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EC number: 262-679-1 | CAS number: 61260-55-7
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 Oct 2005 - 07 Mar 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Version / remarks:
- adopted January 22, 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Freie und Hansestadt Hamburg, Behörde für Soziales, Familie, Gesundheit und Verbraucherschutz, Hamburg, Germany
- Limit test:
- no
Test material
- Reference substance name:
- N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine
- EC Number:
- 262-679-1
- EC Name:
- N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine
- Cas Number:
- 61260-55-7
- Molecular formula:
- C24H50N4
- IUPAC Name:
- N1,N6-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CD/Crl: CD (SD)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sulzfeld, Germany
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 193-243 g
- Housing: singly in Makrolon cages
- Diet (ad libitum): commercial Ssniff R-Z V1324
- Water (ad libitum): tap water
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- The test substance is instable in water. Hence, corn oil was employed as vehicle. Test substance was suspended in the vehicle to the appropriate concentrations and was administered orally at a constant volume of 5 mL/kg bw. The dose of the test substance was adapted to the animal´s body weight daily.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- At start of the administration period and at termination (12 samples). The samples were analysed according to a gas chromatographic method.
- Details on mating procedure:
- Sexually mature male rats (8-9 weeks) served as partners. 1 male and 1 female animal were placed together in one cage during the dark period. Each morning a vaginal smear was taken to check for the presence of sperm and the stage of oestrus cycle. If findings were negative, mating was repeated with the same partner. The day on which sperm was found was considered as the day of conception (day 0 of pregnancy).
- Duration of treatment / exposure:
- GD 6-19
- Frequency of treatment:
- once daily
- Duration of test:
- until gestation day 20; 14 day treatment period
Doses / concentrations
- Remarks:
- Doses / Concentrations:
44, 110, 275 mg/kg bw/d
Basis:
nominal conc.
- No. of animals per sex per dose:
- 25
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Dose levels were selected based on the results of the dose-range-finding study in rats (LPT study no. 19520/05, REG-No. 2005-0298-DGT). Test substance was administered to two dams/group once daily from the 6th to 19th day of pregnancy. Dose levels of 40, 120 and 360 mg/kg bw/d were administered at a constant administration volume of 5 mL/kg bw.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
behavior, external appearance and nature of faeces, viability
BODY WEIGHT: Yes
- Time schedule for examinations: body weight was recorded on day 0 of gestation followed by daily weighings. Body weight gain was also calculated in intervals.
FOOD CONSUMPTION: Yes
Quantity of food consumed by each rat was recorded daily with the exception of gestation day 20. Food intake per rat (g/rat/day) was calculated using the total amount of food given to and left by each rat in each group on completion of a treatment day. The relative food consumption was calculated.
WATER CONSUMPTION: Yes
- Time schedule for examinations: Daily monitoring by visual appraisal of the drinking water bottles was maintained throughout the study.
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day #20
- Organs examined: The ovaries and the uteri of the dams were removed; the uteri (in total) were weighed. In order to check for possible drug effects, a dissection with macroscopic examination of the internal organs and placentae of the dams was carried out on the day of scheduled laparatomy or on the day on which the animals were found dead. In case of macroscopical findings, the affected maternal tissues were preserved in 7% buffered formalin for possible future histopathological examinations. - Fetal examinations:
- Fetuses were removed and following examinations performed: macroscopic inspection of the placentae (focal indurations), number of fetuses (alive and dead) and placentae, sex and viability, number and size of resorptions, corpora lutea in the ovaries, implantations and location of fetuses in the uterus, gravid uterus weight, weights of fetuses and weights of the placentae, fetuses were inspected externally for damages, especially for malformations
- Statistics:
- For all numerical values, homogeneity of variances was tested using the Bartlett chi-square test. When the variances were homogenous, the Dunnett test was used to compare the experimental groups with the control group. In case of heterogeneity of variances, the Student´s t-test was carried out.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Mortality: 275 mg/kg bw/d: 3 of 21 pregnant dams died prematurely on GD 12 or 17
Clinical signs: 110 mg/kg bw/d: one dam showed piloerection on some test days; 275 mg/kg bw/d: pilo-erection, laboured breathing or clonic convulsions were noted in individual high-dosed dams on one to several test days
Body weight: 275 mg/kg bw/d: significant reductions were determined for the mean maternal body weight change on GD 6 to 9 and 9 to 12 and for the net weight change from day 6 onwards
Food and water consumption: no effects
Necropsy: 275 mg/kg bw/d: necropsy of the three prematurely decreased dams revealed reddened lungs in two dams and a reddened stomach in one dam.
Uterus and carcass weight: no effects
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
Corpora lutea, implantation sites, resorptions, weight and number of live fetuses, placental weights: no effects
Mortality: no
Malformations or Variations: no
Soft tissue evaluations: 275 mg/kg bw/d: slightly but significantly increased fetal and litter incidences for hemaorrhagic foci in the liver and for total soft tissue variations.
Retardations: no effects
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 275 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
- Dose descriptor:
- NOAEL
- Effect level:
- 110 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: embryotoxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Analysis of the test substance-carrier mixtures revealed that formulations were correctly prepared and the results of 94.1% to 109.4% of the nominal value were within the admissible limits of 90% to 110%.
The maternotoxic effects reported in this study correlate with those observed in a subchronic study carried out with the test substance (refer to Section 7.5.1). In that study, all changes observed were considered to be due to the local corrosive changes noted, causing behavioural, biochemical and haematological changes and in some cases mortality. The changes observed were not considered to be due to systemic toxicity of the test substance given by gavage but due to its corrosive properties.
Applicant's summary and conclusion
- Conclusions:
- The test substance possessed no teratogenic properties up to a dose level of 275 mg/kg bw/d. No test substance-related increase was noted in the incidence of fetal malformations, external or skeletal variations. At the maternotoxic dose (275 mg/kg bw/d) marginal embryotoxic properties were noted in form of slightly increased incidences of soft tissue variations.
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