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EC number: 227-372-9 | CAS number: 5810-11-7
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2-chloro-N,N-dimethyl-3-oxobutyramide
- EC Number:
- 227-372-9
- EC Name:
- 2-chloro-N,N-dimethyl-3-oxobutyramide
- Cas Number:
- 5810-11-7
- Molecular formula:
- C6H10ClNO2
- IUPAC Name:
- 2-chloro-N,N-dimethyl-3-oxobutanamide
- Details on test material:
- Name: Dimetbyl-2-ch1oroacetoacetamide
Batch No.: 502001
Physical state: clear yellowish liquid
Density: 1.20 g/m3
Storage: ambient, protected from light
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Species: rat
Strain: Hsd/Cpb:WU
Source: Fa. Harlan Winkelmann GmbH, Gartenstr. 27, 33178 Borchen
Date of receipt: March 15, 1995 (females), April 19 and May 10, 1995 (males)
Acclimatization period: at least 5 days
Animal selection: random
Animal identification: with colored markings; cage labelled with dosage, sex, date of study initiation, project no.
Weight range at study initiation: m: 210 - 302 g, f: 170 - 210 g
Husbandry
Housing: collective housing up to a maximum of 5 animals per cage (Makrolon@ type 111)
lllumination: artificial lighting (120 lux) from 7.00 a.m. - 7.00 p.m.
Temperature: 22:+/-3 °C
Relative humidity: 30 -70 %
Measurement: twice daily
Prior to study initiation, the animals were acclimatized to laboratory conditions for at least 5 days. Only healthy animals were used in the test. The animals were fasted from 16 h before until 3 - 4 h after administration of the test article.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- A preliminary range finding test with doses of 2000, 1000, 500 and 200 mg/kg body weight was conducted using two female rats per dose. Due to a marked sex difference observed in the main test at the dose of 500 mg/kg body weight, a range finding test with doses of 2000 and 1000 mg/kg body weight was additionally conducted in two male rats.
- Doses:
- Doses: 200, 500, and 1000 mg/kg
- No. of animals per sex per dose:
- 5 females (200 mg/kg bw), 5 males and 5 females (500 mg/kg bw), 5 males (1000 mg/kg bw)
- Control animals:
- yes
- Details on study design:
- In each animal a number of clinical-toxicological signs were evaluated according to a modified Irwin-Screening procedure (Screening Methods in Pharmacology, R. A. Turner, 1965, p. 26). Any change from the normal condition was noted (increase or decrease) and the degree of severity of any clinical symptoms was assessed. The animals were examined at the following post-treatment intervals: 5 min (at 1000 mg/kg) 10 min, 1 h, 2 h, 6 h, 24 h, and thereafter once daily up to day 14. The body weights of all animals were recorded immediately before treatment (day 0) and surviving animals were reweighed on days 7 and 14 p.a. (termination). Animals found dead were immediately necropsied. The survlvmg animals were sacrificed by CO2 asphyxiation after 14 days and gross pathological examinations were subsequently performed.
- Statistics:
- LDSO values were calculated by the linear interpolation.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 917 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no condfidence interval given
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 275 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no condfidence interval given
- Mortality:
- females: 2/5 at 200 mg/kg Bw; 4/5 at 500 mg/kg Bw
males: 0/5 at 500 mg/kg Bw; 3/5 at 1000 mg/kg Bw - Clinical signs:
- other: Marked clinical signs were observed mainly within 24 h p.a. in animals which died subsequently. The most frequent findings were reduced activity, abdominal and squatting position, abnormal gait, reduced reflexes, piloerection, increased salivation and dec
- Gross pathology:
- Gross pathological examinations on animals found dead and at 14 days p. a. (terminal necropsy) revealed alterations in the stomach, in the intestinal tract and in the kidney which were considered to be test article-related. In animals found dead the most striking findings were redness of the mucous membrane in the gastro-instinal tract associated with bleeding, redness of the renal medulla and the renal pelvis and induration of the caecum. In animals of group I and II sacrificed at day 14 p.a. the most striking findings was adhesion of the forestomach with inner organs.
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test article Dimetbyl-2-ch1oroacetoacetamide is harmful to rats under the conditions used.
- Executive summary:
The acute oral toxicity of Dimetbyl- 2-ch1oroacetoacetamide was investigated according to OECD guideline 401 in 3 groups of Wistar rats, containing 5 males and 5 females (group II), 5 females (group I) or 5 males (group III). On the basis of the range finding results, the animals were given a single oral administration of "DMCAA" at doses of 200 mg/kg (group I), 500 mg/kg (group II) and 1000 mg/kg (group III).
Clinical observations were conducted at regular intervals during the 14-day observation period. Body weights were measured at days 0, 7 and 14 p.a. Gross pathological examinations were performed immediately on animals found dead and at termination on surviving animals. LD50 values were determined after 24 hand 14 days.
9 of 20 animals died pre-terminally. Marked clinical signs were observed mainly within 24 h p.a. in animals which died subsequently. The most striking findings were reduced activity, tremor, twitches, abdominal and squatting position, decreased reflexes, abnormal gait, increased salivation, piloerection and decreased respiratory rate. In the surviving animals there were normal or reduced weight gains as well as unaltered or decreased body weights. Gross pathological examinations in animals found dead and at 14 days p.a. (terminal necropsy) revealed alterations in the gastro-intestinal tract, in the kidney and in the abdominal cavity which were considered to be test article-related. Approx. 917 mg/kg and approx. 275 mg/kg bw were determined as LD50 values were determined for males and females respectively.
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