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EC number: 201-474-3 | CAS number: 83-41-0
- 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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 3-nitro-o-xylene
- EC Number:
- 201-474-3
- EC Name:
- 3-nitro-o-xylene
- Cas Number:
- 83-41-0
- Molecular formula:
- C8H9NO2
- IUPAC Name:
- 1,2-dimethyl-3-nitrobenzene
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: 23; received from the sponsor of the study; BG Chemie
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in a refrigerator (at 4°C)
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- (Bor:WISW; Wistar-outbred)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
Breeding Centre for Laboratory Animals, F. Winkelmann GmbH, Borchen, F.R. Germany
- Age at study initiation:
ca. 5 weeks
- Weight at study initiation: 92-93g (females); 99-100g (male animals)
- Housing:
5 animals per cage, separated by sex, in suspended stainless steel cages, fitted with wire mesh floor and front
- Diet (e.g. ad libitum):
Institute's stock diet. A powdered cereal-based, open-formula diet
- Water (e.g. ad libitum):
drinking bottles were filled daily with fresh tap water, except for the weekends
- Acclimation period:
10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.5 °C - 22.5 °C
- Humidity (%): 60-80 %
- Air changes (per hr): about 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
DIET PREPARATION
- Rate of preparation of diet (frequency): twice during the study
- Mixing appropriate amounts with (Type of food): standard lab diet
- Storage temperature of food: -20 °C
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Immediately after preparation of the first batch of diets, three samples of each test diet were taken fron different locations in the blender. These samples were analysed in duplo for the homogenous distribution of the test substance in the diet. One sample of the control diet was analysed as well.
The diet was extracted with ethanol and analyzed using a HPLC technique. - Duration of treatment / exposure:
- 28 days/ 42 days (recovery groups)
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 ppm
- Dose / conc.:
- 100 ppm
- Dose / conc.:
- 500 ppm
- Dose / conc.:
- 2 500 ppm
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, plain diet
- Details on study design:
- - Dose selection rationale: based on the results of a 5-day range finding study
- Rationale for selecting satellite groups: to examine the reversibility of the effects found
- Post-exposure recovery period in satellite groups: 14 days
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily on working days; once daily during the weekend
DETAILED CLINICAL OBSERVATIONS: Yes / No / Not specified
- Time schedule:
BODY WEIGHT: Yes
- Time schedule for examinations: on day 0; then twice weekly as well as on the day of autopsy
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: No; food consumption was recorded twice weekly
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No; The efficiency of food utilization was calculated over one-week periods and expressed as grams weight gain per gram food consumed.
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: At autopsy on day 28
- Anaesthetic used for blood collection: Yes (ether)
- Animals fasted: Not specified
- How many animals: All; except for the animals of the recovery group
- Parameters examined:
- red blood cell count; haemoglobin concentration; packed cell volume; prothrombin time; total white blood cell count; differential white blood cell count; thrombocyte count; mean corpuscular volume (MCV); mean corpuscular haemoglobin (MCH); mean corpuscular haemoglobin concentration (MCHC)
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: On day 26 for glucose measurements; on day 28 for the other parameters.
- Animals fasted: Yes (prior to blood sampling on day 26): deprivation of water for 24 hours and of food during the last 16 hours.
- How many animals: All; except for those of the recovery groups
- Parameters examined:
- alkaline phosphatase activity; total protein; aspartate aminotransferase activity; albumin/globulin ratio; alanine aminotransferase activity; urea; gamma qlutamyl transferase activity; creatinine; total bilirubin; sodium; potassium; calcium; inorganic phosphate; chloride; albumin
At autopsy of the rats of the recovery study on day 42, blood was collected and analysed for:
- alanine aminotransferase activity
- gamma glutamyl transferase activity
- total protein
URINALYSIS: Yes
- Time schedule for collection of urine: Day 25-26
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Yes
- Parameters examined:
- volume; density; appearance; protein; glucose; urobilinogen; bilirubin; occult blood; ketones; pH; microscopic examination of the sediment
NEUROBEHAVIOURAL EXAMINATION: No
IMMUNOLOGY: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
Samples of the following tissues and organs were preserved:
adrenals; ovaries, heart, testes, kidneys, spleen, liver, all gross lesions
Following organs were weighed: adrenals, testes, kidneys, spleen, liver
HISTOPATHOLOGY: Yes
liver, kidneys, heart, adrenals and spleen of all rats of the control group and the topdose
group - Statistics:
- Body weights were evaluated by one-way analysis of co-variance followed by Dunnett's multiple comparisons test; or (for the two groups of the
recovery study) by the two sample t-test. Data on red blood cell variables, total white blood cell counts, clinical chemistry values, volume and density of the urine, and organ weights were evaluated by one-way analysis of variance (ANOVA) followed by Dunnett's multiple comparison test. The above data of the recovery study were analysed by the two sample t-test. Differential white blood cell counts and semi-quantitative urinary observations were analysed by the Mann-
Whitney u-test. The histopathological changes were examined by Fishers exact probability test. All data were tested two-sided.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- One rat showed some alopecia and another rat inflammation of the eyes.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Body weights were slightly decreased in the high-dose group in both sexes. The differences with the controls were not always statistically significant. Body weights of the mid-dose rats tended to be lower than in controls.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Food intake of both sexes was slightly lower in the high-dose group than in the controls.
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- Water consumption showed slightly lower values in the high-dose females than in controls in both the main study and the recovery study. In males no dose-related differences between test groups and controls were observed.
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Thrombocyte count was slightly increased in the high-dose group. Such an effect was not observed at the end of the recovery period.
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Plasma protein concentration was slightly decreased in the high-dose group in both sexes, and in females of the mid-dose group. Plasma alanine aminotransferase activity was slightly decreased in females of the high dose-group. Albumin/globulin ratio and gamma glutamyl transferase activity were slightly increased in the
high-dose group in males, although with respect to the latter finding the difference with the controls was not statistically significant. An increase in albumin/globulin ratio occurred also in males of the mid-dose group. A decreased plasma alanine aminotransferase activity was still present after the recovery period, whereas gamma glutamyl transferase activity and protein concentration had returned to normal. - Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- At autopsy of the rats of the sub-acute study (killed an day 28), one male of the mid-dose group showed one kidney with a pale area. At autopsy of the rats of the recovery study (killed on day 42), gross examination was essentially negative.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- no effects observed
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 500 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical biochemistry
- food consumption and compound intake
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Because no distinct changes of toxicological importance were observed in the low- and mid- dose groups in the present 28-day study, it is concluded
that the no-effect level of 3-nitro-1,2-dimethylbenzol was 500 ppm in the diet of rats when fed for a period of four weeks. This dietary level
provided an intake of about 50 mg/kg body weight/day.
Applicant's summary and conclusion
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.
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