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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 939-509-6 | CAS number: -
- 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
- Remarks:
- combined repeated dose and reproduction / developmental screening
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No GLP defined
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 996
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)
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 1,3-dichloro-4-nitrobenzene
- EC Number:
- 210-248-3
- EC Name:
- 1,3-dichloro-4-nitrobenzene
- Cas Number:
- 611-06-3
- Molecular formula:
- C6H3Cl2NO2
- IUPAC Name:
- 2,4-dichloro-1-nitrobenzene
- Details on test material:
- Purity: 98.0 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Males, 45 days
Females, from 14 days before mating to day 3 of lactation - Frequency of treatment:
- no data
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0 (Vehicle), 8, 40, 200 mg/kg/day
Basis:
other: vehicle: corn oil
- No. of animals per sex per dose:
- Males: 12; Females: 12/group
- Control animals:
- yes
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- effects observed, treatment-related
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- effects observed, treatment-related
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- < 8 mg/kg bw/day (nominal)
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
There were no abnormal clinical signs attributable to the administration of the test substance, although, one female rat given 200 mg/kg died during delivery. The body weight gain of females given 200 mg/kg was lower than that of the controls during the gestation period.
Hematological examination revealed decreases in red blood cells in males given 8 mg/kg or more, decreases in hematocrit and hemoglobin, increases in reticulocytes, and slight anemia in males given 40 and 200 mg/kg. Blood clinical examination revealed increases in total protein, albumin and gamma-GTP and decreases in creatinine in males given 40 and 200 mg/kg. Total bilirubin and the A/G ratio were increased in males given 200 mg/kg. Absolute and relative liver and kidney weights showed increase or a tendency for increase in both sexes given 200 mg/kg. necropsy revealed enlargement of the liver in both sexes given 200 mg/kg, and enlargement of kidneys in males given 200 mg/kg. Other treatment-related gross findings included atrophy of the thymus and enlargement of the adrenal glands in treated females.
Histopathological examination revealed swelling and single cell necrosis of liver cells in both sexes given 200 mg/kg. Moreover, mitosis of liver cells were observed in males given 200 mg/kg. The slight increase in the incidence of hyaline droplets of the renal tubules in males and basophilic change of the renal tubules in females, both given 200 mg/kg, were also noted in a few females given 8 mg/kg or more, and necrosis of the renal tubules was observed in a few females given 40 and 200 mg/kg. A variety of lesions including a moderate degree of pigment deposit in the spleen, atrophy of the thymus, swelling of the liver cells, ulcer action in the stomach, duodenum and large intestine, single liver cell necrosis and fibrosis of the renal tubular epithelium, were observed in females that delivered all stillborn pups and in females where all pups died, in the group given 200 mg/kg. Counting of numbers of spermatogenic cells at stage VIII in the testes from control males and males given 200 mg/kg revealed no treatment-related effects.
Applicant's summary and conclusion
- Executive summary:
The test substance was studied for oral toxicity in an OECD combined repeat dose and reproductive/developmental toxicity screening test at doses of 0, 8, 40 and 200 mg/kg/day. With regard to repeat dose toxicity, one female rat given 200 mg/kg died during delivery. Body weight gain of females given 200 mg/kg was lower than that of controls during the gestation period. hematological examination showed decreases of red blood cells in males given 8 mg/kg or more, as well as decreases of hematocrit and hemoglobin, increases of reticulocytes, and slight anemia in males given 40 and 200 mg/kg. Blood chemical examination revealed increases in total protein, albumin and y-GTP and decreases in creatinine in males given 40 and 200 mg/kg. Increases in total bilirubin and A/G ratio were also observed in males given 200 mg/kg. Absolute and relative weights of the liver and kidneys showed increases or a tendency for increase in both sexes given 200 mg/kg and mg/kg. As gross findings, enlargement of the liver was observed in both sexes given 200 mg/kg and enlargement of the kidneys in males given 200 mg/kg. Histopathologial examination revealed swelling and single cell necrosis of liver cells in both sexes given 200 mg/kg. Moreover, mitosis of liver cells were observed in the liver of males given 200 mg/kg. The slight increase in the incidence of hyaline droplets of renal tubules in males and basophilic change of the renal tubules in females, both given 200 mg/kg, were also noted in a few females given 8 mg/kg or more, and necrosis of the renal tubules was observed in a few females given 40 and 200 mg/kg.
The author declared 8 mg/kg as LOEL, because slight effects on red blood cells in male rats (red blood counts: control 7.98 mg/kg; 8 mg/kg= 7.79 mg/kg) and histopathology were observed, but the effects on red blood cells were isolated effects and no other effects were observed.
Basophile changes (contol group= 1 rat; 8 mg/kg= 2 rats; 40 mg/kg= 1 rat; 200 mg/kg 5 rats) The results were not dose related and no signifficant effect was seen in the 8 mg/kg group of female rats
Because the effects were not seen as advers the LOEL = NOAEL of 8 mg/kg.
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.