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EC number: 608-211-5 | CAS number: 284462-37-9
- 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
LD50 oral cut-off(rat): 2000 mg/kg bw [report, Schüngel 2004]
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:
- June to November 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 17 December 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Strain: Hsd Cpb:WU (SPF)
- Age at study initiation: 10-14 weeks
- Mean weight at study initiation: 166-205 g
- Housing: in groups of 3 animals. The animals were group caged conventionally in polycarbonate cages on low dust wood granulate bedding (J. Rettenmaier & Söhne, 73479 Ellwangen-Holzmühle,
Germany). The cages of the animals were placed on racks, in ascending group number order.
- Diet: ad libitum, standard diet “Provimi Kliba 3883.0.15 Maus/Ratte Haltung, Kaiseraugst Switzerland”
- Water: ad libitum, tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 55 +/- 5
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route of administration:
- oral: gavage
- Vehicle:
- other: formulated in demineralized water with the aid of 2% Cremophor EL
- Details on oral exposure:
- - Application volume: 10 mL/kg bw
- Rationale for the selection of the starting dose:
As described in the flow charts of Annex 2, OECD guideline 423, the starting dose level should be that which is most likely to produce mortality in some of the dosed animals. Therefore, the limit dose 2000 mg/kg bw was chosen as starting dose.
VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Purity: demineralized water with 2% Cremophor
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw - Doses:
- 300 and 2000 mg/kg
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least once daily (clinical signs, mortality) or once weekly (weight gain)
- Necropsy of survivors performed: yes
- Clinical signs including body weight: yes, please refer to results
- Other examinations performed: clinical signs, body weight, gross pathology - Statistics:
- none (limit test)
- Key result
- Sex:
- female
- Dose descriptor:
- other: LD50 cut-off
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- At the dose 2000 mg/kg bw 4 out of 6 animals died within 2 days after treatment. The dose 300 mg/kg bw was tolerated by all 6 females without mortalities.
- Clinical signs:
- other: At 2000 mg/kg bw decreased motility, uncoordinated gait, narrowed palpebral fissure, lateral position, spasmodic state, tachypnea, abdominal position, labored breathing, temporary lateral position, poor reflexes, lacrimation/increased lacrimation and dysp
- Gross pathology:
- No gross pathological findings were observed in animals that died during the observation period and at the end of the study.
- Other findings:
- none
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- According to OECD TG 423 the LD50 cut-off of Picolinamid-Phenylether is 2000 mg/kg bw (Category 4 of the Globally Harmonized Classification System). At the limit-dose 2000 mg/kg bw 4 out of 6 animals died within 2 days after treatment. The dose 300 mg/kg bw was tolerated by all 6 females without mortalities. At 2000 mg/kg bw decreased motility, uncoordinated gait, narrowed palpebral fissure, lateral position, spasmodic state, tachypnea, abdominal position, labored breathing, temporary lateral position, poor reflexes, lacrimation/increased lacrimation and dyspnea were observed up to day 2 after treatment. The dose 300 mg/kg bw was tolerated by all animals without clinical signs. In both doses neither effects on body weight gain nor gross pathological findings were observed.
- Executive summary:
In an acute oral toxicity study similar to OECD TG 423 (adopted 17 December 2001), groups of fasted, female Wistar rats, weighing 166-205 g, (3/treatment) were given a single oral dose of Picolinamid phenyletherin 2% Cremophor in demineralized water at a doses of 300 and 2000 mg/kg bw and observed for 14 days.
Oral LD50 Combined = 2000 mg/kg bw cut-off
Limit test
At the dose 2000 mg/kg bw 4 out of 6 animals died within 2 days after treatment. The dose 300 mg/kg bw was tolerated by all 6 females without mortalities.
There were no treatment related clinical signs, necropsy findings or changes in body weight in all animals of the 300 mg/kg bw group. At 2000 mg/kg bw decreased motility, uncoordinated gait, narrowed palpebral fissure, lateral position, spasmodic state, tachypnea, abdominal position, labored breathing, temporary lateral position, poor reflexes, lacrimation/increased lacrimation and dyspnea were observed up to day 2 after treatment.
The test item exhibited a LD50 cut off in female Wistar rats of 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Quality of whole database:
- The study is GLP compliant and is of high quality (Klimisch score=1)
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 an acute oral toxicity study similar to OECD TG 423 (adopted 17 December 2001), groups of fasted, female Wistar rats, weighing 166-205 g, (3/treatment) were given a single oral dose of Picolinamid phenyletherin 2% Cremophor in demineralized water at a doses of 300 and 2000 mg/kg bw and observed for 14 days.
Oral LD50 Combined = 2000 mg/kg bw cut-off
Limit test
At the dose 2000 mg/kg bw 4 out of 6 animals died within 2 days after treatment. The dose 300 mg/kg bw was tolerated by all 6 females without mortalities.
There were no treatment related clinical signs, necropsy findings or changes in body weight in all animals of the 300 mg/kg bw group. At 2000 mg/kg bw decreased motility, uncoordinated gait, narrowed palpebral fissure, lateral position, spasmodic state, tachypnea, abdominal position, labored breathing, temporary lateral position, poor reflexes, lacrimation/increased lacrimation and dyspnea were observed up to day 2 after treatment.
The test item exhibited a LD50 cut off in female Wistar rats of 2000 mg/kg bw.
Justification for classification or non-classification
Based on the study results (oral LD50 cut-off value: 2000 mg/kg bw ) a classification with Acute Toxicity Cat. 4 (H302:harmful if swallowed) according to Regulation (EC) No.1272/2008 (CLP) is required.
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