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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
All positive control groups showed significantly increased mutation frequencies which demonstrates the sensitivity of the test system.
the test substance was not toxic up to 5 mg/plate. all used concentrations could be evaluated.
In none of the tested concentrations and with none of the used strains a statistically significant increase of the mutation frequency was obtained. Metabolic activation did not change these results.
The test substance is therefore non mutagenic in Ames test.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October-December 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- under GLP requirenents
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial forward mutation assay
- 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) - Target gene:
- Histidine
- Species / strain / cell type:
- S. typhimurium TA 97
- Remarks:
- Mutation D6610, rfa,uvrB, pkM101
- Additional strain / cell type characteristics:
- other: D6610 is a frameshift mutation, rfa leads to reduced lipopolysaccharide barriere in the cell wall . uvrB results in a loss of the DNA excision repair system. pkM101 increases the sensitivity to mutagens as well.
- Species / strain / cell type:
- S. typhimurium TA 98
- Remarks:
- Mutation D3052, rfa, uvrB, pkM101
- Additional strain / cell type characteristics:
- other: D3052 is a frameshift mutation, rfa, uvrB, pkM101 as in TA 97
- Species / strain / cell type:
- S. typhimurium TA 100
- Remarks:
- Mutation G46 , rfa, uvrB, pkM101
- Additional strain / cell type characteristics:
- other:
- Remarks:
- G46 is a base pair mutation, rfa, uvrB, pkM101 as in TA97
- Species / strain / cell type:
- S. typhimurium TA 102
- Remarks:
- Mutation G428, rfa, pkM101
- Additional strain / cell type characteristics:
- other: G428 is an ochre mutation with sensitivity to hydroperoxides and crosslinking substances, rfa and pkM101 as in TA97
- Metabolic activation:
- with and without
- Metabolic activation system:
- microsomal fraction of homogenized livers of rats treated once with 500 mg/kg arcolor 1240
- Test concentrations with justification for top dose:
- high concentration 1: 5000 µg/plate 3 samples
concentration 2: 1667 µg/plate 3 samples
concentration 3: 555 µg/plate 3 samples
concentration 4: 185 µg/plate 3 samples
low concentration 5: 62 µg/plate 3 samples
control (water): 6 samples
Postive control: Aflatoxine B1, 1µg/plate, for strains TA97 and TA100 at samples with S9-mix. - Vehicle / solvent:
- water
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- other: water
- Positive controls:
- yes
- Positive control substance:
- other: Aflaxotine B1
- Details on test system and experimental conditions:
- see attached document on test system (1-3)
- Rationale for test conditions:
- The study was conducted according to OECD 471. according to Ames (1983) mutationRes. 113, 173-215 the strains TA97 and TA 102 are recommended instead of TA1535 and TA1537 and they give better response to the mutagen spectrum. theses are the strain used in this test.
- Statistics:
- see attached document on test system (1-3)
- Key result
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks:
- tested only with metabolic activation
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks:
- tested without metabolic activation
- Remarks on result:
- other: not mutagenic
- Conclusions:
- All positive control groups showed significantly increased mutation frequencies which demonstrates the sensitivity of the test system.
the test substance was not toxic up to 5 mg/plate. all used concentrations could be evaluated.
In none of the tested concentrations and with none of the used strains a statistically significant increase of the mutation frequency was obtained. Metabolic activation did not change these results.
The test substance is therefore non mutagenic in Ames test. - Executive summary:
MEP was tested for mutagenic action with the salmonella thyphimurium reverse mutation assay (Ames test). The study was conducted according to OECD 471.
The test substance was tested at concentrations ranging from 62 µg to 5 mg per plate. with and without external metabolizing system S9 -mix.
The following bacterial strains were used: TA 97, TA 98, TA 100 and TA 102, as well as negative (vehicle) and positive control.
All positive control groups showed significantly increased mutation frequencies which demonstrates the sensitivity of the test system.
the test substance was not toxic up to 5 mg/plate. all used concentrations could be evaluated.
In none of the tested concentrations and with none of the used strains a statistically significant increase of the mutation frequency was obtained. Metabolic activation did not change these results.
The test substance is therefore non mutagenic in Ames test.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
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
Link to relevant study records
- 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
- 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
- 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) - 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. - 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
- 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)
- Tissues and cell types examined:
- Bone marrow
- Details of tissue and slide preparation:
- see attached document on methods
- Statistics:
- see attached document on methods
- 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
- 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
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (positive)
Additional information
Justification for classification or non-classification
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.