Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 212-603-8 | CAS number: 831-52-7
- 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
Endpoint summary
Administrative data
Description of key information
Repeated dose toxicity: via oral route;
NOAEL was considered to be 20 mg/kg/day for test substance in Wistar rats by oral (gavage) administration in a 14 day study.
Repeated inhalation study:
According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance sodium 2-amino-4,6-dinitrophenolate ( 831-52-7) which is reported as 3.36E13mmHg at 25 C. Thus, exposure to inhalable dust, mist and vapour of the chemical sodium 2-amino-4,6-dinitrophenolate is highly unlikely. Therefore this study is considered for waiver.
Repeated dermal study;
The acute toxicity value for sodium 2-amino-4,6-dinitrophenolate ( 831-52-7) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that sodium 2-amino-4,6-dinitrophenolate shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that sodium 2-amino-4,6-dinitrophenolate shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from secondary source.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Principles of method if other than guideline:
- Repeated dose toxicity study for test substance was conducted in male and female rats for 14 days by oral gavage.
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- other: HanBrl:WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data available
- 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
- 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
- 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. - Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- 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.
- 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
- Description (incidence and severity):
- 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 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.Reduced size of testes, epididymis, prostate and seminal vesicles was seen in three males treated at the dose of 250 mg/kg bw/day.
- 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
- Other effects:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 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 test chemical
- 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.
- Remarks on result:
- other: No toxic effect were observed .
- Critical effects observed:
- not specified
- Conclusions:
- NOAEL was considered to be 20 mg/kg/day for test substance in Wistar rats by oral (gavage) administration in a 14 day study.
- Executive summary:
In a repeated dose toxicity study the effect of test substance was observed in male and female Wistar rats for 14 days. The male and female Wistarrats were exposed to test substance on a daily basis at dose concentration of 0, 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 test substance. Therefore NOAEL was considered to be 20 mg/kg/day for test chemical inWistarrats by oral (gavage) for 14 days.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 20 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Data is published by european commission.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The data available for the test chemical was reviewed to determine the toxic nature of sodium 2-amino-4,6-dinitrophenolate ( 831-52-7)repeated exposure by oral route. The study is as mentioned below:
Repeated dose toxicity: via oral route;
In a repeated dose toxicity study the effect of test substance was observed in male and female Wistar rats for 14 days. The male and female Wistarrats were exposed to test substance on a daily basis at dose concentration of 0, 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 test substance . Therefore NOAEL was considered to be 20 mg/kg/day for test chemical in Wister rats by oral (gavage) for 14 days.
In a repeated dose toxicity study the effect of test substance was observed in male and female Wistarrats for13 weeks. The male and female Wistarrats were exposed to test substance on a daily basis at dose concentration of 0, 5, 15 and 80 mg/kg bw/day. No mortality was observed during the study.At high dpse group 80 mg/kg bw/d: increase in food consumption in male and female rats; haematological changes in male and female rats; clinical biochemistry changes (metabolic changes); increase in liver (reversible increase), kidney and spleen weight and decrease in testes weights (irreversible increase) and tubular degeneration; ulceration or inflammation of the caecum in both male and female rats hemopoiesis extra or intra medullary, vacuolation in the adrenals of male rats were observed. At 15 mg/kg bw/d: haematological changes was observed in female rats; ulceration or inflammation of the caecum in female rats, microscopic findings in the kidney and liver in female and male rats were observed.
Therefore No Observed Adverse Effect Level (NOAEL) in rats after daily oral treatment is determined to be 5 mg/kg bw/day, corresponding to 3.1 mg/kg bw/day active ingredient.
Repeated inhalation study:
According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance sodium 2-amino-4,6-dinitrophenolate ( 831-52-7) which is reported as 3.36E13mmHg at 25 C. Thus, exposure to inhalable dust, mist and vapour of the chemical sodium 2-amino-4,6-dinitrophenolate is highly unlikely. Therefore this study is considered for waiver.
Repeated dermal study;
The acute toxicity value for sodium 2-amino-4,6-dinitrophenolate ( 831-52-7) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that sodium 2-amino-4,6-dinitrophenolate shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that sodium 2-amino-4,6-dinitrophenolate shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver.
Based on the data available for the test chemical sodium 2-amino-4,6-dinitrophenolate ( 831-52-7) not likely to exhibit toxic nature upon repeated exposure by oral, inhalation and dermal route of exposure and hence is not likely to classify as per the criteria mentioned in CLP regulation.
Justification for classification or non-classification
Based on the data available for the test chemical sodium 2-amino-4,6-dinitrophenolate ( 831-52-7) not likely to exhibit toxic nature upon repeated exposure by oral, inhalation and dermal route of exposure and hence is not likely to classify as per the criteria mentioned in CLP regulation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.