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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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- based on test type (migrated information)
- 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 internationally recognised 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
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
- Details on mating procedure:
- - M/F ratio per cage: No data
- Length of cohabitation: 2 weeks - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Females - Approximately 2 weeks pre-mating, a cohabitation (mating) period of approximately 2 weeks, a gestation period of approximately 3 weeks and a lactation period of approximately 4 days.
Males - Total of 31 days - Frequency of treatment:
- Daily, 7 days / week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 20, 100 and 300 mg/kg/day
Basis:
nominal conc.
- No. of animals per sex per dose:
- 12 male / 12 female
- Control animals:
- yes, concurrent vehicle
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes - Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: yes
- If yes, maximum of [...] pups/litter ([...]/sex/litter as nearly as possible); excess pups were killed and discarded - No data.
PARAMETERS EXAMINED
The following parameters were examined in F1 offspring:
number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain, physical or behavioural abnormalities - Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals - after 31 days of treatment
- Maternal animals: All surviving animals - Day 4 post-partum
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations including the cervical, thoracic, and abdominal viscera. - Postmortem examinations (offspring):
- SACRIFICE
- The F1 offspring were sacrificed at 4 days of age.
- These animals were subjected to postmortem examinations (macroscopic and/or microscopic examination) - 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
Cochran-Armitage trend test - Clinical observations, mating index, fertility index and gestation index
Jonckheere-Terpstra trend test - Gestation time, implantation site numbers, implantation efficiency, mean number of pups/litter, % live pups, day 0-4 viability of pups, viability index, number of corpora lutea , sex ratio, pre-implantation loss and post-implantation loss.
linear contrast of the least square means - Mean pup weights
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
Reproductive function / performance (P0)
- Reproductive performance:
- effects observed, treatment-related
Details on results (P0)
Increased incidences of salivation, stained and/or wet fur were observed in males and females dosed at 100 and 300 mg/kg/day. Salivation was observed in males and females dosed at 20 mg/kg/day.
BODY WEIGHT (PARENTAL ANIMALS)
In females, there were no treatment related effects on body weight or weight gain in animals dosed at 300 mg/kg/day during the pre-mating period. By the end of the gestation period (day 21), body weight was 5% lower than controls and for the interval of gestation (days 0-21) weight gain was 13% lower than control values. There were no effects on body weight or weight gain at any dose level during the lactation period.
In males, a treatment related decrease in body weight and/or weight gain was observed in animals dosed at 300 mg/kg/day. On test day 28, body weight of males was 7.5% lower than controls. Body weight gain in males over the period of test days 1-28 was 19% lower than controls. Instances of decreased body weight and/or weight gain were also noted in animals dosed at 100 mg/kg/day.
FOOD CONSUMPTION (PARENTAL ANIMALS)
In females, statistically significant decreases in food consumption and/or food efficiency occurred in animals dosed at 300 mg/kg/day during the gestation period. Food consumption and food efficiency were decreased by 7.5% and 7.3%, respectively during gestation (days 0-21).
In males, transient changes in food consumption and/or food efficiency were observed in males dosed at 100 or 300 mg/kg/day.
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS)
No treatment related effects or statistically significant differences in mating index, fertility index, gestation length, number of implantation sites, implantation efficiency, pre-implantation loss, post-implantation loss, or number of corpora lutea were observed.
HISTOPATHOLOGY (PARENTAL ANIMALS)
There were no treatment related effects on morphology of the reproductive tract in either males or females.
Effect levels (P0)
- Dose descriptor:
- NOEL
- Effect level:
- 300 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Fertility
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
Details on results (F1)
No effects
BODY WEIGHT (OFFSPRING)
Decreased mean pup weight was observed in pups from females dosed at both at 100 and 300 mg/kg/day.
GROSS PATHOLOGY (OFFSPRING)
No effects
Effect levels (F1)
open allclose all
- Dose descriptor:
- NOEL
- Generation:
- F1
- Effect level:
- 20 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Developmental toxicity
- Dose descriptor:
- LOEL
- Generation:
- F1
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Developmental toxicity
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Repeated administration of the test substance to male and female Sprague Dawley rats at dose levels of 0, 20, 100 or 300 mg/kg/day produced no evidence of teratogenicity. Pups born from females treated at 100 and 300 mg/kg/day showed decreased body weight. Based on these findings the no-observedeffect level (NOEL) for developmental toxicity in pups was considered to be 20 mg/kg/day.
There was no evidence of adverse effects on any measures of reproductive function. A no-observed-effect level (NOEL) for reproductive toxicity (fertility) was considered to be 300 mg/kg/day based on these findings. - Executive summary:
Repeated administration of the test substance to male and female Sprague Dawley rats at dose levels of 0, 20, 100 or 300 mg/kg/day produced no evidence of teratogenicity. Pups born from females treated at 100 and 300 mg/kg/day showed decreased body weight. Based on these findings the no-observedeffect level (NOEL) for developmental toxicity in pups was considered to be 20 mg/kg/day.
There was no evidence of adverse effects on any measures of reproductive function. A no-observed-effect level (NOEL) for reproductive toxicity (fertility) was considered to be 300 mg/kg/day based on these findings.
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