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EC number: 254-414-3 | CAS number: 39322-78-6
- 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 15,000 mg/kg bw. Five females out of ten died at 10,000 mg/kg bw, 9 at 12,500 mg/kg bw and all animals at 15,000 mg/kg bw. Observed clinical signs were vomiting and spasm. The necropsy of the deceased females did only reveal local effects in the stomach. These findings are considered to be attributed to the 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 10,490 mg/kg bw. Due to the findings described above (LD50 oral in rats 10,490 mg/kg bw) Phosphoric acid, dodecyl ester, potassium salt does not have to be classified as acute orally toxic.
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:
- Sept 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Equivalent to OECD401; performed before GLP.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- only one sex tested, limitations in study reporting
- GLP compliance:
- no
- Remarks:
- performed before GLP guidelines
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain: Hoe WISKf(SPF71)
- Source: Hoechst AG Kastengrund - SPF breed
- Weight at study initiation: 90-112 g (female); (mean = 100 g; n = 60)
- Age at study initiation: no data
- Fasting period before study: 16 hours before and 2 hours after application
- Diet: Altromin 1324 (Altromin GmbH, Lage/Lippe), ad libitum
- Water: Tap water ad libitum
- Acclimatization period: no data
ENVIRONMENTAL CONDITIONS
- Housing: in groups, in plastic cages, softwood pellets - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- - concentration in vehicle: 25 % (w/v)
- Doses:
- 6300 mg/kg
8000 mg/kg
9000 mg/kg
10000 mg/kg
12500 mg/kg
15000 mg/kg - No. of animals per sex per dose:
- 10 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations after application / Weighing once weekly
- Necropsy of survivors performed: yes - Statistics:
- Probit analysis (method by Linder and Weber);
Confidence limits according to Cavalli-Sforza - Preliminary study:
- Preliminary experiments did not show differences related to gender. Therefore only females used for main study.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 10 490 mL/kg bw
- 95% CL:
- > 9 833 - <= 11 191
- Mortality:
- Sex: female, Dose: 6300 mg/kg bw, Mortality rate: 0 / 10
Sex: female, Dose: 8000 mg/kg bw, Mortality rate: 0 / 10
Sex: female, Dose: 9000 mg/kg bw, Mortality rate: 0 / 10
Sex: female, Dose: 10000 mg/kg bw, Mortality rate: 5 / 10
Sex: female, Dose: 12500 mg/kg bw, Mortality rate: 9 / 10
Sex: female, Dose: 15000 mg/kg bw, Mortality rate: 10 / 10 - Clinical signs:
- other: Mortally poisened animals died within 1-2 days after application. Following symptoms were observed: disturbance of equilibrium, spasm. The test substance was vomitted.
- Gross pathology:
- Dissection of rats killed at the end of the observation period revealed no macroscopic findings.
Necropsy of the deceased animals revealed following macroscopic findings: Stomach and oesophagus were filled with white foam. - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The median lethal dose of the test item (LD50) was 10490 mg per kg body weight. Based on the result of this study the test item is not subject for labelling and classification requirements according to regulatory requirements.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 10 490 mg/kg bw
- Quality of whole database:
- 2 (reliable with restrictions)
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Based on the results of an oral toxicity study the LD50 value for acute oral toxicity was calculated to be 10,490 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, dodecyl ester, potassium saltdoes not exert systemic toxic effects after acute inhalation exposure and thus does not have to be classified, because
- the LD50value for acute oral toxicity of Phosphoric acid, dodecyl ester, potassium salt is 10,490 mg/kg bw, and
- exposure of humans via inhalation is considered unlikely taking into account the vapour pressure and the physical form (pasty) of the substance.
Therefore, it is concluded that testing of acute inhalation toxicity of of Phosphoric acid, dodecyl ester, potassium salt is not scientifically necessary.
It can reasonably be deduced that Phosphoric acid, dodecyl ester, potassium salt 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 a single oral dose of up to 9,000 mg/kg bw in rats. Due to the combination of its polar (ionic) character and the long extent of the alcoholic chain 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 15,000 mg/kg bw/d) will be systemically available via the 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
The study performance is equivalent to OECD401; study performed before GLP.
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 10,490 mg/kg bw) Phosphoric acid, dodecyl ester, potassium salt does not have to be classified as acute orally toxic. Based on the substance's physico-chemical properties no higher systemical exposure via inhalation or dermal penetration is expected to occur than that tested in the course of the oral toxicity study. Therefore, Phosphoric acid, dodecyl ester, potassium salt does not have to be classified as acute toxic.
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