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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 205-999-9 | CAS number: 280-57-9
- 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)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was conducted according to OECD 422 guidelines and GLP principles
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
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:
- 1,4-diazabicyclooctane
- EC Number:
- 205-999-9
- EC Name:
- 1,4-diazabicyclooctane
- Cas Number:
- 280-57-9
- Molecular formula:
- C6H12N2
- IUPAC Name:
- 1,4-diazabicyclooctane
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- deionized
- Details on mating procedure:
- Following 14 days of dose administration, 10 F0 males were paired 1:1 with 10 F0 females from the same treatment group in the Reproductive/Developmental Toxicity Phase on September 7, 1999. A breeding record containing the male and female identification numbers and the date of cohabitation was generated. Positive evidence of mating was confirmed by the presence of sperm in a vaginal smear or a copulatory plug. Each mating pair was examined daily with the following exception. On study day 25 (September 18, 1999), the examination for evidence of mating for 300 mg/kg/day group female no. 28451 was inadvertently not documented. This female was determined to be nongravid at the scheduled necropsy. This deviation had no impact on the integrity or outcome of the study due to its singular occurrence. The day when evidence of mating was identified was termed day 0 of gestation. A maximum of 14 days was allowed for mating. Following 14 days of cohabitation, females that did not have positive evidence of mating were transferred to plastic maternity cages containing nesting material. It should be noted that animals selected for the Recovery Phase (five rats/sex, Groups 1 and 4) were not to be evaluated for reproductive parameters. However, the Recovery Phase animals were inadvertently paired for breeding. The females that did not show evidence of mating by the presence of a copulatory plug or by a vaginal smear for sperm were randomized, via a computer program, to determine the five females assigned to the Recovery Phase. The males paired with these selected females were also assigned to the Recovery Phase. This deviation did not affect the quality or integrity of the study.
- Duration of treatment / exposure:
- Exposure period: 29 days
Premating exposure period (males): 14 days
Premating exposure period (females): 14 days
Duration of test: 57 days - Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 300, 1000 mg/kg/day
Basis:
- Control animals:
- yes, concurrent vehicle
Examinations
- Litter observations:
- All females from each dose group in the Reproduction/Developmental Phase were allowed to deliver naturally and rear their young to postnatal day 4 (PND 4). During the period of expected parturition, the females were observed twice daily for initiation and completion of parturition and for signs of dystocia. The duration of gestation was calculated for each animal using the date delivery initiated. The day on which delivery was judged complete was designated lactation day 0.
When parturition was complete, litters were sexed and examined for gross malformations, and the number of stillborn and live pups was recorded. All pups were individually identified by the application of tattoo markings on the digits at the completion of parturition. Each litter was observed daily for survival and all deaths were recorded. A daily record of litter size was maintained.
Litters were examined daily for any adverse changes in appearance and behavior. Each pup received a detailed clinical examination on PND 1 and 4. Any abnormalities in nesting and nursing behavior were recorded. Each pup was sexed on lactation days 0 and 4.
Pups were individually weighed on PND 1 and 4.
All surviving pups were euthanized and necropsied on PND 4 with emphasis placed on developmental morphology. Stillborn pups and pups dying between birth and PND 4 were also necropsied. Tissues were preserved in 10% neutral buffered formalin for possible future histopathologic examination only as deemed necessary by the gross findings. All carcasses were then discarded.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
Reproductive function / performance (P0)
- Reproductive performance:
- no effects observed
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- clinical signs
- mortality
Results: F1 generation
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 300 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Oral administration of Triethylenediamine at dose levels of 100, 300, and 1000 mg/kg/day did not adversely affect F0 survival, pregnancy status or duration of gestation.
Test article-related effects on reproductive performance were limited to the 1000 mg/kg/day group and consisted of a slight decrease in the mean number of pups born per litter and the live litter size on PND 0. One female in the 1000 mg/kg/day group had an entirely resorbed litter. The only potential disturbance in parturition was the euthanasia of a single 1000 mg/kg/day group female on lactation Day 0 due to dystocia. This female delivered nine pups, had three late resorptions retained in utero and one late resorption retained in the vagina. No other test article-related effects were noted on male and female reproductive performances at any dose level.
Applicant's summary and conclusion
- Conclusions:
- Oral administration of Triethylenediamine resulted in F0 toxicity in both males and females at a dose level of 1000 mg/kg/day as evidenced by changes in clinical conditions of the animals, reduced body weight and food consumption, reduced motor activity (females only), increased serum alkaline phosphatase concentrations (females only), increased liver weights (females only) and microscopic changes (inflammatory and/or proliferative lesions) in the kidneys and urinary bladder of a single 1000 mg/kg/day group female, none of the above findings persisted to the end of the 14-day recovery period. F0 toxicity in the 300 mg/kg/day groups was limited to chronic inflammation of the kidneys in the males. There were no indications of F0 toxicity in the 100 mg/kg/day group males and females.
F0 mating and fertility indices were not affected by test article administration.
F1 neonatal toxicity was exhibited at 1000 mg/kg/day by decreased live litter size, decreased postnatal pup survival and decreased pup body weights. No indications of neonatal toxicity were observed at 100 and 300 mg/kg/day.
Based on the data obtained, NOAEL (no-observed-adverse-effect level) for F0 reproductive toxicity was considered to be 300 mg/kg/day. The NOAEL for Fl neonatal toxicity was considered to be 300 mg/kg/day. The NOAEL for F0 parental systemic toxicity was considered to be 100 mg/kg/day. - Executive summary:
Oral administration of Triethylenediamine resulted in F0 toxicity in both males and females at a dose level of 1000 mg/kg/day as evidenced by changes in clinical conditions of the animals, reduced body weight and food consumption, reduced motor activity (females only), increased serum alkaline phosphatase concentrations (females only), increased liver weights (females only) and microscopic changes (inflammatory and/or proliferative lesions) in the kidneys and urinary bladder of a single 1000 mg/kg/day group female, none of the above findings persisted to the end of the 14-day recovery period. F0 toxicity in the 300 mg/kg/day groups was limited to chronic inflammation of the kidneys in the males. There were no indications of F0 toxicity in the 100 mg/kg/day group males and females.
F0 mating and fertility indices were not affected by test article administration.
F1 neonatal toxicity was exhibited at 1000 mg/kg/day by decreased live litter size, decreased postnatal pup survival and decreased pup body weights. No indications of neonatal toxicity were observed at 100 and 300 mg/kg/day.
Based on the data obtained, NOAEL (no-observed-adverse-effect level) for F0 reproductive toxicity was considered to be 300 mg/kg/day. The NOAEL for Fl neonatal toxicity was considered to be 300 mg/kg/day. The NOAEL for F0 parental systemic toxicity was considered to be 100 mg/kg/day.
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.