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Diss Factsheets
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EC number: 931-722-2 | 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 germ cell study: cytogenicity / chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Hypothesis for read-across: Lead (Pb) is the main component of the target substance, and considered the major driver for adverse effects based on its properties and relative quantity in the substance. For toxicity assessment the bioavailable part is relevant. From the target substance itself, Pb is poorly soluble. For read-across purpose, however, data from more soluble compounds was used. Therefore, it is considered that the used read-across data gives worst-case estimate on the adverse effects.
Data source
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Male mice (n=12) were exposed to lead chloride in drinking water (1.33 g/L) for six weeks. Half of the mice were injected with cyclophosphamide (120 mg/kg) one week prior to mating with untreated females. On day 14 of gestation, the uteri of dams were examined for evidence of dominant lethal mutations by counting live fetuses, early implantation losses (resporption sites), and late implantation losses.
- GLP compliance:
- not specified
- Type of assay:
- rodent dominant lethal assay
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bomholt Gaard Breeding and Research Centre Ltd. (Ry, Denmark).
- Age at study initiation: 9 weeks.
- Assigned to test groups randomly: yes.
- Fasting period before study: none.
- Housing: males housed invdividually, females housed in groups of four.
- Diet: ad libitum, laboratory chow (EWOS, R34).
- Water: ad libitum, tap water.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23-25
- Humidity (%): >55
- Photoperiod: 12 hours light/12 hours dark
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- Tap water.
- Details on exposure:
- 1.33 g/L lead chloride was provided in the drinking water for six weeks. Controls received untreated tap water.
- Duration of treatment / exposure:
- 6 weeks.
- Frequency of treatment:
- Animals drank treated water ad libitum.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1.33 g/L
Basis:
nominal conc.
- No. of animals per sex per dose:
- 6 males per group (lead-treated or lead + cyclophosphamide)
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide.
Examinations
- Tissues and cell types examined:
- Blood from male rats was analyzed for lead concentration. Ovaries and uteri were excised and uteri were scored for evidence of dominant lethal mutations.
- Statistics:
- Treatment effects on dominant lethal mutations were evaluated by nonparametric tests (Wilcoxon rank sum test, Kruskall-Wallis test). Dichotomous outcomes were analyzed for treatment effects by table analysis and unconditional logistic regression analysis with exact tests for significance and computation of estimated odds ratios and 95% confidence limits. A significance level of less than 0.05 (two-tailed) was taken as criterion of a positive result.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not examined
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
Any other information on results incl. tables
There was no effect on the number of implantations or resorptions reported for the lead chloride treatment group compared to the vehicle control group. In the lead chloride + cyclophosphamide treatment group, as well as the cyclophosphamide-treated positive controls, the number of implantations decreased and the number of readsorptions and mean mortality both increased compared to the vehicle control group. Although signs of fetotoxicity were evident, the significance of the negative response is equivocal due to the relatively low blood lead level (25 mcg/dL) achieved by the single administered dose of lead.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative.
The authors concluded that lead chloride did not influence the mutagenicity of cyclophosphamide in the dominant lethal test. - Executive summary:
Male mice (n=12) were exposed to lead chloride in drinking water (1.33 g/L) for six weeks. Half of the mice were injected with cyclophosphamide (120 mg/kg) one week prior to mating with untreated females. On day 14 of gestation, the uteri of dams were examined for evidence of dominant lethal mutations by counting live fetuses, early implantation losses (resporption sites), and late implantation losses. There was no effect on the number of implantations or resorptions reported for the lead chloride treatment group compared to the vehicle control group. In the lead chloride + cyclophosphamide treatment group, as well as the cyclophosphamide-treated positive controls, the number of implantations decreased and the number of readsorptions and mean mortality both increased compared to the vehicle control group. The authors concluded that lead chloride did not influence the mutagenicity of cyclophosphamide in the dominant lethal test.
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