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EC number: 404-360-3 | CAS number: 119313-12-1 CG 25-369; IRGACURE 369; TK 11-319
- 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
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987-04-06, 1987-09-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone
- EC Number:
- 404-360-3
- EC Name:
- 2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone
- Cas Number:
- 119313-12-1
- Molecular formula:
- C23 H30 N2 O2
- IUPAC Name:
- 2-benzyl-2-(dimethylamino)-1-[4-(morpholin-4-yl)phenyl]butan-1-one
- Details on test material:
- - Physical state: Solid
- Analytical purity: Lab. sample
- Lot/batch No.: WR 629
- Expiration date of the lot/batch: 1990-02
- Stability under test conditions: Stable
Constituent 1
Test animals
- Species:
- hamster, Chinese
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Tierfarm, Sisseln, Switzerland
- Age at study initiation: Females 6 - 10 weeks; males 4 - 9 weeks
- Weight at study initiation: Females 23-32 g; males 26-35 g
- Assigned to test groups randomly: yes
- Diet: Ad libitum, standard diet: NAFAG No.924
- Water: Ad libitum
- Acclimation period: 4 - 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 51 - 74
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle used: Carboxymethylcellulose (CMC) 0.5 % in water
- Justification for choice of solvent/vehicle: TK 11319 is insoluble in water
- Concentration of test material in vehicle: 5000 mg/kg bw in 20 mL/kg bw - Duration of treatment / exposure:
- Single dose exposure
- Frequency of treatment:
- Single dose
- Post exposure period:
- 16, 24, and 48 hours
Doses / concentrations
- Dose / conc.:
- 5 000 mg/kg bw/day (actual dose received)
- Remarks:
- In a preliminary toxicity test the dose of 5000 mg/kg was determined as the highest applicable in the mutagenicity assay.
- No. of animals per sex per dose:
- 8 per sex per group
- Control animals:
- yes, concurrent no treatment
- Positive control(s):
- A dose of 64 mg/kg bw of cyclophosphamide was used as positive control. The route of administration was oral per gavage.
Examinations
- Tissues and cell types examined:
- 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 polished cover glass. 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. 1000 polychromatic erythrocytes (PCE) per animal were used to determine the incidence of micronucleated PCE. A total of 1000 erythrocytes were counted for determination of the ratio of polychromatic to normochromatic erythrocytes (PCE/NCE -ratio).
- Statistics:
- The significance of difference is assessed by χ2-test.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Remarks:
- No significant differences in the PCE/NCE-ratio between treated groups and controls.
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1. Effect of test article on bone marrow cells of chinese hamster: arithmetic mean per sex and group.
Sacrifice (h) | ||||||||||||
16 | 24 | 48 | ||||||||||
Control | TK 11319 | Control | TK 11319 | Control | TK 11319 | |||||||
sex of the animals | ♀ | ♂ | ♀ | ♂ | ♀ | ♂ | ♀ | ♂ | ♀ | ♂ | ♀ | ♂ |
polychromatic erythrocytes (P) | 626 | 520 | 550 | 551 | 489 | 471 | 482 | 486 | 555 | 539 | 459 | 485 |
normochromatic erythrocytes (N) | 374 | 480 | 450 | 449 | 511 | 529 | 518 | 514 | 445 | 461 | 541 | 515 |
ratio P/N | 1.7 | 1.1 | 1.2 | 1.2 | 1.0 | 0.9 | 0.9 | 0.9 | 1.2 | 1.2 | 0.8 | 0.9 |
P with micronuclei | 0.2 | 0.2 | 0.4 | 0.2 | 0.6 | 1.0 | 1.0 | 0.6 | 0.8 | 0.8 | 0.6 | 0.6 |
percent of P with micronuclei | 0.02 | 0.02 | 0.04 | 0.02 | 0.06 | 0.10 | 0.10 | 0.06 | 0.08 | 0.08 | 0.06 | 0.06 |
Table 1 (cont.). Effect of test article on bone marrow cells of chinese hamster: arithmetic mean per sex and group (positive control).
Sacrifice (h) | ||||
24 | ||||
Control | Cyclophosphamide (64 mg/kg) | |||
sex of the animals | ♀ | ♂ | ♀ | ♂ |
polychromatic erythrocytes (P) | 489 | 471 | 452 | 450 |
normochromatic erythrocytes (N) | 511 | 529 | 548 | 550 |
ratio P/N | 1.0 | 0.9 | 0.8 | 0.8 |
P with micronuclei | 0.6 | 1.0 | 27.0 | 32.2 |
percent of P with micronuclei | 0.06 | 0.10 | 2.70 | 3.22 |
Applicant's summary and conclusion
- Conclusions:
- The substance tested in the in vivo Micronucleus Test with Chinese Hamster (method similar to OECD 474) up to 5000 mg/kg bw was not genotoxic.
- Executive summary:
In this guideline (OECD 474) study conducted to GLP standards, the test material (EC 404-360-3) was tested in vivo on chinese hamsters (male and female) aged 4 -10 weeks. The test substance was administered via oral gavage in a vehicle of 0.5% carboxymethylcellulose (concentration of test material in vehicle was 5000 mg/kg bw in 20 ml/kg bw). 8 animals of each sex per dose were tested, with various sacrifice times (16, 24 and 48 hours). After sacrifice, bone marrow was harvested from the shafts of both femurs with fetal calf serum for analysis. As well as a control, there was a positive control using 64 mg/kg bw of cyclophosphamide (also administered via oral gavage). The bone marrow tissue was then examined for incidence of polychromatic erythrocytes (PCE) - an increase in frequency being an indicator of induced chromosome damage. No PCE was observed for the test material, therefore EC 404 -360 -3 is not genotoxic.
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