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Diss Factsheets
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EC number: 202-544-6 | CAS number: 96-91-3
- 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
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Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
Data source
Reference
- Reference Type:
- secondary source
- Title:
- OPINION ON Picramic acid and sodium picramate COLIPA n° B28
- Author:
- Scientific Committee on Consumer Safety
- Year:
- 2 012
- Bibliographic source:
- Scientific Committee on Consumer Safety, (SCCS) 18 September 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- To evaluate the acute toxicity of picramic acid in CFY rats.
- GLP compliance:
- not specified
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- 2-amino-4,6-dinitrophenol
- EC Number:
- 202-544-6
- EC Name:
- 2-amino-4,6-dinitrophenol
- Cas Number:
- 96-91-3
- Molecular formula:
- C6H5N3O5
- IUPAC Name:
- 2-amino-4,6-dinitrophenol
- Test material form:
- other: Dark red needles
- Details on test material:
- - Name of test material (as cited in study report): Picramic acid
- Molecular formula (if other than submission substance): C6H5N3O5
- Molecular weight (if other than submission substance): 199.125g\mol
- Substance type: Organic
- Physical state: Dark red needles
- Purity No data available.
- Impurities (identity and concentrations): No data available.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CFY
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: NO data available.
- Age at study initiation: NO data available.
- Weight at study initiation: 95 to 120 g
- Fasting period before study: Starved overnight before treatment
- Housing: NO data available.
- Diet (e.g. ad libitum): NO data available.
- Water (e.g. ad libitum): NO data available.
- Acclimation period: NO data available.
ENVIRONMENTAL CONDITIONS
No data available.
IN-LIFE DATES: From: To: NO data available.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 10% suspension in aqueous gum tragacanth (0.5%) containing 0.05% sodium sulfite.
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0, 100, 160, 250, 400 and 640 mg/kg bw
- Amount of vehicle (if gavage): 10%suspension in aqueous gum tragacanth (0.5%) containing 0.05% sodium sulfite.
- Justification for choice of vehicle: No data available.
- Lot/batch no. (if required):
- Purity:
MAXIMUM DOSE VOLUME APPLIED: No data available.
DOSAGE PREPARATION (if unusual): Picramic acid was prepared as a 10% suspension in aqueous gum tragacanth (0.5%) and administered by oral intubation at a range of dosage volumes of 1.0 to 6.4 ml/kg bw, corresponding to doses from 100 to 640 mg/kg bw.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The results of preliminary range finding tests indicated that the median lethal oral dose (LD5O), was in the region of 100 to 400 mg/kg bw. Dosing was then extended to larger groups of rats (five males and five females) in order to set the median lethal dose more precisely. - Doses:
- 0, 100, 160, 250, 400 and 640 mg/kg bw
- No. of animals per sex per dose:
- 0 mg/kg bw- 5 males and 5 females
100 mg/kg bw- 5 males and 5 females
160 mg/kg bw - 5 males and 5 females
250 mg/kg bw - 5 males and 5 females
400 mg/kg bw - 5 males and 5 females
640 mg/kg bw-- 5 males and 5 females - Control animals:
- yes
- Details on study design:
- Control animals: Yes ,concurrent vehicle.( Rats treated with the vehicle alone (6.4 ml/kg bw) served as controls
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: From1st of the treatment to the 14 day of treatment.
- Necropsy of survivors performed: yes, All rats that died were examined macroscopically to identify the target organs and surviving animals were similarly examined after the observation period to detect possible damage.
- Other examinations performed: Mortality,clinical signs, body weight, organ weights and gross pathology were observed. - Statistics:
- No data available
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 110 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 63 - 176
- Mortality:
- Mortality was observed from within one to 19 hours of treatment.
- Clinical signs:
- other: Signs of reactions to treatment were observed shortly after dosing, including lethargy, piloerection and orange staining of external extremities. These signs were accompanied within five hours by gasping in six rats treated at 100 mg/kg bw. Recovery of su
- Gross pathology:
- Autopsy revealed discoloration of the liver, pallor of the kidneys and spleen, and orange staining of the inner body wall.
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category III
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 was found to be 110 mg/kg bw for Picramic acid in CFY male and female rats.
- Executive summary:
In acute oral median lethal dose (LD50) for Picramic acid was determined in CFY male and female rats. Signs of reactions to treatment were observed shortly after dosing, including lethargy, piloerection and orange staining of external extremities. These signs were accompanied within five hours by gasping in six rats treated at 100 mg/kg bw.
Death occurred from within one to 19 hours of treatment. Autopsy revealed discoloration of the liver, pallor of the kidneys and spleen, and orange staining of the inner body wall. Recovery of survivors, as judged by external appearance and behaviour was apparently complete within five days after treatment. Bodyweight gains were within normal limits compared with controls and normal autopsy findings.
The acute median lethal oral dose (LD50) and its 95% confidence limits to CFY male and female rats of picramic acid were calculated to be 110 (63-176) mg/kg bw.
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