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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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From Jun. 2, 1986 to Nov. 3, 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- no
- Type of assay:
- micronucleus assay
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: solid
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- hamster, Chinese
- Strain:
- other: random outbred
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 21-32 g (females) and 23-35 g (males)
- Housing: individual caging
- Diet: NAFAG No. 924, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 3-4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23°C
- Humidity (%): 52-78%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: 0.5% CMC (carboxymethyl cellulose)
- Amount of vehicle (if gavage or dermal): 20 ml/kg - Details on exposure:
- The preparation was administered orally to groups of 24 female and 24 male animals each in the negative and in the 5000 mg/kg dose group. The positive control group consisted of 8 female and 8 male animals. Treatment consisted of a single application. 16, 24 and 48h after application 8 female and 8 male animals per sampling time were sacrificed by dislocation of the cervical vertebrae.
- Duration of treatment / exposure:
- Single dose administered orally.
- Frequency of treatment:
- Once
- Post exposure period:
- 16, 24, 48 hours after treatment application.
Doses / concentrations
- Dose / conc.:
- 5 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 8/sex/sampling time
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
- Route of administration: gavage
- Doses / concentrations: 64 mg/kg in 20 ml/kg 0.5% CMC
Examinations
- Tissues and cell types examined:
- Bone marrow was harvested from the shafts of both femurs.
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
A preliminary test was performed to determine the highest dosage of the test substance to be applied in the mutagenicity assay. The highest dose causing no deaths is used as the highest in the mutagenicity test. No deaths were registered at any of the three groups of four Chinese hamsters (two female and two male animals ) treated with the doses 200, 1000 and 5000 mg/kg respectively, within the observation period of three days. Thus, the dose of 5000 mg/kg was chosen as no death occurred at this concentration.
TREATMENT AND SAMPLING TIMES:
16, 24 and 48h after application, 8 female and 8 male animals per sampling time were sacrificed by dislocation of the cervical vertebrae.
DETAILS OF SLIDE PREPARATION:
Bone marrow was harvested from the shafts of both femurs with fetal calf serum. After centrifugation small drops of the sediment mixture were transferred on the end of a slide, spread out with the aid of a glass slide and the preparations were air-dried. Within 24 hours, the slides were stained in undiluted May-Grünwald solution for 3 min then in May-Grünwald solution/water 1/1 for 2 min. After being rinsed in distilled water, the slides were left immersed in diluted Giemsa solution (16.6%), for 10 min. After rinsing with distilled water and air-drying, the slides were cleared in Xylene and mounted.
METHOD OF ANALYSIS:
The slides of five animals from each sex showing the best differentiation between mature and polychromatic erythrocytes were selected for later scoring. The slides of five female and five male animals each of the negative control group and of the dosage group sacrificed at 16, 24 and 48 hours post treatment were examined. From the animals of the positive control group which were sacrificed 24 hours after application, the slides of five female and five male animals were scored. 1000 polychromatic erythrocytes per animal each were scored for the incidence of micronuclei. The ratio of polychromatic to normochromatic erythrocytes was determined for each animal by counting a total of 1000 erythrocytes. - Evaluation criteria:
- Statistically significant increase in the number of micronucleated polychromatic erythrocytes in comparison with the negative control animals at any sampling time.
- Statistics:
- The significance of difference was assessed by Chi square-test.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
In the preliminary tolerability test, no deaths were registered at any of the three groups of four Chinese hamsters (two female and two male animals ) treated with the doses 200, 1000 and 5000 mg/kg respectively, within the observation period of three days. Thus, the dose of 5000 mg/kg was chosen for the micronucleus test as no death occurred at this concentration.
RESULTS OF DEFINITIVE STUDY
- Statistical evaluation: No statistically significant increase (p>0.05) in the number of micronucleated polychromatic erythrocytes in comparison with the negative control animals at all three sampling times.
By contrast, the positive control (cyclophosphamide, 64 mg/kg) yielded a marked increase of the percentage of micronucleated cells. Here the mean percentage of polychromatic erythrocytes with micronuclei was 2.66. In comparison with the negative control (0.11) this value is highly significant (p<0.05).
Any other information on results incl. tables
Table: The effect of the test substance on bone marrow cells of Chinese hamster (arithmetic mean per sex and group).
Sacrifice |
Dose |
Sex |
PCE |
NCE |
Ratio of PCE/NCE |
No. of PCE with MN |
% of PCE with MN |
16 h |
Control |
Female |
583 |
417 |
1.40 |
2.0 |
0.20 |
Male |
514 |
486 |
1.06 |
0.8 |
0.08 |
||
TS |
Female |
650 |
350 |
1.86 |
0.6 |
0.06 |
|
Male |
511 |
489 |
1.04 |
1.2 |
0.12 |
||
24 h |
Control |
Female |
595 |
405 |
1.47 |
1.2 |
0.12 |
Male |
562 |
438 |
1.28 |
1.0 |
0.10 |
||
TS |
Female |
515 |
485 |
1.06 |
2.0 |
0.20 |
|
Male |
508 |
492 |
1.03 |
0.8 |
0.08 |
||
48 h |
Control |
Female |
564 |
436 |
1.29 |
1.8 |
0.18 |
Male |
561 |
439 |
1.28 |
1.6 |
0.16 |
||
TS |
Female |
520 |
480 |
1.08 |
0.6 |
0.06 |
|
Male |
456 |
544 |
0.83 |
1.0 |
0.10 |
||
Positive control |
|||||||
24 h |
Control |
Female |
595 |
405 |
1.47 |
1.2 |
0.12 |
Male |
562 |
438 |
1.28 |
1.0 |
0.10 |
||
CPA |
Female |
514 |
484 |
1.06 |
23.6 |
2.36 |
|
Male |
459 |
541 |
0.85 |
29.0 |
2.96 |
TS: test substance; PCE: polychromatic erythrocytes; NCE: normochromatic erythrocytes; MN: micronuclei; CPA: cyclophosphamide
Applicant's summary and conclusion
- Conclusions:
- There was no significant increase in the number of micronucleated polychromatic erythrocytes in the animals treated with the dose of 5000 mg/kg bw of the test substance as compared with the negative control animals. Under the conditions of this experiment, no evidence of mutagenic effects was obtained in chinese hamster treated with the test substance.
- Executive summary:
A micronucleus test in hamster was performed to evaluate any mutagenic effect of the test substance on polychromatic erythrocytes in bone marrow cells in vivo. To that end, the animals were treated once by gavage with the highest applicable dose of 5000 mg/kg and sacrificed 16, 24 and 48 hours thereafter. From the bone marrow smears were made. Mutagenic effects present themselves in form of micronuclei in polychromatic erythrocytes in the bone marrow. These micronuclei are small particles consisting of acentric fragments of chromosomes or entire chromosomes which lag behind at anaphase stage during the mitotic process. After telophase, these fragments may not be included in the nuclei of daughter cells and form single or multiple micronuclei in the cytoplasm. The increase in micronucleated polychromatic erythrocytes shows a clear dose dependency, comparable to the occurrence of chromosome aberrations in metaphase preparations. In this experiment, the bone marrow smears from animals treated with the dose of 5000 mg/kg showed no statistically significant increase (p>0.05) in the number of micronucleated polychromatic erythrocytes in comparison with the negative control animals at all three sampling times. The respective "positive control" experiments with cyclophosphamide (64 mg/kg) yielded an average of 2.66% polychromatic erythrocytes with micronuclei. This is significantly different from the controls (0.11%) treated with the vehicle (0.5% CMC) alone. It is concluded that under the conditions of this experiment, no evidence of mutagenic effects was obtained in Chinese hamsters treated with the test article.
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