Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 - 28 Feb 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- (1996)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- (Commission Directive 96/54/EC)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- MINISTERIUM FÜR RAUMORDNUNG UND UMWELT DES LANDES SACHSEN-ANHALT, Germany
- Test type:
- acute toxic class 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: 233.7 ± 10.0 g (males), 193.7 ± 17.9 g (females)
- Fasting period before study: overnight, and until 3 h after administration
- 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
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2 g/10 mL
- Amount of vehicle: 1 mL/100 g bw
MAXIMUM DOSE VOLUME APPLIED: 1 mL/100 g bw
CLASS METHOD
- Rationale for the selection of the starting dose: The study was performed as limit test. - Doses:
- 2000 mg/kg bw (step 1 and 2)
- No. of animals per sex per dose:
- 3 males (step 1) and 3 females (step 2)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality, morbidity and general clinical condition continuously on the day of administration and subsequently once daily for 14 days. 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 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical observations, body weight - Statistics:
- Body weights and body weight gain: Calculation of group mean values and standard deviations.
Results and discussion
Effect levels
- 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:
- Not any alterations of the general state of well-being were observed 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 was retarded in comparison to the historical control data in the testing facility 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.
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 oral toxicity study in rats a LD50 value of > 2000 mg/kg bw was found.
- Executive summary:
The acute oral toxicity of the test substance was assessed in a study according to OECD Guideline 423, EU Method B.1 tris and in compliance with GLP (2001). A total dose of 2000 mg/kg bw (limit test) test substance was administered to 3 male (1st step) and 3 female rats (2nd step). Animals were observed for mortality and general clinical condition on the day of administration and once daily thereafter for 14 days. 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 symptoms were observed during the study. The body weight gain was not affected by the administration of the test substance. The body weight gain of one female animal was retarded in comparison to the historical control data in the testing facility but it can be assumed that this is not caused by the administration of the test substance and seems to be accidental. No pathological findings were observed at necropsy. Based on the results of this study, the oral LD50 value was determined to be > 2000 mg/kg bw in rats.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.