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EC number: - | CAS number: -
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Remarks:
- Combined Repeated Dose Toxicity Study and Reproductive/Developmental Toxicity Screening Test in Rats
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OPPTS 870.3650 Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- CAS 68477-54-3
- IUPAC Name:
- CAS 68477-54-3
- Reference substance name:
- Low Dicyclopentadiene Resin Oil
- IUPAC Name:
- Low Dicyclopentadiene Resin Oil
- Reference substance name:
- Low DCPD Resin Oil
- IUPAC Name:
- Low DCPD Resin Oil
- Reference substance name:
- CAS 68516-20-1
- IUPAC Name:
- CAS 68516-20-1
- Details on test material:
- - Name of test material (as cited in study report): Low Dicyclopentadiene Resin Oil / Low DCPD Resin Oil
- Supplier: Equistar Chemicals, LP
- Substance type: Low DCPD Resin Oil is a C8 to C10 distillate obtained from a pyrolysis gasoline stream produced by an ethylene production process (steam cracking process).
- Physical state: colourless / light yellow liquid
- Composition of test material, percentage of components: up to 100% aromatics, including substituted mono and diaromatics (<0.01% benzene).
- Stability under test conditions: The test substance appeared to be stable under the conditions of the study.
- Storage condition of test material: stored at or below 70º F, and protected from light and air.
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD (Sprague-Dawley) IGS BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc. (Raleigh, North Carolina, USA)
- Age at study initiation: Approximately 8-10 weeks
- Weight at study initiation: 114.8-165.3 on day after arrival
- Housing: Rats were housed singly in stainless steel, wire-mesh cages, suspended above cage boards, except during cohabitation when one male was added to each cage. Females in the satellite group were housed in polycarbonate pans with bedding (Bed-o-Cobs®) from gestation day 19 or the end of the cohabitation period (if evidence of copulation was not detected) until sacrifice.
- Diet: PMI® Nutrition International, LLC Certified Rodent LabDiet® 5002 (chunk chow) ad libitum
- Water: tap water ad libitum- Acclimation period: At least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22±3°C
- Humidity: 40%-60%
- Air changes (per hr): Not reported
- Photoperiod: approximate 12-hour light/dark cycle
IN-LIFE DATES: Not reported
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Dosing formulations of the test substance were prepared daily by adding the corn oil to the measured amount of test substance and stirring to establish uniformity.
DOSE VOLUME: 2 mL/kg bw - Details on mating procedure:
- - M/F ratio per cage: 1:1
- Length of cohabitation: 2 weeks
- Proof of pregnancy: vaginal plug / sperm in vaginal smear referred to as day 0 of pregnancy
- Further matings after two unsuccessful attempts: no
- After successful mating each pregnant female was caged in polycarbonate pans with bedding (Bed-o-Cobs®) from gestation day 19 until sacrifice. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Near the beginning of the study, 4 samples (approximately 3 mL per sample) were collected from each formulation, and were analyzed for homogeneity/concentration verification, and 5-hour stability at room temperature. Near the middle and end of the dosing period, duplicate samples were taken from all formulations and analyzed for concentration verification. Analysis was by gas chromatography. The test substance was mixed homogeneously, was at the targeted levels, and was stable under the conditions of study.
- Duration of treatment / exposure:
- Satellite groups of 12 young, nulliparous, female rats were administered an oral, daily dose of the test substance during a premating period of approximately 2 weeks, a cohabitation period of approximately 2 weeks, a gestation period of approximately 3 weeks, and a lactation period of approximately 4 days. The males were exposed for 30 days.
- Frequency of treatment:
- 7 days/week
- Details on study schedule:
- Satellite groups of 12 young, nulliparous, female rats were administered an oral, daily dose of 0, 35, 125, or 375 mg/kg/day during a premating period of approximately 2 weeks, a cohabitation period of approximately 2 weeks, a gestation period of approximately 3 weeks, and a lactation period of approximately 4 days. Following the 2-week premating period, each satellite female was paired with a male of the same respective dosage group during a 2 week cohabitation period.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 35, 125, 375 mg/kg/day
Basis:
other: nominal in corn oil
- No. of animals per sex per dose:
- 12
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Dose levels for the main study were selected based on the results of a range-finding study conducted in time-mated pregnant female rats.
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes
- Time schedule: Days 1, 8 and 15 pre-mating, weekly during mating, daily during gestation and days 0 and 4 lactation.
FOOD CONSUMPTION: - Time schedule: Days 1, 8 and 15 pre-mating, days 0, 7, 14 and 21 of gestation and days 0 and 4 of lactation.
WATER CONSUMPTION: No - Oestrous cyclicity (parental animals):
- Not assessed
- Sperm parameters (parental animals):
- Not assessed
- Litter observations:
- Offspring were weighed and evaluated for external abnormalities at birth and on lactation days 1 and 4, and were sacrificed on postnatal day 4.
- Postmortem examinations (parental animals):
- After postpartum day 4, lactating females, and nonpregnant females were sacrificed, selected organs were weighed, and selected tissues were evaluated microscopically. The males were exposed for a total of 30 days, and were then necropsied. Male reproductive organ weights and gross/histopathology of the reproductive tract were assessed.
- Postmortem examinations (offspring):
- Offspring were evaluated for external abnormalities, and sacrificed on postnatal day 4
- Statistics:
- Group means and standard deviations were calculated for all measured parameters. Body weight, weight gain, food consumption, and organ weights were analyzed by Jonckheere-Terpstra trend test. Food efficiency was analyzed by one-way analysis of variance followed with Dunnett’s test. Clinical observations, mating index, fertility index, and gestation index were analyzed by Cochran-Armitage trend test. Gestation length, implantation site numbers, implantation efficiency, mean number of pups per litter, percent of pups born alive, day 0-4 viability of pups, viability index, number of corpora lutea, sex ratio, pre-implantation loss, and post-implantation loss were analyzed by Jonckheere-Terpstra trend test. Mean pup weights were analyzed by linear contrast of the least square means.
- Reproductive indices:
- Mating index, fertility index, gestation length, number of implantation sites, implantation efficiency, pre-implantation loss, post-implantation loss, number of corpora lutea
- Offspring viability indices:
- Gestation index.
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:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
Details on results (P0)
BODY WEIGHT AND WEIGHT GAIN: Test substance-related increases in the incidence of stained fur, and/or wet fur was observed in males, and females following administration of 375 mg/kg/day Low DCPD Resin Oil. Stained and/or wet fur were also occasionally observed in males and females administered 125 mg/kg/day.
BODY WEIGHT AND WEIGHT GAIN: Decreases in body weight and/or weight gain were observed in males and females as 375 mg/kg/day and 125 mg/kg/day. During the premating period, gestation and lactation, body weight and weight gain of 375 mg/kg/day females was lower than the control. During lactation, body weights of 125 mg/kg/day females were statistically significantly lower than the control values.
FOOD CONSUMPTION AND FOOD EFFICIENCY: Decreased food consumption and food efficiency occurred in 125 mg/kg/day and above males
REPRODUCTIVE INDICES: No test substance-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.
REPRODUCTIVE PATHOLOGY: There were no test substance-related effects on morphology of the reproductive tract in either males or females.
Effect levels (P0)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- systemic toxicity
- Effect level:
- 35 mg/kg bw/day (nominal)
- Sex:
- male
- Basis for effect level:
- other: lower body weight and food consumption at 125 mg/kg/day
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- systemic toxicity
- Effect level:
- 125 mg/kg bw/day (nominal)
- Sex:
- female
- Basis for effect level:
- other: lower body weight at 373 mg/kg/day
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
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
Details on results (F1)
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 375 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: Reproductive Toxicity
Target system / organ toxicity (F1)
- Key result
- Critical effects observed:
- no
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Repeated oral administration of Low Dicyclopentadiene Resin Oil to male and female rats at 0, 35, 125, or 375 mg/Kg/day produced no evidence of adverse effects on any measures of reproductive function. Pups from the 375 mg/Kg/day group had decreased body weight. The NOAEL for reproductive toxicity was 375 mg/Kg/day and the NOAEL for systemic toxicity was 35 mg/Kg/day in males and 125 mg/Kg /day in females.
- Executive summary:
Low Dicyclopentadiene Resin Oil (Low DCPD Resin Oil; CAS 68477-54-3) was evaluated for potential toxicity using a combined repeated dose toxicity/reproduction/developmental toxicity study. To assess reproductive/developmental effects Low DCPD Resin Oil was administered during premating (approximately 2 weeks), gestation (approximately 3 weeks), and lactation through day 4. Gonadal function, mating behaviour, fertility, implantation, development of the conceptus, parturition, gross pathology, and histopathology were evaluated.
There was no evidence of adverse effects on any measures of reproductive function. At 375 mg/Kg/day clinical signs of toxicity, lower body weight and food consumption and histopathological changes were observed in adults. In addition, effects on body weight, clinical signs and food consumption were observed in males at 125 mg/Kg/day. Pups from the 375 mg/Kg/day group had decreased body weight on day 4.
The NOAEL for reproductive toxicity was 375 mg/Kg/day (the highest dose tested) and the NOAEL for systemic toxicity was 35 mg/Kg/day in males and 125 mg/Kg/day in females.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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