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EC number: 225-897-8 | CAS number: 5137-70-2
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 16/11/2015 to 25/02/2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study following OECD guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 2015-04-06
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
- Age at study initiation: 9-10 weeks old
- Weight at study initiation: 202 – 237 g
- Fasting period before study: yes all the night before treatment
- Housing: 3 animals / cage
- Cage type: type II polypropylene/polycarbonate
- Cage sizes:Hight: 18 cm, length: 38 cm, width: 23 cm
- Diet (e.g. ad libitum): ssniff® SM R/M "Autoclavable complete diet for rats and mice – breeding and maintenance" produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany (Batch no.: 575 4308, expiry date: March 2016), ad libitum, except for the night before treatment.
- Water (e.g. ad libitum): Tap water from the municipal supply, as for human consumption from a 500 ml bottle, ad libitum.
- Acclimation period: 19-20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.4 – 24.0°C
- Humidity (%): 30 – 58 %
- Air changes (per hr): 15 – 20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.
IN-LIFE DATES: From: To: - Route of administration:
- oral: gavage
- Vehicle:
- other: Distilled water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL /kg
- Lot/batch no. (if required): 6820914
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
DOSAGE PREPARATION (if unusual): The test item was freshly formulated at a concentration of 200 mg/mL in the vehicle, in the Pharmacy of CiToxLAB Hungary Ltd. on the day of administration. The formulation container was magnetic stirred continuously up to the end of dose administration procedures.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The initial dose level was selected by the Study Director to be that which is most likely to produce mortality in some of the dosed animals. In the lack of any preliminary toxicological information, 2000 mg/kg bw was selected to be the starting dose - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 2 groups of three female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations : 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter
- Frequency of weighing: on the day before treatment (Day -1), on the day of the treatment (Day 0) and weekly thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: Macroscopic examination - Statistics:
- Not applicable
- Preliminary study:
- Not applicable
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Dodecylphosphonic acid did not cause mortality at a dose level of 2000 mg/kg bw.
- Clinical signs:
- other: Acute oral administration of Dodecylphosphonic acid did not cause any test item related effect
- Gross pathology:
- There was no evidence of the macroscopic observations at a dose level of
2000 mg/kg bw - Other findings:
- Not applicable
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the acute oral LD50 value of the test item Dodecylphosphonic acid was found to be above 2000 mg/kg bw in female Crl:WI rats.
- Executive summary:
A study was performed to assess the acute oral toxicity of the test material in the Wistar strain rat according to OECD 403 and in compliance with GLP. Two groups of three fasted animals (females) were given a single oral dose of test material, as a suspension in distilled water at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of dosing and were then killed for gross pathological examination.
There were no deaths. No signs of systemic toxicity were noted during the study. All animals showed expected gain in bodyweight during the study. No other abnormalities were noted at necropsy.
The acute oral median lethal dose (LD50) of the test material in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight. Therefore, no classification is required according to the regulation (EC) N°1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- LD50 > 2000 mg/kg
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In the key study, in female rats, the LD50 was >2000 mg/kg bw. Acute oral administration of Dodecylphosphonic acid did not cause any test item related effect. There were no effects on body weights or body weight gains that could be attributed to treatment with ofDodecylphosphonic acid. There was no evidence of the macroscopic observations at a dose level of 2000 mg/kg bw.
Justification for classification or non-classification
Oral:
As the LD50/ female rat is >2000 mg/kg bw in the Key study, DodecylPhosphonic acid is not classified for acute oral toxicity according to the regulation (EC) N°.1272/2008 nor according to the Directive 67/548/EEC criteria.
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