Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-299-8 | CAS number: 105-45-3
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- the study was performed before GLP- and OECD-testing guidelines were available and in force; therefore the study was considered to have Klimisch 2, however itprovides enough information to assess the acute toxicity after to rats after oral application
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- GLP-guidelines not yet in force at date of the study
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Methyl acetoacetate
- EC Number:
- 203-299-8
- EC Name:
- Methyl acetoacetate
- Cas Number:
- 105-45-3
- Molecular formula:
- C5H8O3
- IUPAC Name:
- methyl 3-oxobutanoate
- Test material form:
- other: non-viscous clear liquid
- Details on test material:
- - Physical state: Colourless liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Fasted albino rats were used in this study.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The product under test was placed in a glass syringe and introduced through the esophagus into the stomach with a stainless steel catheter.
- Doses:
- 6 dose groups (males & females) with dosages of:
- 0 mg/kg (control)
- 1000 mg/kg
- 2000 mg/kg
- 2500 mg/kg
- 3200 mg/kg
- 4000 mg/kg
- 8000 mg/kg - No. of animals per sex per dose:
- Five animals per sex and dose
- Control animals:
- yes
- Details on study design:
- A group of approximately 70 albino male and female rats, fasted for twenty-four hours were employed to establish an LD50 range for each product under test. Young adult rats which had not been used for previous test purposes were assigned to various dose levels at random. Both sexes were equally distributed. Body weight of the rats was 200-300 grams at the beginning of the study. Animals on the same dosage level were then placed in a common cage with free access to food and water. The animals were observed daily for a two week period. No postmortem, or histopathology examinations were performed in this particular study.
- Statistics:
- no data
Results and discussion
- Preliminary study:
- No preliminary test performed.
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 580 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 2 230 - 2 980
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 3 370 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 2 920 - 3 900
- Mortality:
- No mortality was observed at dose concentrations of 1000 and 2000 mg/kg. Animals were found dead at 2500 mg/kg and above in males and at 3200 mg/kg and above in females. Details are given in the table below.
- Clinical signs:
- other: Males & females dosed at 1.0 g/kg and 2.0 g/kg were sluggish and unkempt following intubation. Normalcy prevailed within 48 hours. Lethargy, nasal hemorrhage and dirty unkempt coats were noted in all animals dosed at levels ranging from 2.5 g/kg. to 4.0 g
- Gross pathology:
- No postmortem, or histopathology examinations were performed in this particular study.
- Other findings:
- no data
Any other information on results incl. tables
Mortality:
Dose Level (mg/kg) |
No. of deaths (males) |
Number of deaths (females) |
1000 |
0 |
0 |
2000 |
0 |
0 |
2500 |
3 |
0 |
3200 |
4 |
2 |
4000 |
5 (4 at day 1 & 1 at day 3) |
4 |
8000 |
5 |
5 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral toxicity on Albino rats was determined to be 2580 mg/kg for males and 3370 mg/kg for females.
- Executive summary:
The study was carried out equivalent or similar to EU Method B.1 and OECD Guideline 401 (Acute Oral Toxicity). 6 groups of 10 rats (5 male, 5 female) were treated by gavage with doses from 1000 up to 8000 mg/kg.Males & females dosed at 1.0 g/kg and 2.0 g/kg were sluggish and unkempt following intubation. Normalcy prevailed within 48 hours. Lethargy, nasal hemorrhage and dirty unkempt coats were noted in all animals dosed at levels ranging from 2.5 g/kg. to 4.0 g/kg. Death animals were observed at dose levels of 2500 mg/kg and above. At 8000 mg/kg, the animals were comatose immediately after forced feeding and succumbed within 15 minutes.The LD50 value obtained for males was 2580 mg/kg bw and for females 3370 mg/kg bw.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.