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EC number: 418-200-5 | CAS number: 69227-51-6
- 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:
- May-October 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- under GLP guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- other: Mammalian Erytrocyte Micronucleous Test
Test material
- Specific details on test material used for the study:
- Cas # 69227-51-6
Batch # 0691
pH: 6-9
Storage: 5°C in the dark
Supplier: Chemson, Polymer-Additive Gesellschaft m.b.H. A-9601 Arnoldstein.
Characterization:
Appearance: Colorless liquid.
pH 6.84
Content 52.2% (estimation of bromide)
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Remarks:
- BR
- Details on species / strain selection:
- Justification for the selection of the species: Recommended by the guideline
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Supplier : Charles River WIGA GmbH (D-8741 Sulzfeld 1)
number in main study 25 males and 25 females
Age: approx. 10 weeks
Body weight (average; gr): males; NC 31.2, PC 30.5, A1 31.1, B1 30.7, C1 30.6
Body weight (average; gr): females; NC 23.5, PC 22.3, A1 23, B1 22.7, C1 22.6
Hygiene: improved conventional conditions
Room number: PHA-18
Room temperature: average of 24°C
Relative humidity: average of 50%
air exchange: 12 per hr
Light: artificial light from 6 am to 6 pm
Cages: Makrolon type III females, type II males
five animals per cage (females), single caging (males)
Bedding material: aspen wood chips, autoclaved
Feed: Altromin 1314 ff, gamma irradiated with 10kGy 60Co, ad libitum
Exception: feed was withdrawn the evening before application and was offered again about one hr after application. Random samples of the food are analysed for contaminants by Altromin, D-4937 Lage.
Water: tap water, from makrolon bottles with stainless steel canules, ad libitum
Identification: labelling with felt-tipped pen on the tail and the cage.
Acclimatization: 10 days.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Distilled water was used for the solution of the test substance and for Negative Control (NC) (dose volume 10 ml/kg body weight).
The test substance was diluted with distilled water and was applied once at a dose of 350 mg/kg body weight by stomach intrubation.
Based on two preliminary range finding study, a dose of 350 mg of test substance per kg body weight was chosen for main study
The negative as well as positive control group was tested as well. - Details on exposure:
- The test substance was diluted with distilled water and was applied once
- Duration of treatment / exposure:
- The animals were killed 24, 48 and 72 hr post application.
One negative control group (distilled water, killed 48 hr p.a) and one positive control (cyclophosphamide, killed 24 hr p.a) were included in the study. - Frequency of treatment:
- Applied once
Doses / concentrationsopen allclose all
- Dose / conc.:
- 350 mg/kg bw/day (nominal)
- Remarks:
- test material
- Dose / conc.:
- 10 other: ml/kg b.w
- Remarks:
- distilled water (negative control)
- Dose / conc.:
- 10 other: ml/kg b.w
- Remarks:
- cyclophosphamide (positive control)
- No. of animals per sex per dose:
- total of 25 males and 25 females (3 groups each)
5 males and 5 females for positive and negative control - Control animals:
- yes
- Positive control(s):
- Cyclophosphamide (Positive Control, PC) was dissolved in distilled water (dose volume 10 ml/kg body weight)
Examinations
- Tissues and cell types examined:
- Bone marrow
- Details of tissue and slide preparation:
- see attached document on methods
- Statistics:
- see attached document on methods
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- positive
- Toxicity:
- yes
- Remarks:
- slight cytotoxic effects, more pronounced in females
- Vehicle controls validity:
- valid
- Remarks:
- Negative control
- Negative controls validity:
- valid
- Remarks:
- No effect
- Positive controls validity:
- valid
- Remarks:
- micronuclei induction as a result of damage or damage to mitotic apparatus in vivo. have cytotoxic properties. amount of polychromatic erythrocyes raised and nucleated cells lowered.
- Additional information on results:
- see attached document on results
Applicant's summary and conclusion
- Conclusions:
- A slight cytotoxic effect of the test substance was noted at all sampling times in animals of both sexes.
The rate of micronucleated polychromatic erythrocytes, which is the target of the study, was increased significantly by the test substance at all sampling times, compared to the negative control group and to historical negative control data.
While no differences between the sexes were noted considering mutagenicity, cytotoxicity was more pronounced in females.
The test substance does produce micronuclei in polychromatic erythrocytes at a dose of 350 mg/kg body weight at sampling time of 24, 48 and 72 hr p.a - Executive summary:
The test substance N-Methyl-Ethyl-Pyrollidinium-Bromid (MEP) was administered to 3 groups of 5 males and 5 female mice each. The test substance, dilluted with distilled water, was applied once at the dose of 350 mg/kg b.w.
The animals were killed 24, 48 and 72 hr p.a. Preperations of bone marrow cells were conducted according to OECD 474.
Negative and positive controls were included in the study as well.
Results: A slight cytotoxic effect of the test substance was noted at all sampling times in animals of both sexes.
The rate of micronucleated polychromatic erythrocytes, which is the target of the study, was increased significantly by the test substance at all sampling times, compared to the negative control group and to historical negative control data.
While no differences between the sexes were noted considering mutagenicity, cytotoxicity was more pronounced in females.
The test substance does produce micronuclei in polychromatic erythrocytes at a dose of 350 mg/kg body weight at sampling time of 24, 48 and 72 hr p.a
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