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EC number: 212-783-8 | CAS number: 868-85-9
- 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:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Comparable to guideline study with deviations (No organ weight determination, no haematological/biochemical examinations, no urinalysis, no data on statistics). Adopted according to OECD SIDS (public available peer reviewed source). The original source is available and has been reviewed.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 985
- Reference Type:
- secondary source
- Title:
- Dimethyl phosphonate - CAS No: 868-85-9 - SIDS Initial Assessment Report.
- Author:
- OECD
- Year:
- 2 004
- Bibliographic source:
- UNEP Publications
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- No organ weight determination, no haematological/biochemical examinations, no urinalysis, no data on statistics
- Principles of method if other than guideline:
- 13-week studies were conducted to evaluate the cumulative toxic effects of repeated administration of dimethyl hydrogen phosphite and to determine the doses in the 2-year studies.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Dimethyl phosphonate
- EC Number:
- 212-783-8
- EC Name:
- Dimethyl phosphonate
- Cas Number:
- 868-85-9
- Molecular formula:
- C2H7O3P
- IUPAC Name:
- dimethyl phosphonate
- Details on test material:
- - Name of test material (as cited in study report): dimethyl hydrogen phosphite
- Analytical purity: ca 96%
- Lot/batch No.: DM 113077
- Stability under test conditions: stable when stored in sealed containers at temperature up to 60°C for 2 weeks. Gas chromatography was used to monitor stability.
- Storage condition of test material: the testing laboratory stored several portions at -20°C as reference samples and the remainder at room temperature. Solutions prepared 1 x wk.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: F344/N
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories (Portage, MI, USA).
- Age at study initiation: 6-7 weeks old.
- Weight at study initiation: 184-194 g (male), 136-138g (female)
- Housing: 5 animals per cage (polycarbonate).
- Diet (e.g. ad libitum): Purina Lab Chow meal (St. Louis, MO); available ad libitum.
- Water (e.g. ad libitum): Acidified with HCl (pH 2.5) tap water; available ad libitum.
- Acclimation period: 2 weeks.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-24 (max 28).
- Humidity (%): 30-70
- Air changes (per hr): 12-15 room air changes/h.
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
Appropriate amounts of dimethyl hydrogen phosphite were mixed with corn oil. Mixtures were resuspended before dosing.
VEHICLE
- Justification for use and choice of vehicle (if other than water): corn oil was chosen because of the potential for chemical hydrolysis in water.
- Concentration in vehicle: 0, 7.50, 15.01. 30.03, 60.06, 120.01 mg/mL
- Amount of vehicle (if gavage): 3.33 mL/kg. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analyses for dimethyl hydrogen phosphite in corn oil were performed on every eighth dose mixture to confirm that the correct concentrations were administered to the test animals. The method of analysis involved a methanolic extraction as a purification step and a gas chromatographic assay as a quantification step.
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 5 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 25, 50, 100, 200, 400 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: fifteen-day repeated administration studies were conducted to determine doses for the 13-week studies.
Based on the mortality data and on the clinical signs, the high dose selected for the 13-week studies was 400 mg/kg. - Positive control:
- No
Examinations
- Observations and examinations performed and frequency:
- CLINICAL OBSERVATIONS AND FREQUENCY:
- Clinical signs: yes (observed twice per day).
- Mortality: yes (observed twice per day).
- Body weight: yes (recorded weekly).
- Organ weight: no
- Food consumption: no
- Water consumption: no
- Haematology: no
- Biochemistry: no
- Urinalysis: no - Sacrifice and pathology:
- ORGANS EXAMINED AT NECROPSY (MACROSCOPIC AND MICROSCOPIC): Necropsy performed on all animals; the following tissues from vehicle control and 400 mg/kg group of rats: gross lesions, parathyroids, colon, esophagus, brain, sternebrae (including marrow), liver, lung and mainstem bronchi, stomach, thymus, pancreas, kidney, urinary bladder, eyes, mandibular lymph node, salivary glands, thyroid gland, small intestine, ovaries/ uterus or testis, trachea, spleen, adrenal glands, pituitary gland, mammary gland.
Eyes of vehicle control and 200 mg/kg groups of rats were examined. - Other examinations:
- No further data
- Statistics:
- Not performed
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
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- observed in male and female rats that received 400 mg/kg bw.
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- TOXIC RESPONSE/EFFECTS BY DOSE LEVEL:
MORTALITY
-100 mg/kg bw, f: 2/10
-200 mg/kg bw, m: 1/10; f: 2/10
-400 mg/kg bw, m: increased mortality in male and female animals; 9/10; f: 8/10.
3/5 deaths that occurred in the 100 and 200 mg/kg groups may be due to the accidental introduction of gavage solutions into the lungs.
BODY WEIGHTS
Final mean body weights of males and females that received 400 mg/kg were depressed 46% and 39% relative to those of the vehicle control. The final mean body weight of females that received 200 mg/kg was depresses 14% relative to that of the vehicle controls.
OTHER EFFECTS
Degeneration of the lens was observed in the eyes of 4/9 females and 1/7 males that received 400 mg/kg. Acute diffuse inflammation of the cornea was observed in 1/9 females that received 400 mg/kg. The eyes of the next lower dose group (200 mg/kg) were examined histologically; eye lesions were not seen in either males (0/10) or females (0/9) (Eyes from all animals were not available for analysis to autolysis). Urinary bladder calculi were observed in 2/10 male rats that received 400 mg/kg.
Lesions were observed in the lungs of vehicle controls and all dosed groups.
Blood taken at the end of the studies was found to be positive by hemagglutination inhibition assay for pneumonia virus and by the complement fixation assay Sendai virus in 5/5 vehicle control females and 5/5 vehicle control males
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Remarks on result:
- other: no adverse effects observed.
- Dose descriptor:
- LOAEL
- Effect level:
- 400 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Body weight decrease, increased urinary bladder calculi, eye changes, increased lung lesions, and increased mortality at 400 mg/kg bw
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Remarks on result:
- other: no adverse effects observed.
- Dose descriptor:
- LOAEL
- Effect level:
- 200 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Body weight decrease at 200 mg/kg bw
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 1. Survival and mean body weights of rats in the thirteen-week gavage studies of dimethly hydrogen phosphite
Mean Body Weights (a) | |||||
Dose (mg/kg) | Survival (b) | Initial | Final | Change (c) | Final Weight Relative to Vehicle Controls (percent) |
MALE | |||||
0 | 10/10 | 186 | 308 | +122 | -- |
25 | 10/10 | 185 | 290 | +105 | 94.2 |
50 | 10/10 | 188 | 266 | + 78 | 86.4 |
100 | 10/10 | 194 | 314 | +120 | 101.9 |
200 | (d) 9/10 | 184 | 298 | +114 | 96.8 |
400 | (e) 1/10 | 184 | 168 | - 16 | 54.5 |
FEMALE | |||||
0 | 10/10 | 136 | 193 | +57 | -- |
25 | 10/10 | 137 | 195 | +58 | 101.0 |
50 | 10/10 | 136 | 191 | +55 | 99.0 |
100 | (f) 8/10 | 138 | 185 | +47 | 95.9 |
200 | (g) 8/10 | 137 | 167 | +30 | 86.5 |
400 | (h) 2/10 | 135 | 117 | -18 | 60.6 |
(a) Only group weights were taken by laboratory; no individual animal weight data are available.
(b) Number surviving /number in group
(c) Mean weight change of the group
(d) Week of death: 10
(e) Week of death : 3, 4, 4, 5, 5, 7, 8, 9
(f) Week of death: 7, 11
(g) Week of death: 9, 12
(h) Week of death: 2, 3, 3, 3, 3, 4, 5, 8, 10
Table 2. Numbers of rats with histopathologic lesions in the eye and lung in hte 13 -week gavage studies of dimethyl hydrogen phosphite
Vehicle Control | 100 mg/kg | 200 mg/kg |
400 mg/kg |
||||
Lesion | Male | Female | Female | Male | Female | Male | Female |
Eye | |||||||
No.animals examined microscopically | -- | -- | -- | 10 | 9 | 7 | 9 |
Degeneration, lens | -- | -- | -- | -- | -- | 1 | 4 |
Inflammation, chronic, diffuse cornea | -- | -- | -- | -- | -- | -- | 1 |
Lung | |||||||
No.animals examined microscopically | 10 | 10 | 2 | 1 | 2 | 10 | 10 |
Inflammation, chronic, focal | 4 | 1 | -- | -- | -- | -- | -- |
Inflammation, chronic, diffuse | 3 | 2 | -- | -- | 1 | 5 | 6 |
Congestion | -- | -- | 2 | 1 | 1 | -- | 1 |
Congestion, diffuse | -- | -- | -- | -- | -- | 3 | 1 |
Congestion, acute | -- | -- | -- | -- | -- | 1 | -- |
Histiocytosis | -- | -- | -- | -- | -- | 5 | -- |
Applicant's summary and conclusion
- Executive summary:
In one sub-chronic investigation male and female Fischer 344 rats were administered 0, 25, 50, 100, 200, 400 mg/kg bw/d dimethyl phosphonate for 5 days/week for 13 weeks via gavage, with a method similar to OECD guideline 408 with restrictions (No organ weight determination, no haematological/biochemical examinations, no urinalysis, no data on statistics). A decreased body weight gain was observed in female rats at 200 mg/kg bw/d and above and for male rats at 400 mg/kg bw/d. Mortality was increased at 400 mg/kg bw/d for both sexes. Eye changes (degeneration of the lens, acute diffuse inflammation of the cornea) and increased lung lesions (inflammation, congestion, histiocytosis) were found in male and female rats at 400 mg/kg bw/d. In male rats increased urinary bladder calculi were observed at 400 mg/kg bw/d. The NOAEL is 100 mg/kg bw/d for female and 200 mg/kg bw/d for male rats.
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