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EC number: 406-810-4 | CAS number: 40649-36-3
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-09-18 to 1990-01-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-propylcyclohexanone
- EC Number:
- 406-810-4
- EC Name:
- 4-propylcyclohexanone
- Cas Number:
- 40649-36-3
- Molecular formula:
- C9H16O
- IUPAC Name:
- 4-propylcyclohexan-1-one
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Chbb: THOM
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Thomae, Biberach
- Age at study initiation: about 7 to 9 weeks
- Weight at study initiation (mean): 201 (187-220) g
- Housing: They were housed under conventional conditions in a 60 m² room with daylight and artificial fluorescent light (light phase: 6 a.m. - 6 p.m.). The treated rats were kept separately in Makrolon cages type III (floor area: 37.5 x 21 cm - 787.5 cm2, height: 15 cm) on mobile racks. During the acclimatization phase and then for the first 28 hours after start of the treatment, the animals were kept on metal grids (placed above the softwood granulate) and then on conventional softwood granulate as bedding. The cages and the metal grids had been machine-cleaned before the beginning of the study. The bedding was changed three times a week.
- Diet: ad libitum, Altromin Strandard Diet Total Pathogen Free TFF N1324
- Water: tpa water; ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 to 31 °C
- Humidity (%): 43 to 56%
- Photoperiod: light phase from 6 a.m. - 6 p.m.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: The backs and abdomens of the rats were shaved with an electric hair clipper approximately one hour before treatment.
- Type of wrap: The test material was applied to the shaven, unscarified skin in an area of 6 x 6 cm and covered with tin foil which was kept in place and sealed by a rubber sleeve.
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h
After exposure rubber sleeve and tin foil were removed and any remaining test material was wiped off carefully.
TEST MATERIAL
- Amount applied: 2.21 mL/kg
- Constant volume or concentration used: yes
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Remarks:
- The control rats were treated with 20 mL/kg 0.25% aqueous Methocel K 4M Premium solution.
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Behavior and general condition of all rats were checked daily. All rats were weighed before treatment, as well as on days 2, 4, 6, 8, 11, 13 and 15 of the study.
- Necropsy of survivors performed: yes
All the rats were sacrificed at the end of the study by CO2-asphyxia and subjected to gross pathological investigation. - Statistics:
- The body weight data were processed by means of the program TOX 511 A, developed by the Department of Technical and Scientific Data Processing of E. Merck, Darmstadt.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All the rats survived the observation period.
- Clinical signs:
- After removal of the rubber sleeve the rats showed neither intoxication nor local symptoms.
- Body weight:
- Body weight development of treated and control rats was normal.
- Gross pathology:
- In the rats which were all sacrificed at the end of the observation period no organ alterations were seen.
Any other information on results incl. tables
On the day of administration general condition and motility of the rats were obviously affected by the method of administration. It was difficult to distinguish between reactions due to fixation by the rubber sleeve and symptoms possibly due to the administration of the test material. Therefore, certain reactions may have been masked.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the result of this study, it is concluded that the test material has no acute toxic potential. The median lethal dose (LD50) for males and females, after an observation period of 15 days, was >2000 mg/kg.
- Executive summary:
A study according OECD TG 402 was performed to determine the acute toxicity in rats after epicutaneous administration. The test material was applied undiluted to shaved backs and abdomens of the rats for 24 hours under occlusive conditions. Behavior and general condition of all rats were checked daily. All rats were weighed before treatment, as well as on days 2, 4, 6, 8, 11, 13 and 15 of the study. All the rats were sacrificed at the end of the study by CO2-asphyxia and subjected to gross pathological investigation. In this limit test with 2000 mg/kg bw no animal died and no gross pathology changes were detected. The median lethal dose (LD50) for males and females, after an observation period of 15 days, was > 2000 mg/kg bw.
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