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EC number: 245-950-9 | CAS number: 23949-66-8
- 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
Endpoint summary
Administrative data
Description of key information
90d-feeding study: NOEL = 600 mg/kg bw/d (10.000 ppm males and females)
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1973
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Well documented study pre-dating OECD protocolls and GLP requirements. However, slight shortcomings regards documentation (e.g. lighting conditions, test substance purity, analytical verification of administered dose) justify a Klimisch 2 rating (reliable with restrictions).
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- study pre-dates OECD protocol but follows the same scientific principles and methodology
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- study pre-dates GLP guideline
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 160 SPF-rats of the Sprague-Dawley strain were randomly devided into 4 groups (as control and three test groups) of 20 males and 20 females each and uniquely numbered for further identification. Animals were kept individually in makrolon cages. The temperature in the animal room was kept at 25 ±0.5 °C and relative humidity was controlled to 50 ±5 %.
- Route of administration:
- oral: feed
- Vehicle:
- other: NAFAG mouse and rat feed, No. 194
- Details on oral exposure:
- The test substance was mixed with NAFAG mouse and rat feed No 194 in portions of 5 kg, using a Turbula mixer (supplier: Bachofen in Basel, Switzerland). Control animals received pure NAFAG mouse and rat feed No 194 without addition of test substance.
Test and control animals received feed and water ad libitum. Feed consumption and body wight of animals were recorded once weekly. Water consumtion was monitored throughout the study but turned out to be obsolete during the course of the study as no differences between control and test animals were noted. - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- continuous; the test substance was supplied by feed ad libitum
- Remarks:
- Doses / Concentrations:
0, 1600, 4000 and 10000 ppm
Basis:
nominal in diet - No. of animals per sex per dose:
- 20 males and 20 females per dose group and control
- Control animals:
- yes, concurrent no treatment
- Positive control:
- none
- Observations and examinations performed and frequency:
- Clinical Chemistry:
Following 4, 8 and 13 weeks of exposure, blood samples were taken from 5 males and 5 females of each dose group from the sublingual vene and these samples investgiated for the following parameters:
- BUN (blood urea nitrogen) according to method of W. Marsch et al., Clin. Chem. 11, 624 (1965) using a Technicon AutoAnalyzer micro method [mg%]
- FBS (fasting blood sugar) according to method of W.S. Hoffmann, J. Biol. Chem. 120, 51 (1937) using a Technicon AutoAnalyzer micro method [mg%]
- SAP (serum alakaline phosphatase)according to method of W. Marsch et al., Clin. Chem. 5, 119 (1959) using a Technicon AutoAnalyzer micro method in [IU]
- SGPT (serum glutamic pyruvat transaminase) according to Boehringer test comination 15978 [IU]
Hämatological examinations:
Following 4, 8 and 13 weeks of exposure, the following examinations from 5 males and 5 females of each dose groupwere performed:
- hämatokrit (HCT) with a coulter counter [%RBC in full blood]
- erythrocytes (RBC) with a coulter counter [million cells/mm3]
- total leokocytes (WBC) with a coulter counter [thousand cells/mm3]
- hämoglobin (HGB) with the Merckotest (Merch Darmstadt) [as hämoglobin cyanide in g/100 ml blood]
- differenciate leukocytes (microscopic) [%WBC] as
* neutrophile leucocytes
* lymphocytes
* monocytes
* eosinophiles
* basophiles
- absolute indices: average erythrocyte volume (MCV) and average hämoglobin concentration per cell (MCHC)
Urinanalysis:
Following the 6th and 12th week of exposureurine of 5 males and 5 females per dose was collected and the following parameters were investigated:
- pH
- pecific weight (refractive, using a TS-meter)
- proteine (using albustix reagent tabs)
- glucose (using Clinistix reagens)
- ketones (according to Libbrecht)
- pigments (benzidin method)
- urinary sediment was checked for the following parameters:
* Erythrocytes (RBC)
* Leucocytes (WBC)
* Epithelial cells (EPC)
* Uric acid crystals (Uric AC)
*calcium oxalate crystals (CA-OXA)
* Triple phosphate (TRIPHO)
* Amorphe urates (AM URA) - Sacrifice and pathology:
- At the end of exposure period (after 13 weeks) 5 males and 5 females of each dose group, which were not used before for other examinations, were sacrificed and the following organs have been investigated macroscopically (organ weight relative to body weight): Thyroids, adrenal glands, pituitary glands, brain, heart, lungs, thymus, spleen, liver, kidneys, uterus/prostate, seminal vesicle.
Following macroscopic examination the organs were examined histologically. - Statistics:
- The Student t-test method was applied for assessing relevance of changes versus control.
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- No clinical signs or mortality were observed. At all dose levels no differences in body weight gain compared to controls were observed. Very slight reduction in food consumption of females (not observed in males) did not affect body weight gain and was considered non-significant. As a result, food efficiency of males was normal and slightly increased for females. Water consumption was comparable in all dose groups to controls.
In the 4th week of exposure males showed a slightly increased medium cell volume (MCV) values and slight increase of red blood cells but still within normal ranges. To investigate whether these effects are substance specific, the experiment was repeated only with male rats (controls and 10000 ppm dose group only) but the effect could not be reproduced. Thus, the effect on males regarding red blood cells and MCV values were considered incidental. The clinical chemistry parameters (BUN, SAP and SGPT) revealed no differences between dose groups and controls. fasting blood sugar values (FBS) were slightly increased in all groups inclucing controls but still within normal range and thus this effect was not considered substance specific. Urinanalyses revealed no specific findings, as specific weight and pH were normal, Acetone and glucose were negativ and blood pigments were not found. In some urine samples (from dose groups and controls) proteines were found (non-dose-dependent), which is often found in rats and therefore not considered treatment specific. Significant deviations (p < 0.05) of absolute and relative organ weights of thyroid, brain, kidneys, adrenal glands and lungs were minor and could be explained by lower standard deviation in dose groups compared to controls. All these deviations were also within biological variability and non-dose specific and therefore were not considered treatment related. No other effects on organ weight were observed.
Finally, also gross pathology and histopatholology showed no treatment related findings. - Dose descriptor:
- NOEL
- Effect level:
- 10 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: In absence of any treatment specific effects the NOEL was set to the highest dose level tested.
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- ca. 600 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: In absence of any treatment specific effects the NOEL was set to the highest dose level tested.
- Dose descriptor:
- NOEL
- Effect level:
- 521.47 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: In absence of any treatment specific effects the NOAEL was set to the highest dose level tested.
- Remarks on result:
- other: as average of all males, considering measured food consumption (19125 mg) and body weight over the exposure period
- Dose descriptor:
- NOEL
- Effect level:
- 663.66 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: In absence of any treatment specific effects the NOEL was set to the highest dose level tested.
- Remarks on result:
- other: as average of all females, considering measured food consumption (15500 mg) and body weight over the exposure period
- Critical effects observed:
- not specified
- Conclusions:
- In this 90 day feeding study with N-(2-ethoxyphenyl)-N'-(2-ethylphenyl)oxamide no treatement related effects were seen in all dose groups (1600, 4000 and 10000 ppm) and thus the "No Observed Effect Level" (NOEL) was set at the highest dose group tested (10.000 ppm) which is equivalent to 521.47 mg/kg bw/d in males and 663.66 mg/kg bw/d in females (ca. 600 mg/kg bw/d males/females).
- Executive summary:
The test substance N-(2-ethoxyphenyl)-N'-(2-ethylphenyl)oxamide was investigated in a 90-day (13 wk) feeding study in Sprague-Dawley rats. 20 Males and 20 females were used per dose group (0, 1600, 4000, 10000 ppm). Development of body weight was normal in all groups and only a very slight food consumption reduction in females was noted which had no effect on body weight development. Unspecific variations in haematological parameters during exposure of males did normalize at the end of the exposure period and therefore were considered incidental. This was supported by a repetition experiment with another group of males (dose groups 0 and 10000 ppm), in which these haematological variations could not be reproduced. Effects on clinical chemistry parameters were not seen and also urine-analysis did not reveal any findings of significance. Pathological microscopy also did not reveal any effects on organ tissue.
In conclusion, up to 10.000 ppm, which is equivalent to 521.47 mg/kg bw/d in males and 663.66 mg/kg bw/d in females (ca. 600 mg/kg bw/d males/females), no effects were seen and thus this was considered the No-Observed-Effect-Level (NOEL) in this study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 600 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In this 90 day feeding study with N-(2-ethoxyphenyl)-N'-(2-ethylphenyl)oxamide no treatement related effects were seen in all dose groups (1600, 4000 and 10000 ppm) and thus the "No Observed Effect Level" (NOEL) was set at the highest dose group tested (10.000 ppm) which is equivalent to 521.47 mg/kg bw/d in males and 663.66 mg/kg bw/d in females (ca. 600 mg/kg bw/d males/females).
The test substance N-(2-ethoxyphenyl)-N'-(2-ethylphenyl)oxamide was investigated in a 90-day (13 wk) feeding study in Sprague-Dawley rats. 20 Males and 20 females were used per dose group (0, 1600, 4000, 10000 ppm). Development of body weight was normal in all groups and only a very slight food consumption reduction in females was noted which had no effect on body weight development. Unspecific variations in haematological parameters during exposure of males did normalize at the end of the exposure period and therefore were considered incidental. This was supported by a repetition experiment with another group of males (dose groups 0 and 10000 ppm), in which these haematological variations could not be reproduced. Effects on clinical chemistry parameters were not seen and also urine-analysis did not reveal any findings of significance. Pathological microscopy also did not reveal any effects on organ tissue.
In conclusion, up to 10.000 ppm, which is equivalent to 521.47 mg/kg bw/d in males and 663.66 mg/kg bw/d in females (ca. 600 mg/kg bw/d males/females), no effects were seen and thus this was considered the No-Observed-Effect-Level (NOEL) in this study.
Long-term studies by inhalation pathway or by dermal exposure are not available.
Justification for classification or non-classification
Based on the outcome of a subchronic feeding study with rats, no long-term exposure effects were seen and thus the substance is not classifiable for long-term toxicity according to DSD (Directive 67/548/EEC) or specific target organ toxicity (STOT) according to CLP (Regulation EC No 1272/2008).
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