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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 401-990-0 | CAS number: 106990-43-6 CHIMASSORB 119; LOWILITE 19
- 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
Immunotoxicity
Administrative data
- Endpoint:
- immunotoxicity
- Remarks:
- acute
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- From Feb. 16, 1993 to Jul. 5, 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable study report which meets basic scientific principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The test substance was assessed for its ability to induce immunomodulatory effects using a murine model (C3H mouse) where a dispersion of material is injected intraperitoneally and cell populations are enumerated and stained after 4 hours and after 48 hours. In addition, the isolated peritoneal cells were analysed for the expression of mRNA species for defined immunomodulatory cytokines.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- N,N',N'',N'''-tetrakis(4,6-bis(butyl-(N-methyl-2,2,6,6-tetramethylpiperidin-4-yl)amino)triazin-2-yl)-4,7-diazadecane-1,10-diamine
- EC Number:
- 401-990-0
- EC Name:
- N,N',N'',N'''-tetrakis(4,6-bis(butyl-(N-methyl-2,2,6,6-tetramethylpiperidin-4-yl)amino)triazin-2-yl)-4,7-diazadecane-1,10-diamine
- Cas Number:
- 106990-43-6
- Molecular formula:
- C132 H250 N32
- IUPAC Name:
- N2-[2-({4,6-bis[butyl(1,2,2,6,6-pentamethylpiperidin-4-yl)amino]-1,3,5-triazin-2-yl}[3-({4,6-bis[butyl(1,2,2,6,6-pentamethylpiperidin-4-yl)amino]-1,3,5-triazin-2-yl}amino)propyl]amino)ethyl]-N2-[3-({4,6-bis[butyl(1,2,2,6,6-pentamethylpiperidin-4-yl)amino]-1,3,5-triazin-2-yl}amino)propyl]-N4,N6-dibutyl-N4,N6-bis(1,2,2,6,6-pentamethylpiperidin-4-yl)-1,3,5-triazine-2,4,6-triamine
- Details on test material:
- - Physical state: white powder
- Storage condition of test material: Stored at room temperature in a dry environment.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- C3H
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: From a specific pathogen-free colony (Olac-Harlan).
- Age at study initiation: 6-8 weeks.
- Weight at study initiation: No data.
- Fasting period before study: No data.
- Housing: During acclimatisation and treatment the mice were housed in cages of five using polypropylene cages with stainless steel tops and grid floors. These cages were suspended on racks over paper to collect the excreta. During treatment the animals in any cage were of the same treatment group. Excess animals were removed from the study room immediately after treatment had commenced.
- Diet (e.g. ad libitum): Rat and Mouse No.l maintenance diet (R/M1(E) SQC) supplied by Special Diets Services, Witham, Essex
- Water (e.g. ad libitum): tap water
- Acclimation period: A minimum of 6 days after receipt.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-24°C.
- Humidity (%): 45-70%.
- Air changes (per hr): Minimum 15/hr with no recirculation, using high efficiency filters.
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light.
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- physiological saline
- Remarks:
- (0.9% sodium chloride)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The suspension was homogenized for approximately 20 seconds immediately prior to use to ensure there was an even suspension. The resulting suspension was administered by intraperitoneal injection at 0.1 mL per 10 g body weight.
VEHICLE
- Amount of vehicle (if gavage): 0.1 mL per 10 g body weight. - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- once
- Frequency of treatment:
- Single exposure.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
5 or 50 mg/kg body weight
Basis:
other: Intraperitoneal injection
- No. of animals per sex per dose:
- 5 mice per dose per time-point.
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: In a preliminary study, a group of 2 mice were injected with a dose equivalent to 50% of the reported rat oral LD50 (< 5000 mg/kg bw) and assessed regularly until 48 hours had elapsed for any signs of morbidity. The dosing solution for 50% LD50 was 250 mg/ml (0.1 ml/10 g bw). If any animals died then the experiment was repeated with lower doses of test article. Test article caused a marked increase in cell numbers recovered by lavage at 48 hours post dose, which was mainly due to an increase in the number of neutrophils. Due to the mortality experienced in the preliminary study the experiment was repeated at 10% of the quoted rat oral LD50 for the test article. No animals showed any signs of ill health in the 72 hours between dosing and post mortem. There was an increase in cell numbers seen in test article dosed mice, again due mainly to an increase in neutrophils. From the results of this study, the maximum tolerated dose was set at 10% of the quoted rat oral LD50 and the low dose at 1% of the quoted rat oral LD50 (50 and 5 mg/kg bw).
Examinations
- Observations and clinical examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: yes, clinical signs and mortalities
DETAILED CLINICAL OBSERVATIONS: No.
BODY WEIGHT: No.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No.
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No.
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No.
OPHTHALMOSCOPIC EXAMINATION: No.
HAEMATOLOGY: No.
CLINICAL CHEMISTRY: No.
URINALYSIS: No.
- Sacrifice and pathology:
- GROSS PATHOLOGY: No.
HISTOPATHOLOGY: No. - Cell viabilities:
- SPLEEN: No.
THYMUS: No.
BONE MARROW: No. - Humoral immunity examinations:
- ANTIBODY PLAQUE FORMING CELLS (PFC) ASSAY: No.
ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA): No.
- Specific cell-mediated immunity:
- ONE-WAY MIXED LYMPHOCYTE CULTURE (MLC) ASSAY: No.
DELAYED-TYPE HYPERSENSITIVITY (DTH) REACTION: No.
CYTOTOXIC T-LYMPHOCYTE (CTL) ASSAY: No. - Non-specific cell-mediated immunity:
- NATURAL KILLER (NK) CELL ACTIVITY: No.
MACROPHAGE NUMBER AND FUNCTION: Yes.
- Method: Four and forty eight hours later, groups of mice were killed and the peritoneal cells were harvested by lavage with 0.9% saline solution. The cells from individual animals were counted and samples removed for a differential count using cytocentrifuge preparations. Total cell numbers and changes in the sub-population distribution of activated macrophage as characterised by the markers MAC-1, MOMA-2, CR3, and Class II were observed.
- Dose groups: 5 and 50 mg/kg groups at 4 and 48 hours.
- No. of animals: 5 mice per dose group per time-point.
- Other functional activity assays:
- SPLEEN CELL PROLIFERATION ASSAY (ANTI-CD3 MEDIATED T CELL PROLIFERATION): No.
ENUMERATION TOTAL B CELLS, TOTAL T CELLS AND T CELL SUBPOPULATIONS: No. - Other examinations:
- Analysis for cytokine mRNA expression (IL-1a, IL-1ß, IL-6, TNFa and a-actin) in the cells recovered from the pertitoneal cavity was conducted.
- Positive control:
- The positive control group were injected with 1.5 mL Thioglycollate broth per mouse intraperitoneally.
- Statistics:
- No data.
Results and discussion
Results of examinations
- Food efficiency:
- effects observed, treatment-related
- Details on results:
- CLINICAL SIGNS AND MORTALITY: No animals showed any signs of ill health in the 72 hours between dosing and post mortem. There was an dose related increase in cell numbers seen in test article dosed mice, again due mainly to an increase in neutrophils.
NON-SPECIFIC CELL-MEDIATED IMMUNITY
-Increase in total cell numbers and in total macrophages.
-No major changes in the sub-population distribution of activated macrophages.
OTHER FINDINGS
- In the saline (negative control) groups there was no expression of mRNAs for IL-1a, IL-1ß, TNFa, IL-6 although expression of the house-keeping gene, actin was detected.
- In the positive control group (thioglycollate broth) mRNAs for IL-1a and IL-1ß were highly induced in the 4 hour treatment groups and TNFa and IL-6 mRNAs were slightly induced. By 48 hours after thioglycollate administration the steady state levels of these mRNAs had declined to background levels.
-Administration of high dose test article (50 mg/kg) induced increased expression of TNFa mRNA, where as at the lower dose level (5 mg/kg bw), there was little effect on TNFa but increased expression of IL-1β compared to the positive control. The high dose caused a slight elevation of IL-1ß mRNA levels but was most noticeable for eliciting a large and sustained increase in the steady state levels of TNFa mRNA; this effect was not seen at the lower dose. The high dose of test substance caused total inhibition of the expression of all mRNA including actin; this could be attributed to a failure of the cells to attach and spread onto the plastic substrate due to the toxic effect of the compound. This effect was dose dependent since limited cytokine expression was evident in the lower dose of test substance and a small percentage of cells could be observed spreading onto the plastic substrate. The high dose of caused total inhibition of the expression of all mRNA including actin; this could be attributed to a failure to attach and spread onto the plastic substrate due to the toxic effect of the compound, a similar situation to the cells from the 4 hour group. This effect was dose dependent since limited cytokine expression was evident in the lower dose, and TNFα mRNA expression was similar to controls after 3 hours stimulation and slightly enhanced after 24 hours.
- After 48 hours exposure there were no significant effects on cytokine expression.
- When cells from the peritoneal cavity of 4 hours exposed mice were cultured and stimulated with lipopolysaccharide, cells from the high dose group failed to adhere properly to substrate and exhibited reduced Cytokine expression. At the lower dose, cytokine gene expression was significantly inhibited for the test substance.
Effect levels
- Dose descriptor:
- NOAEL
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Any other information on results incl. tables
Effect of intraperitoneal administration of test articles on cytokine mRNA expression in peritoneal cells recovered by lavage
Test article |
Cytokine mRNA levels |
||||
IL1a |
IL1ß |
IL6 |
TNFa |
Actin |
|
4 h post dosing |
|||||
Positive control |
++ |
+++ |
+ |
+ |
++ |
TS, 50 mg/kg bw |
± |
+ |
± |
+++ |
+ |
TS, 5 mg/kg bw |
+ |
++ |
± |
± |
++ |
Saline control |
± |
- |
± |
± |
++ |
48 h post dosing |
|||||
Positive control |
± |
± |
- |
+ |
++ |
TS, 50 mg/kg bw |
- |
+ |
- |
+ |
++ |
TS, 5 mg/kg bw |
- |
± |
- |
± |
+++ |
Saline control |
- |
- |
- |
± |
++ |
4 hours post dosing and cultured with LPS for 3 hours |
|||||
Positive control |
++ |
++ |
+ |
++ |
+++ |
TS, 50 mg/kg bw |
- |
- |
- |
- |
- |
TS, 5 mg/kg bw |
- |
± |
- |
+ |
± |
Saline control |
+++ |
+++ |
++ |
+++ |
+++ |
48 hours post dosing and cultured with LPS for 3 hours |
|||||
Positive control |
+++ |
+++ |
++ |
+++ |
+++ |
TS, 50 mg/kg bw |
- |
- |
- |
- |
- |
TS, 5 mg/kg bw |
+ |
± |
- |
+++ |
++ |
Saline control |
++ |
++ |
++ |
+++ |
+++ |
TS: test substance
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.