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EC number: 258-380-0 | CAS number: 53126-67-3
- 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
oral: The LD50 of the test item is greater than 2000 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
Please refer to the attached read-across justification in section 13. - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- 2001
- Deviations:
- no
- Preliminary study:
- In preliminary experiments undertaken to set the dose, no male or female fatalities were observed even on administration of 2000 mg/kg.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 value of the read across-substance dibutyl phosphate (CAS 107-66-4) was found to be > 2000 mg/kg bw.
- Executive summary:
A study of the acute oral toxicity of the read across-substance dibutyl phosphate (CAS 107-66-4) in rats was undertaken. No fatalities were observed after administration of 2000 mg/kg bw (chosen on the basis of the results of preliminary test). The symptoms of toxicity observed in males and females after dosing were as follows: there were symptoms of systemic suppression such as decreased locomotor activity, deepening respiration and eyelid ptosis. Abdomina were urine-stained and on the day after dosing inhibition of body weight increase or body weight decrease was observed. Some animals exhibited transient salivation and the excretion of red urine. There was recovery such that by 4 days after dosing none of these changes were observed anymore. Necropsy revealed no visible abnormalities of the organs. From these results it was concluded that the minimum lethal dose and thus also the LD50 is higher than 2000 mg/kg bw.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1978
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Control animals:
- no
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of the test item was found to be >5000 mg/kg bw.
- Executive summary:
A study was conducted to assess the acute oral toxicity of the test item in rats. As a result, the LD50 value was determined to be >5000 mg/kg bw.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd., l,lanston, Kent, U.K
- Age at study initiation (main study): five to eight weeks old
- Weight at study initiation: males weighed 153 - 170g, and the females 135 -157g
- Fasting period before study: overnight before dosing
- Housing: The animals were housed in groups of five by sex in solid-floor polypropylene cages with sawdust bedding
- Diet: Rat and Mouse Expanded Diet No. l, Special Diet Services Limited, Witham, Essex, U.K)
- Water: ad libitum)
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 46-70
- Air changes (per hr): appr. 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
-
MAXIMUM DOSE VOLUME APPLIED: 1.9 mL/kg bw
- Doses:
- only one (limit) dose: 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths or overt signs of toxicity 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. Individual bodyweights were recorded prior to dosing on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, external examination, opening of the abdominal and thoracic cavities, appearance of macroscopic abnormalities - Preliminary study:
- A range-finding study was performed to determine a dosing regime. 1 male and 1 female rat received a dose of 2000 mg/kg bw. No deaths occured.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortalitiy occured
- Clinical signs:
- other: Hunched posture was noted in all animals for two hours folIowing dosing. Lethargy was also noted in four animals. All animals recovered four hours after dosing.
- Gross pathology:
- No abnormalities were noted.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 value of the test item was found to be >2000 mg/kg bw.
- Executive summary:
A study according to OECD guideline 401 was conducted with Sprague Dawley rats to identify the acute oral median lethal dose (LD50) of the test material. 5 males and 5 females of each sex were dosed (gavage, single application of 2000 mg/kg bw) and observed for 14 days for mortality and clinical signs. As no deaths occurred, the LD50 was determined to be greater than 2000 mg/kg bw.
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2007-05-28 to 2007-04-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- no details given in report
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- - Rationale for the selection of the starting dose:
Following a sighting test in which there were no mortalities at dose levels of 300 and 2000 mg/kg bw, the main test was started. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 4
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- not necessary
- Preliminary study:
- In preliminary experiments undertaken to set the dose, none of the exposed females died at dose levels of 300 or 2000 mg/kg bw.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality observed
- Clinical signs:
- other: none
- Gross pathology:
- No abnormalities were observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 value of the test substance is > 2000 mg/kg bw.
- Executive summary:
A study of the acute oral toxicity of the test item in rats was undertaken following OECD Guideline No. 420 (fixed dose-procedure). No mortality and no clinical signs were observed during the 14 days-observation period after the administration of 2000 mg/kg bw (chosen on the basis of the results of a preliminary test). At necropsy, no abnormalities were detected. From these results it was concluded that the LD50 value of the test item is higher than 2000 mg/kg bw.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The weight-of evidence approach included guideline and GLP-studies, which were assessed to be suitable for assessment.
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
Several studies are available which were used to assess the oral toxicity of the substance based on a weight of evidence-approach:
Read across to dibutyl phosphate (CAS 107-66-4), OECD 420
A study of the acute oral toxicity of the read across-substance dibutyl phosphate (CAS 107-66-4) in rats was undertaken. No fatalities were observed after administration of 2000 mg/kg bw (chosen on the basis of the results of preliminary test). The symptoms of toxicity observed in males and females after dosing were as follows: there were symptoms of systemic suppression such as decreased locomotor activity, deepening respiration and eyelid ptosis. Abdomina were urine-stained and on the day after dosing inhibition of body weight increase or body weight decrease was observed. Some animals exhibited transient salivation and the excretion of red urine. There was recovery such that by 4 days after dosing none of these changes were observed anymore. Necropsy revealed no visible abnormalities of the organs. From these results it was concluded that the minimum lethal dose and thus also the LD50 is higher than 2000 mg/kg bw.
OECD 401
A study according to OECD guideline 401 was conducted with Sprague Dawley rats to identify the acute oral median lethal dose (LD50) of the test material (as aqueous solution, 80 % water). 5 males and 5 females of each sex were dosed (gavage, single application of 2000 mg/kg bw) and observed for 14 days for mortality and clinical signs. As no deaths occurred, the LD50 was determined to be greater than 2000 mg/kg bodyweight.
OECD 420
A further study of the acute oral toxicity of the test item (aqueous solution, 45 % water) in rats was undertaken following OECD Guideline No. 420 (fixed dose-procedure). No mortality and no clinical signs were observed during the 14 days-observation period after the administration of 2000 mg/kg bw (chosen on the basis of the results of a preliminary test). At necropsy, no abnormalities were detected. From these results it was concluded that the LD50 value of the test item is higher than 2000 mg/kg bw.
Similar to OECD 401
A study was conducted to assess the acute oral toxicity of the test item (aqueous solution, 80 % water) in rats. As a result, the LD50 value was determined to be >5000 mg/kg bw. The study documentation is very limited, therefore it was allocated to reliability 4 (not assignable).
Taken together, no mortality was observed in the available studies and therefore it was concluded that the LD50 of the test substance is > 2000 mg/kg bw.
Even though only studies with the test substance itself at lower purity (aqueous solutions) are available, the substance was judged to be not toxic after acute oral administration, taking also the results of the analogue substance into account.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008 (CLP). As a result the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the twelth time in Regulation (EU) No 2019/521.
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