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EC number: 951-920-2 | CAS number: -
- 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:
- 17 Nov 2018 to 18 Dec 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF Guidelines (2000), including the most recent revisions
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- (1s,3s)-N1-methyl-N1-{7H-pyrrolo[2,3-d]pyrimidin-4-yl}cyclobutane-1,3-diamine; phosphoric acid
- EC Number:
- 951-920-2
- Molecular formula:
- C11H15N5* H3PO4
- IUPAC Name:
- (1s,3s)-N1-methyl-N1-{7H-pyrrolo[2,3-d]pyrimidin-4-yl}cyclobutane-1,3-diamine; phosphoric acid
1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 50 - <= 300 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD100
- Effect level:
- >= 300 - <= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- At 2000 and 300 mg/kg all animals were found dead on Day 1 post-treatment.
At 50 mg/kg, no mortality occurred. - Clinical signs:
- other: At 2000 mg/kg, piloerection was noted for the animals on Day 1. At 300 mg/kg, lethargy, flat posture, hunched posture, piloerection and/orptosiswere noted on Day 1. At 50 mg/kg, hunched posture, quick breathing, uncoordinated movements, piloerection, ptos
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The oral LD50 value ofPF-03817968-09 in Wistar Han rats was established to be within the range of 50-300 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value was considered to be 200 mg/kg body weight.
Based on these results: according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2017) (including all amendments),PF03817968-09 should be classified as: Toxic if swallowed (Category 3). According to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments),PF-03817968-09 should be classified as Category 3 and should be labeled as H301: Toxic if swallowed. - Executive summary:
The objective of this study was to determine the potential toxicity of PF-03817968-09, when given by oralgavageat a single dose to rats of a single sex (females) at one or more defined doses to evaluate the potential reversibility of any findings. The study was carried out in compliance with the guidelines described in OECD No.423 (2001) "Acute Oral Toxicity, Acute Toxic Class Method", EC No 440/2008, part B: "Acute Oral Toxicity, Acute Toxic Class Method".Initially, PF-03817968-09 was administered by oralgavageat a single dose to three female Wistar Han rats at 2000 mg/kg body weight. In a stepwise procedure three additional groups of three females were dosed at 300, 50 and 50 mg/kg body weight. All animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed on the day of death or after terminal sacrifice (Day 15). At 2000 mg/kg and 300 mg/kg, all animals were found dead on Day 1. At 50 mg/kg, no mortality occurred. At 2000 mg/kg, piloerection was noted on Day 1. At 300 mg/kg, lethargy, flat posture, hunched posture, piloerection and/orptosiswere noted on Day 1. At 50 mg/kg, hunched posture, quick breathing, uncoordinated movements, piloerection,ptosisand/or focal erythema (ears, legs, nose, tail and/or general) were noted between Days 1 and 3. The body weight gain shown by the surviving animals over the study period was considered to be similar to that expected for normal untreated animals of the same age and strain. Macroscopic abnormalities of the thymus (many, several dark red foci) were found in all animals at 2000 mg/kg that died during the study. Macroscopic postmortemexamination of the other animals that died during the study and of the surviving animals did not reveal any abnormalities. The oral LD50 value ofPF-03817968-09 in Wistar Han rats was established to be within the range of 50-300 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value was considered to be 200 mg/kg body weight. Based on these results and according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2017) (including all amendments), PF03817968-09 should be classified as: Toxic if swallowed (Category 3) according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments) and should be labeled as H301: Toxic if swallowed
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