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EC number: 619-290-0 | CAS number: 97780-06-8
- 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 / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 84-2
- GLP compliance:
- yes
- Type of assay:
- mammalian germ cell cytogenetic assay
Test material
- Reference substance name:
- Reference substance 002
- Cas Number:
- 97780-06-8
- Test material form:
- solid
- Details on test material:
- -Purity: 96.8%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(BR)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Kingston, N.Y.
- Age at study initiation: 58 days old
- Weight at study initiation: Males: 237 g (range 217-254 g) and Females: 186 g (range 168-200 g)
- Assigned to test groups randomly: Yes, under following basis:computer-generated random numbers
- Fasting period before study: No data
- Housing: Individually in standard wire mesh cages
- Diet (e.g. ad libitum): Purina Certified Rodent Chow®, Lot Nov 14 851 C)
- Water (e.g. ad libitum): No data regarding the source of the water
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.7-22.2°C
- Humidity (%): 40-42%
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12-hr light/dark cycles
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Corn oil
- Duration of treatment / exposure:
- Single gavage dose
- Frequency of treatment:
- Single gavage dose
- Post exposure period:
- animals were sacrificed 6, 24, or 48 hours later for bone marrow sampling.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 500 mg/kg bw (total dose)
- Dose / conc.:
- 1 500 mg/kg bw (total dose)
- Dose / conc.:
- 5 000 mg/kg bw (total dose)
- No. of animals per sex per dose:
- 15 males and 15 females
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Yes, cyclophosphamide - 20 mg/kg
Examinations
- Tissues and cell types examined:
- Bone marrow cells
- Details of tissue and slide preparation:
- TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields):6, 24, and 48 hours after administration
DETAILS OF SLIDE PREPARATION: Bone marrow cells were processed according to the procedure of Kilian, et al (1977), with minor modifications. Immediately following sacrifice, the marrow from both femurs of each animal was aspirated into 5 mL pre-warmed (37°C) Hanks' Balanced Salt Solution. The marrow button was collected by centrifugation (IEC Centrifuge Model HNS-II) at approximately 1000 rpm for 5 min and then resuspended in pre-warmed (37°C) 0.075M KCl. After incubation for 15 min in a 37°C waterbath, the centrifugation step was repeated and the resulting pellet resuspended in 5 mL cold fixative (methanol: acetic acid, 3:1). Two or more additional centrifugations and fixative washes were done. After the final centrifugation, the pellet was resuspended in approximately 1.0 mL of fixative. Drops of the cell suspension were dispersed onto pre-cleaned glass microscope slides (wetted in ice-chilled distilled water) and flame-dried. Four slides per animal were prepared. The slides were stained for 7 min with 10% Giemsa (Harleco) in phosphate buffer (pH 6.8), and rinsed with distilled water. After clearing in xylene for 5 min, the slides were coverslipped with Permount®.
METHOD OF ANALYSIS: Representative slides from each animal were scored in a blind manner by H & W Cytogenetic Services, Inc. Chromosomes were examined under high power (1000X) using an oil immersion objective. Fifty metaphase cells per rat were analyzed for chromosomal aberrations. The following observations were recorded for each animal:
• Number and type of structural chromosomal aberrations, and the vernier locations of any abnormal metaphases.
• Number of chromosomes in each cell. The modal number of chromosomes in the rat is 42.
Cells having 40-44 chromosomes were judged acceptable for scoring.
• The mitotic index, as determined by counting the number of mitotic cells among 500 total
cells in the optic fields scanned. - Evaluation criteria:
- Chromosomal aberrations were characterized as follows: a) Chromatid-type Aberrations: Damage expressed as breakage of single chromatids or breakage and reunion between chromatids.
These aberrations included: chromatid breaks (tb), isochromatid breaks (ib), fragments (f), triradials (tr), quadriradials (qr)
intrachanges (int), and cells having 10 or more aberrations (≥ 10)
b) Chromosome-type Aberrations: Changes which result from damage expressed in both chromatids at the same site. These aberrations
included: acentric fragments (af), double minutes (dm), ring chromosomes (r), translocations (t), dicentric chromosomes (d), pulverized chromosomes (pu), and pulverized cells (pc)
c) Chromatid (tg) and Isochromatid (ig) Gaps. These were recorded but not scored as aberrations. - Statistics:
- For all endpoints, each treated group was compared with the respective negative control group (6, 24, or 48 hours); the positive
indicator group was compared to the 24-hour negative controls. Each animal was considered an experimental unit and treatment effects were examined for each sex independently. For each time point, Mann-Whitney U tests (Conover, 1971) were conducted between the negative control and the treated groups for the analysis of percent abnormal cells, percent abnormal cells with more than one aberration, and aberrations per cell.
In cases where 75% or more of the observations were the same (e.g., where none of the animals in a group had cells with more than one aberration), Fisher exact tests (Conover, 1971) were substituted for Mann-Whitney U tests. Jonckheere tests for trend (Jonckheere, 1954) were also conducted.
Mitotic indices and body weight changes were tested using analysis of variance (Snedecor and Cochran, 1980). Where the F-test for treatment
level was significant, pairwise comparisons were made between each treatment group and the control using Dunnett's test (Steel and Torrie,
1980). Significance was judged at the 5% level.
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
Any other information on results incl. tables
Table 1A Summary of aberration data - 6-hour sacrifice
Treatment |
Sex |
Number of animals per group |
Number of Metaphases Analyzed per Group |
Percent Abnormal Cells per Group |
Percent Cells per Group with > 1 Aberration |
Average Number of Aberrations per Cell |
Average Number of Mitoses per 500 cells (S.E.) |
Corn oil |
M F |
5 5 |
250 250 |
1.2 0.4 |
0.0 0.0 |
0.012 0.004 |
17.8 (1.3) 18.6 (1.4) |
500 mg/kg |
M F |
5 5 |
250 250 |
0.0 0.0 |
0.0 0.0 |
0.000 0.000 |
12.4 (1.5) 12.2 (2.5) |
1500 mg/kg |
M F |
5 5 |
250 250 |
0.4 0.4 |
0.0 0.0 |
0.004 0.004 |
10.2** (1.8) 12.4 (1.8) |
5000 mg/kg |
M F |
5 5 |
250 250 |
0.0 0.0 |
0.0 0.0 |
0.000 0.000 |
7.6*** (1.3) 11.0* (1.6) |
* p < 0.05
** p < 0.01
*** p < 0.001
Table 1B Summary of aberration data - 24-hour sacrifice
Treatment |
Sex |
Number of animals per group |
Number of Metaphases Analyzed per Group |
Percent Abnormal Cells per Group |
Percent Cells per Group with > 1 Aberration |
Average Number of Aberrations per Cell |
Average Number of Mitoses per 500 cells (S.E.) |
Corn oil |
M F |
5 5 |
250 250 |
0.0 0.4 |
0.0 0.0 |
0.000 0.004 |
9.2 (1.0) 7.4 (1.8) |
500 mg/kg |
M F |
5 5 |
250 250 |
0.0 0.0 |
0.0 0.0 |
0.000 0.000 |
6.6 (0.8) 10.6 (1.5) |
1500 mg/kg |
M F |
5 5 |
250 250 |
0.0 0.0 |
0.0 0.0 |
0.000 0.000 |
9.6 (0.6) 14.4 (1.2) |
5000 mg/kg |
M F |
5 5 |
250 250 |
0.0 0.0 |
0.0 0.0 |
0.000 0.000 |
10.2 (1.2) 10.0 (1.1)
|
20 mg/kg Cyclophosphamide |
M F |
5 5 |
250 250 |
18.4*** 33.2*** |
16.0*** 27.2*** |
1.108*** 1.744*** |
8.8 (1.5) 6.0 (1.8) |
*** p < 0.001
Table 1C Summary of aberration data - 48-hour sacrifice
Treatment |
Sex |
Number of animals per group |
Number of Metaphases Analyzed per Group |
Percent Abnormal Cells per Group |
Percent Cells per Group with > 1 Aberration |
Average Number of Aberrations per Cell |
Average Number of Mitoses per 500 cells (S.E.) |
Corn oil |
M F |
5 5 |
250 250 |
0.4 0.0 |
0.0 0.0 |
0.004 0.000 |
9.8 (1.1) 10.6 (1.3) |
500 mg/kg |
M F |
5 5 |
250 250 |
0.0 0.0 |
0.0 0.0 |
0.000 0.000 |
9.4 (1.5) 12.4 (1.5) |
1500 mg/kg |
M F |
5 5 |
250 250 |
0.0 0.0 |
0.0 0.0 |
0.000 0.000 |
7.4 (0.9) 8.6 (2.2) |
5000 mg/kg |
M F |
5 5 |
250 250 |
0.0 0.0 |
0.0 0.0 |
0.000 0.000 |
9.2 (1.9) 8.0 (1.8) |
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this assay, the test substance is non-clastogenic.
- Executive summary:
The test substance was tested for its clastogenic potential in male and female rat bone marrow cells following single acute exposures (500, 1500 or 5000 mg/kg body weight) by oral intubation. Metaphase cells collected 6, 24 and 48 hours after dosing showed no statistically significant increase in structural chromosomal aberrations. Under the conditions of this assay, the test substance is non-clastogenic.
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