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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- 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:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- 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
- Details on test animals or test system and environmental conditions:
- Sex: Female
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 - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- No data available
- Duration of treatment / exposure:
- During day 5 to day 15 of gestation
- Frequency of treatment:
- Daily
- Duration of test:
- 10 days
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
Examinations
- Maternal examinations:
- The mortality, signs of intoxication, body weight and food consumption were recorded.
- Ovaries and uterine content:
- For each ovary, corpora lutea were counted.
- Fetal examinations:
- Foetuses were individually weighed and sexed.
- Statistics:
- Yes ,appropriate data is not available.
- Indices:
- Yes ,appropriate data is not available.
- Historical control data:
- No data available.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
No mortality was observed during the treatment period. 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. Mean maternal bodyweight gains and mean food consumptions over the gestation period were normal when compared to the control group. Gross necropsy did not reveal any organ alterations related to treatment. No significant differences in the number of viable fetuses, the male to female sex ratio, birth- position, number of runts, post-implantation losses, implantations, resorptions and corpora lutea between dosage groups and the control group were observed. The highest dose (60 mg/kg/day) group showed an increase in fetal body weight and uteri weights with a tendency towards dose-relation.
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
Examination of the fetuses yielded minor variations (wavy ribs) at comparable inter-group frequencies and incidences within the historical control animals of this strain. 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.
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 30 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was found to be 30 mg/kg/day for Picramic acid in male and female Wistar derived SPF-Albino Crl:Wi/Br rats where there dams 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 devlopmental study of Picramic acid was assessed in male and female Wistar derived SPF-Albino Crl:Wi/Br rats where there dams were exposed at concentration 0, 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 and foetal organisms.
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