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Diss Factsheets
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EC number: 200-662-2 | CAS number: 67-64-1
- 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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study meets generally accepted scientific principles with the following restrictions: single test concentration, daily exposure time limited to 3 hrs, limited number of endpoints investigated, less detailed documentation; study acceptable for weight of evidence approach
Data source
Reference
- Reference Type:
- publication
- Title:
- Evaluation of toluene and acetone inhalant abuse. II. Model development and toxicology
- Author:
- Bruckner JV, Peterson RG
- Year:
- 1 981
- Bibliographic source:
- Toxicol Appl Pharmacol 61: 302-312
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Examined endpoints: body weight gain, organ weights (liver, kidney, brain, lung), histopathology of liver, kidney, brain, lung, and heart, serum clinical chemistry
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Acetone
- EC Number:
- 200-662-2
- EC Name:
- Acetone
- Cas Number:
- 67-64-1
- Molecular formula:
- C3H6O
- IUPAC Name:
- propan-2-one
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: ARS/Sprague-Dawley, Madison, Wisconsin
- Age at study initiation: 4 w
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5-7 d
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: 16 liter-chamber
- Method of holding animals in test chamber: cages used for housing were also used for exposure, with a wire mesh bottom placed into the cages instead of the feed and wood shaving bedding material
- Air flow rate: 24 L/min
TEST ATMOSPHERE
- Brief description of analytical method used: gas chromatographic analysis at 30-sec intervals
- Samples taken from breathing zone: no data
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- gas chromatographic analysis at 30-sec intervals
- Duration of treatment / exposure:
- 2, 4, 8 w
- Frequency of treatment:
- 5 d/w, 3 hrs/d
Doses / concentrations
- Remarks:
- Doses / Concentrations:
19,000 ppm corresponding to 45,000 mg/m3
Basis:
nominal conc.
- No. of animals per sex per dose:
- 9 per timepoint: N=5 for serum biochemical and organ weight investigations, N=4 for histopathological examination
- Control animals:
- yes, sham-exposed
- Details on study design:
- Post-exposure observation group: 8 w exposure followed by 2 without exposure
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: twice per week
FOOD CONSUMPTION: No data
WATER CONSUMPTION: No data
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: No
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at 4, 8 w of exposure and after 2 w post-observation period
- Animals fasted: No data
- How many animals: 5
- Parameters examined: serum glutamic-oxaloacetic transaminase (SGOT), lactate dehydrogenase (LDH), blood urea nitrogen (BUN)
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- ORGAN WEIGHTS: liver, kidney, lung, brain at 0, 4, 8 w of exposure and after 8 w of exposure and 2 w of recovery
HISTOPATHOLOGY: liver, kidney, lung, heart, brain at 0, 4, 8 w of exposure and after 8 w of exposure and 2 w of recovery - Statistics:
- Student's t-test
Results and discussion
Effect levels
- Dose descriptor:
- NOAEC
- Effect level:
- 19 000 ppm
- Sex:
- male
- Basis for effect level:
- other: overall effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
The only significant changes were decreases of absolute weights of kidney (only after 4 w of exposure) and of brain weight (at 4 and 8 w of exposure) in comparison to control animals. These changes were reversible within 2 w of post-observation. Weight gain also showed a tendency to depression (never significant). There were no recognizable histopathological changes in these tissues.
Table 1: Changes of absolute organ weights (g wet weight; N= 5 rats/timepoint)
Organ | Group | Timepoint | |||
0 | 4 w exposure | 8 w exposure | 2 w post-exposure | ||
Brain | Control | 1.49 | 1.71 | 1.91 | 1.84 |
Exposed | 1.60 * | 1.70 * | 1.80 | ||
Kidney | Control | 0.71 | 1.65 | 2.26 | 2.22 |
Exposed | 1.38 ** | 2.12 | 2.29 |
* statistically significant, p<0.02
** statistically significant, p<0.01
Applicant's summary and conclusion
- Conclusions:
- After 8 weeks of exposure of rats to 19,000 ppm (3 hrs/day) there were no indications of an adverse systemic toxic effect from the investigated endpoints.
- Executive summary:
Groups of male rats (N=9) were exposed to a single concentration of 19,000 ppm acetone (45,000 mg/m3) for 2,4 or 8 weeks, 5 days/week and 3 hours/daily. Under the conditions of this exposure there were no indications of an adverse toxic effect from the investigated endpoints being body weight gain, organ weights (liver, kidney, brain, lung; N=5), histopathology of liver, kidney, brain, lung, and heart (N=4) and serum clinical chemistry parameters (SGOT, LDH and BUN; N=5). Slight significant decreases of weights of brain (at 4 and 8 w of exposure) and of kidney (only at 4 w of exposure) correlated with a depression of body weight gain (not significant) and were without a histological correlate. Based on the investigated endpoints the NOAEC is 19,000 ppm acetone or 45,000 mg/m3.
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