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EC number: 266-235-8 | CAS number: 66204-44-2
- 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:
- Sept 24, 2001 to July 25, 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- No details about the purity of the test substance (responsibility of the sponsor, minor restriction). Contradiction between the description of the results of the preliminary study on page 15 (no effects at 500 mg/kg bw) and page 19/Appendix 3 (100% mortality at 500 mg/kg bw) of the report. No differentiation between structural and numerical chromosome aberration (minor restriction).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- CONTRAM™ MBO (1/6120) / Bakzid
- IUPAC Name:
- CONTRAM™ MBO (1/6120) / Bakzid
- Details on test material:
- - Name of test material (as cited in study report): 3,3'-methylenebis[5-methyl- oxazolidine]
- Density: 1,0668 (20°C)
- Substance type: Formaldehyde releaser
- Physical state: Clear colourless liquid
- Analytical purity: Content of formaldehyde 42,28%; 1% in LM at 20°C (no further data)
- Composition of test material, percentage of components: Reaction product from paraformaldehyde and 2 hydroxypropylamine (ratio of 3:2)
- Purity test date: Sept 10, 2001
- Lot/batch No.: 24773
- Storage condition of test material: At room temperature in tightly closed container
- Other: No purity/stability data available with the performing Laboratory
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Details on species / strain selection:
- Crl:NMRI BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, D 97633 Sulzfeld
- Age at study initiation: 29 to 30 days
- Weight at study initiation: males 20-25 g and females 19-23 g at administration
- Assigned to test groups randomly: yes
- Fasting period before study: no
- Housing: 5 per sex and cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: From Octber 17, 2001 to January 25, 2002
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: Corn oil
- Justification for choice of solvent/vehicle: to obtain a homogeneous suspension
- Concentration of test material in vehicle: 0, 0.15, 0.5, and 1.5%
- Amount of vehicle (if gavage): 20 mL/kg bw - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The test item was suspended at the required concentartions in corn oil
- Duration of treatment / exposure:
- Exposure: 24 hours for all dose levels including vehicle control; 48 hours for vehicle control, positive control and high dose group
- Frequency of treatment:
- One single oral dosing
- Post exposure period:
- 24 h (all dose levels including vehicle controls or 48 h (vehicle and positive control and high dose level only)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 30, 100, 300 mg/kg bw plus positive control
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Positive control substance: cyclophosphamide
- Justification for choice of positive control(s): To confirm the sensitivity of the test system
- Route of administration: Intraperitoneal
- Doses / concentrations: 27 mg/kg bw
Examinations
- Tissues and cell types examined:
- Erythrocytes in bone marrow
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: Preliminary dose range finding study.At ≥ 500 mg/kg bw all animals died ≤ 60 minutes after application. At 250 mg/kg bw abnormal clinical signs: moderately reduced motility, slight to moderate ataxia, slightly reduced muscle tone, slight to moderate dyspnoea. Hence 300 mg/kg bw was considered to be the maximum tolerated dose (MTD).
DETAILS OF SLIDE PREPARATION: Femora were excised and the bone marrow was flushed out and centrifuged. The supernatant was removed and sediment was suspended in a drop of calf serum. Then a smear was prepared, dried and fixed wit methanol. Cells were stained with Mayers Haemalum.
METHOD OF ANALYSIS: By microscopic analysis with coded slides, random analysis - Evaluation criteria:
- The test item was considered positive if:
- a statistically significant increase in the frequency of micronucleated PCE occurred for at least on dose at one kill time
- the frequence of micronucleated PCE at such a point exceeded the historical control range
- corrobating evidence was obtained, for example, increased but statistically insignificant frequencies or micronucleated PCE at other doses or kill times or dose reponse profiles - Statistics:
- Chi-square test corrected for continuity according to Yates
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- At 300 mg/kg bw slightly to moderately reduced motility, slight ataxia, slightly reduced muscle tone, and slight dyspnoea 15 minutes to 3 hours after administration
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: 250, 500, 1000 and 2000 mg/kg bw; single oral dose (gavage)
- Solubility: Suspension in corn oil
- Clinical signs of toxicity in test animals: At ≥ 500 mg/kg bw all animals died ≤ 60 minutes after application. At 250 mg/kg bw abnormal clinical signs: moderately reduced motility, slight to moderate ataxia, slightly reduced muscle tone, slight to moderate dyspnoea
RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): No significant differences to control
- Ratio of PCE/NCE (for Micronucleus assay): No significant differences to control
- Appropriateness of dose levels and route: Dose levels and route were appropriate as the clinical signs at the MTD (300 mg/kg bw) such as slightly to moderately reduced motility, slight ataxia, slightly reduced muscle tone, and slight dyspnoea 15 minutes to 3 hours after administration indicated systemic toxicity without mortality.
The quotient polychromatic/normochromatic erythrocytes (per 1000 erythrocytes) in the bone marrow was not altered compared to the concurrent control or historical controls of the same laboratory indicating no cytotoxic effects at the MTD.
- Statistical evaluation: see Table
Any other information on results incl. tables
Mouse bone marrow micronucleus assay
Treatment, dose in mg/kg bw |
Number of cells scored |
Sampling time |
Ratio polychro-matic/normochromatic erythrocytes |
Polychromatic cells with micronuclei per 1000 cells |
Males |
||||
0 |
2000 |
24 h |
0.65+-0.14 |
2.1+-1.3 |
30 |
2000 |
24 h |
0.64+-1.12 |
2.1+-0.5 |
100 |
2000 |
24 h |
0.71+-0.16 |
2.5+-1.1 |
300 |
2000 |
24 h |
0.68+-0.08 |
1.5+-0.5 |
0 |
2000 |
48 h |
0.76+-0.19 |
1.7+-1.3 |
300 |
2000 |
48 h |
0.55+-0.05 |
1.9+-0.5 |
Positive control |
2000 |
24 h |
0.71+-0.18 |
12.2+-3.3* |
Historical vehicle control |
|
|
0.65 (range 0.29-1.16) |
2.34 (range 0.9-3.9) |
Females |
||||
0 |
2000 |
24 h |
0.56+-0.10 |
2.2+-0.6 |
30 |
2000 |
24 h |
0.53+-0.07 |
1.9+-1.4 |
100 |
2000 |
24 h |
0.72+-0.07 |
2.6+-1.6 |
300 |
2000 |
24 h |
0.69+-0.07 |
1.6+-0.4 |
0 |
2000 |
48 h |
0.63+-0.25 |
0.7+-0.8 |
300 |
2000 |
48 h |
0.64+-0.07 |
1.4+-1.1 |
Positive control |
2000 |
24 h |
0.69+-0.14 |
10.3+-4.7* |
Historical vehicle control |
|
|
0.72 (range 0.32-1.09) |
2.46 (range 0.8-3.7) |
Mean values and standard deviations are given of 5 males or 5 females. *:statistical significant |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The concurrent negative and positive controls are valid. Under the conditions of this assay the test substance did not induce a statistical significant increase in the number of micronuclei at a dose level up to 300 mg/kg bw, the maximum tolerated dose. Therefore the tes item had no chromosome mutagenic activity under the conditions of the study. - Executive summary:
Study performed according to OECD guideline 474, mouse bone marrow micronucleus test; 5m + 5f per dose and sampling time received via gavage 0, 30, 100, 300 mg/kg bw (0, 0.15, 0.5, and 1.5% in corn oil); cytotoxicity and clastogenicity in bone marrow measured 24 or 48 h after single application. No mutagenic effect observed, as there was no substance-related increase in micronuclei in any treatment group.
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