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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 204-508-5 | CAS number: 121-92-6
- 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:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from J-check database
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test of test substance by oral administration in rats
- Author:
- National Institute of Technology and Evaluation
- Year:
- 2 018
- Bibliographic source:
- Japan Chemicals Collaborative Knowledge Database, 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Principles of method if other than guideline:
- Combined repeated dose repro-devp. Screen of m-Nitrobenzoic acid in rat orally
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 3-nitrobenzoic acid
- EC Number:
- 204-508-5
- EC Name:
- 3-nitrobenzoic acid
- Cas Number:
- 121-92-6
- Molecular formula:
- C7H5NO4
- IUPAC Name:
- 3-nitrobenzoic acid
- Details on test material:
- - Name of test material: m-nitrobenzoic acid
- Molecular formula: C7H5NO4
- Molecular weight: 167.121 g/mol
- Substance type: Organic
- Purity: 99.2%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl: CD(SD)
- Details on species / strain selection:
- No data
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data available
- Age at study initiation: 9 weeks old (initiation of dosing)
- Weight at study initiation: No data available
- Fasting period before study: No data available
- 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
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
IN-LIFE DATES: From: To: No data available
Administration / exposure
- Route of administration:
- oral: gavage
- Details on route of administration:
- No data
- Vehicle:
- other: 0.1 w/v% Tween 80 +0.5 w/v% Sodium carboxymethylcellulose solution
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: The test chemical was dissolved in 0.1 w/v% Tween 80 +0.5 w/v% Sodium carboxymethylcellulose solution to give dose levels of 0, 20, 100 or 500 mg/Kg/day
DIET PREPARATION
- Rate of preparation of diet (frequency): No data available
- Mixing appropriate amounts with (Type of food): No data available
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): 0.1w/v% Tween 80 +0.5w/v% Sodium carboxymethylcellulose solution
- Concentration in vehicle: 0, 20, 100, 500 mg/kg/day
- Amount of vehicle (if gavage): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data available
- Duration of treatment / exposure:
- Males: 42 days
Females: 55 days (from 14 days before mating to day 4 of lactation) - Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 20, 100, 500 mg/kg/day
Basis:
no data
- No. of animals per sex per dose:
- Total: 116
0 mg/kg/day: 12 male, 12 female
20 mg/kg/day: 12 male, 12 female
100 mg/kg/day: 12 male, 12 female
500 mg/kg/day: 12 male, 12 female
Recovery:
0 mg/kg/day: 5 male, 5 female
500 mg/kg/day: 5 male, 5 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: No data available
- Rationale for animal assignment (if not random): No data available
- Rationale for selecting satellite groups: No data available
- Post-exposure recovery period in satellite groups: 14 days
- Section schedule rationale (if not random): No data available - Positive control:
- No data
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: No data available
- Cage side observations checked in table [No.?] were included. Mortality were observed
DETAILED CLINICAL OBSERVATIONS: Yes , but no detailed information available
- Time schedule: No data available
BODY WEIGHT: Yes , but no detailed information
- Time schedule for examinations: Observed during dosing period
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
- Compound intake calculated as time-weighted averages from the consumption and body weight :No data
HAEMATOLOGY: Yes
- Time schedule for collection of blood: No data
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. Red blood cell count, hemoglobin concentration and hematocrit value were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. A/G ratio, Pi, K, BUN, TP, Cl and ALT were examined.
URINALYSIS: No data
- Time schedule for collection of urine: No data
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked in table [No.?] were examined No data
NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data
OTHER:
Organ weight: Brain R, Liver R, Kidney R, Testes A/R, Epididymides A/R, Thymus A and Spleen were in males and liver R, Spleen R, Spleen A, Thymus A, Kidney A from females was weighed - Sacrifice and pathology:
- HISTOPATHOLOGY: Yes
Organ examined:
Forestomach, testes, epididymides, seminiferous tubular epithelium, epididymides duct, femur bone were examined in male rats and forestomach, trabecular bone in femur bone, female genital tract were examined in female rats - Other examinations:
- No data
- Statistics:
- No data
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- When treated with 500 mg/kg/day, Salivation was observed in male and female rats and decrease in locomotor activity, irregular respiration, prone position and drastic worsening was observed in female rat.
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- When treated with 500 mg/kg/day, 3 female rat were died.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 500 mg/kg/day, restrained body weight gain was noted in male rats.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- effects observed, treatment-related
- Description (incidence and severity):
- A decrease in food consumption was noted on day 8 in 500 mg/Kg bw/day male and female rats
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- AT 500 mg/Kg bw/day, a decrease in red blood cell, hemoglobic and hematocrit values was noted in male and female rats
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- An increase in the A/G ration, Pi, K was noted in males and ALT increase was noted in females at 500 mg/Kh bw/day dose. However, a decrease in BUN, TP and CL was noted in male rats at 500 mg/Kg bw/day
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- No effects were noted for urianalysis in male and female rats at any of the dose levels.
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 500 mg/kg/day, in male rats, relative weight of Brain, Liver and Kidney increased, absolute and relative weight of Testes, Epididymides and absolute weight of Thymus decreased. During recovery, absolute and relative weigh of Testes and Epididymides were decreased in male rats.
In female rats, when treated with 500 mg/kg/day, relative Liver and Spleen weight increased and absolute Thymus weight decreased. During recovery, absolute spleen and kidney weight increased. - Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- In male rats, Squamous hyperplasia, Erosion and Focal inflammatory cell infiltration in the forestomach, Small and soft testes, Small epididymides, Degeneration in seminiferous tubular epithelium in the testes, Decrease in sperm and Cell debris in the epididymides duct and increase in trabecular bone in the femur bone were observed in 500 mg/kg/day treated and in recovery period.
When treated with 100 mg/kg/day, Squamous hyperplasia in the forestomach were observed in male rats.
In female, Squamous hyperplasia, Erosion in the forestomach and an Increase in trabecular bone in the femur bone in 500 mg/kg/day treated and an Increase in trabecular bone in the femur bone in recovery period at mg/Kg/day was noted. - Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 20 other: mg/kg/day
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: No effect on survival, clinical signs, body weight and weight gain, food consumption, haematology, clinical chemistry, organ weights and histopathology
- Dose descriptor:
- NOAEL
- Effect level:
- 100 other: mg/kg/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No adverse effect on survival, clinical signs, body weight and weight gain, food consumption, haematology, clinical chemistry, organ weights and histopathology
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The no-observed- adverse-effect-level (NOAEL) for male rats was considered to be 20 mg/kg/day and NOAEL for female rats was considered to be 100 mg/kg/day when Crl:CD (SD) male and female rat were treated with test substance.
- Executive summary:
In a combined repeated dose repro-devp. Screen, Crl:CD (SD) male and female rats were treated with test chemical in the concentration of 0, 20, 100, 500 mg/kg/day orally for 42 days in male rats and 55 days (from 14 days before mating to day 4 of lactation). The animal were fed the diet containing the test chemical daily and were observed for clinical signs, mortality, body weight and food consumtion changes, hematological and urine analysis, organ weight changes and histopathology. When treated with 500 mg/kg/day, Salivation was observed in male and female rats and decrease in locomotor activity, irregular respiration, prone position and drastic worsening was observed in female rat. 3 female rat died at 500 mg/Kg/day. When treated with 500 mg/kg/day, restrained body weight gain was noted in male rats. A decrease in food consumption was noted on day 8 in 500 mg/Kg/day male and female rats. At 500 mg/Kg/day, a decrease in red blood cell, hemoglobic and hematocrit values was noted in male and female rats. An increase in the A/G ration, Pi, K was noted in males and ALT increase was noted in females at 500 mg/Kg/day dose. However, a decrease in BUN, TP and CL was noted in male rats at 500 mg/Kg/day. No effects were noted for urianalysis in male and female rats at any of the dose levels. When treated with 500 mg/kg/day, in male rats, relative weight of Brain, Liver and Kidney increased, absolute and relative weight of Testes, Epididymides and absolute weight of Thymus decreased. During recovery, absolute and relative weigh of Testes and Epididymides were decreased in male rats. In female rats, when treated with 500 mg/kg/day, relative Liver and Spleen weight increased and absolute Thymus weight decreased. During recovery, absolute spleen and kidney weight increased. In male rats, Squamous hyperplasia, Erosion and Focal inflammatory cell infiltration in the forestomach, Small and soft testes, Small epididymides, Degeneration in seminiferous tubular epithelium in the testes, Decrease in sperm and Cell debris in the epididymides duct and increase in trabecular bone in the femur bone were observed in 500 mg/kg/day treated and in recovery period. When treated with 100 mg/kg/day, Squamous hyperplasia in the forestomach were observed in male rats. In female, Squamous hyperplasia, Erosion in the forestomach and an Increase in trabecular bone in the femur bone in 500 mg/kg/day treated and an Increase in trabecular bone in the femur bone in recovery period at 500 mg/Kg/day was noted. Based on the observations made, the no-observed- adverse-effect-level (NOAEL) for male rats was considered to be 20 mg/kg/day and NOAEL for female rats was considered to be 100 mg/kg/day when Crl:CD (SD) male and female rat were treated with test chemical.
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.