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EC number: 247-724-5 | CAS number: 26472-00-4
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well conducted, GLP compliant study, according to recognised international test methods
Data source
Reference
- Reference Type:
- other: USEPA High Production Volume Information System (HPVIS)
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Methylcyclopentadiene
- EC Number:
- 247-724-5
- EC Name:
- Methylcyclopentadiene
- Cas Number:
- 26472-00-4
- Molecular formula:
- not applicable, UVCB substance
- IUPAC Name:
- 3a,4,7,7a-tetrahydro-1H-4,7-methanoindene
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- At least 28 days
- Frequency of treatment:
- Daily, 7 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 20, 100 and 300 mg/kg
Basis:
no data
- No. of animals per sex per dose:
- 12 male / 12 female
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Rationale for selecting satellite groups: Assessment of reproductiuve toxicity parameters
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
FOOD CONSUMPTION AND COMPOUND INTAKE
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
WATER CONSUMPTION AND COMPOUND INTAKE: No data
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: Yes
- Time schedule for collection of blood: At end of treatmet period
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: At end of treatment period
- Animals fasted: No data
URINALYSIS: No data
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: Prior to treatmemt and again at end of treatment period
- Dose groups that were examined: All
- Battery of functions tested: sensory activity / grip strength / motor activity - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- Group means and standard deviations were calculated for all measured parameters.
Jonckheere-Terpstra trend test - Body weight, weight gain, food consumption and organ weights
One-way analysis of variance followed with Dunnett’s test - Food efficiency and clinical pathology parameters
Cochran-Armitage trend test - Clinical observations and FOB parameters
One-way analysis of variance and Dunnett’s test - Grip strength, foot splay, rearing and body temperature
Repeated measures analysis of variance with linear contrasts or Jonckheere’s trend test - Motor activity
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- effects observed, treatment-related
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Behaviour (functional findings):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Details on results:
- CLINICAL SIGNS AND MORTALITY
Increased incidences of salivation, stained fur and/or wet fur were observed in males and females dosed at 100 or 300 mg/kg/day. Lachrymation was observed in females dosed at 300 mg/kg/day. Salivation was observed males and satellite females dosed at 20 mg/kg/day.
No treatment related mortality occurred.
BODY WEIGHT AND WEIGHT GAIN
Treatment related decreases in body weight and/or weight gain were observed in males and females dosed at 300 mg/kg/day. On test day 28 the body weight of males and females dosed at 300 mg/kg/day was 7.5% and 4% lower than control values, respectively.
Body weight gain over the interval of test days 1-28 for males and females dosed at 300 mg/kg/day was 19% and 16% lower than control values, respectively.
Instances of decreased body weight and/or weight gain were observed in males and females dosed at 100 mg/kg/day.
FOOD CONSUMPTION AND FOOD EFFICIENCY
Significant decreases in food consumption and/or food efficiency occurred in females dosed at 300 mg/kg/day. Food consumption was 9% lower than control value over the test days 1-28 interval. Transient changes in food consumption and/or food efficiency were also observed in males and/or
females dosed at 100 or 300 mg/kg/day.
HAEMATOLOGY AND CLINICAL CHEMISTRY
Haematological or clinical chemistry parameters in male or female rats showed no effects of treatment.
NEUROBEHAVIOUR
Significantly decreased motor activity was observed in males dosed at 300 mg/kg/day during the last 20 minutes of the assessment period for the Week 4 evaluation. This was not apparent in females dosed at the same level. No treatment related effects were observed in grip strength, foot splay, rearing, body temperature, or in any of the other FOB parameters.
ORGAN WEIGHTS
Females dosed at 300 mg/kg/day exhibited a slight increase in kidney weight.
Increased liver weight observed in females dosed at 100 and 300 mg/kg/day and in males dosed at 300 mg/kg/day.
Adrenal gland weights in females dosed at 300 mg/kg/day were slightly increased.
HISTOPATHOLOGY: NON-NEOPLASTIC
An increase in hyaline droplets in the kidneys was observed in all treated male rats. Increased
hyaline droplets were not observed in females. The hyaline droplet accumulation in male rats is species and sex specific and is not predictive of an effect on other species.
Hepatocellular hypertrophy was observed in females dosed at 100 and 300 mg/kg/day and in males dosed at 300 mg/kg/day. It was considered that this change may be secondary to enzyme induction as a pharmacological response to treatment with the substance.
Minimal to mild thyroid follicular hypertrophy was observed in males dosed at 300 mg/kg/day which was considered to be substance related.
The change in adrenal gland weights noted in females dosed at 300 mg/kg/day was not associated with morphological changes.
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- 20 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Systemic toxicity and pahology
- Dose descriptor:
- NOAEL
- Effect level:
- 20 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Systemic toxicity and pathology
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
- Dose descriptor:
- LOEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Systemic toxicity and pathology
- Dose descriptor:
- LOEL
- Effect level:
- 20 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Systemic toxicity and pathology
- Dose descriptor:
- NOEL
- Effect level:
- 300 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Neurobehaviour parameters
- Dose descriptor:
- NOEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Neurobehavioural parameters
- Dose descriptor:
- LOEL
- Effect level:
- 300 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Neurobehavioural parameters
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Repeated administration of the test substance to male and female Sprague Dawley rats at a dose level of 300 mg/kg/day resulted in clinical signs of toxicity, effects on body weight, food consumption, motor activity and histopathological changes. Effects on body weight, clinical signs and food consumption were observed at the lower dose of 100 mg/kg/day. Clinical signs of toxicity were observed in males at 20 mg/kg/day.
Based on these findings the no-observed-adverse-effect level (NOAEL) for systemic toxicity was 20 mg/kg/day in females and was not established in males. - Executive summary:
Repeated administration of the test substance to male and female Sprague Dawley rats at a dose level of 300 mg/kg/day resulted in clinical signs of toxicity, effects on body weight, food consumption, motor activity and histopathological changes. Effects on body weight, clinical signs and food consumption were observed at the lower dose of 100 mg/kg/day. Clinical signs of toxicity were observed in males at 20 mg/kg/day.
Based on these findings the no-observed-adverse-effect level (NOAEL) for systemic toxicity was 20 mg/kg/day in females and was not established in males.
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