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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 12th May 2014 to 27th May 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducetd according to international guidelines. No relevant deviations have been reported so that the study is considered reliable.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- N-(2-ethoxyphenyl)-N'-(2-ethylphenyl)oxamide
- EC Number:
- 245-950-9
- EC Name:
- N-(2-ethoxyphenyl)-N'-(2-ethylphenyl)oxamide
- Cas Number:
- 23949-66-8
- Molecular formula:
- C18H20N2O3
- IUPAC Name:
- N-(2-ethoxyphenyl)-N'-(2-ethylphenyl)ethanediamide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- name of the substance as cited in the report: N-(2-Ethoxyphenyl)-N’-(2-ethylphenyl) oxamide
CAS n. 23949-66-8
Appaerance: slightly yellow powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Species, strain, weight:
Rats, Wistar, 160 – 180g – weight suits to age of animals 6 – 7 weeks.
Females were nulliparous and non-pregnant.
Number and sex:
From the ordered 9 female and 3 male animals only 3 females and 3 males were employed, as the conditions of limit test at the dose 2000 mg/kg were satisfied.
Normally females are used in the test according to OECD TG 423 because mostly females are more sensitive gender, but if a new product is tested, there is still a possibility that this assumption will not be confirmed. For this reason one dose in males was used to verify sensitivity of sexes. In time of application animals reached body weight 195 – 215 g females, and 250 g males what falls into recommended age 8 – 12 weeks.
Source:
Accredited Breeding Velaz Prague (CZ)
Identification:
The animals were housed in groups by 3 in cages after application. They were marked on tail and numbering the cage with indicating sex, dose and date of application.
Housing:
Animals were housed in experimental animal house on the bedding (Lignocel S 3/4, Lufa – ITL GmbH Germany) in groups by 3 in cages in conformity with laboratory animals welfare legislation.
Diet:
A standard certified laboratory diet (supplier MP – OŠ – 06 extrudes, Snina, Slovak Republic) was served. The diet was routinely analysed by the manufacturer for nutritional components and environmental contaminants and by the independent laboratory.
Water:
Bottled tap drinking water, routinely (quarterly) analysed by accredited laboratory, was accessible ad libitum.
Environment:
Environmental controls for the animal room were set to maintain 22 ± 2oC, a relative humidity of 55 ± 10 %. The temperature and relative humidity of air were recorded and the records are included in primary documentation. A minimum of 10 air changes/hour, and artificial light regime12 h light/12 h dark were implemented.
Acclimation:
The animals were acclimated under the conditions of the test seven days before the beginning of the treatment.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 1%
- Details on oral exposure:
- The test item was administered in a single dose by gavage using a stomach tube. Animals were fasted prior to dosing (food but not water was withheld over- night). Following the period of fasting, the animals were weighed and the test item administered. After the test item has been administered, food was withheld for a further 3-4 hours.
- Doses:
- The starting dose could be selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg. Available information indicated test item is likely to be nontoxic considering to acute toxicity.
A limit dose of 2000 mg/kg was used as starting dose. Group of 3 rats’ females were dosed.
As no test item-related mortality was produced additional group of 3 male rats were tested at the same dose no further dosing was necessary. - No. of animals per sex per dose:
- From the ordered 9 female and 3 male animals only 3 females and 3 males were employed, as the conditions of limit test at the dose 2000 mg/kg were satisfied.
- Control animals:
- no
- Details on study design:
- Animals were observed individually immediately, ½, 1, 2, and 4 hours after application and daily thereafter, for a total of 14 days.
Additional observations were not necessary. Clinical signs and conditions associated with pain, suffering, and impending death, are described in detail in a separate OECD Guidance
Observations included changes in skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous systems, and somatomotor activity and behaviour pattern. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. No animal was found in a moribund condition.
Individual weights of animals were determined shortly before the test item was administered and weekly thereafter. Weight changes after first and second weeks after application were calculated and recorded.
All test animals were subjected to gross necropsy. Full, detailed gross necropsy included careful examination of external surface of the body, all orifices, and cranial, thoracic and abdominal cavities and their contents. All gross pathological changes were recorded for each animal. - Statistics:
- not applicable
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All 3/3 females and 3/3 males survived the limit dose 2000 mg/kg. No further dosing was necessary.
- Clinical signs:
- other: Neither in females nor in males visible symptoms were observed at the dosage of 2000 mg/kg during first 4 hours after application or in 14 day observation period.
- Gross pathology:
- All 3 males and 3 females survived observation period and were necropsied after euthanasia.
During necropsy no macroscopically changes were noticed
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The test item applied to 3 males and 3 females in limit dose 2000 mg/kg did not cause death either visible symptoms of toxicity during 14 day observation period. It can be concluded that the LD50 of the test item UV 312 is ˃ 2000 mg/kg after single oral administration to Wistar rats.
- Executive summary:
The objective of the study was to obtain information on the acute toxicity of test item when administered per orally in single dose to Wistar rats. The study was carried out in compliance with OECD TG 423 where the doses could be selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg. A limit dose of 2000 mg/kg was used as a starting dose. Groups of 3 females and 3 males were dosed. Since all 3/3 females and 3/3 males survived limit dose 2000 mg/kg no further dosing was necessary. The test item was applied to 3 males and 3 females. The limit dose 2000 mg/kg did not cause death, visible symptoms of toxicity during 14 day observation period or body weight loss. It can be concluded that LD50 of the test item is ˃ 2000 mg/kg, after single oral administration to Wistar rats.
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