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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
Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: no data
- 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:
- Evaluation on the Reprotoxicity of Picramic acid in rats
- GLP compliance:
- not specified
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): 199.12 g/mol
- Substance type: Organic
- Physical state: solid
- Purity: 100% pure
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar derived SPF-Albino Crl:Wi/Br
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- No data available.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% sodium carboxymethylcellulose
- Details on exposure:
- VEHICLE
- Justification for use and choice of vehicle (if other than water):
- Concentration in vehicle: 0, 10, 30 and 60 mg/kg bw/day.
- Amount of vehicle (if gavage): 10 ml/kg bw
- Lot/batch no. (if required):
- Purity - Details on mating procedure:
- No data available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- During day 5 to day 15 of gestation
- Frequency of treatment:
- Daily
- Details on study schedule:
- 80 pregnant rats of the Wistar strain were treated once daily by oral gavage of picramic acid in 0.5% sodium carboxymethylcellulose during day 5 to day 15 of gestation atdoses of 0, 10, 30 and 60 mg/kg bw/d. The animals received a constant volume of 10 ml/kg bw/d. The test procedure followed the OECD guideline and was conducted in compliance with the principles of GLP.During the study the mortality, signs of intoxication, body weight and food consumption were recorded. All mated females were sacrified on day 20 of gestation. In the pregnant female, a complete autopsy and a macroscopic examination of the organs were carried out. Uterus were weighed and examined. For each ovary, corpora lutea were counted and foetuses were individually weighed and sexed. A gross examination of all foetuses was performed and one-third of the foetuses were examined for visceral anomalies. The other foetuses were evaluated for skeletal defects.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 10, 30 and 60 mg/kg bw/day
Basis:
no data
- No. of animals per sex per dose:
- Total no of animals-80
0 mg/kg bw/day- 20 female rats
10 mg/kg bw/day - 20 female rats
30 mg/kg bw/day- 20 female rats
60 mg/kg bw/day - 20 female rats - Control animals:
- yes, concurrent vehicle
Examinations
- Parental animals: Observations and examinations:
- The mortality, signs of intoxication, body weight and food consumption were recorded. For each ovary, corpora lutea were counted.
- Oestrous cyclicity (parental animals):
- No data available.
- Sperm parameters (parental animals):
- No data available.
- Litter observations:
- Foetuses were individually weighed and sexed.
- Postmortem examinations (parental animals):
- All mated females were scarified on day 20 of gestation. In the pregnant female, a complete autopsy and a macroscopic examination of the organs were carried out. Uterus were weighed and examined
- Postmortem examinations (offspring):
- A gross examination of all foetuses was performed and one-third of the foetuses were examined for visceral anomalies. The other foetuses were evaluated for skeletal defects
- Reproductive indices:
- No data available.
- Offspring viability indices:
- Yes, appropriate data is not available
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No toxic effects were reported during the study. Females of all dose groups had orange-brown discolored urine throughout the application period at dose related intensity.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Mean maternal bodyweight gains and mean food consumptions over the gestation period were normal when compared to the control group
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Mean maternal bodyweight gains and mean food consumptions over the gestation period were normal when compared to the control group
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 30 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No significant effect were observed in foetal body weight and uteri weights
Results: F1 generation
Details on results (F1)
There were no biologically significant differences in the number of litters with malformations or developmental variations between any of the dose groups and the control group
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was found to be 30 mg/kg/day for Picramic acid in female Wistar derived SPF-Albino Crl:Wi/Br rats when they were exposed at concentration 0, 10, 30 and 60 mg/kg bw/day during gestation period of 5-15 days by oral gavage.
- Executive summary:
In a reprotox study of Picramic acid was assessed in female Wistar derived SPF-Albino Crl:Wi/Br rats when they were exposed at concentration0, 10, 30 and 60 mg/kg bw/day during gestation period of 5-15 days. At 60mg/kg/day dose group ,there was an increase in foetal body weight and uterine weights and it was dose related change.No significant chage was observed at 30 mg/kg/day.
Therefore the No Observed Adverse Effect Level (NOAEL) of picramic acid in female rats after daily oral treatment is determined to be 30 mg/kg bw/day for the maternal toxicity.
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