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EC number: 224-778-8 | CAS number: 4488-57-7
- 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
- Remarks:
- combined repeated dose and reproduction / developmental screening
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP study, guideline study, available as unpublished report and summary information sheet (provided by Japan Chemical Industry Ecology-Toxicology and Information Center (JETOC)), minor restrictions in design and/or reporting but otherwise adequate for assessment.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- other: Information sheet
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 3a,4,7,7a-tetrahydro-4,7-methanoindene
- EC Number:
- 201-052-9
- EC Name:
- 3a,4,7,7a-tetrahydro-4,7-methanoindene
- Cas Number:
- 77-73-6
- Molecular formula:
- C10H12
- IUPAC Name:
- 3a,4,7,7a-tetrahydro-1H-4,7-methanoindene
- Reference substance name:
- dicyclopentadiene
- IUPAC Name:
- dicyclopentadiene
- Details on test material:
- - Name of test material (as cited in study report): dicyclopentadiene
- Analytical purity: 94.65%
- Physical state: colourless liquid with a camphor-like odour
- Lot/batch No.: D93028
- Stability under test conditions: confirmed to be stable by the manufacturer for the study period
- Storage condition of test material: room temperature
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: Sprague Dawley Crj:CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Japan, Inc.
- Age at study initiation: 8 weeks
- Weight at study initiation: males 304-339 g, females 186-227 g
- Housing: individually, except during mating, in polycarbonate cages
- Diet: CRF-1 (Oriental Yeast Co) assumed ad libitum
- Water: ultraviolet irradiated water (assumed ad libitum)
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20-25°C
- Humidity: 40-70%
- Air changes: approximately 12 per hr
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: Not reported
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: Test substance mixed with olive oil, dose rate 10mL/kg bodyweight
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Stability and achieved concentration of dosing preparations was confirmed prior to dosing
- Duration of treatment / exposure:
- Males 44 days; Females from 14 days before mating through gestation and parturition until day 3 of lactation
- Frequency of treatment:
- once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 4, 20 or 100 mg/kg/day
Basis:
other: nominal in olive oil
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Based on the results obtained in a 10 day oral dosing preliminary study where doses of 0, 30, 100 and 300 mg/kg were administered.
Examinations
- Observations and examinations performed and frequency:
- CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION: Yes
FOOD EFFICIENCY: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes (males only)
- Time schedule for collection of blood: termination
- Anaesthetic used for blood collection: Yes (sodium thiopental)
- Animals fasted: Yes (assumed)
- How many animals: 10/group
- Parameters examined: red blood cell, white blood cell, platelets, haemoglobin, haematocrit, differential white cell count, reticulocyte, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration
CLINICAL CHEMISTRY: Yes (males only)
- Time schedule for collection of blood: termination
- Anaesthetic used for blood collection: Yes (sodium thiopental)
- Animals fasted: Yes (assumed)
- How many animals: 10/group
- Parameters examined: GOT, GPT, ALP, γ-GTP, urea nitrogen, glucose, total cholesterol, triglycerides, creatinine, total bilirubin, total protein, albumin, A/G ratio, calcium, inorganic phosphorus, sodium, potassium, chloride
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
ORGAN WEIGHTS: Yes
- organs weighed: thymus, liver, kidneys, adrenals, testes, epididymes
HISTOPATHOLOGY: Yes (liver, kidney and adrenals all groups, other tissues controls and 100 mg/kg groups only)
- tissues examined: thymus, liver, kidneys, adrenals, testes, epididymes, brain, heart, spleen, ovaries, - Statistics:
- Bartlett's test if uniformly distributed analysis of variance, Kruskal-Wallis if non-uniform for quantitative data. When significant differences found between groups, Dunnett-type test or Scheff test. Significance level of 5% or less.
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 efficiency:
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Details on results:
- CLINICAL SIGNS AND MORTALITY
- Two females in the high dose (100 mg/kg) group died. Transient salivation after dosing at 100 mg/kg for the initial 8 days of dosing was present in approximately half of the males and females. Also occasionally present in males at the two lower doses.
BODY WEIGHT AND WEIGHT GAIN
- Males and surviving females showed slight suppression of body wt gain.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
- Males and surviving females showed slightly decreased food consumption.
HAEMATOLOGY
- No treatment-related effects
CLINICAL CHEMISTRY
- Blood chemistry of 100 mg/kg males showed increase in GOT and GPT
ORGAN WEIGHTS
- Increased weight of liver and kidneys of male rats given 100 mg/kg (neither achieved statistical significance) and statistically significantly increased actual and relative liver weight in males at 20 mg/kg/day.
HISTOPATHOLOGY: NON-NEOPLASTIC
- In male rats given 100 mg/kg, single cell necrosis in liver, and hyaline droplets and basophilic changes in tubular epithelium of kidneys under microscopic examination were observed. Increase in fatty droplets in fascicular zone of adrenals was observed in both males and females in the 100 mg/kg group. Similar histopathological changes were seen in kidneys of four 20 mg/kg group male rats and in adrenals of 20 mg/kg group male rats.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 4 mg/kg bw/day (actual dose received)
- Sex:
- male
- Basis for effect level:
- other: histological changes in kidneys and adrenals at 20 mg/kg/day
- Dose descriptor:
- NOAEL
- Effect level:
- 20 mg/kg bw/day (actual dose received)
- Sex:
- female
- Basis for effect level:
- other: 2/10 deaths, lower body weight and food consumption and histological changes in liver and kidney at 100 mg/kg/day
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Dicyclopentadiene induced systemic toxicity in male and female rats including death of two females at the 100 mg/kg/day dose level.
- Executive summary:
In a combined repeat dose toxicity study with reproduction/developmental toxicity screening, groups of 10 males and 10 females were dosed by oral gavage with solutions of 0, 4, 20 or 100 mg/kg DCPD in olive oil. Animals were dosed for 2 weeks prior to mating and during mating (approximately 2 weeks). Males and females were then dosed through gestation until day 3 of lactation. Females were killed on day 4 of lactation and males were killed on day 45 of the study. Two females at 100 mg/kg/day died during the study and surviving males and females showed decreased food consumption and bodyweight gain at this dose level. Pathological changes in the liver and kidney were seen in males dosed at 100 mg/kg/day (single cell necrosis in the liver, hyaline droplet formation and basophilic changes in the tubular epithelium of the kidney) and an increase in fatty droplets in the adrenals was observed in both males and females in the 100 mg/kg group. Similar changes were seen in the kidney and adrenals of some male rats dosed at 20 mg/kg group male rats. The no effect level for systemic toxicity was therefore considered to be 20 mg/kg/day for females and 4 mg/kg/day for male rats.
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