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EC number: 284-716-0 | CAS number: 84962-20-9
- 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
Endpoint summary
Administrative data
Description of key information
Acute toxicity after single oral application was tested in female rats, which received up to 5,000 mg/kg bw. Two females out of ten died at 3,200 mg/kg bw, 8 at 4,000 mg/kg bw and all animals at 5,000 mg/kg bw. Observed clinical signs were closed eye lid, abnormal breathing, and crouched posture. The necropsy of the deceased females did only reveal local effects in the stomach. These findings are considered to be attributed to the (mucosa )irritant properties of the test substance and are not considered to be of systemically nature. The LD50 value for acute oral toxicity was calculated to be 3575 mg/kg bw.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 3 575 mg/kg bw
- Quality of whole database:
- 1 (reliable without restrictions)
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
Based
on the results of an oral toxicity study the LD50value for
acute oral toxicity was calculated to be 3575 mg/kg bw.
In
accordance with REACH “Column 2” in Annex VIII there is sufficient
weight of evidence from several independent sources of information
leading to the conclusion thatPhosphoric
acid, mixed esters with Bu.Alc. and Ethylene glycol does
not exert systemic toxic effects after acute inhalation exposure and
thus does not have to be classified, because
- the LD50value for acute oral toxicity ofPhosphoric acid, mixed esters with Bu.Alc. and Ethylene glycol is 3575 mg/kg bw, and
- exposure of humans via inhalation is considered unlikely taking into account the vapour pressure of the substance.
With reference to its strong eye irritant properties the only effect to be expected after inhalative exposure would local irritation of the respiratory mucosa.
Therefore, and for animal welfare reasons, it is concluded that testing of acute inhalation toxicity ofPhosphoric acid, mixed esters with Bu.Alc. and Ethylene glycolis not scientifically necessary.It can reasonably be deduced that Phosphoric acid, mixed esters with Bu.Alc. and Ethylene glycol does not exert systemic toxic effects after dermal application and thus does not have to be classified, because this substance did not cause lethal effects after administration of single oral doses up to 2,500 mg/kg bw in rats (LD50: 3575 mg/kg bw). Due to its polar (ionic) character and its poor lipophilicity (log POW: -0.8) the penetration into the stratum corneum will be limited (please refer to Guidance on information requirements and chemical safety assessment, Chapter R.7c, p.157) and therefore, it is unlikely that higher amounts (limit dose of dermal toxicity testing according OECD 402: 2,000 mg/kg bw/d) than tested in the acute oral toxicity study (tested up to 5,000 mg/kg bw/d) will be systemically available via the intact skin barrier even if the most unlikely amount of 100% penetration is assumed. Therefore, testing is not scientifically necessary.
Justification for selection of acute toxicity – oral endpoint
Study design equivalent to OECD Guideline 401 with sufficient reporting.
Justification for selection of acute toxicity – inhalation endpoint
n.a.
Justification for selection of acute toxicity – dermal endpoint
n.a.
Justification for classification or non-classification
Due to the findings described in the acute oral toxicity study (LD50 oral in rats 3575 mg/kg bw) Phosphoric acid, mixed esters with Bu.Alc. and Ethylene glycol does not have to be classified as acute orally toxic. Based on the substance's physico-chemical properties no higher systemically exposure via inhalation or dermal penetration is expected to occur than that tested in the course of the oral toxitiy study. Therefore, Phosphoric acid, mixed esters with Bu.Alc. and Ethylene glycol does not have to be classified as acute toxic.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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