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EC number: 835-183-3 | CAS number: 83420-16-0
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11.03.2020 - 25.06.2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- N4,N4'-hexane-1,6-diylbis[N-butyl-6-chloro-N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)-1,3,5-triazine-2,4-diamine]
- EC Number:
- 835-183-3
- Cas Number:
- 83420-16-0
- Molecular formula:
- C56 H102 Cl2 N14
- IUPAC Name:
- N4,N4'-hexane-1,6-diylbis[N-butyl-6-chloro-N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)-1,3,5-triazine-2,4-diamine]
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and batch number of test material:SUQIAN UNITECH CORP., LTD 190701
-Expiry Date: 24-07-2021
- Purity:91%
- Purity test date: 24-10-2019
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
OTHER SPECIFICS
Due to the purity of 91% of the test item, all weighing steps were done in consideration of a correction factor of 1.0989.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant:[ye
- Age at study initiation: 9 – 11 weeks
- Weight at study initiation: Step 1: 180 – 188 g; Step 2: 158 – 166 g Step 3: 150 – 170 g
- Fasting period before study: Prior to the administration food was withheld from the test animals for 16 to 19 hours
- Housing: The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Diet (e.g. ad libitum): Free access to Altromin 1324 maintenance diet for rats and mice
- Water (e.g. ad libitum): Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Relative humidity: 55 ± 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: 10 x / hour
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.2 g/mL
- Justification for choice of vehicle:The substance is insoluble in water
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg - Doses:
- 300, 2000 mg/kg bw.
The starting dose was selected to be 300 mg/kg bw.
A second step was performed at a dose of 2000 mg/kg bw.
A third step was performed at a dose of 2000 mg/kg bw. - No. of animals per sex per dose:
- 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). As soon as symptoms were noticed they were recorded. Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. All abnormalities were recorded.
- Necropsy of survivors performed: yes
- Clinical signst: Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 500 mg/kg bw
- Mortality:
- One animal of the third step treated with the test item at a dose of 2000 mg/kg bw was found dead
on day 8 post-application. The remaining animals survived until the end of the study at 300 or 2000 mg/kg bw. - Clinical signs:
- other: No clinical signs were detected at 300 mg/kg bw during the whole observation period. The only clinical finding observed was piloerection in animals of the second step, 3 hours post-dose.All animals recovered within the fourth hour post-dosing. The clin
- Gross pathology:
- No specific gross pathological changes were recorded for any animal.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an acute oral toxicity study(acute toxic class) in the rat, the LD50(female) for N4,N4`-hexane- 1,6-diylbis[N-butyl-6-chloro-N,N`-bis(2,2,6,6-tetramethylpiperidin-4-yl)-1,3,5-triazine-2,4-diamine] was
2500 mg/kg bw. - Executive summary:
In an acute oral toxicity study (OECD 423/GLP), groups of Wistar female rats (3/per step) were given a single oral dose of N4,N4`-hexane-1,6-diylbis[N-butyl-6-chloro-N,N`-bis(2,2,6,6-tetramethylpiperidin-4-yl)-1,3,5-triazine-2,4-diamine] (91 %) in corn oil by oral gavage at doses of 300 or 2000 mg/kg bw. Animals were then observed for 14 days.
Oral LD50 cut off (females) = 2500 mg/kg bw
All animals of the first and second steps treated with the test item at a dose of 300 mg/kg bw and 2000 mg/kg bw, respectively, survived until the end of the study. The animals of the first step did not show any signs of toxicity. The only clinical finding observed was piloerection in animals of the second step, 3 hours post-dose. All animals recovered within the fourth hour post-dosing. One animal of the third step treated with the test item at a dose of 2000 mg/kg bw was found dead on day 8 post-application. The remaining animals survived until the end of the study, showing slight signs of toxicity, which were fully reversible by the end of the observation period. The most relevant clinical findings in the animals of the third step were diarrhoea and piloerection. At necropsy, no treatment-related macroscopic findings were observed in any animal of any step.
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