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EC number: 601-017-1 | CAS number: 110964-79-9
- 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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed OECD and GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 4-methanesulfonyl-2-nitrobenzoic acid
- EC Number:
- 601-017-1
- Cas Number:
- 110964-79-9
- Molecular formula:
- C8 H7 N1 O6 S1
- IUPAC Name:
- 4-methanesulfonyl-2-nitrobenzoic acid
- Details on test material:
- - Name of test material (as cited in study report): MNBA (2-nitro-4-methylsulphonylbenzoic acid)
- Physical state: Solid
- Analytical purity: 97.1 % (CORRECTED for purity)
- Lot/batch No.: WRC 15483-30-1
- Storage condition of test material: Ambient temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Alpk:APfSD
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
The dosing preparations were formulated in corn oil and were found to be suspensions. Each preparation was thoroughly mixed and subdivided into aliquots. Fresh aliquots were used for each day of the study. Further preparations were made at approximately weekly intervals throughout the study. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Representative samples of dosing preparations from the first and third preparations were analysed to verify the achieved concentration of MNBA in corn oil. Samples were taken for the determination of homogeneity at 1.5 and 100 mg/ml (low and high dose levels) in corn oil.
The chemical stability of MNBA in corn oil, stored at room temperature, was determined over a period of at least 12 days prior to the start of the study at concentrations of 1.5 and 100mg /ml. - Duration of treatment / exposure:
- The animals were dosed for 28 consecutive days.
- Frequency of treatment:
- once per day
Doses / concentrations
- Remarks:
- Doses / Concentrations:
The rats were dosed orally by gavage at 1.0ml/100g according to their daily individual bodyweights.
Basis:
other: 0, 15, 150, 1000 mg/kg/day
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Positive control:
- not applicable
Examinations
- Observations and examinations performed and frequency:
- Clinical observations
Prior to the start of the study, all rats were examined to ensure that they were physically normal and exhibited normal activity. Detailed clinical observations were recorded daily. Any rats requiring euthanasia were killed and subjected to an examination post mortem. Any rats found dead were subjected to an examination post mortem as soon as possible after death.
Bodyweights
The bodyweight of each rat was recorded daily, immediately prior to dosing on days 1 to 28 and prior to termination on day 29.
Food consumption
Food consumption was recorded continuously throughout the study.
Functional observational battery
A functional observational battery (FOB) was carried out in week 4.
Motor activity
Locomotor activity was monitored by an automated activity recording apparatus. All animals were tested in week 4.
Clinical pathology
At termination, all rats were bled by cardiac puncture and samples were analysed.
Haematology: red blood cell count, total white cell count, haemoglobin, differential count, haematocrit, platelet count, mean cell volume, mean cell haemoglobin concentration, mean cell haemoglobin. Clotting measurements of prothrombin time and activated partial thromboplastin time with kaolin were made on samples of blood collected into tubes containing trisodium citrate as an anticoagulant. Blood cell morphology, including a differential white blood cell count was assessed by automated methods for all animals.
Blood clinical chemistry
urea, calcium, creatinine, phosphorus (as phosphate), glucose, total bilirubin, albumin, creatinine kinase activity, total protein, alkaline phosphatase activity, cholesterol, aspartate aminotransferase activity, sodium, alanine aminotransferase activity, potassium, gamma-glutamyl transferase activity
chloride - Sacrifice and pathology:
- All rats were killed by exsanguination under terminal anaesthesia induced by halothane.
Organ weights: adrenal glands, epididymides, kidneys, thymus, liver, spleen, testes, brain, heart
Macroscopic examination: All animals were subjected to a full examination post mortem.
Tissue submission: abnormal tissue, adrenal gland, brain (cerebrum, cerebellum, medulla and mid brain), caecum, cervix, duodenum, epididymis, femur ( bone marrow), heart, ileum, jejunum, kidney, large intestine, liver, lung, lymph nodes (cervical* and mesenteric), ovary, prostate gland, rectum, sciatic nerve, seminal vesicle, spinal cord, spleen, stomach, testis, thymus, thyroid gland, trachea ,urinary bladder, uterus.
* From terminal kill animals cervical lymph node was not submitted in error. However thymic lymph node was available for the majority of animals and was examined instead.
Microscopic examination: All selected tissues from the control and lOOOmg MNB A/kg/day were examined by light microscopy. - Statistics:
- All data were evaluated using the GLM procedure in SAS (1989). Group mean bodyweight data are presented graphically in Figure 1. The differences from control based on the analysis of bodyweight are also presented graphically in Figure 2. The centre of each bar represents the mean percentage difference between control and treated group least-squares means, and the top and bottom of each bar represents the upper and lower 95% confidence limits for this difference A statistically significant difference between the treated group and the control group is present when the bar does not cross the zero difference line. For ease of reference, lines have been added to the plot to show differences of ± 10%.
Results and discussion
Results of examinations
- Details on results:
- There were no treatment-related clinical observations. There were no effects on bodyweight or clinical observations.
There were no effects on sensory reactivity to stimuli or grip strength. Motor activity was increased in females receiving l000mg/kg/day MNBA during the second half of the observation period but this was considered not to be toxicologically significant
There were no toxicologically significant changes in haematology or clinical pathology parameters. There were no changes on organ weights or macroscopic or microscopic findings that could be attributed to administration of MNBA
Effect levels
- Dose descriptor:
- NOAEL
- Remarks:
- (no evidence of toxicity associated with MNBA administration)
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: Up to the highest dose tested (1000 mg/kg bw/day) no signs of substance related adverse effects.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- There was no evidence of toxicity associated with MNBA administration at dose levels up to and including 1000 mg/kg/day.
- Executive summary:
Groups of five male and five female AIpk:APfSD (Wistar-derived) rats were dosed orally by gavage with 0 (control), 15, 150, or l000mg MNBA/kg/day (using corn oil as the control substance and vehicle) for 28 consecutive days. Clinical observations, bodyweights and food consumption were measured throughout the study. In the fourth week of the study the following tests were assessed: sensory reactivity to stimuli; grip strength and motor activity. At the end of the scheduled period, the animals were killed and subjected to an examination post mortem. Cardiac blood samples were taken for clinical pathology, selected organs were weighed and specified tissues were taken for subsequent histopathology examination.
There were no treatment-related clinical observations. There were no effects on bodyweight or clinical observations. There were no effects on sensory reactivity to stimuli or grip strength. Motor activity was increased in females receiving l000mg/kg/day MNBA during the second half of the observation period but this was considered not to be toxicologically significant There were no toxicologically significant changes in haematology or clinical pathology parameters. There were no changes on organ weights or macroscopic or microscopic findings that could be attributed to administration of MNBA.
In conclusion there was no evidence of toxicity associated with MNBA administration at dose levels up to and including 1000mg/kg/day.
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