinalysis values were obtained at wk 6 and 12. Gross and microscopic pathological changes were observed and organ weights recorded. The high-dose females had increased absolute and relative liver weights; this was considered to be related to dose. Other statistically significant events that occurred sporadically within the test groups were unrelated to dose and were considered to be normal adaptive change. No toxicological or pathological effects were noted at any of the dose levels after 91 consecutive days of feeding dibenzyl ether. A no-effect level was achieved at 196 mg/kg bw/day. The NOAEL was 620 mg/kg bw/day.
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