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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 458-430-3 | 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 June 2004 to 16 July 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Orient C., Ltd., Seoul, Korea
- Age at study initiation: six weeks
- Weight at study initiation: 23.5-27.0 g
- Assigned to test groups randomly: using algorithm of Path/Tox so that each group had similar body weight distribution
- Fasting period before study:
- Housing: up to six animals per cage in polycarbonate cages with bedding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23°C ± 3°C
- Humidity (%): 50%
- Air changes (per hr): 10-20
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: mid-May 2004 To: July 8 2004
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- - Vehicle(s)/solvent(s) used: olive oil
- Justification for choice of solvent/vehicle: test item is insoluble in water
- Concentration of test material in vehicle: no information
- Amount of vehicle (if gavage or dermal): no information. It is not stated if administration was by gavage, but this is presumed to be the case - Duration of treatment / exposure:
- 24 hours
- Frequency of treatment:
- Two treatments at 24 hour intervals
Doses / concentrations
- Remarks:
- Doses / Concentrations:
500, 1000 and 2000 mg/kg bw
Basis:
- No. of animals per sex per dose:
- Six males
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Positive control substance: cyclophosphamide
- Justification for choice of positive control(s): widely used in micronucleus assays
- Route of administration: intraperitoneal
- Doses / concentrations: 70 mg/kg bw
Examinations
- Tissues and cell types examined:
- Bone marrow
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: preliminary toxicity study
TREATMENT AND SAMPLING TIMES (in addition to information in specific fields): animals were sacrificed 24 hours after the second administration
DETAILS OF SLIDE PREPARATION: cells were collected in fetal bovine serum, centrifuged and smeared onto slides. Preparations were dried and fixed by submerging in methanol. Slides were stained with May-Grunwald and Giesma stains, then rinsed dried and mounted.
METHOD OF ANALYSIS: Slides were examined under x1000 magnification. Small round or oval bodies (1/5 to 1/20 diameter of PCE) were counted as micronuclei. Micronuclei were counted in 200 PCE's. The (PCE):(PCE+NCE) ratio was calculated by counting 500 cells - Evaluation criteria:
- The result was judged as positive if there was a statistically significant and dose-related increase or a reproducible increase in the frequency of MNPCEs at least at one dose level.
- Statistics:
- Differences of numbers of MNPCRs between treated and vehicle control: Kruskal-Wallis' H-test and Dunnett's test.
Differences of numbers of MNPCRs between positive and vehicle control: Mann-Whitney's U-test.
Differences of PCE/(PCE+NCE) between treated and vehicle control:
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Remarks:
- No effects observed in bone marrow, and no clinical signs were noted
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1: Micronucleus test in male ICR mice
Chemical treated |
Dose (mg/kg) |
No. of animals |
MNPCE/2000 PCEs |
PCE/(PCE+NCE) |
Vehicle |
0 |
6 |
1.17 |
0.52 |
Test item |
500 |
6 |
1.33 |
0.49 |
Test item |
1000 |
6 |
1.83 |
0.55 |
Test item |
2000 |
6 |
2.00 |
0.55 |
CPA |
70 |
6 |
94.83** |
0.45* |
* Significantly different from the control at P <0.01
** Significantly different from the control at P < 0.05
Applicant's summary and conclusion
- Conclusions:
- The test substance has been tested in an in vivo micronucleus assay conducted according to OECD 474 and in compliance with GLP. No evidence of induction of micronuclei was observed in male ICR mice. No signs of systemic toxicity were observed and the test item did not cause toxicity in the bone marrow. Solvent and positive controls gave expected responses. It is concluded that the test substance is negative for the induction of micronuclei under the conditions of the study.
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.
Although ECHA is providing a lot of online material in your language, part of this page is only in English. More about ECHA’s multilingual practice.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
the-echa-website-uses-cookies
find-out-more-on how-we-use-cookies