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Diss Factsheets
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EC number: 208-293-9 | CAS number: 520-45-6
- 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: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Circa 1950
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- publication
- Title:
- Dehydroacetic acid (DHA): 1. Acute and chronic toxicity
- Author:
- Spencer HC, Rowe VK & McCollister DD
- Year:
- 1 950
- Bibliographic source:
- J. Pharmacol. Exp. Therap., 99; 57-68
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Essentially an oral gavage four-week sub-acute toxicity study, conducted in the rat (a well-established experimental model), in which key toxicity endpoints were evaluated.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 3-acetyl-6-methyl-2H-pyran-2,4(3H)-dione
- EC Number:
- 208-293-9
- EC Name:
- 3-acetyl-6-methyl-2H-pyran-2,4(3H)-dione
- Cas Number:
- 520-45-6
- Molecular formula:
- C8H8O4
- IUPAC Name:
- 3-acetyl-6-methyl-2H-pyran-2,4(3H)-dione
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Not specified
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 24 doses in 34 days
- Frequency of treatment:
- Daily - presumed not at weekends
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- Vehicle control
- Dose / conc.:
- 10 mg/kg bw/day (nominal)
- Dose / conc.:
- 30 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5 or 6
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Male rats 10 weeks old at start of study
- Positive control:
- No
Examinations
- Observations and examinations performed and frequency:
- General condition, body weight
- Sacrifice and pathology:
- Pathology (lung, heart, liver, kidney, spleen, adrenal, pancreas, testis, and stomach), histopathology, blood urea-N
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- At 300 mg/kg bw/day - animals were emaciated, thin and unkempt
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- At 300 mg/kg bw/day - two deaths, one at 7 days the other at 11 days (7 doses)
Remaining rats killed after 11 days
No adverse effects at 0, 10, 30, 100 mg/kg bw/day - Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- At 300 mg/kg bw/day - 20 to 30% of their body weight loss
No adverse effects at 0, 10, 30, 100 mg/kg bw/day - Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- Blood urea-N was determined; the data were inconclusive
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- At 300 mg/kg bw/day - contracted stomach with blood tinged contents, a congested mucosa, and a few haemorrhagic areas.
No adverse effects at t 0, 10, 30, 100 mg/kg bw/day - Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No adverse effects at 0, 10, 30, 100 mg/kg bw/day
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not specified
Effect levels
open allclose all
- Key result
- Dose descriptor:
- LOEL
- Effect level:
- ca. 300 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
- clinical signs
- mortality
- Remarks on result:
- other:
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: No adverse toxicity at 100 mg/kg bw/day.
Target system / organ toxicity
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 300 mg/kg bw/day (nominal)
- System:
- gastrointestinal tract
- Organ:
- stomach
- Treatment related:
- yes
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Any other information on results incl. tables
Data from the second group of rats treated at 300 mg/kg bw/day were similar to the first group at the same dosage.
Applicant's summary and conclusion
- Conclusions:
- General condition and body weight at 0, 10, 30, 100 mg/kg bw/day was unaffected. Additionally, no adverse effects were noted for blood urea-N or after histopathological examination of selected tissues (lung, heart, liver, kidney, spleen, adrenal, pancreas, testis, and stomach). At 300 mg/kg bw/day loss, two deaths occurred (7 & 11 days). The remaining animals at 300 mg/kg bw/day were killed after 11 days (7 doses). These animals lost 20 to 30% of their body weight and were thin and unkempt. Examination of each of these animals revealed marked emaciation and contracted stomach with blood tinged contents, a congested mucosa, and a few haemorrhagic areas. The NOAEL was onsidered to be 100 mg/kg bw/day.
- Executive summary:
In a repeat dose toxicity study (24 doses in 34 days) rats were dosed by oral gavage: 2 groups of 5 or 6 (10 weeks old at start), the dosages were: 0, 10, 30, 100 or 300 mg/kg bw/day (vehicle: olive oil).
There were no adverse effects at 10, 30, 100 mg/kg bw/day. At 300 mg/kg bw/day loss, two deaths occurred (7 & 11 days), there was 20 to 30% body weight loss, the animals appeared thin and unkempt and had a contracted stomach with blood tinged contents, a congested mucosa, and a few haemorrhagic areas. A NOAEL of 100 mg/kg bw/day was determined.
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