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EC number: 242-555-3 | CAS number: 18755-43-6
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Principles of method if other than guideline:
- Dimethyl propylphosphonate (DMPP) was administered daily via gavage in maize germ oil to 5 male and 5 female Wistar rats per dose group, in doses of 0, 5 and 20 mg/kg body weight for a period of 4 weeks. This study is a supplementary study to a 4-week rat study, in which a NOEL concerning effects on the kidney and liver could not be established.
The animals were regularly observed and weighed. Food intake was determined. Plasma levels of cholesterol, urea, and protein as well as plasma alkaline phosphatase activities were detennined. Brain, kidneys and liver were weighed. Gross lesions and specimen of the kidneys, liver and bone marrow of the sternum were investigated histopathologically. - GLP compliance:
- yes
Test material
- Reference substance name:
- Dimethyl propylphosphonate
- EC Number:
- 242-555-3
- EC Name:
- Dimethyl propylphosphonate
- Cas Number:
- 18755-43-6
- Molecular formula:
- C5H13O3P
- IUPAC Name:
- dimethyl propylphosphonate
- Test material form:
- other: colourless liquid
- Details on test material:
- - Purity: 98.6%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- maize oil
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 4 weeks
- Frequency of treatment:
- once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 5, or 20 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 5 male and five female rats/dose
- Control animals:
- yes, concurrent vehicle
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- LOEL
- Effect level:
- 5 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: alpha-2-microglobulin nephropathy; not regarded to be relevant for human risk assessment
- Dose descriptor:
- NOAEL
- Effect level:
- 20 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: NOAEL for effects not related to alpha-2-microglobulin; relevant for human risk assessment
- Dose descriptor:
- NOAEL
- Effect level:
- 20 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No adverse effect observed at any dose tested
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Mortality as well as behavior and appearance of the rats were not influenced by the treatment up to 20 mg/kg.
Body weights and food intake were unaffected up to 20 mg/kg.
There was no change in plasma cholesterol, urea and protein as well as APh activity up to 20 mg/kg.
Brain, kidney and liver weights were not remarkably changed.
Hepatocellular hypertrophy occurred more frequently in 20 mg/kg males.
The bone marrow of the sternum was not altered by the treatment up to 20 mg/kg.
Two of five 20 mg/kg females showed tubular vacuolation in the kidney.
Corresponding to renal surface changes noted macroscopically in males at 5 and 20 mg/kg morphological kidney lesions such as tubular degeneration with hyaline droplets, tubular dilation and increased basophilic tubules were detected in males of both substance exposed groups. This hyaline droplet nephropathy, which is known to be related to alpha-2-microglobulin and to occurs only in male rats, is discussed to be of no toxicological relevance for humans.
Gross investigations in the other organs gave no indication of dimethyl propylphosphonate related effects.
According to the kidney findings a NOEL for dimethyl propylphosphonate can not be established for male rats. However, as the alpha-2-microglobulin nephropathy of the male rat is generally not regarded to be relevant for man, a NOAEL for effects not related to alpha-2-microglobulin can be established at 20 mg/kg body weight/day for human relevance.
Applicant's summary and conclusion
- Executive summary:
Dimethyl propylphosphonate (DMPP) was administered daily via gavage in maize germ oil to 5 male and 5 female Wistar rats per dose group, in doses of 0, 5 and 20 mg/kg body weight for a period of 4 weeks. This study is a supplementary study to a 4-week rat study, in which a NOEL concerning effects on the kidney and liver could not be established.
The animals were regularly observed and weighed. Food intake was determined. Plasma levels of cholesterol, urea, and protein as well as plasma alkaline phosphatase activities were detennined. Brain, kidneys and liver were weighed. Gross lesions and specimen of the kidneys, liver and bone marrow of the sternum were investigated histopathologically.
Mortality as well as behavior and appearance of the rats were not influenced by the treatment up to 20 mg/kg.
Body weights and food intake were unaffected up to 20 mg/kg.
There was no change in plasma cholesterol, urea and protein as well as APh activity up to 20 mg/kg.
Brain, kidney and liver weights were not remarkably changed.
Hepatocellular hypertrophy occurred more frequently in 20 mg/kg males.
The bone marrow of the sternum was not altered by the treatment up to 20 mg/kg.
Two of five 20 mg/kg females showed tubular vacuolation in the kidney.
Corresponding to renal surface changes noted macroscopically in males at 5 and 20 mg/kg morphological kidney lesions such as tubular degeneration with hyaline droplets, tubular dilation and increased basophilic tubules were detected in males of both substance exposed groups. This hyaline droplet nephropathy, which is known to be related to alpha-2-microglobulin and to occurs only in male rats, is discussed to be of no toxicological relevance for humans.
Gross investigations in the other organs gave no indication of dimethyl propylphosphonate related effects.
According to the kidney findings a NOEL for dimethyl propylphosphonate can not be established for male rats. However, as the alpha-2-microglobulin nephropathy of the male rat is generally not regarded to be relevant for man, a NOAEL for effects not related to alpha-2-microglobulin, and consequently relevant for human risk assessment, can be established at 20 mg/kg body weight/day in male rats, taking into account that the slight hepatocellular hypertrophy is oberved only in males and considered to be an adaptive effects and/or secondary to nephropathy.
For female rats a NOAEL at 20 mg/kg body weight/day is derived. The only observation in females in this study is tubular vacuolation in the kidney at 20 mg/kg/day. Since tubular vacuolation in the kidney was observed in the previously reported sub-acute study at higher doses (40, 200 and 1000 mg/kg/day) only in males but not in females (0/5, 0/5 and 0/5, respectively), the isolated observation at 20 mg/kg/day in females in this study is not regarded as an adverse effect.
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