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A mixture of: 4-(2,2,3-trimethylcyclopent-3-en-1-yl)-1-methyl-2-oxabicyclo[2.2.2]octane; 1-(2,2,3-trimethylcyclopent-3-en-1-yl)-5-methyl-6-oxabicyclo[3.2.1]octane; spiro[cyclohex-3-en-1-yl-[(4,5,6,6a-tetrahydro-3,6',6',6'a-tetramethyl)-1,3'(3'aH)-[2H]cyclopenta[b]furan]; spiro[cyclohex-3-en-1-yl-[4,5,6,6a-tetrahydro-4,6',6',6'a-tetramethyl)-1,3'(3'aH)-[2H]cyclopenta[b]]furan]
EC number: 422-040-1 | CAS number: 426218-78-2 CASSIFFIX
- 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
Key value for chemical safety assessment
Effects on fertility
Description of key information
Reproduction screening test (OECD TG 421): The parental NOAEL was determined to be >=550 mg/kg bw based on the absence of toxic adverse effects in the parental animals. The fertility NOAEL is >= 550 mg/kg bw based on the absence of reproductive toxicity.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 550 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The information from the reproscreen study and from the information on the gonads of males and females in the 28-day repeated dose study have been derived from OECD/EC guidelines under GLP and are of high quality.
Additional information
In a Reproscreen study (OECD TG 421, GLP), the test substance was administered via the diet to Sprague-Dawley rats at dosages of 70, 170 or 550 mg/kg bw. Control animals received a plain diet. All parameters from the OECD TG 421 have been recorded. The following results were found:
Clinical signs: No effects were seen on body weight (gain) and food consumption. Some piloerection was seen in the females. (Relative) liver weights were increased in males and females in the high dose and minimal liver hepatocellular hypertrophy was noted at minimal degree and was considered to be an adaptive non adverse finding. Adrenal weights were decreased but no macroscopic or microscopic findings related to treatment were noted.
Fertility: Mating index, fertility index, conception index, gestation index and duration of gestation index were not affected by the substance.
Based on the absence of toxicologically relevant effects, the parental NOEAL and the NOAEL for reproduction were determined to be >= 550 mg/kg bw.
Effects on developmental toxicity
Description of key information
Reproductive screening test (OECD TG 421): The parental NOAEL was determined to be >=550 mg/kg bw based on the absence of toxic adverse effects in the parental animals. The developmental NOAEL is >= 550 mg/kg bw based on the absence of developmental toxicity in the first generation animals.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 550 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The information from the reproscreen study has been derived from OECD/EC guidelines under GLP and is of high quality.
Additional information
In a Reproscreen study (OECD TG 421, GLP), the test substance was administered via the diet to Sprague-Dawley rats at dosages of 70, 170 or 550 mg/kg bw. Control animals received a plain diet. All parameters from the OECD TG 421 have been recorded. The following results were found:
Clinical signs: No effects were seen on body weight (gain) and food consumption. Some piloerection was seen in the females. (Relative) liver weights were increased in males and females in the high dose and minimal liver hepatocellular hypertrophy was noted at minimal degree and was considered to be an adaptive non adverse finding. Adrenal weights were decreased but no macroscopic or microscopic findings related to treatment were noted.
Developmental: Number of dead and living pups at first litter check, postnatal loss, viability index and sex ratio were unaffected by treatment. Two pups of the control group, two pups at 1.000 ppm and one pup at 2.500 ppm were found dead or missing during the first days of lactation. No toxicological relevance was attributed to these dead/missing pups since the mortality incidence did not show a dose-related trend and remained within the range considered normal for pups of this age.
Based on the absence of toxicologically relevant effects, the parental NOEAL and the NOAEL for development were determined to be >= 550 mg/kg bw.
Justification for classification or non-classification
Based on the results of the available Repeated dose and Reproductive toxicity studies, the substance does not have to be classified for reproductive toxicity (fertility and developmental toxicity) according to EU CLP (EC 1272/2008 and its amendments).
Additional information
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.
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