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EC number: 438-930-8 | CAS number: 2550-52-9
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 - 27 Feb 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- occlusive instead of semi-occlusive dressing
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- (1987)
- Deviations:
- yes
- Remarks:
- occlusive instead of semi-occlusive dressing
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- (Commission Directive 92/69/EEC)
- Deviations:
- yes
- Remarks:
- occlusive instead of semi-occlusive dressing
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- MINISTERIUM FÜR RAUMORDNUNG UND UMWELT DES LANDES SACHSEN-ANHALT, Germany
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 438-930-8
- EC Name:
- -
- Cas Number:
- 2550-52-9
- Molecular formula:
- C16H30O
- IUPAC Name:
- cyclohexadecanone
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approx. 7 weeks
- Weight at study initiation: 263.8 ± 7.9 g (males), 204.8 ± 8.6 g (females)
- Fasting period before study: no
- Housing: individually in Makrolon Type 3 cages, granulated soft wood bedding
- Diet: ALTROMIN 1324, pelleted standard diet (ALTROMIN, Lage/Lippe, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.5 - 23.5
- Humidity (%): 30 -40, with a shortly falling below to 23
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- corn oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 6 x 6 cm shaved skin from the dorsal area of the trunk
- Type of wrap if used: two layers of gaze patch covered with aluminium foil, which was held in contact with the skin by occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing: yes, rinsed with corn oil
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount applied: 1 mL/100 g bw
- Concentration: 20% (w/v)
VEHICLE
- Amount applied: 1 mL /100 g bw - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for mortality, morbidity and general clinical condition continuously on the day of administration and once daily thereafter (in the morning). The following signs were given predominant consideration: changes in skin, fur, eyes and mucous membranes; gait and posture; respiratory, circulatory, autonomic and central nervous system; occurrence of secretions and excretions; presence of clonic or tonic movements and stereotypies or bizarre behaviour. Body weights were recorded on the day of administration and on days 7 and 14 thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight; Skin of administration area was observed for erythema and/or edema one hour after patch removal and once daily thereafter. - Statistics:
- Body weights and body weight gain: Calculation of group mean values and standard deviations.
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:
- None of the animals died during the course of the study.
- Clinical signs:
- None of the animals showed alterations of the general state of well-being during the course of
the study. - Body weight:
- The body weight gain was not affected by the administration of the test item, it was in the range of the historical control data in the testing facility. The body weight gain of one female animal stagnated in the first week but it can be assumed that this is not caused by the administration of the test item and seems to be accidental.
- Gross pathology:
- There were no macroscopic pathological findings in the animals.
- Other findings:
- None of the animals showed alterations of the skin on the administration area.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- In this acute dermal toxicity study a LD50 value > 2000 mg/kg bw in male and female rats was found.
- Executive summary:
The acute dermal toxicity of the test substance was assessed in a limit test performed in 5 male and 5 female Wistar rats according to OECD Guideline 402, EU Method B.3 and in compliance with GLP (2001). The test substance was applied at a single dose of 2000 mg/kg body weight to a shaved dorsal area of the trunk of the animals and was then held in contact with the skin with an occlusive dressing for 24 hours. Animals were observed for mortality, general clinical condition and alterations of the administration area (erythema and/or oedema) for a 14-day period. Body weights were recorded on the day of administration and on days 7 and 14 thereafter. Macroscopic examination was performed in the end of the observation period at terminal sacrifice. None of the animals died and no clinical signs or skin alterations on the administration area were observed. The body weight gain was not affected by the administration of the test item. The body weight gain of one female animal stagnated in the first week but it can be assumed that this is not caused by the administration of the test item and seems to be accidental. No pathological findings were observed at necropsy. Based on the results of this study, the LD50 value for acute dermal toxicity was determined to be > 2000 mg/kg bw in rats.
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