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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 202-996-4 | CAS number: 102-01-2
- 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: Acceptable well documented study report, which meets basic scientific principles. Study was conducted prior to GLP and OECD guideline implementation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Company guideline similar to OECD 401
- Deviations:
- not applicable
- GLP compliance:
- no
- Remarks:
- prior to GLP implementation
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Acetoacetanilide
- EC Number:
- 202-996-4
- EC Name:
- Acetoacetanilide
- Cas Number:
- 102-01-2
- Molecular formula:
- C10H11NO2
- IUPAC Name:
- 3-oxo-N-phenylbutanamide
- Details on test material:
- - Name of test material (as cited in study report): Acetoacet anilide
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Age: young adults
- Weight: 200-300 g
- Caging: Animals on the same dosage level where placed in a common cage
- Diet/water: water and food, ad libitum
- Animals were fasted for 24hrs prior to the oral administration of the test item
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Doses:
- 4.0, 5.0, 6.4, 8.0, 10.0, 12.6, 16.0 g/kg bodyweight (females)
4.0, 5.0, 6.4, 8.0, 10.0, 12.6, 16.6 g/kg bodyweight (males) - No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Observation: daily for a two week period
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- 4 other: g/kg bw
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 5.4 other: g/kg bw
- 95% CL:
- 4.7 - 6.2
- Sex:
- female
- Dose descriptor:
- LD100
- Effect level:
- 8 other: g/kg bw
- Sex:
- male
- Dose descriptor:
- LD0
- Effect level:
- 4 other: g/kg bw
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 6.5 other: g/kg bw
- 95% CL:
- 5.3 - 8
- Sex:
- male
- Dose descriptor:
- LD100
- Effect level:
- 12.6 other: g/kg bw
- Mortality:
- male
4000 mg/kg bw: 0/5
5000 mg/kg bw: 1/5
6400 mg/kg bw: 2/5
8000 mg/kg bw: 4/5
10000 mg/kg bw: 5/5
12600 mg/kg bw: 5/5
16600 mg/kg bw: 5/5
female
4000 mg/kg bw: 0/5
5000 mg/kg bw: 2/5
6400 mg/kg bw: 4/5
8000 mg/kg bw: 5/5
10000 mg/kg bw: 5/5
12600 mg/kg bw: 5/5
16000 mg/kg bw: 5/5 - Clinical signs:
- other: male 4000 mg/kg bw.: lethargy, tremors 5000 and 6400mg/kg bw.: lethargy, tremors, cyanotic extremities 8000 and 10000mg/kg bw.: lethargy, tremors, cyanotic extremities, coma 12600 and 16000 mg/kg bw.: labored breathing, tremors, coma female 4000 mg/kg bw
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Data support conclusion that lethality is caused by MetHb formation. With respect to MetHb forming substances rats are known to react with lower sensitivity than humans. Based on LD50 values of 5400 or 6500 mg/kg bw for female or male rats, the human acute toxic dose is estimated to be not higher than 2000 mg/kg bw.
- Executive summary:
LD50, male: 6500 mg/kg body weight
LD50, female: 5400 mg/kg body weight
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.