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EC number: 218-792-3 | CAS number: 2235-46-3
- 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
Repeated dose toxicity: Oral
NOAEL was considered to be in the range of 90 to 1000 mg/kg bw when mice and rat were treated wtih N,N-Diethyl-3-oxobutyramide.
Thus, comparing this value with the criteria of CLP regulation N,N-Diethyl-3-oxobutyramide (CAS no 20306-75-6) is not likely to classify as repeated dose toxicant.
Repeated dose inhalation toxicity:
According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance N,N-Diethyl-3-oxobutyramide (CAS no 20306-75-6),which is reported as 0.01 mmHg at 25 C. Thus, exposure to inhalable dust, mist and vapour of the chemical 2-Undecanone is highly unlikely. Therefore this study is considered for waiver.
Repeated dose dermal toxicity:
In accordance with coloumn 2 of Annex IX, this end point was considered for waiver since the acute toxicity by the dermal route has already been provided in section 7.2.3 (as part of the Annex VIII information requirements)Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- chronic toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- Experimental data of read across substances
- Justification for type of information:
- Weight of evidence approach based on structurally similar chemicals
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- WoE report is based on two repeated dose toxicity studies 1.Repaeted dose oral toxicity study of test chemical in mice 2. Repaeted dose oral toxicity study of test chemical in rat
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- other: 1. mice, 2. rat
- Strain:
- other: 1. CD-1
- Sex:
- male/female
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 1. 90 days2. 10 days
- Frequency of treatment:
- Daily
- Remarks:
- 1. 0, 300, 1000, 3000, 6000, and 10,000 mg/kg/day
- Remarks:
- 2. ca. 90 or 940 mg/kg/d
- No. of animals per sex per dose:
- 1. Total: 1800 mg/kg/day: 15 male, 15 female 300 mg/kg/day: 15 male, 15 female1000 mg/kg/day: 15 male, 15 female3000 mg/kg/day: 15 male, 15 female6000 mg/kg/day: 15 male, 15 female10,000 mg/kg/day: 15 male, 15 female
- Control animals:
- yes
- Details on study design:
- not specified
- Positive control:
- not specified
- Observations and examinations performed and frequency:
- 1 CAGE SIDE OBSERVATIONS: Yes - Time schedule:- Cage side observations checked in table [No.?] were included.DETAILED CLINICAL OBSERVATIONS: Yes / No / No data- Time schedule:BODY WEIGHT: Yes - Time schedule for examinations:FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes - Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes / No / No data- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / No data2. DETAILED CLINICAL OBSERVATIONS: Yes - Time schedule:BODY WEIGHT: Yes - Time schedule for examinations:FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes HAEMATOLOGY: Yes CLINICAL CHEMISTRY: Yes
- Sacrifice and pathology:
- 1. and 2. GROSS PATHOLOGY: Yes HISTOPATHOLOGY: Yes
- Other examinations:
- not specified
- Statistics:
- not specified
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- 1. No treatment-related clinical signs were observed in treated mice.
- Mortality:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- 1. When treated with 3000 mg/kg bw, decreased body weight gain were observed in animals
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- 1. No treatment-related effects on food consumption were observed in treated mice.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 1. When treated with 1000 mg/kg bw, increase Absolute and relative liver weights were observed in males and females mice. When treated with 300 mg/kg bw, increase Absolute and relative liver weights were observed in female mice. Increased liver weights and the corresponding hypertrophy were considered to be adaptive changes rather than an indication of systemic toxicity.2. When treated with 940 mg/kg bw, relative liver weight and relative and absolute kidney weights slightly increased n treated rats.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- 1. No treatment-related effects on gross pathology were observed in treated mice.
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- 1. When treated with 3000 mg/kg bw, Multifocal hepatocellular hypertrophy was observed at high incidence in males and females mice. When treated with 1000 mg/kg bw, Multifocal hepatocellular hypertrophy was observed at a lower incidence in females mice. Hypertrophy was considered to be adaptive changes rather than an indication of systemic toxicity.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Dose descriptor:
- NOAEL
- Effect level:
- 90 - 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical signs
- food consumption and compound intake
- gross pathology
- histopathology: non-neoplastic
- organ weights and organ / body weight ratios
- Remarks on result:
- other: No effect observed
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Conclusions:
- NOAEL was considered to be in the range of 90 to 1000 mg/kg bw when mice and rat were treated wtih N,N-Diethyl-3-oxobutyramide.
- Executive summary:
Data available for the read across chemicals was reviewed to determine the reproductive toxicity of N,N-Diethyl-3-oxobutyramide (CAS no. 2235-46-3). The studies are as mentioned below:
Study 1:
Repeated dose toxicity test were performed on CD-1 mice with test chemical in the concentration of 0, 300, 1000, 3000, 6000, and 10,000 mg/kg/day orally in diet for 90 days. No treatment-related clinical signs or effects on food consumption were observed in treated mice. Decreased body weight gain were observed in animals at 3000 mg/kg bw. Increase Absolute and relative liver weights were observed in males and females mice at 1000 mg/kg bw. Increase Absolute and relative liver weights were observed in female mice at 300 mg/kg bw. Increased liver weights were considered to be adaptive changes rather than an indication of systemic toxicity. In addition, No treatment-related effects on gross pathology were observed in treated mice. Multifocal hepatocellular hypertrophy was observed at high incidence in males and females mice at 3000 mg/kg bw. Multifocal hepatocellular hypertrophy was observed at a lower incidence in females mice at 1000 mg/kg bw. Hypertrophy was considered to be adaptive changes rather than an indication of systemic toxicity. Therefore, NOAEL was considered to be 1000 mg/kg bw when CD-1 male and female mice were treated with test chemical orally in diet for 90 days.
Study 2:
In repeated dose oral toxicity study, rats were treated with test chemical in the concentration of 90 or 940 mg/kg/d orally in diet for 10 days. Relative liver weight and relative and absolute kidney weights slightly increased in treated rats at 940 mg/kg bw. Therefore, NOAEL was considered to be 1000 mg/kg bw when CD-1 male and female mice were treated with test chemical orally in diet for 90 days.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- chronic
- Species:
- mouse
- Quality of whole database:
- Data is Klimicsh 2 and from authoritative database
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: inhalation, other
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
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
Link to relevant study records
- Endpoint:
- repeated dose toxicity: dermal, other
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated dose toxicity: Oral
Data available for the read across chemicals was reviewed to determine the reproductive toxicity of N,N-Diethyl-3-oxobutyramide (CAS no. 2235-46-3). The studies are as mentioned below:
Study 1:
Repeated dose toxicity test were performed on CD-1 mice with test chemical in the concentration of 0, 300, 1000, 3000, 6000, and 10,000 mg/kg/day orally in diet for 90 days. No treatment-related clinical signs or effects on food consumption were observed in treated mice. Decreased body weight gain were observed in animals at 3000 mg/kg bw. Increase Absolute and relative liver weights were observed in males and females mice at 1000 mg/kg bw. Increase Absolute and relative liver weights were observed in female mice at 300 mg/kg bw. Increased liver weights were considered to be adaptive changes rather than an indication of systemic toxicity. In addition, No treatment-related effects on gross pathology were observed in treated mice. Multifocal hepatocellular hypertrophy was observed at high incidence in males and females mice at 3000 mg/kg bw. Multifocal hepatocellular hypertrophy was observed at a lower incidence in females mice at 1000 mg/kg bw. Hypertrophy was considered to be adaptive changes rather than an indication of systemic toxicity. Therefore, NOAEL was considered to be 1000 mg/kg bw when CD-1 male and female mice were treated with test chemical orally in diet for 90 days.
Study 2:
In repeated dose oral toxicity study, rats were treated with test chemical in the concentration of 90 or 940 mg/kg/d orally in diet for 10 days. Relative liver weight and relative and absolute kidney weights slightly increased in treated rats at 940 mg/kg bw. Therefore, NOAEL was considered to be 1000 mg/kg bw when CD-1 male and female mice were treated with test chemical orally in diet for 90 days.
Thus, Based on the data available for the read across chemical, No Observed Adverse Effect Level (NOAEL) was considered to be above 90 -1000 mg/kg bw . Thus, comparing this value with the criteria of CLP regulation N,N-Diethyl-3-oxobutyramide (CAS no 20306-75-6) is not likely to classify as repeated dose toxicant.
Repeated dose inhalation toxicity:
According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance N,N-Diethyl-3-oxobutyramide (CAS no 20306-75-6),which is reported as 0.01 mmHg at 25 C. Thus, exposure to inhalable dust, mist and vapour of the chemical 2-Undecanone is highly unlikely. Therefore this study is considered for waiver.
Repeated dose dermal toxicity:
In accordance with coloumn 2 of Annex IX, this end point was considered for waiver since the acute toxicity by the dermal route has already been provided in section 7.2.3 (as part of the Annex VIII information requirements)
Justification for classification or non-classification
Based on the data available for the read across chemical and criteria of CLP regulation N,N-Diethyl-3-oxobutyramide (CAS no 20306-75-6) is not likely to classify as repeated dose oral, dermal and inhalation toxicant.
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