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EC number: 232-190-8 | CAS number: 7789-79-9
- 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
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- Flash point
- Auto flammability
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- 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
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- Endpoint summary
- Stability
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- 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
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- Sediment toxicity
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- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- Genetic toxicity
- Carcinogenicity
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- Specific investigations
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- Additional toxicological data

Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From January 16 to April 12, 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study is conducted on a read across test material. The complete read across justification is attached in section 13. The reliability of the original study is 1.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
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:
- other: Guidelines for Testing of Toxic Chemicals, Ministry of Health, People’s Republic of China, 272.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Guidelines for the testing of chemicals Section 4: Health Effects, Ministry of environmental protection of People’s Republic of China, 474, 2003.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5395 (In Vivo Mammalian Cytogenetics Tests: Erythrocyte Micronucleus Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Similar Substance 1
- IUPAC Name:
- Similar Substance 1
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Shanghai SLAC Laboratory Animals Co., Ltd
- Age at study initiation: 6-8 weeks old
- Weight at study initiation: 26.7 - 29.6 g.
- Quarantined: for 5 days after receipt and were observed each day for signs of illness.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.8 - 22.5 °C
- Humidity (%): 42 - 50 %.
- Photoperiod: 12 hour light/dark cycle.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle used: corn oil
- Concentration of test material in vehicle: 10 ml/kg body weight - Duration of treatment / exposure:
- Two oral gavages (two treatments at 24 hour intervals).
- Frequency of treatment:
- Single application.
- Post exposure period:
- All mice were euthanized at approximately 24 hours following the final treatment.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- range finding study
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Remarks:
- range finding study
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Remarks:
- range finding study
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- Remarks:
- range finding study
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- main study
- Dose / conc.:
- 250 mg/kg bw/day (nominal)
- Remarks:
- main study
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Remarks:
- main study
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Remarks:
- main study
- No. of animals per sex per dose:
- 1 animal per sex per dose (range finding test)
5 animals per sex per dose (main test) - Control animals:
- yes
Examinations
- Tissues and cell types examined:
- Polychromatic erythrocytes (PCEs) and normochromatic erythrocytes (NCEs) were analyzed.
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: range finding study.
- Evaluation criteria:
- CRITERIA FOR A VALID TEST
The mean incidence of micronucleated PCEs must not exceed 5/1000 PCEs (0.5 %) in the negative (vehicle) control. The incidence of micronucleated PCEs in the positive control group must be significantly increased relative to the vehicle control group (p <0.01).
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not examined
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Range finding study: no death was observed in animals at 500, 100, 0 mg/kg bw during the course of the range finding study. However, sag, fluffy fur, salivating and death were observed in animals at 2000 mg/kg bw. All mice treated with the control articles, other test article appeared normal following administration.
Main study: no death was observed during the course of the study. Sag, fluffy fur and salivating were observed in animals at 1000 mg/kg bw. Reductions in PCEs/ECs ratio weren’t observed in Aluminium hypophosphite-treated groups compared to the vehicle control at 24 hours post dosing. A statistically significant increase in the number of micronucleated PCEs per 10,000 PCEs (total PCEs per group) was not observed at any dosage at harvest relative to the respective vehicle control.
Any other information on results incl. tables
All criteria for a valid test were met. Cyclophosphamide (CP) induced a significant increase in micronucleated PCEs (p<0.01) and a reduction in the PCEs/ECs ratio of 14.1 % and 13.4 % in female and male mice, respectively. In addition, the negative and positive control data were consistent with historical control data, indicating that the study was validly conducted.
Applicant's summary and conclusion
- Conclusions:
- A two oral administration (two treatment at 24 hour intervals) of the test item did not induce a statistically significant increase in the incidence of micronucleated PCEs in the bone marrow of male and female ICR mice. Therefore, the substance was concluded to be negative in the in vivo mouse micronucleus assay.
- Executive summary:
The purpose of this study was to evaluate the clastogenic potential of the test item, as measured by its ability to induce micronuclei in the polychromatic erythrocytes (PCEs) in the bone marrow of ICR mice.
According to the result to mice in the range finding study, a two oral administration at 24 hours interval of the substance was conducted by oral gavages to 5 male mice and 5 female mice per group at 0 (vehicle control, corn oil), 250, 500, 1000 mg/kg bw. Five male mice and five female mice received a two abdominal injection dosage of 40 mg/kg of CP as positive control. The dose volume for all groups was 10 ml/kg. All mice were euthanized at approximately 24 hours following the final treatment. After euthanasia, bone marrow was collected from sternum, and smears were prepared and stained with Giemsa stain. 2000 PCEs per animal were examined microscopically for the presence of micronucleated PCEs. The proportion of PCEs to total erythrocytes (PCEs/ECs ratio) was also determined to evaluate the test article bone marrow toxicity.
Under the conditions of the assay described in this report, a two oral administration of the test item at all dose level, did not induce a significant increase in the incidence of micronucleated PCEs in the bone marrow of male and female ICR mice. Therefore, the substance was concluded to be negative in the in vivo mouse micronucleus assay.
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