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EC number: 204-514-8 | CAS number: 122-00-9
- 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
Endpoint summary
Administrative data
Description of key information
Oral (subchronic): NOEL = 578 mg/kg bw/day 4'-methylacetophenone (data derived from subchronic acetophenone study with systemic NOEL = 518 mg/kg bw/day)
Oral (subacute): NOAEL = 251 mg/kg bw/day 4'-methylacetophenone (data derived from subacute acetophenone study with systemic NOAEL = 225 mg/kg bw/day); LOAEL = 838 mg/kg bw/day 4'-methylacetophenone (data derived from subacute acetophenone study with systemic LOAEL = 750 mg/kg bw/day)
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Pre-GLP, pre-OECD TG study with sufficient detail in documentation
- Principles of method if other than guideline:
- The study was conducted prior to the publication of OECD TGs. Rats received daily oral doses of the test substance dissolved in corn oil for a period of 17 weeks.
- GLP compliance:
- no
- Limit test:
- no
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: not reported
- Age at study initiation: weanling
- Weight at study initiation: not reported
- Fasting period before study: not reported
- Housing: individually in wire cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not reported
ENVIRONMENTAL CONDITIONS
- not reported - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
appropriate amounts of test substance were weighed and mixed in the diet - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Loss of acetophenone from laboratory animal diet during a 7-day period: 31 %
Percentage loss = 100-(100xday 7 recovery/day 0 recovery) - Duration of treatment / exposure:
- 17 weeks
- Frequency of treatment:
- Continuously
- Remarks:
- Doses / Concentrations:
0, 1000, 2500 and 10000 ppm
Basis:
nominal in diet - Remarks:
- Doses / Concentrations:
0, 75, 118, 750 mg/kg bw/day
Basis:
other: calculated from assumed body weight (400 g) and food consumption (30 mg/day/rat) - No. of animals per sex per dose:
- 10 males and 10 females
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Dose selection rationale: not reported
- Positive control:
- No
- Observations and examinations performed and frequency:
- Body weight, food intake and general conditions: every week
Haematology (white cell count, red cell count, haemoglobins, haematocrits): after three months
Gross pathology: at termination of study
Histopathology: at termination of study - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- Not reported
- Statistics:
- Not reported
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- There was no effect on growth or haematology, and no macroscopic or microscopic change in the tissues.
- Dose descriptor:
- NOEL
- Effect level:
- 100 000 ppm
- Based on:
- test mat.
- Remarks:
- acetophenone
- Sex:
- male/female
- Basis for effect level:
- other: No effect
- Dose descriptor:
- NOEL
- Effect level:
- 518 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Remarks:
- acetophenone
- Sex:
- male/female
- Basis for effect level:
- other: No effect observed at the highest received dose = 750 mg/kg bw/day, but assuming 31 % loss of acetophenone from laboratory animal diet during a 7-day period
- Dose descriptor:
- NOEL
- Effect level:
- 578 mg/kg bw/day (nominal)
- Based on:
- other: 4'-methylacetophenone
- Sex:
- male/female
- Critical effects observed:
- not specified
- Conclusions:
- Oral repeated exposure of rats to acetophenone by feeding over a period of 17 weeks resulted no adverse effects up to 100000 ppm in the diet. Considering 31 % of acetophenone loss from laboratory animal diet during a 7-day period, the corrected NOEL is 518 mg/kg bw/day.
- Executive summary:
The oral repeated dose toxicity of acetophenone to male and female Osborne-Mendel rats was studied over a period of 17 weeks. The test substance was added in the food at doses of 1000, 2500 and 100000 ppm to ten males and ten females in each dose group. A untreated control group was investigated in parallel. All animals were weanling at the beginning of the study. The body weight, food consumption and general condition of animals were recorded regularly. Haematological investigations were performed after 3 months. At the end of the study all animals were sacrificed. Gross pathology was performed on every rat and organs were weighed. Sections were prepared from relevant organs for histopathological studies, which were performed for a representative fraction of animals (6 or 8) in high dose and control groups evenly divided by sex. No effects on growth or haematology, and no macroscopic or microscopic change in the tissues were found at the end of the study up to 100000 ppm dose level. It was concluded that the no-effect level (NOEL) was at 100000 ppm or 750 mg/kg bw/day in male and female Osborne-Mendel rats. Considering 31 % of acetophenone loss from laboratory animal diet during a 7-day period, the corrected NOEL is 518 mg/kg bw/day.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 578 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Two reliable studies, one subacute and one subchronic, with read across substance acetophenone are available.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
There are no repeated dose toxicity data on 4'-methylacetophenone.
- Repeated dose toxicity: oral (read across from acetophenone)
A repeated dose toxicity study is available for acetophenone, which is a read-across substance for 4'-methylacetophenone. The substance is deemed to not show classifiable specific target organ toxicity. One reliable subacute study conducted according to OECD TG 422 and GLP in rats is available (Thorsrud 2003) using oral (gavage) dose levels of acetophenone at 0, 75, 225 and 750 mg/kg bw/day. The NOAEL for repeated dose toxicity of acetophenone was 225 mg/kg bw/day (equivalent to 251 mg/kg bw/day 4'-methylacetophenone), based on neurobehavioural findings at 750 mg/kg bw/day acetophenone. Therefore, the LOAEL was 750 mg/kg bw/day acetophenone (equivalent to 838 mg/kg bw/day 4'-methylacetophenone).
Another reliable subchronic study (17-week) conducted in rats according to scientific principles is also available (Hagan et al 1967). Using oral (feeding) dose levels of acetophenone at 0, 1000, 2500 and 100000 ppm, the NOEL was determined at 100000 ppm. Assuming 400 g rat body weight and 30 mg food consumption per day, 100000 ppm corresponds to 750 mg/kg bw/day dose. In this feeding study, 31 % loss of acetophenone from laboratory animal diet during a 7-day period should be considered. Therefore the NOEL should be reduced to 518 mg/kg bw/day acetophenone (equivalent to 578 mg/kg bw/day 4’-methylacetophenone).
The NOEL from the subchronic feeding study (578 mg/kg bw/day) was selected as a starting point for the DNEL derivation as the more reliable result of a prolonged subchronic study (17-weeks or 119 days).
According to CLP Regulation, the classification of a substance for repeated dose toxicity is based on the LOAEL defined in a subchronic study. The LOAEL obtained from a subacute toxicity study may be converted by applying an uncertainty factor of 3. Consequently, a 28-day LOAEL value of equal to or less than 300 mg/kg bw/day would trigger classification. The LOAEL for acetophenone (and the LOAEL calculated for 4'-methylacetophenone) is considerably greater than 300 mg/kg bw/day. Classification for repeated dose toxicity is not required.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
The reliable subchronic study available for acetophenone was taken as read across to 4'-methylacetophenone.
Justification for classification or non-classification
- Repeated dose toxicity, oral:
Based on the above stated assessment of the specific target organ toxicity potential after repeated oral exposure to acetophenone, 4'-methylacetophenone does not need to be classified according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) or according to CLP (Regulation (EC) No 1272/2008 of the European Parliament and of the Council) as implementation of UN-GHS in the EU.
- Repeated dose toxicity, dermal:
As no data on of the specific target organ toxicity potential after repeated dermal exposure of 4'-methylacetophenone is available a classification is not possible according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and according to CLP (Regulation (EC) No 1272/2008 of the European Parliament and of the Council) as implementation of UN-GHS in the EU.
- Repeated dose toxicity, inhalation:
As no reliable data on of the specific target organ toxicity potential after repeated inhalation exposure of 4'-methylacetophenone is available a classification is not possible according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and according to CLP (Regulation (EC) No 1272/2008 of the European Parliament and of the Council) as implementation of UN-GHS in the EU.
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