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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 202-764-2 | CAS number: 99-54-7
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- only one treatment and one sampling after 24 h (no 2nd sampling after 48 h)
- Deviations:
- yes
- Remarks:
- one treatment only and only one sampling after 24 h (no 2nd sampling after 48 h)
- GLP compliance:
- not specified
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- 1,2-dichloro-4-nitrobenzene
- EC Number:
- 202-764-2
- EC Name:
- 1,2-dichloro-4-nitrobenzene
- Cas Number:
- 99-54-7
- Molecular formula:
- C6H3Cl2NO2
- IUPAC Name:
- 1,2-dichloro-4-nitrobenzene
- Details on test material:
- no data on purity
Constituent 1
- Specific details on test material used for the study:
- Manufactured by Tokio Kasei Kogyo Co. Ltd., Japan
Test animals
- Species:
- mouse
- Strain:
- ICL-ICR
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dae-Han Laboratory Animal Co., Eumsunggun Korea
- Age at study initiation: 7-8 weeks old
- Assigned to test groups randomly: yes
- Housing: six animals were housed for each group
- Diet (e.g. ad libitum): commercial pellets ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 1 week
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: CMC (carboxymethyl cellulose)
- Amount of vehicle (if gavage or dermal): 10mL/kg - Duration of treatment / exposure:
- The test substance was given once
- Frequency of treatment:
- Once
- Post exposure period:
- 24 h
Doses / concentrationsopen allclose all
- Dose / conc.:
- 692 mg/kg bw/day (nominal)
- Dose / conc.:
- 346 mg/kg bw/day (nominal)
- Dose / conc.:
- 173 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 6 males
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Mitomycin C, 2 mg/kg, i.p.
Examinations
- Tissues and cell types examined:
- bone marrow from both femora
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: The rationale for the dose selection was the selection of half of the LD50 value as highest dose. The LD50 value from RTECS database for mice was 1384 mg/kg bw.
TREATMENT AND SAMPLING TIMES (in addition to information in specific fields): From the freshly killed animal both femora 24 h after administration were removed in toto, which means that one was cutting through pelvis and tibia. The bones were then freed from muscle by the use of gauze and fingers. With the needle of appropriate size mounted, about 1mL of serum was pulled from the tube into a disposable plastic syringe. Then the needle (24 gauge) was inserted a few mm into the proximal part of marrow canal to flush the marrow cells.
DETAILS OF SLIDE PREPARATION: After centrifugation, the supernatant was removed, and cell pellet suspension of bone marrow cells was dropped onto glass slides, and then air dried. After fixation in methanol, slides were stained with 4% Giemsa in 1/15M sodium phosphate buffered saline (PBS, pH 6.8) for 30 min, washed with PBS, and then air dried for microscopic observation.
METHOD OF ANALYSIS: In scoring the preparations, micronuclei were counted in polychromatic and separately in normochromatic erythrocytes. The rate of micronucleated cells, expressed in percentage, were based on the total of polychromatic erythrocytes present in the scored optic fields. This mode of scoring, which must always be followed where the test substance markedly influences the proliferation rate in the bone marrow, prevents a distortion of the results by the influx of peripheral blood into the damaged marrow. The scoring of micronucleated normocytes not only serves to recognize the presence of artifacts (which is rare in preparations from mouse) but provides additional interesting information on the mode of action of the test substance. Generally, an incidence of more than 1 micronucleated normocyte per thousand polychromatic erythrocytes indicates an effect on cell stages past the S-phase.
- Statistics:
- pariwise comparison to corresponding control
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Remarks:
- no decreased no. of immature erythrocytes observed, clinical signs of toxicity not described
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Test chemicals | Dose (mg/kg) | Route | Sampling time (hr) | MNPCE%/PCE (Mean ± SD) | Ratio % of PCE/PCE+NCE (Mean ± SD) | p-value |
Negative control | - | i.p | 24 | 0.11±0.07 | 0.49±0.02 | - |
- | p.o | 24 | 0.14±0.08 | 0.50±0.1 | - | |
Positive control (Mitocycin C) | 2 | i.p | 24 | 3.42±0.79 | 0.50±0.01 | 0.0000 |
1,2-dichloro 4-nitrobenzene (99-54-7) | 692 | p.o | 24 | 0.17±0.06 | 0.48±0.02 | >0.05 |
346 | 24 | 0.12±0.08 | 0.45±0.07 | >0.05 | ||
173 | 24 | 0.13±0.16 | 0.43±0.03 | >0.05 |
pariwise comparison to corresponding control, significant at P < 0.05
MNPCE%/PCE: percentage of Micronucleuated polychromatic erythrocytes/1,000 polychromatic erythrocytes
PCE/PCE+NCE: polychromatic erythrocytes/1,000 erthrocytes
Applicant's summary and conclusion
- Conclusions:
- No significant induction ratio of percentage of micronucleated polychromatic erythrocytes/1,000 poly chromatic erythrocytes (MNPCE &/ PCE) compared to solvent control.
- Executive summary:
Bone marrow micronucleus assay was performed in mice. About 7-8 weeks old male ICR mice were exposed to the test item via oral gavage. Doses of 692, 346 and 173 mg/kg bw/d were applied. The rationale for the dose selection was the selection of half of the LD50 value as highest dose. The LD50 value from RTECS database for mice was 1384 mg/kg bw. 24 h after a single substance administration, the animals were killed and the bone marrow from the femurs was analysed. No significant induction ratio of percentage of micronucleated polychromatic erythrocytes/1,000 polychromatic erythrocytes (MNPCE &/ PCE) compared to solvent control was observed.
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.