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Registration Dossier
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EC number: 608-874-0 | CAS number: 33494-81-4
- 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
- Acute toxicity by oral route: The acute oral median lethal dose (LD50) of Di-tert-butyl phosphate in rat was calculated to be greater than 2372 mg/kg bw.
- Acute toxicity by inhalation route: no data available.
- Acute toxicity by dermal route: no data available
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 2012-07-23 to 2012-12-04
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read-across with Di-tert-butyl potassium phosphate. Study conducted in compliance with international standard guidelines under GLP conditions. The study report was well documented with all mandatory information included.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: 12 NohSan N° 8147, JMAFF 2002
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (2012-09-07)
- 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: Harlan Laboratories UK Ltd., Oxon, UK
- Age at study initiation: eight to twelve weeks
- Weight at study initiation: The bodyweights fell within an interval of ±20% of the mean initial bodyweight of the first treated group (from 159g to 173 g)
- Fasting period before study: Yes
- Housing: in groups of three in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): 2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK
- Water (e.g. ad libitum): free access to mains drinking
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): fifteen changes per hour
- Photoperiod (hrs dark / hrs light): the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness
IN-LIFE DATES: From: 20 September 2012 To: 18 October 2012 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
For the 2000 mg/kg dose level:
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: No data
- Lot/batch no. (if required): No data
- Purity: No data
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Based on results of available data - Doses:
- 2000 mg/kg bw.
- No. of animals per sex per dose:
- 3 per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
+ Observations: The first day: 0.5h, 1h, 2h, 4h and then once daily
+ Weighing: day 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross necropsy - Statistics:
- No statistics were performed.
- Preliminary study:
- Not applicable.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks:
- DTBPOK
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 372 mg/kg bw
- Based on:
- act. ingr.
- Remarks:
- di-tert-butyl phosphate
- Mortality:
- There were no deaths.
- Clinical signs:
- other: No signs of systemic toxicity were noted.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- No data.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions of this study, the acute oral median lethal dose (LD50) of Di-tert-butyl potassium phosphate in rat was estimated to be greater than 2000 mg/kg bw. The acute oral median lethal dose (LD50) of Di-tert-butyl phosphate in rat was calculated to be greater than 2372 mg/kg bw.
- Executive summary:
The acute oral toxicity study was assessed on the potassium salt analogue of the target substance, di-tert-butyl potassium phosphate, in a study according to acute toxicity class method procedure (OECD Guideline 423; EC test method B1.tris, EPA OPPTS 870.1100 and Japanese MAFF, 2000) and in accordance with GLP.
No abnormalities were detected in the two groups tested at 2000 mg/kg bw.
Under the test conditions of this study, the acute oral median lethal dose (LD50) of Di-tert-butyl potassium phosphate in rat was estimated to be greater than 2000 mg/kg bw. The acute oral median lethal dose (LD50) of Di-tert-butyl phosphate in rat was calculated to be greater than 2372 mg/kg bw. Based on these data, no classification is required for both Di-tert-butyl potassium phosphate and Di-tert-butyl phosphate according to EU criteria.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Key study performed according to the OECD 423 guideline study and in compliance with the GLP (Klimisch score = 2).
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
The substance considered in the present dossier is manufactured as a 15% solution in 85% n-heptane (CAS: 142 -82 -5). No data are available on the test substance. By analogy with Di-tert-butyl potassium phosphate, the median lethal dose (LD50) of Di-tert-butyl phosphate in rat was calculated to be greater than 2372 mg/kg bw. Heptane is not classified by oral route in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation). Based on these data, the test substance is considered as not harmful if swallowed.
Justification for selection of acute toxicity – oral endpoint
Only one study was available.
Justification for classification or non-classification
The substance considered in the present dossier is manufactured as a 15% solution in 85% n-heptane.
- As n-heptane is not classified by oral route in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation) and LD50 calculated of Di-tert-butyl phosphate in rat is > 2372 mg/kg bw, the test substance is not classified by oral route according to CLP Regulation (1272/2008) criteria.
- As n-heptane is classified as Asp. Tox. 1 (H304) in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation), therefore the test substance in 85% n-heptane is classified as Asp. Tox. 1 (H304) according to CLP Regulation (1272/2008) criteria.
- As n-heptane is classified as STOT SE 3 (H336) in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation), therefore the test substance in 85% n-heptane is classified as STOT SE 3 (H336) according to CLP Regulation (1272/2008) criteria.
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