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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31st March 2020 - 14th May 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes (incl. QA statement)
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
- Details on test material:
- light yellow powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: SUQIAN UNITECH CORP., LTD; 190701
- Expiration date of the lot/batch: : July 24, 2021
- Purity:91%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At receipt, the test item was stored, in its original packaging, in premises fitted out to that effect, at room temperature and away from light.Stable under the storage and test conditions.
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Calves eyes were collected in the slaughterhouse of Sobeval Boulazac 24759 - France
- Characteristics of donor animals (e.g. age, sex, weight): Corneas of calves aged less than 8 months.
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): transported in a Hanks’s buffered saline solution with antibiotic to the laboratory.
- Selection and preparation of corneas:For each selected eye, an incision with a scalpel was practiced at the level of the scleral ring by means of scissors.
- Quality check of the isolated corneas: At reception, the eyes were carefully examined under lighting and these showing a visible (scratches, pigmentation, neo-vascularization) defect were eliminated.
Test system
- Vehicle:
- other: paraffin oil (validated solvent)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 μL
- Concentration (if solution): 20%
Test item appearance after dilution: thick granular yellowish (liquid which then became a paste). The dilution of the test item was tested at room temperature and was mixed by vortex just before contact with the cornea, in order to aid the solubilisation process.
VEHICLE: Paraffin oil (Sigma, CAS: 8012-95-1; Batch: BCBT6467) - Duration of treatment / exposure:
- 4 hours.
- Number of animals or in vitro replicates:
- 3 corneas per group
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
Corneas were deposited, endothelial side upwards, on the posterior part of cornea holders. Then the anterior part was firmly clamped in place with 3 screws. The anterior (epithelial side) and posterior (endothelial side) compartments were then filled (posterior chamber first), with pre-warmed Eagle’s Minimum Essential Medium (EMEM) without phenol, with a pipette, taking care to eliminate air bubbles. The watertightness was insured by toric caps.
As soon as the corneas were mounted, the holders were maintained at 32 ± 1°C for 1 hour (pre-incubation) in a water bath, in horizontal position, immersed at the three-quarters of their height. After pre-incubation, compartments were emptied with the specific sucking up system and fresh EMEM pre-warmed at 32 ± 1°C was added in both compartments.
QUALITY CHECK OF THE ISOLATED CORNEAS
The opacity at t=0 (OPT0) was then determined. Corneas showing a value of opacity greater than seven opacity units were discarded. 3 corneas were selected as negative control. The remaining corneas were then distributed into treatment and positive control groups.
NUMBER OF REPLICATES:3
NEGATIVE CONTROL USED:Paraffin oil
POSITIVE CONTROL USED:Imidazole 20% in 0.9% sodium chloride solution
APPLICATION DOSE AND EXPOSURE TIME:The test item was tested diluted at 20 % with paraffin oil. The exposure time was 4 hours in a bain-marie (32 ± 1°C).
TREATMENT METHOD: open chamber
POST-INCUBATION PERIOD: No.
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: At least three times.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Opacity was determined by the amount of light transmission thought the cornea. Corneal opacity was measured quantitatively with the aid of an opacitometer (OP-KIT), resulting in opacity values measured on a scale. The opacitometer was calibrated and the opacity of each cornea was measured at 2 times, just before treatment with the test item (measurement called OPT0) and immediately after the end of the exposure period. (measurement called OPT2).
- Corneal permeability: The permeability was determined by the amount of sodium fluorescein solution (1 ml of a sodium fluorescein solution 5 mg/mL at 32 ±1°C for 90 ± 5 mins) that penetrated all corneal cell layers. The Optic Density (OD) of the different media was then measured with a spectrophotometer (Labsystems) at 490 nm (software VISION liteTM version 2.2). For each cornea a value was obtained and therefore 3 values for the control and 3 values for the test item.
- Others: The aspect of the cornea was observed and visible modifications of the cornea were noted.
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
An In Vitro Irritancy Score (IVIS) was then calculated with the mean adjusted values according to the formula:
IVIS = mean opacity value + (15 x mean permeability OD490 value)
DECISION CRITERIA: As per guideline
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Test item
- Value:
- 24.4
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- other: 24.4 ± 10.3
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: The aspect of the cornea was observed and visible modifications of the cornea were noted: High epithelium detachment (test item); Oedema and High epithelium detachment (positive control).
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The test was considered acceptable if the negative control gives the opacity OP < 8 and the optical density OD < 0.053. They were respectively: OP=1.0 and OD= 0.008.
- Acceptance criteria met for positive control: The test was considered acceptable if the positive control gives an IVIS that fall within two standard deviations of the current historical mean (87.3< IVIS < 148.3). It was 123.3 ± 38.6.
Historical database: The historical (10 years of data) averages and difference were calculated every time an acceptable test was realized.
Applicant's summary and conclusion
- Interpretation of results:
- other: As there is evidence of epithelial detachment, the substance will be classified as Category 1.
- Conclusions:
- In the in vitro BCOP assay, no prediction can be made for the classification of the test item N4, N4’hexane-1,6-diylbis[N-butyl-6-chloro-N,N’-bis(2,2,6,6-tetrametylpiperidin-4-yl)-1,3,5-triazine-2,4-diamine] concerning eye irritation or serious eye damage.
- Executive summary:
In the in vitro eye irritation Bovine Corneal Opacity and Permeability (BCOP) assay (OECD 437/GLP), isolated bovine corneas were exposed to N4, N4’hexane-1,6-diylbis[N-butyl-6-chloro-N,N’-bis(2,2,6,6-tetrametylpiperidin-4-yl)-1,3,5-triazine-2,4-diamine] (91%) in a paste (20 % in paraffin oil) for 4 hours using the open-chamber method. Paraffin oil was used for the negative control and 20% imidazole in 0.9% sodium chloride was used for the positive control. The corneas were rinsed and then the opacity and permeability of each cornea was recorded.
The positive control gave the appropriate response (IVIS = 123.3). High epithelial detachment was noted in test item-treated corneas. The mean opacity value for the test substance was 22.7±10.1. The mean permeability OD490 for the test substance was 0.116±0.068. The IVIS for the test substance was 24.4±10.3. The IVIS for N4, N4’hexane-1,6-diylbis[N-butyl-6-chloro-N,N’-bis(2,2,6,6-tetrametylpiperidin-4-yl)-1,3,5-triazine-2,4-diamine] is > 3 and simultaneously ≤ 55, therefore the classification according to CLP classification criteria for eye irritation or serious eye damage is: no prediction can be made.
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