Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 620-341-4 | CAS number: 61358-25-6
- 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
Oral (OECD 423), rat: LD50 (cut-off) > 2500 mg/kg bw/day
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:
- 10 Jan - 16 Feb 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline 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
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- THE DEPARTMENT OF HEALTH OF THE GOVERNMENT OF THE UNITED KINGDOM
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: RccHan: WIST
- 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: 8-12 weeks
- Weight at study initiation: 173-180 g (group 1), 165-167 g (group 2), 167- 184 g (group 3)
- Fasting period before study: animals were fasted overnight prior to dosing and for approximately 3 to 4 h after dosing.
- Housing: animals were housed in groups of 3 in suspended solid-floor polypropylene cages furnished with wood flakes.
- Diet: 2014C Teklad Global Rodent diet (Harlan Laboratories UK Ltd., Oxon, UK), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- other: arachis oil BP
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 mg/mL (300 mg/kg bw dose group) and 200 mg/mL (2000 mg/kg bw dose group)
- Justification for choice of vehicle: arachis oil BP was used because the test substance did not dissolve/suspend in distilled water.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
DOSAGE PREPARATION: the dose formulations were freshly prepared within two hours before application to the animals, since the stability of the test formulation was assumed for this duration.
CLASS METHOD
- Rationale for the selection of the starting dose: in the absence of data regarding the toxicity of the test substance, 300 mg/kg bw was chosen as the starting dose. - Doses:
- 300 mg/kg bw (group 1), 2000 mg/kg bw (group 2 and group 3)
- No. of animals per sex per dose:
- 3 in group 1, group 2 and group 3, respectively
- Control animals:
- other: not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed for clinical signs and mortality within the first 30 min and at approximately 1, 2 and 4 h after treatment on Day 1. During the observation period, animals were observed once daily for mortality and clinical signs. Individual body weights were recorded on Day 1 (prior to dosing) as well as 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weights - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: experimental result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: LD50 cut-off according to OECD 423
- Mortality:
- No mortalities were observed at a dose level of 300 mg/kg bw in animals of group 1. In group 2, one animal treated at 2000 mg/kg bw was found dead on Day 9 of the 14-day observation period. Due to the occurrence of severe clinical signs, one animal of group 3, which received the test substance at at a dose level of 2000 mg/kg bw, was killed for humane reasons 4 h after dosing.
- Clinical signs:
- other: Signs of systemic toxicity were noted 1 to 4 h after dosing in the animal of group 2, which was treated with 2000 mg/kg bw and humanely killed 4 h after dosing. Clinical signs started with noisy respiration 1 h after dosing, followed by hunched posture, a
- Gross pathology:
- At the unscheduled deaths, abnormalities were noted in two animals treated at 2000 mg/kg bw. In the animal of group 1, which was found dead on Day 9 of the study, abnormally red lungs, dark liver, dark kidneys, haemorrhage and epithelial sloughing of the gastric mucosa as well as gaseous and reddened small and large intestines were observed. In the animal of group 2, which was humanely killed 4 h after dosing, white substance in the stomach and epithelial sloughing of the gastric mucosa were seen. No abnormalities were noted at necropsy of animals which were killed at the end of the 14-day observation period.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified - Executive summary:
The acute oral toxicity of PF-6 was investigated in a GLP-conform study according to the acute toxic class method (OECD guideline 423). In the first step, the test substance was administered to 3 female RccHan:WIST rats at a starting dose of 300 mg/kg bw in arachis oil BP by single oral gavage. In two further steps, two groups of 3 female rats each, were treated with PF-6 diluted in arachis oil BP at doses of 2000 mg/kg bw. Two unscheduled deaths occurred during the study period. One animal treated with 2000 mg/kg bw in the second step was found dead on Day 9 during the study without showing clinical signs. A further animal treated with 2000 mg/kg bw was humanely killed 4 h after dosing in the third step due to overt signs of toxicity (noisy respiration, hunched posture, ataxia, pilo-erection and lethargy). No mortality was observed in animals receiving the test substance at 300 mg/kg bw. Two animals treated in the second step and one animal treated in the third step, showed loss in body weight at 2000 mg/kg bw during the first week, but achieved the expected body weight gain during the second week of the study. All other animals showed the expected gain in body weight after treatment with the test substance. No macroscopic findings were recorded at necropsy in animals treated at 300 mg/kg bw and animals treated at 2000 mg/kg bw that survived the study period. At the unscheduled deaths, abnormalities were noted in two animals treated at 2000 mg/kg bw. In the animal found dead during the second step of treatment, abnormally red lungs, dark liver, dark kidneys, haemorrhage and epithelial sloughing of the gastric mucosa as well as gaseous and reddened small and large intestines were observed. In the animal humanely killed 4 h after dosing during the third step of treatment, white substance in the stomach and epithelial sloughing of the gastric mucosa were seen. Based on these experimental results, the LD50 of PF-6 was greater than 2000 mg/kg bw. According to the criteria of OECD guideline 423, the LD50 cut-off of PF-6 may be considered to be 2500 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
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
Oral
The acute oral toxicity of PF-6 was investigated in a GLP-conform study according to the acute toxic class method (OECD guideline 423) (Bradshaw, 2012). In the first step, the test substance was administered to 3 female RccHan:WIST rats at a starting dose of 300 mg/kg bw in arachis oil BP by single oral gavage. In two further steps, two groups of 3 female rats each, were treated with PF-6 diluted in arachis oil BP at doses of 2000 mg/kg bw. Two unscheduled deaths occurred during the study period. One animal treated with 2000 mg/kg bw in the second step was found dead on Day 9 during the study without showing clinical signs. A further animal treated with 2000 mg/kg bw was humanely killed 4 h after dosing in the third step due to overt signs of toxicity (noisy respiration, hunched posture, ataxia, pilo-erection and lethargy). No mortality was observed in animals receiving the test substance at 300 mg/kg bw. Two animals treated in the second step and one animal treated in the third step, showed loss in body weight at 2000 mg/kg bw during the first week, but achieved the expected body weight gain during the second week of the study. All other animals showed the expected gain in body weight after treatment with the test substance. No macroscopic findings were recorded at necropsy in animals treated at 300 mg/kg bw and animals treated at 2000 mg/kg bw that survived the study period. At the unscheduled deaths, abnormalities were noted in two animals treated at 2000 mg/kg bw. In the animal found dead during the second step of treatment, abnormally red lungs, dark liver, dark kidneys, haemorrhage and epithelial sloughing of the gastric mucosa as well as gaseous and reddened small and large intestines were observed. In the animal humanely killed 4 h after dosing during the third step of treatment, white substance in the stomach and epithelial sloughing of the gastric mucosa were seen. Based on these experimental results, the LD50 of PF-6 was greater than 2000 mg/kg bw. According to the criteria of OECD guideline 423, the LD50 cut-off of PF-6 may be considered to be 2500 mg/kg bw.
Justification for classification or non-classification
The available data on the acute toxicity of PF-6 do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.