Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 225-533-8 | CAS number: 4904-61-4
- 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:
- one-generation reproductive toxicity
- Remarks:
- based on generations indicated in Effect levels (migrated information)
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Referenceopen allclose all
- Title:
- No information
- Author:
- DuPont Co. (2000). Haskell Laboratory Report No. DuPont-3682 (unpublished);|cited in DuPont Co. (2001). Robust summary for 1,5,9-cyclododecatriene. Submitted to U.S. EPA on 11 Dec. 2001.
- Reference Type:
- publication
- Title:
- Reproductive and repeated dose toxicity of cyclododecatriene (CDDT) in rats following oral (gavage) treatment.
- Author:
- Malley LA, Everds NE, Makovec GT and Kennedy GL jr.
- Year:
- 2 002
- Bibliographic source:
- Drug Chem. Toxicol. 25 (2), 149-170.
- Reference Type:
- publication
- Title:
- Robust summary for 1,5,9-cyclododecatriene (revised).
- Author:
- DuPont Safety, Health & Environmental Excellence Center, Wilmington (Del., USA)
- Year:
- 2 003
- Bibliographic source:
- U.S. EPA, 46 pp
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)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 1,5,9-cyclododecatriene
- IUPAC Name:
- 1,5,9-cyclododecatriene
- Details on test material:
- 1,5,9-cyclododecatriene, purity 99.86%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD (SD)IGS BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ORGANISMS
- Age: males 59 days, females 52 days (approximately)
Administration / exposure
- Route of administration:
- oral: gavage
- Details on exposure:
- ADMINISTRATION / EXPOSURE
- Vehicle: corn oil
- Concentration in vehicle: 6, 20, 60 mg/ml
- Total volume applied: 5 ml/kg bw/dose - Details on mating procedure:
- MATING PROCEDURES:
- mating period approximately 1-2 weeks, beginning after approximately four weeks of dosing. - Duration of treatment / exposure:
- Exposure period: males through test day 55; females 4 weeks premating through 4-day lactation period
Premating exposure period (males): approximately 4 weeks
Premating exposure period (females): approximately 4 weeks
Duration of test: approximately 60 days - Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
30, 100, 300 mg/kg bw/day
Basis:
- No. of animals per sex per dose:
- Number of animals: 10 per sex and per dose group
- Control animals:
- yes, concurrent vehicle
Examinations
- Parental animals: Observations and examinations:
- - Clinical signs: at least once daily
- Mortality: at least twice daily
- Body weight: weekly, for females also on lactation days 0 and 4
- Food consumption: weekly
- Ophthalmoscopic examination: Both eyes of all rats prior to study and on test day 24, prior to clinical pathology evaluation (surviving rats).
- Clinical pathology evaluation on all rats after 4 weeks of dosing, and on male rats at the time of scheduled sacrifice:
- hematology / coagulation: erythrocyte count, total leukocyte count, platelet count, hemoglobin concentration, hematocrit, differential leukocyte count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, absolute reticulocyte counts, red cell distribution width, microscopic blood examination, activated partial thromoboplastin time, prothrombin time.
- clinical chemistry: alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, sorbitol dehydrogenase, glucose, urea nitrogen, calcium, inorganic phosphorus, total bilirubin, cholesterol, triglyceride, creatinine, total protein, albumin, globulin, sodium, potassium, chloride.
- urine: volume, specific gravity, urobilinogen, blood, glucose, protein, appearance (quality, transparency, color), pH, bilirubin, ketones, sediment microscopy.
- Other: Neurobehavioral Functional Observational Battery (FOB) on all study rats prior to exposure and following approximately 4 weeks of test substance administration. - Litter observations:
- OFFSPRING: gestation length, mating index, gestation index, fecundity index, implantation site numbers, implantation efficiency, sex ratio, pups born alive, viability index
- Postmortem examinations (parental animals):
- ORGANS EXAMINED AT NECROPSY (MACROSCOPIC AND MICROSCOPIC):
- Time: Sacrifice and necropsy of males on day 56 and of females on days 56-64.
- Organ weights P: liver, kidneys, adrenal glands, thymus, brain, spleen, heart, testes, epididymides. Calculation of ratios to final body and brain weights.
- Histopathology P: all high dose and control rats: testes, epididymides, ovaries, gross lesions; 5 high dose and 5 control rats per sex: additional 37 tissues 5 females from other groups with >= 1 offspring: liver - Postmortem examinations (offspring):
- Implantation site number and efficiency, sex ratio, mean pup weights, pups born alive, viability index
- Statistics:
- STATISTICAL METHODS:
- All weight parameters (P, not F), gestation length, clinical pathology, grip strength, foot splay: One-way analysis of variance followed with Dunnett's test or Kruskal-Wallis test; followed with Dunn's test.
- Incidence of clinical and FOB observations; mating, gestation, fecundity indexes: Sequential application of Cochran-Armitage test for trend
- Implantation site number and efficiency, sex ratio, pups born alive, viability index: Jonckheere's test
- Mean pup weights: Linear contrast of the least square means
- Motor activity: Levene's and Shapiro-Wilk tests followed by repeated measures analysis of variance followed by contrasts of Jonckheere's trend test.
Results and discussion
Results: P0 (first parental generation)
Details on results (P0)
- NOAEL 30 mg/kg for females, 100 mg/kg for males
- LOAEL 100 mg/kg for females, 300 mg/kg for males
ACTUAL DOSE RECEIVED BY DOSE LEVEL BY SEX: At the targeted level
- Number of deaths at each dose: One high-dose male was sacrificed in extremis due to a dosing-related injury. One high-dose female was found dead on day 57 from dystocia. No other deaths occured during the study.
TOXIC RESPONSE/EFFECTS BY DOSE LEVEL:
- Body weight: Decreased body weight gain was observed and considered to be compound-related and of biological significance: 300 mg/kg males (-19 % for days 1-56, not statistically significant; weight -7%); 100 and 300 mg/kg females (only during gestation: gains -13% and -20%, weights -7% and -12%, respectively, statistically significant).
- Food/water consumption: Increased food consumption was observed and considered to be compound-related and of biological significance: 300 mg/kg males (+19%) 100 mg/kg (+7%, not statistically significant) and 300 mg/kg females (+13%, statistically significant) during gestation. As a consequence, food efficiency was significantly reduced: 300 mg/kg males (-33%) 100 and 300 mg/kg females during gestation (+14 and +29%, respectively, statistically significant).
- Ophthalmoscopic examination: no test substance-related effects
- Description, severity, time of onset and duration of clinical signs: There were no test substance-related effects on clinical observations as well as in neurobehavioral parameters or motor activity.
- Fertility index: no test substance-related effects
- Duration of gestation: no test substance-related effects
- Gestation index: no test substance-related effects
- Hematological findings incidence and severity: no test substance-related effects
- Clinical biochemistry findings incidence and severity: no test substance-related effects
- Gross pathology incidence and severity: no test substance-related effects
- Number of implantations: no test substance-related effects
- Organ weight changes: no test substance-related adverse effects.
- Liver weights were statistically significantly increased in several dosed groups: Males: 30 mg/kg +10% relative; 100 mg/kg +14 % absolute, +21% relative; 300 mg/kg +34 % absolute, +45% relative. Females: 100 mg/kg +15% relative; 300 mg/kg +36% absolute, +42% relative. In females it was associated with microscopic centrilobular hepatocellular hypertrophy, which is indicative of a physiological response-induction of enzymes associated with metabolism, and is not considered biologically adverse. In males, minimal diffuse hypertrophy may have occurred, which is hard to identify histologically.
- Kidney weights were statistically significantly increased in several dosed groups: Males: 100 mg/kg +16% absolute, +21% relative; 300 mg/kg +22%, +37% relative Females: 100 mg/kg +11% relative; 300 mg/kg +15% absolute, +17% relative These findings were associated with some evidence of diuresis in high-dose males and females, but there were no compound-related changes in any other kidney parameter including histopathology.
These weight changes may be an adaptive response to the physiological changes that occur following administration of large doses of a test material. They were not considered to be biologically adverse.
- Histopathology incidence and severity: no test substance-related adverse effects
- Other observations Mating index: no test substance-related effects; Implantation efficiency: no test substance-related effects
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day
- Sex:
- male
- Dose descriptor:
- NOAEL
- Effect level:
- 30 mg/kg bw/day
- Sex:
- female
Results: F1 generation
Details on results (F1)
- LOAEL 300 mg/kg for pups
- Body weights of pups in the 300 mg/kg group were significantly decreased (-17% on lactation day 4)
- Sex and sex ratios: no test substance-related effects
- Viability index: no test substance-related effects
- Pups born alive: no test substance-related effects
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 100 mg/kg bw/day
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Summary of reproductive outcomes:
- Dose (mg/kg) 0 30 100 300
- Mating Index(%): 80.0 90.0 100.0 100.0
- Fertility Index (%): 87.5 77.8 70.0 70.0
- Gestation Length (days): 22.0 22.0 22.0 22.0
- Implantations (mean/litter): 16.0 15.6 16.3 16.1
- Implantation efficiency (%): 92.1 96.2 92.0 89.5
- Gestation Index: 100.0 100.0 100.0 100.0
- Mean % Born Alive: 98.3 99.1 99.2 99.0
- 0-4 Day Viability (%): 98.0 99.0 98.2 98.3
- Sex Ratio (males): 0.45 0.50 0.49 0.45
Applicant's summary and conclusion
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.