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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 202-808-0 | CAS number: 99-99-0
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable deviations (bone marrow samples were collected only once after the last treatment. No informations about staining technique)
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 001
- Reference Type:
- secondary source
- Title:
- 4-Nitrotoluene - CAS N°: 99-99-0 - SIDS Initial Assessment Report.
- Author:
- OECD
- Year:
- 2 003
- Bibliographic source:
- UNEP Publications
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- bone marrow samples were collected only once after the last treatment. No informations about staining technique
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 4-nitrotoluene
- EC Number:
- 202-808-0
- EC Name:
- 4-nitrotoluene
- Cas Number:
- 99-99-0
- Molecular formula:
- C7H7NO2
- IUPAC Name:
- 1-methyl-4-nitrobenzene
- Details on test material:
- - Name of test material (as cited in study report): p-nitrotoluene
- Analytical purity: 99%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) corn oil
- Details on exposure:
- Rats were injected intraperitoneally
- Duration of treatment / exposure:
- 72 hours
- Frequency of treatment:
- 3 times at 24 hour interval
- Post exposure period:
- no
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 150, 300, 600 mg/kg bw in corn oil
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
Examinations
- Tissues and cell types examined:
- Rat bone marrow
- Details of tissue and slide preparation:
- The animals were killed 24 hours after the third injection, and blood smears were prepared from bone marrow cells
obtained from the femurs. Air-dried smears were fixed and stained; 2,000 polychromatic erythrocytes (PCEs) were
scored in up to five animals per dose group. - Evaluation criteria:
- In the micronucleus test, an individual trial is considered positive if the trend test P value is less than or equal to 0.025 or if the P value for any single dosed group is less than or equal to 0.025 divided by the number of dosed groups. A final call of positive for micronucleus induction is preferably based on reproducibly positive trials. Ultimately, the final call is determined by the scientific staff after considering the results of statistical analyses, the reproducibility of any effects observed, and the magnitudes of those effects.
- Statistics:
- Statistical software package that tested for increasing trend over dose groups with a one-tailed Cochran-armitage trend test followed by pairwisecomparison between each dosed group and the control group (Integrated Laboratory Systems (ILS) (1990).Micronucleus Data Management and Statistical AnalysisSoftware, Version 1.4. ILS, P.O. Box 13501, Research Triangle Park, NC 27707.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- no signs of intoxication were reported; no increases in micronucleated PCE's in the bone marrow of male rats (P<=0.466):
Any other information on results incl. tables
Induction of micronuclei in bone marrow polychromatic erythrocytes of male rats treated with p-nitrotoluene by intraperitoneal injectiona
Compound | Dose (mg/kg) | Number of rats with erythrocytes scores | Micronucleated PCEs/1000 PCEb | P value c |
Corn oild | 0 | 5 | 0.80 ± 0.12 | |
p-nitrotoluene | 150 | 5 | 1.00 ± 0.22 | 0.3186 |
300 | 5 | 0.80 ± 0.12 | 0.5000 | |
600 | 5 | 0.90 ± 0.33 | 0l4041 | |
p=0.466 e | ||||
Cyclphosphamide f | 25 | 5 | 10.30 ± 2.79 | 0.0000 |
a Study was performed at Integrated Laboratory Systems, Inc.
b PCE=polychromatic erythrocyte b Mean ± standard error
c Pairwise comparison with the vehicle control. Dosed group values are significant at P<=0.008; positive control values are significant at P<= 0.05
d Vehicle control
e Significance of micronucleated PCEs/1,000 PCEs tested by the one-tailed trend test; significant at P <=0.025
f Positive control
Applicant's summary and conclusion
- Executive summary:
4-Nitrotoluene caused no increases in micronucleated polychromatic erythrocytes (PCEs) in the bone marrow of male rats given 0, 150, 300, or 600 mg/kg bw by intraperitoneal injection three times at 24 hour intervals. In male mice, treated with 0, 150, 300, or 600 mg/kg bw by intraperitoneal injection three times at 24 hour intervals, results of a first trial were considered positive, based on the responses of the two lowest doses; the trend test was not significant due to a downturn at the highest dose level. A second trial failed to induce a significant increase in micronucleated PCEs over the same dose range. Therefore the authors concluded the overall results as negative. Neither in the study with rats nor in the studies with mice were any signs of toxicity reported (U.S. Department of Health and Human Services, 2002).
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.