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EC number: 259-423-6 | CAS number: 54982-83-1
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 1991-12-10 to 1991-12-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The information is used for read across to Zenolide.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- A mixture of: (E)-oxacyclohexadec-12-en-2-one; (E)-oxacyclohexadec-13-en-2-one; a) (Z)-oxacyclohexadec-(12)-en-2-one and b) (Z)-oxacyclohexadec-(13)-en-2-one
- EC Number:
- 422-320-3
- EC Name:
- A mixture of: (E)-oxacyclohexadec-12-en-2-one; (E)-oxacyclohexadec-13-en-2-one; a) (Z)-oxacyclohexadec-(12)-en-2-one and b) (Z)-oxacyclohexadec-(13)-en-2-one
- Molecular formula:
- C15H26O2
- IUPAC Name:
- (12E)-1-oxacyclohexadec-12-en-2-one; (12Z)-1-oxacyclohexadec-12-en-2-one; (13E)-1-oxacyclohexadec-13-en-2-one; (13Z)-1-oxacyclohexadec-13-en-2-one
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Ranch Rabbits, Crawley Down, Sussex - England
- Weight at study initiation: 2.7, 3.4, 2.8 & 3.2 kg
- Housing: individually housed in grid bottomed metal cages.
- Diet: Free access to antibiotic-free pelleted diet, SQC Stanrab (Special Diets Services, Witham, Essex). (Quality checked)
- Water: Free access via an automatic watering system were freely available. (Quality checked)
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 to 22 (On 3 occasions the temperature fell below the protocol specified range, the temperature of 15°C being recorded on only one of these occasions. These deviations were considered not to have affected the outcome of the study)
- Humidity (%): 37 to 59
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 10 Dec 1991 2004 To: 20 Dec 1991
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Observation period (in vivo):
- Approximately 1 hour and 24, 48 and 72 hours following treatment. An assessment of the initial pain reaction was made immediately after administration of the test material.
- Number of animals or in vitro replicates:
- 4
- Details on study design:
- A volume of 0.1 ml of the test material was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for a few second immediately after treatment, to prevent loss of the test material, and then released. One rabbit was dosed initially to assess the severity of irritation or pain. As the response to treatment was considered acceptable the remaining three animals were then dosed.
TOOL USED TO ASSESS SCORE: animals were examined under a standard light source designed to comply with the requirements of BS 950 Part 1 (Artificial Daylight for the Assessment of Colour).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- One hour after dosing, conjunctival discharge and hyperaemia was apparent in the treated eye of all 4 animals. In addition, conjunctival chemosis was noted in one rabbit. Twenty four hours after dosing, these signs of irritation were no longer apparent and the eyes of all 4 rabbits appeared normal at the 48 and 72 hour observation periods.
Applicant's summary and conclusion
- Interpretation of results:
- other: Not an eye irritant
- Remarks:
- according to EU CLP (EC 1272/2008 and its amendments)
- Conclusions:
- In an OECD guideline 405 study conducted in compliance with GLP, the test substance is considered to be not irritating to the eye.
- Executive summary:
In an eye irritation study performed according to GLP and OECD guideline 405, 0.1 ml of the test substance was instilled into one eye of each of four rabbits. The animals were then observed for seven days. One hour after dosing, conjunctival discharge and hyperaemia were apparent in the treated eye of all 4 animals. In addition, conjunctival chemosis was noted in one rabbit. Twenty four hours after dosing, these signs of irritation were no longer apparent and the eyes of all 4 rabbits appeared normal at the 48 and 72 hour observation periods. As such, the substance does not need to be classified for eye irritation.
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