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Diss Factsheets
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EC number: 407-420-7 | CAS number: -
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- From Jul. 1, 1992 to Nov. 11, 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted according to OECD Guideline 474 in compliance with GLP
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Substance H112323
- Physical state: Dark blue powder
- Storage condition of test material: Ambient temperature in the dark
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Limited, Manston Road, Margate, Kent, UK
- Age at study initiation: 7-9 wk in Phase I and 6-20 wk in Phase II
- Diet (e.g. ad libitum): Porton Combined Diet , ad libitum
- Water (e.g. ad libitum): Filtered tap water, ad libitum
- Acclimation period: at least 6 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±2 °C
- Humidity (%): 55±15 %
- Air changes (per hr): 25
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: corn oil
- Justification for choice of solvent/vehicle: Soluble in corn oil - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Dosing suspensions of the test substance were prepared in corn oil.
A solution of cyclophosphamide was prepared in physiological saline. All dosing preparations were administered at a volume of 20 mL/kg bw. - Duration of treatment / exposure:
- Not applicable
- Frequency of treatment:
- Twice at an interval of 24 h
- Post exposure period:
- 24 h after last dosing
Doses / concentrations
- Remarks:
- Doses / Concentrations:
5600 mg/kg (equivalent to 5000mg/kg corrected for a water content of 10.5 % w/w)
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide
- Route of administration: oral, gavage
- Doses / concentrations: 65 mg/kg bw
Examinations
- Tissues and cell types examined:
- Bone marrow erythrocytes
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: Based on patterns of lethalities or severe toxicity observed over a 4-d observation period following a single oral dose in a maximum tolerated dose (MTD)-Phase I
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): Bone marrow smears were prepared 24 and 48 h after dosing for the vehicle control and treated animals and 24 h after dosing for the cyclophosphamide treated animals.
DETAILS OF SLIDE PREPARATION: The preparations were stained with polychrome methylene blue and eosin to visualise the various cell types.
METHOD OF ANALYSIS: Prior to microscopic assessment, all slides were furnished with code numbers, so that the counting was blind. The following counts were made:
Number of polychromatic erythrocytes (PCE) per slide: 1000 PCE
Percentage of polychromatic erythrocytes in the total erythrocyte population: 1000 Erythrocytes - Evaluation criteria:
- A substance is considered positive if there is a significant increase in the number of micronucleated polychromatic erythrocytes compared with the concurrent negative control group
- Statistics:
- - The incidence of micronucleated PCE and percentage PCE in the erythrocyte sample, were considered by ANOVA.
- All analyses were carried out using the GLM procedure in SAS.
- One-sided Student's t-test:
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Remarks:
- No significant adverse reactions to treatment
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: 5600 mg/kg (5000 mg/kg corrected for a water content of 10.5 % w/w in the test sample)
- Clinical signs of toxicity in test animals: No significant reactions to treatment were recorded during the 4 d observation period. All animals excreted blue/black urine and faeces and to have staining of the genital area, tail and coat.
- Evidence of cytotoxicity in tissue analyzed: No
RESULTS OF DEFINITIVE STUDY
- Types of structural aberrations for significant dose levels (for Cytogenetic or SCE assay): Nil
- Induction of micronuclei (for Micronucleus assay): No significant difference as compared to controls
- Ratio of PCE/NCE (for Micronucleus assay): No statistically or biologically significant increases in the incidence of micronucleated polychromatic erythrocytes. No statistically significant decreases in the percentage of polychromatic erythrocytes, compared to the vehicle control values were observed.
- Appropriateness of dose levels and route: Yes
- Statistical evaluation: Yes
Others:
No significant adverse reactions to treatment were recorded for the majority of animals dosed with test substance, the only clinical signs observed being black colouration of the faeces, blue colouration of the urine and skin (subcutaneous fat) and blue staining of the genital area and coat. In addition, colouration of the internal organs and skin (subcutaneous fat) was also observed when the animals were dissected following termination
Any other information on results incl. tables
Table 1. Mean incidence of micronucleated PCE/1000 polychromatic erythrocytes ± SD (SD) at two sampling times
|
|
|
Mean Incidence of MPE/1000 PE ± SD Males |
Mean Incidence of MPE/1000 PE ± SD Females |
|
||
Group |
Compound |
Dose |
24 h |
48 h |
24 h |
48 h |
|
11 |
Vehicle Control (corn oil) |
20ml/kg |
0.8±1.1 |
0.0±0.0 (4) |
0.2±0.5 |
0.4±0.6 |
|
12 |
Cyclophosphamide |
65 mg/kg |
29.0±3.7 |
- |
21.8±13.2 |
- |
|
13 |
Test substance |
5600 ± |
0.8±1.0 (4) |
0.3±0.6 (3) |
1.0±1.7 |
0.4±0.9 |
|
** 'Statistically significant increase in micronucleated polychromatic erythrocytes at p<0.01 in the Student's 't' test (one-sided) on transformed data.
All means based on 5 animals except where indicated in parentheses
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Under the test conditions, test substance is not clastogenic in the mouse micronucleus assay. - Executive summary:
A study was conducted to assess the potential of the test substance to induce micronucleated polychromatic erythrocytes in the bone marrow of CD-1 mice performed according to OECD Guideline 474 in compliance with GLP.
A single oral dose was given to groups of 5 male and 5 female mice at a dose level of 5600 mg/kg (equivalent to 5000 mg/kg corrected for a water content of 10.5 % w/w), this being the limit dose level for the assay. Bone marrow samples were taken 24 and 48 h after dosing.
No statistically or biologically significant, increases in the incidence of micronucleated PCE, over the vehicle control values, were seen in either sex at either of the sampling times investigated. Comparison of the percentage of PCE showed, no statistically significant decreases, compared to the vehicle control values, in either sex at either of the sampling times. However, colouration of the urine, internal tissues and skin (subcutaneous fat) was observed in the animals treated with test substance, indicating that the test substance was absorbed following administration via the oral route.
The test system positive control, cyclophosphamide, induced statistically significant and biologically meaningful increases in micronucleated polychromatic erythrocytes, compared to the vehicle control values, thus demonstrating the sensitivity of the test system to a known clastogen.
Under the test conditions, test substance is not clastogenic in the mouse micronucleus assay.
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.
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