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EC number: 700-296-8 | CAS number: 61337-89-1
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 August 2017 - 05 September 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- December 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- December 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Appendix to Director General Notification, No. 12-Nousan-8147. Agricultural Production Bureau, Ministry of Agriculture, Forestry and Fisheries of Japan (JMAFF)
- Version / remarks:
- November 2000, including the most recent revisions
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- {2-[(2R)-4-methyl-2-phenylpiperazin-1-yl]pyridin-3-yl}methanol; {2-[(2S)-4-methyl-2-phenylpiperazin-1-yl]pyridin-3-yl}methanol
- EC Number:
- 700-296-8
- Cas Number:
- 61337-89-1
- Molecular formula:
- C17-H21-N3-O
- IUPAC Name:
- {2-[(2R)-4-methyl-2-phenylpiperazin-1-yl]pyridin-3-yl}methanol; {2-[(2S)-4-methyl-2-phenylpiperazin-1-yl]pyridin-3-yl}methanol
- Test material form:
- solid: particulate/powder
- Details on test material:
- Physical appearance: white powder
Storage conditions: at room temperature
Constituent 1
- Specific details on test material used for the study:
- No correction factor for the purity of the test item was applied.
Test animals
- Species:
- rat
- Strain:
- other: Crl: WI(Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Animals: 9 young adult females (nulliparous and non-pregnant) of approximately 10-12 weeks old
- Weight at study initiation: 177 -219 g
- Fasting period before study: Animals were deprived of food overnight (for a maximum of 20 hours) prior to dosing and until 3-4 hours after administration of the test item. Water was available.
- Housing: up to 5 animals of the same sex and same dosing group were housed together in in polycarbonate cages (Makrolon MIV type; height 18 cm.) containing sterilized sawdust as bedding material equipped with water bottles. For psychological/environmental enrichment, animals were provided with paper, except when interrupted by study prcedures/activities.
- Diet: Pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany) was provided ad libitum throughout the study, except during designated procedures.
- Water: municipal tap-water was available ad libitum.
- Acclimation period: at least 5 days before the commencement of dosing.
ENVIRONMENTAL CONDITIONS (set to maintain)
- Temperature (°C): 18-24 (actual: 21-22)
- Humidity (%): 40-70 (actual: 49-72
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 15 August 2017 - 05 September 2017
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Remarks:
- specific gravity: 1.036
- Details on oral exposure:
- - Justification for choice of vehicle: Trial preparations (non-GLP) were performed at the Test Facility to select the suitable vehicle and to establish a suitable formulation procedure. The vehicle is accepted by international guidelines.
- Method of application: a single dose of test item was administered to the appropriate animals by oral gavage on day 1, using a syringe with a plastic gavage cannula attached. The dosing formulations were stirred continuously during dose administration.
- Justifiction for dose level: the dose level was based on the OECD guidelines. - Doses:
- 2000 and 300 mg test item/kg bodyweight
Treatment was performed in a stepwise manner; a first group was treated at a dose level of 2000 mg/kg bw, based on the results two additional groups were dosed at 300 mg/kg. - No. of animals per sex per dose:
- 3 females per treatment group (9 animals in total)
- Control animals:
- no
- Details on study design:
- - Method: The test was performed in a stepwise treatment of 3 females, starting with a dose level of 2000 mg/kg bw. Based on the results, two additional groups were dosed at 300 mg/kg.
- Duration of observation period following administration: 14 days
- Frequency of observations:
Mortality and moribundity: twice daily
Weighing: individually on day 1 (pre-dose), day 8 and day 15.
Other examinations: at least three times on the day of dosing and once daily thereafter.
- Necropsy: yes, all moribund animals and animals surviving to the end of the observation period were sacrificed by oxygen/carbon dioxide procedure. All animals assigned to the study were subjected to necropsy and descriptions of all internal macroscopic abnormalities were recorded. - Statistics:
- No statistical analysis was performed.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: The oral LD50 was within the range of 300-2000 mg/kg bw.
- Mortality:
- At 2000 mg/kg, two animals were found dead on day 1 and one animal was found dead on day 6.
At 300 mg/kg, no mortality occurred. - Clinical signs:
- other: At 2000 mg/kg, hunched posture, flat posture, piloerection, clonic spasms, uncoordinated movements, quick breathing, shallow respiration and/or ptosis were noted between days 1 and 5 for the three animals found dead during the study. At 300 mg/kg, hunched
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination of the animals.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Classified as Category 4 according to Regulation (EC) No. 1272/2008
- Conclusions:
- The oral LD50 of HYDROPIP-NR was established in an acute oral toxicity study in rats (Acute Toxic Class Method), to be within the range of 300-2000 mg/kg bw. Based on these results, the test item is classified as Category 4 (harmful if swallowed) for acute toxicity by oral route according to the GHS and according to Regulation (EC) No. 1272/2008.
- Executive summary:
An acute oral toxicity study (Acute Toxic Class method) was performed according to OECD guideline 423 and GLP principles, to determine the potential toxicity of HYDROPIP-NR. Nine female Winstar rats were dosed in a stepwise manner starting with the treatment of one group of three animals with a dose of 2000 mg/kg bw. Based on the results two additional groups of three females were treated with a dose of 300 mg/kg bw. At 2000 mg/kg, two animals were found dead on day 1 and one animal was found dead on day 6, whereas at 300 mg/kg, no mortality occurred. At 2000 mg/kg, hunched posture, flat posture, piloerection, clonic spasms, uncoordinated movements, quick breathing, shallow respiration and/or ptosis were noted between days 1 and 5 for the three animals found dead during the study. At 300 mg/kg, hunched posture, uncoordinated movements and piloerection were noted for all animals between days 1 and 4.
The mean bodyweight gain shown by the animals over the study period was considered to be normal for all treatment groups and no abnormalities were found at marcroscopic post mortem examination of the animals.The oral LD50 value of HYDROPIP-NR in Wistar rats was established to be within the range of 300 -2000 mg/kg body weight. The LD50 cut-off value was considered to be 500 mg/kg body weight, according to OECD guideline 423.
Based on these results, HYDROPIP-NR is classified as Category 4 (harmful when swallowed) for acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).
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