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EC number: 212-091-6 | CAS number: 762-04-9
- 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
- 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:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- 6 rats/sex and dose instead of 5 rats/sex and dose
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Diethyl phosphonate
- EC Number:
- 212-091-6
- EC Name:
- Diethyl phosphonate
- Cas Number:
- 762-04-9
- Molecular formula:
- C4H11O3P
- IUPAC Name:
- diethyl phosphonate
- Test material form:
- other: liquid
- Details on test material:
- content: 98.86 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation: 6 weeks
- Weight at study initiation: males: 166 g; females: 132 g
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 50-60
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12 /12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- as described in the respective guideline
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- details not given
- Duration of treatment / exposure:
- 29 days
- Frequency of treatment:
- once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 30, 150, 750 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 6 males/dose and 6 females/dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- dose selction rational:
the doses were selected following a pre-test in which male and female rats received bygavage 0 and 1000 mg/kg bw/day over a period of 3 weeks. At the end of the treatment period body weight development in the treatment groups were about 30% lower than in the respective control groups
main study is performed as described in the respective guideline - Positive control:
- not required
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: twice per week
BODY WEIGHT: Yes
- Time schedule for examinations:
before the start of the study and then once per week
FOOD CONSUMPTION: yes
WATER CONSUMPTION : Yes
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: Yes
Differential blood picture. Erys, hemoglobin. hematocrit, leucos, MCH, MCHC, MCV , thrombos, clotting time.,
CLINICAL CHEMISTRY: Yes
Alkale phosphatase. Aspartate, GOT, , GPT, Albumin, bilirubin, cholestrol, total protein, urea, creatinine, glucose, anorganic phosphate, CA, K, Na, .Cloride
URINALYSIS: No data
NEUROBEHAVIOURAL EXAMINATION: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
weights of brain, heart, testes, liver, spleen, kidneys and adrenals
HISTOPATHOLOGY: Yes
as required by the guideline - Statistics:
- yes: mean value calculation including standard deviation, U-test according to mann and Whitney, Wilcoxon test,
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- not examined
- Description (incidence and severity):
- gavage study
- Food efficiency:
- not specified
- Description (incidence and severity):
- gavage study
- Water consumption and compound intake (if drinking water study):
- not examined
- Description (incidence and severity):
- gavage study
- Ophthalmological findings:
- not examined
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- CLINICAL SIGNS AND MORTALITY
the test item was tolerated without mortality in males and females
the test item was tolerated without clinical signs up to and including 150 mg/kg bw
at 750 mg/kg bw
poor general condition, apathy. and increased salivation was observed in males and females
BODY WEIGHT AND WEIGHT GAIN
up to and including 150 mg/kg bw/day, males and females:
there were no significant differences in body weight and body weight gain compared to the respective controls
at 750 mg/kg bw/day, males and females:
from the second treatment week onwards body weight gain was significantly reduced. At the end of the treatment period
body weight of males was about 23 % and body weight of females was about 14 % reduced when compared to the concurrent controls
HAEMATOLOGY
up to and including 150 mg/kg bw/day, males and females.
there were no pathological findings
at 750 mg/kg bw/day, males and females,
compared to the concurrent controls
erythrocyte count was significantly increased and and MCV values and MCH-values were significantly decreased
CLINICAL CHEMISTRY
up to and including 750 mg/kg bw/day, males:
there were no pathological findings
up to and including 150 mg/kg bw/day, females:
there were no pathological findings
at 750 mg/kg bw/day, females:
compared to the concurrent controls
concentration of cholesterine , protein and albumine was significantly decreased
GROSS PATHOLOGY, ORGAN WEIGHTS
up to and including 750 mg/kg bw/day, males and females:
compared to the concurrent controls
there were no findings which could be attributed to treatment
HISTOPATHOLOGY: NON-NEOPLASTIC
females: up to and including 150 mgkg bw/day, ´
there were no no pathological findings
males: from 150 mg/kg bw/day onwards
perivascular granulocate infiltation in the lungs were observed
males and females: 750 mg/kg bw/day:
interstititial pneumonia, pulmonary fibrosis, presence of giant cells. distinctive hyperplasia of the bronchial mucous membrane.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 150 mg/kg bw/day (actual dose received)
- Sex:
- female
- Basis for effect level:
- other: based on clinical signs, reduced body weight development, affected hematology and clinical chemistry values and histopathological changes in kidneys and lungs at 750 mg/kg bw/day
- Dose descriptor:
- NOAEL
- Effect level:
- 30 mg/kg bw/day (actual dose received)
- Sex:
- male
- Basis for effect level:
- other: based on perivasculare granulocyte infiltration from 150 mg/kg bw/day onwards and clinical signs, reduced body weight development, affected hematological values and histopathological changes in lungs at 750 mg/kg bw
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Executive summary:
Diethylphosphite was examined for subacute toxicity according to the OECD TG 407 and GLP. 6 male and 6 female Wistrar rats/dose received by gavage 0, 30, 150 or 750 mg/kg bw/day diluted in polyethylene glycol 400 once daily for 29 days. Only at the highest test dose animals showed poor general condition, apathy, increased salivation and reduced body weight development (males 23 % and females 14 % lowered when compared to the controls). No rat died during the study. The only pathological findings in hematology or clinical chemistry occurred in females at the top dose including increase in erythrocite count, reduced MCV- and MCH-values, reduced cholesterol, protein and albumin. Histopathological examination revealed, in males, from 150 mg/kg bw/day onwards perivascular granulocate infiltation in the lungs and at 750 mg/kg bw/day, in males and females, interstititial pneumonia, pulmonary fibrosis, presence of giant cells. distinctive hyperplasia of the bronchial mucous membrane.
Thus, under condition of this test, the NOAEL (male rat) is 30 mg/kg bw/day and the NOAEL (female rat) is 150 mg/kg bw/day.
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