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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
Toxicity to reproduction
Administrative data
- Endpoint:
- reproductive toxicity, other
- Remarks:
- other: toxicity study with specific investigation of effects on male fertility
- 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 basic scientific principles as a study of effects on male fertility with the following restictions: as the acetone-treated groups were part of a study on the combined action of acetone and DEHP at fixed acetone concentrations only a single acetone concentration was used for each exposure period, negative results not presented in detail; study acceptable for weight of evidence approach
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicity study of di(2-ethylhexyl)phthalate (DEHP) in combination with acetone in rats
- Author:
- Dalgaard M, Ostergaard G, Lam HL, Hansen EV, Ladefoged O
- Year:
- 2 000
- Bibliographic source:
- Pharmacol Toxicol 86: 92-100
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Assessment of male fertility via reproductive indices (matings after 3 w pretreatment), immunohistochemistry of testes, and histopathology of male reproductive organs; systemic toxicity assessed by body weights, clinical biochemistry parameters, behavioural toxicity, organ weights and histopathology
- 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
- Details on test material:
- - Analytical purity: analytical grade (no further data)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Möllegaard Breeding Centre Ltd., DK-4623 Ll. Skensved, Denmark
- Age at study initiation: Females 10 weeks
- Weight at study initiation: Males: 160 g
- Housing: 2 rats/cage
- Diet: ad libitum
- Water: libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +- 1
- Humidity (%): 55 +- 5
- Photoperiod (hrs dark / hrs light): 12/12 (reversed day / night cycle)
Administration / exposure
- Route of administration:
- oral: drinking water
- Details on mating procedure:
- - M/F ratio per cage: 1/1
- Length of cohabitation: 1 week during the 4th week of exposure
- Proof of pregnancy: vaginal plug
- After successful mating each pregnant female was caged for 15 days - Duration of treatment / exposure:
- 4 weeks: 1.0 %-dose group
9 weeks: 0.5 %-dose group - Frequency of treatment:
- daily
- Details on study schedule:
- During the last week of the 4-week study all male rats were mated with undosed females. A female rat was placed in a cage with a male rat for 6 h daily until mating was recognised (presence of vaginal plug) or for the maximum of 7 days.
On day 15 after mating female rats were sacrificed and the uteri were examined for the presence of implantations and foetuses.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 5000 mg/L (0.5 %)
Basis:
nominal in water
9 week exposure, corresponding to an estimated dose of 650 mg/kg bw/d
- Remarks:
- Doses / Concentrations:
0, 10000 mg/L (0, 1 %)
Basis:
nominal in water
4 week exposure; corresponding to a dose of 1300 mg/kg bw/d
- No. of animals per sex per dose:
- 10 treated males per dose and exposure duration
10 untreated females per male dose group (only in the 4 week study) - Details on study design:
- - Further dose groups exposed to DEHP as the intention of the study was to investigate the combined toxicity of DEHP and acetone.
- Positive control:
- - Dose groups treated with DEHP can be regarded as positive control groups.
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: twice daily
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION: Yes
- Time schedule for examinations: weekly for each cage (2 animals)
WATER CONSUMPTION : Yes
- Time schedule for examinations: weekly for each cage (2 animals)
OTHER: Yes
CLINICAL BIOCHEMISTRY: blood samples taken on day before sacrifice from orbital plexus. Plasma was isolated and analysis was performed on a COBAS-MIRA autoanalyzer by use of commercially available test kits. Clinical biochemical parameters examined were: alanine aminotransferase ALAT, bilirubin, cholesterol, glucose, triglycerides, creatinine, urea, protein, uric acid, lactate dehydrogenase LDH
BEHAVIOUR: Rats observed in Functional Observation Battery during handling and in an open field for a number of sensory, motor and physiological endpoints, for responsiveness to visual, auditory and tactile stimuli. Additionally, foot splay, righting reflex and fore- and hindlimb grip strength were measured. - Sperm parameters (parental animals):
- Histopathology of testes, epididymis, seminal vescicles
grading of histopathological findings of the testes: normal, slight/moderate atrophy, severe atrophy
Expression of the cell structure protein vimentin: immunohistochemisty in Sertoli cells, surrounding basal lamina pria and in interstitial cells - Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals after termination of exposure
- Maternal animals: on day 15 after mating
ORGAN WEIGHTS (male rats): liver, kidneys, adrenals, heart, spleen, brain, testes, epididymis, seminal vescicles
HISTOPATHOLOGY
- Male rats: light microscopic examination of liver, kidneys, adrenals, heart, spleen, brain, male reproductive organs (see Sperm parameters) - Statistics:
- two-factor ANOVA: FOB test, food and water consumption, clinical biochemistry, body and organ weights
Chi-square test: fertility data - Reproductive indices:
- - Number of males without recognised mating
- Number of pregnant females
- Number of implantations
- Number of dead or retarded foetuses
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Details on results (P0)
- Glucose level in plasma (mmol/l): significant decrease in 1 % acetone-treated rats (p<0.05); control 10.4 mmol/L, 1 % acetone 8.34 mmol/L
BEHAVIOUR
- Hindlimb grip strength: significant decrease in 1 % acetone-treated rats (p<0.05); control 820, 1 % acetone 650
- Forelimb grip strength: decrease in 1 % acetone-treated rats not significant; control 1080, 1 % acetone 890
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS)
- Number of males without recognised matings: control 1/10, 1 % acetone 0/10
- Number of pregnant females: control 9/10, 1 % acetone 9/10
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- 10 000 mg/L drinking water
- Sex:
- male
- Basis for effect level:
- other: male fertility
- Dose descriptor:
- LOAEL
- Effect level:
- 10 000 mg/L drinking water
- Sex:
- male
- Basis for effect level:
- other: other: behavioural effect
Results: F1 generation
Effect levels (F1)
- Remarks on result:
- other: Not investigated, specific study on male fertility
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Acetone exposure (5000 mg/L drinking water for 8 weeks or 10000 mg/L drinking water for 4 weeks) had no adverse effect on male fertility.
- Executive summary:
Male Wistar rats were exposed to 0 or 10,000 mg acetone/L drinking water for 4 weeks or 0 or 5,000 mg acetone/L drinking water for 9 weeks (corresponding to doses of 1,300 or 650 mg/kg bw/d). Clinical signs, body weight, food and water consumption, organ weights, and clinical biochemical parameters were examined. Behavioural toxicity was screened via a Functional Observation Battery. In the last week of the 4 -week study each male was mated with an untreated female rat to investigate reproductive performance (number of males without recognised mating, number of pregnant females, number of implantations, number of dead or retarded fetuses). Histopathology was performed on liver, kidneys, adrenals, heart, spleen, brain, and with special emphasis on male reproductive organs (testes, epididymis, seminal vescicles). Expression of the cell structure protein vimentin was analyzed via immunohistochemistry in the testes in Sertoli cells, the surrounding basal lamina propria and in interstitial cells.
Acetone exposure had no adverse effect on male fertility (NOEL 10,000 mg/L). Four weeks of exposure to the 10,000 -mg/L dose level exerted effects outside the reproductive system as the glucose level was decreased in plasma and parameters of behavioural toxicity were changed. Hindlimb and forelimb grip strengths were decreased with a significant effect on the former parameter only.
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