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EC number: 404-170-0 | CAS number: 70750-63-9
- 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:
- 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Details on test material:
- - Lot/batch No.: Mix 51785
- Stability under test conditions: Stable under storage conditions
- Storage condition of test material: At room temperature in the dark
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, F.R.G.
- Age at study initiation: approximately 8 weeks
- Weight at study initiation: 27-36 g (males) and 20-29g (females)
- Assigned to test groups randomly: yes
-Fasting period before study: Withheld overnight before dosing until about 4 hours after administration of the test substance
- Housing: polycarbonate cages
- Diet (e.g. ad libitum): free access to standard laboratory animal diet
- Water (e.g. ad libitum):free access to tap-water
- Acclimation period: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2C
- Humidity (%): 63-65%
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark
IN-LIFE DATES: From: January 30, 1989 To: March 15, 1989
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: corn oil
- Concentration of test material in vehicle: 3000 mg/kg - Duration of treatment / exposure:
- Bone marrow was sampled 24, 48, and 72 hours after dosing
- Frequency of treatment:
- once
- Post exposure period:
- Bone marrow was sampled 24, 48, and 72 hours after dosing
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Basis:
nominal conc.
- No. of animals per sex per dose:
- 3000 mg/kg -Five males and five males at 24 hour sacrifice time
3000 mg/kg -Five males and five males at 48 hour sacrifice time
3000 mg/kg -Five males and five males at 72 hour sacrifice time - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
-Route of administration: oral
-Doses / concentrations: 50 mg/kg body weight
Examinations
- Tissues and cell types examined:
- Bone marrow
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: 3000 mg/kg was chosen as the appropriate dose for this assay as it was the highest dose that could be achieved because of aggregation of the test substance in suspension and it did not show adverse clinical.
CRITERIA FOR DOSE SELECTION: 3000 mg/kg was chosen as the appropriate dose for this assay as it was the highest dose that could be achieved because of aggregation of the test substance in suspension and it did not show adverse clinical.
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): Animals were dosed once and the bone marrow was sampled at either 24, 48 or 72 hours.
DETAILS OF SLIDE PREPARATION: A drop of the bone marrow suspension was added to the slides. The drop was spread by moving a clean slide with the drop of bone marrow suspension, The preparations were air dried and fixed for 5 minutes in 100% methanol and air-dried overnight. The slides were stained for 3 min. in undiluted May-Gruwald solution following 2 min in May-Gruwald solution diluted 1:1 with Sorensen buffer pH 6.8. The slides were then rinsed in this buffer and stained for 25 min. in 5% (v/v) Giemsa solution in Sorensen buffer pH 6.8. The preparations were rinsed for 1 min in running tap-water and blotted dry between filter paper. The dry slides were cleared by dipping them in xylol before they were embedded in DePeX and mounted with a coverslip.
METHOD OF ANALYSIS: The slides were first screened at a magnification of 1000x for regions of suitable technical quality. The slides were then scored at a magnification of 1000x. The number of micronuclei was counted in 1000 polychromatic erythrocytes. The ratio polychromatic to normochromatic erythrocytes was determined by counting and differentiating the first 1000 erythrocytes at the same time. Micronuclei were counted in polychromatic erythrocytes only.
Wilcoxon rank-sum to assess the significant differences between the numbers of micronuclei in the treatment and control groups. - Evaluation criteria:
- Wilcoxon rank-sum to assess the significant differences between the numbers of micronuclei in the treatment and control groups.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF DEFINITIVE STUDY
- Ratio of PCE/NCE (for Micronucleus assay): The ratios for males was 1.13, 0.97, and 1.19 for 24, 48, and 72 hours respectively and for females was 1.11, 0.92, 1.02 for 24, 48, and 72 hours respectively.
- Appropriateness of dose levels and route: The oral route was selected taking into account the possible route of human exposure during manufacture, handling and use. 3000 mg/kg was chosen as the appropriate dose for this assay as it was the highest dose that could be achieved because of aggregation of the test substance in suspension and it did not show adverse clinical.
Any other information on results incl. tables
The test material caused no increases in the frequency of micronuclei. The incidence of micronuclei in the control animals were within the historical control ranges. The groups treated with the positive control showed a decrease in the ratio of polychromatic to normochromatic erythrocytes, which reflects a toxic effect of this compound on the erythrocytes. The positive control substance induced in both sexes a statistically significant increase in the number of micronuclei
Sex (M/F) |
Group |
Treatment |
Dose (mg/kg body weight) |
Sampling time (hours) |
Number of micronuclei per 1000 polychromatic erythrocytes (mean +/- S.D.)a |
Ratio polychromatic/normochromatice erythrocytes (mean +/- S.D.) |
M |
A |
Vehicle b) |
-- |
24 |
0.4 +/- 0.5 |
1.10 +/- 0.16 |
M |
B |
Vehicle |
-- |
48 |
1.0 +/- 1.0 |
0.97 +/- 0.08 |
M |
C |
Vehicle |
-- |
72 |
0.2 +/- 0.4 |
1.15 +/- 0.09 |
M |
D |
Test material |
3000 |
24 |
0.6 +/- 0.5 |
1.13 +/- 0.18 |
M |
E |
Test material |
3000 |
48 |
0.8 +/- 1.3 |
0.97 +/- 0.16 |
M |
F |
Test material |
3000 |
72 |
1.2 +/- 1.1 |
1.19 +/- 0.17 |
M |
G |
CP |
50 |
48 |
14.2 +/- 8.5* |
0.33 +/- 0.14 |
F |
A |
Vehicle b) |
-- |
24 |
0.2 +/- 0.4 |
1.06 +/- 0.17 |
F |
B |
Vehicle |
-- |
48 |
0.4 +/- 0.5 |
1.08 +/- 0.12 |
F |
C |
Vehicle |
-- |
72 |
0.2 +/- 0.4 |
1.15 +/- 0.12 |
F |
D |
Test material |
3000 |
24 |
0.0 +/- 0 |
1.11 +/- 0.10 |
F |
E |
Test material |
3000 |
48 |
0.0 +/- 0 |
0.92 +/- 0.21 |
F |
F |
Test material |
3000 |
72 |
1.16 +/- 1.1 |
1.02 +/- 0.10 |
F |
G |
CP |
50 |
48 |
8.6 +/- 2.1* |
0.37 +/-0.10 |
a) Five animals per treatment group
b) Corn oil
c) Significantly different from corresponding control group (Wilcoxon rank sum test, P <=0.05)
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
The test material was non-mutagenic under the conditins of the assay. - Executive summary:
The test material did not show any evidence of causing chromosomal damage or bone marrow toxicity when administered orally by gavage in this in vivo assay.
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