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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
Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Remarks:
- OECD 408 (repeated 90 day oral toxicity in rodents)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remarks'
- Remarks:
- Comparable to guideline study (No organ weight determination, no haematological/biochemical examinations, 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:
- Toxicology and carcinogenesis studies of dimethyl hydrogen phosphite (CAS No. 868-85-9) in F344/N rats and B6C3F1 mice (gavage studies)
- Author:
- National Toxicology Program
- Year:
- 1 985
- Bibliographic source:
- Technical Report Series No. 287, NIH Publication No. 86-2543: 1 - 179
- Reference Type:
- review article or handbook
- 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:
- other: OECD 408 (repeated 90 day oral toxicity in rodents)
- Deviations:
- yes
- Remarks:
- No organ weight determination, no haematological/biochemical examinations, no data on statistics.
- Principles of method if other than guideline:
- Necropsy performed on all animals; the following tissues from vehicle control and all but the 95 mg/kg bw dosed group of mice were microscopically examined: gross lesions, skin , parathyroids, colon, esophagus, brain, sternebrae (including marrow), liver, lung and mainstem bronchi, stomach, thymus, pancreas, kidney, urinary bladder, eyes, mandibular lymph node, saliva glands, thyroid gland, small intestine, ovaries/ uterus or prostate / testes, heart, trachea, spleen, adrenal glands, pituitary gland, gallbladder, mammary gland. Only heart, liver, and kidney examined for the 95 mg/kg group of mice.
- GLP compliance:
- not specified
- Type of method:
- in vivo
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:
- mouse
- Strain:
- B6C3F1
- 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: 6-8 weeks old.
- Weight at study initiation: 23-25 g (male), 18-19 g (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 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, 28.53, 57.06, 112.61, 225.22, 450.45 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:
- 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
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 95, 190, 375, 750, 1500 mg/kg/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- CLINICAL OBSERVATIONS AND FREQUENCY:
- Clinical signs: yes (observed twice per day)
- Mortality: yes (observed twice per day)
- Body weight: yes (weeklyl)
- Organ weight: no
- Food consumption: no
- Water consumption: no
- Haematology: no
- Biochemistry: no
- Urinalysis: no
Necropsy performed on all animals; the following tissues from vehicle control and all but the 95 mg/kg bw dosed group of mice were microscopically examined: gross lesions, skin , parathyroids, colon, esophagus, brain, sternebrae (including marrow), liver, lung and mainstem bronchi, stomach, thymus, pancreas, kidney, urinary bladder, eyes, mandibular lymph node, saliva glands, thyroid gland, small intestine, ovaries/ uterus or prostate / testes, heart, trachea, spleen, adrenal glands, pituitary gland, gallbladder, mammary gland. Only heart, liver, and kidney examined for the 95 mg/kg group of mice.
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- Reproduction Toxicity
- Effect level:
- 190 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LOAEL
- Remarks:
- Reproduction Toxicity
- Effect level:
- 375 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Testicular atrophy, characterized by hypospermatogenesis with the formation of large giant spermatids and syncytial cells, was seen in male mice at 375, 750, and 1500 mg/kg. These effects were probably secondary to the general toxicity.
Observed effects
All the mice of each sex that received 750 or 1500 mg/kg died during the first 4 weeks. Two of 10 males and 5 of 10 females that received 375 mg/kg also died. Mice that received 375 mg/kg or more had tremors and decreased activity. Final weights of surviving dosed and vehicle control mice were comparable. Lung congestion in males and females, cardiac mineralization in males, and hepatocellular vacuolization in females were probably compound related. Pulmonary congestion was observed in animals that died during the studies. Testicular atrophy, characterized by hypospermatogenesis with the formation of large giant spermatids and syncytial cells, was seen in male mice at 375, 750, and 1500 mg/kg.
These effects were probably secondary to the general toxicity.
Any other information on results incl. tables
Table1. Survival and mean body weights of mice in the thirteen-week gavage studies of dimethyl hydrogen phosphite.
Mean Body Weights (a) (grams) | |||||
Dose (mg/kg) | Survival (b) | Initial | Final | Change (c) | Final Weight Relative to Vehicle Controls (percent) |
MALE | |||||
0 |
10/10 |
24 |
29 |
+ 5 |
-- |
95 | 10/10 | 24 | 30 | + 6 | 103.4 |
190 | 10/10 | 25 | 31 | + 6 | 106.9 |
375 | (d) 8/10 | 24 | 28 | + 4 | 96.6 |
750 | (e) 0/10 | 25 | (f) | (f) | (f) |
1500 | (g) 0/10 | 23 | (f) | (f) | (f) |
FEMALE | |||||
0 | 10/10 | 18 | 23 | +5 | -- |
95 | 10/10 | 18 | 23 | +5 | 100.0 |
190 | 10/10 | 18 | 22 | +4 | 95.7 |
375 | (f) 5/10 | 19 | 24 | +5 | 104.3 |
750 | (g) 0/10 | 18 | (f) | (f) | (f) |
1500 | (h) 0/10 | 18 | (f) | (f) | (f) |
(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: 11, 12
(e) Week of death : 1, 3, 3, 3, 4, 4, 4, 4, 4, 4
(f) No results are reported due to the 100% mortality in this group.
(g) Week of death: 1, 1, 1, 1, 1, 2, 2, 2, 4, 4
(h) Week of death: 5, 10, 11, 12, 12
(i) Week of death: 3, 4, 4, 4, 4, 4, 4, 4, 4, 4
(j) Week of death: 1, 1, 1, 1, 1, 1 ,1, 1, 3, 4
Table 2. Histopathologic lesions observed in mice in the thirteen-week gavage studies of dimethyl hydrogen phosphite.
Dose (mg/kg) | Hepatocellular Vacuolization (a) |
Cardiac Mineralization (minimal severity) |
Testicular Atrophy |
Lung Congestions |
MALE | ||||
0 |
1/10 |
0/10 |
0/10 |
0/10 |
95 |
(b) 1/10 |
0/10 |
0/10 |
0/10 |
190 |
1/10 |
9/10 |
0/10 |
0/10 |
375 |
2/10 |
3/10 |
3/10 |
1/10 |
(c) 750 |
2/9 |
0/10 |
9/10 |
7/10 |
(c) 1500 |
1/10 |
1/10 |
2/10 |
7/10 |
FEMALE | ||||
0 |
0/10 |
1/10 |
- | 0/10 |
95 |
0/10 |
0/10 |
- | 0/10 |
190 |
5/10 |
1/10 |
- | 0/10 |
375 |
5/10 |
2/10 |
- | 4/10 |
(c) 750 |
0/9 |
0/9 |
- | 7/10 |
(c) 1500 |
2/7 |
0/10 |
- | 9/10 |
(a) Male: diffuse or focal: diffuse.
(b) Observed by quality assurance pathologist.
(c) Most animals in these groups died early.
Applicant's summary and conclusion
- Executive summary:
A repeated dose toxicity study equivalent or similar to OECD 408 (repeated 90 day oral toxicity in rodents) was conducted. AnNecropsy performed on all animals. The following tissues from vehicle control and all but the 95 mg/kg bw dosed group of mice were microscopically examined: gross lesions, skin , parathyroids, colon, esophagus, brain, sternebrae (including marrow), liver, lung and mainstem bronchi, stomach, thymus, pancreas, kidney, urinary bladder, eyes, mandibular lymph node, saliva glands, thyroid gland, small intestine, ovaries/ uterus or prostate / testes, heart, trachea, spleen, adrenal glands, pituitary gland, gallbladder, mammary gland. Only heart, liver, and kidney examined for the 95 mg/kg group of mice.
TOXIC RESPONSE/EFFECTS BY DOSE LEVEL:
All the mice of each sex that received 750 or 1500 mg/kg died during the first 4 weeks. Two of 10 males and 5 of 10 females that received 375 mg/kg also died. Mice that received 375 mg/kg or more had tremors and decreased activity. Final weights of surviving dosed and vehicle control mice were comparable. Lung congestion in males and females, cardiac mineralization in males, and hepatocellular vacuolization in females were probably compound related. Pulmonary congestion was observed in animals that died during the studies. Testicular atrophy, characterized by hypospermatogenesis with the formation of large giant spermatids and syncytial cells, was seen in male mice at 375, 750, and 1500 mg/kg.
These effects were probably secondary to the general toxicity.
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