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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- 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:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Sodium picramate
- IUPAC Name:
- Sodium picramate
- Reference substance name:
- Sodium 2-amino-4,6-dinitrophenoxide
- EC Number:
- 212-603-8
- EC Name:
- Sodium 2-amino-4,6-dinitrophenoxide
- Cas Number:
- 831-52-7
- IUPAC Name:
- sodium 2-amino-4,6-dinitrophenolate
- Details on test material:
- - Name of test material (as cited in study report): Sodium picramate
- Molecular formula (if other than submission substance): C6H4N3NaO5
- Molecular weight (if other than submission substance): 221.10 g/mol
- Substance type: Organic
- Physical state: Solid
- Impurities (identity and concentrations): 62.4%
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: HanBrl:WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data available
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Bi-distilled water
- Details on oral exposure:
- VEHICLE
- Justification for use and choice of vehicle (if other than water): Water was used.
- Concentration in vehicle: 0, 20, 100 and 250 mg/kg bw/day
- Amount of vehicle (if gavage): 10 ml/kg bw
- Lot/batch no. (if required):
- Purity: - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 14 day
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 20, 100 and 250 mg/kg bw/day
Basis:
no data
- No. of animals per sex per dose:
- Total no of animals-40
0 mg/kg bw/day -5 male and 5 female.
20 mg/kg bw/day 5 male and 5 female.
100 mg/kg bw/day 5 male and 5 female.
250 mg/kg bw/day 5 male and 5 female. - Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data available.
DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
FOOD EFFICIENCY: No data available.
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water studies): No data available.
OPHTHALMOSCOPIC EXAMINATION: No data available.
HAEMATOLOGY: No data available.
CLINICAL CHEMISTRY: No data available.
URINALYSIS: No data available.
NEUROBEHAVIOURAL EXAMINATION: No data available.
OTHER: - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes,
Histological examinations were performed on organs and tissues from all control and high dose animals, and all gross lesions from all animals were recorded.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Deaths were observed at the high dose(250 mg/kg bw/day) -two males: Days 5 and 7; three females: Days 1, 3 and 7
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- Deaths were observed at the high dose(250 mg/kg bw/day) -two males: Days 5 and 7; three females: Days 1, 3 and 7
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- The mean absolute body weights were decreased in males treated at the dose of 250 mg/kg bw/day. In females of this dose 250 mg/kg bw/day showed, a non -statistically significant decrease was observed.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- The mean absolute food intake was slightly decreased in males and females treated at the dose of 250 mg/kg bw/day and the mean relative food intake was also decreased in males and females treated at this dose when compared to control rats
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- The macroscopic lesions observed and possibly related to treatment consisted of enlarged spleen observed in 3 male rats and 1 female rat of the 250 mg/kg bw group. They could be correlated to the increase of the weight of the spleen.
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Changes in colon as foci, nodules or thickened organ were observed in three male rats and one female rats treated at the dose of 250 mg/kg bw/day and in one female rat treated at the dose of 100 mg/kg bw/day.
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Clinical signs:
In rats treated at the dose of 250 mg/kg bw/day several clinical signs were observed: during the first treatment week, slightly ruffled fur was observed in one female on treatment days 4 and 5 and in an other one on treatment day 3; slight emaciation was observed in four females and two males in the first treatment week and moderate emaciation in a further male on treatment day 6. Decreased spontaneous activity was observed in one female on treatment day 4 and 5 and in one male on treatment day 6. Slightly brown urine was seen in two females and three males on the last day of treatment.
Body weight and weight gain:
The mean body weight gain was decreased in males and females from the high dose group (250 mg/kg bw/day).
Organ weights:
Increased dose-related mean spleen weights and spleen to body ratios were observed in males and females rats treated at 250 mg/kg bw/day. The mean liver to body weight ratio was increased in males treated at the dose of 100 mg/kg bw/day or 250 mg/kg bw/day and in females at the dose of 250 mg/kg bw/day and 100 mg/kg bw/day but at this dose the increase was not statistically significant. An increase of the mean brain to body weight ratio was also observed in male rats at the dose of 250 mg/kg bw/day.
Gross pathology:
Reduced size of testes, epididymis, prostate and seminal vesicles was seen in three males treated at the dose of 250 mg/kg bw/day.
Histopathology:
Thickened cecum was observed in three male rats and foci were seen on the caecum of two males and two females treated at the dose of 250 mg/kg bw/day.
Other:
Other signs observed were discoloration of lung, lung not collapsed and thickened thymus, but they were not considered to be related to the treatment with sodium picramate.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 20 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No significant effect was observed in clinical change, mortality, body weight, Food intake, organ weight, grosspathology and histopathology.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was found to be 20 mg/kg/day for Sodium picramate in Wistar rats by oral (gavage) administration in a 14 day study.
- Executive summary:
In a repeated dose toxicity study the effect of Sodium picramate was observed in male and femaleWistarrats for 14 days. The male and female Wistarrats were exposed to Sodium picramate on a daily basis at dose concentration of0, 20, 100 and 250 mg/kg bw/day.Deaths were observed at the high dose [two males: Days 5 and 7; three females: Days 1, 3and 7].Control animals, animals treated at the dose of 20 mg/kg bw/day or 100 mg/kg bw/day showed no treatment related clinical effects.
In rats treated at the dose of 250 mg/kg bw/day several clinical signs were observed:during the first treatment week, slightly ruffled fur was observed in one female on treatment days 4 and 5 and in another one on treatment day 3; slight emaciation was observed in four females and two males in the first treatment week and moderate emaciation in a further male on treatment day 6. Decreased spontaneous activity was observed in one female on treatment day 4 and 5 and in one male on treatment day 6. Slightly brown urine was seen in two females and three males on the last day of treatment. The mean absolute food intake was slightly decreased in males and females treated at the dose of 250 mg/kg bw/day and the mean relative food intake was also decreased in males and females treated at this dose when compared to control rats. The mean absolute body weights were decreased in males treated at the dose of 250 mg/kg bw/day when compared to the control group. In females of this dose group a not statistically significant decrease was observed. The mean body weight gain was decreased in males and females from the high dose group.Increased dose-related mean spleen weights and spleen to body ratios were observed in males and females rats treated at 250 mg/kg bw/day. The mean liver to body weight ratio was increased in males treated at the dose of 100 mg/kg bw/day or 250 mg/kg bw/day andin females at the dose of 250 mg/kg bw/day and 100 mg/kg bw/day but at this dose the increase was not statistically significant. An increase of the mean brain to body weight ratio was also observed in male rats at the dose of 250 mg/kg bw/day. The macroscopic lesions observed and possibly related to treatment consisted of enlarged spleen observed in 3 male rats and 1 female rat of the 250 mg/kg bw group. They could be correlated to the increase of the weight of the spleen and were considered related to the treatment. Reduced size of testes, epididymes, prostate and seminal vesicles was seen in three males treated at the dose of 250 mg/kg bw/day. Changes in colon as foci, nodules or thickened organ were observed in three male rats and one female rats treated at the dose of 250 mg/kg bw/day and in one female rat treated at the dose of 100 mg/kg bw/day. Thickened caecum was observed in three male rats and foci were seen on the caecum of two males and two females treated at the dose of 250 mg/kg bw/day. Other signs observed were discoloration of lung, lung not collapsed and thickened thymus, but they were not considered to be related to the treatment with sodium picramate. Therefore NOAEL was considered to be 20 mg/kg/day for Sodium picramate inWistarrats by oral (gavage) for 14 days.
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