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Diss Factsheets
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EC number: 203-400-5 | CAS number: 106-46-7
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline not defined.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
- Principles of method if other than guideline:
- Method: other: Repeated Dose Toxicity study , focusing on the effects on the kidney during the oral administration by gavage of test substance in F344 rats during 13 weeks).
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 1,4-dichlorobenzene
- EC Number:
- 203-400-5
- EC Name:
- 1,4-dichlorobenzene
- Cas Number:
- 106-46-7
- Molecular formula:
- C6H4Cl2
- IUPAC Name:
- 1,4-dichlorobenzene
- Test material form:
- other: solid
- Details on test material:
- IUCLID4 Test substance: as prescribed by 1.1 - 1.4
purity of 99,9%.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation: 6-8 weeks
-Mean Weight at study initiation: males 176g; females: 114g
- Fasting period before study:
- Housing: individuelly
- Diet ad libitum
- Water ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 55
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 1
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- Groups of 10 male and 10 female rats redeived once daily by gavage, 7 days per week 13 weeks different doses of testsubstance dissolved in conrn oil ,
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 13 wk
- Frequency of treatment:
- once daily, 7 days per week.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 75, 150, 300 or 600 mg/kg bw /d
Basis:
- No. of animals per sex per dose:
- 10 male and 10 female rats per each dose. (0, 75, 150 300 600 mg/kg bw).
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Groups of 10 male and 10 female rats redeived once daily by gavage, 7 days per week 13 weeks different doses of testsubstance dissolved in conrn oil , interim kill of 5 rats/sex/dose was performed after 5 experimental weeks. Post-exposure period: none
- Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- The experimental animals were inspected twice daily.
The body weight of the experimental animals was recorded at the start of the study and weekly thereafter.
Laboratory investigations of blood and urine samples were performed after 2 and 8 days and after 4 and 12 weeks in 5 animals per dose and sex. - Sacrifice and pathology:
- interim kill after 5 experimental weeks; terminal killl after the end of treatment
animals were subjected to makroscopical examination, organ weight determination and histopathological evaluation mainly of kidney tissue - Statistics:
- arithmetic group mean values, significance test (U test) according to Mann and Whitney
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 efficiency:
- not specified
- Ophthalmological findings:
- not specified
- Haematological 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
- Details on results:
- A study (GLP) focusing on the effects on the lidney during the oral administration by gavage of the test substance in F344 rats was carried out during 13 weeks. Following doses were tested: 75, 150, 300 or 600 mg/kg bw d. No substance related effects on mortality, clinical signs, food consumption or growth in male or female rats were observed. A dose-dependent increased water consumption in all treated males from 20% (75 mg/kg) to 40% (600 mg/kg) was seen and slightlyelevated water intake (23%) in females at 600 mg/kg were noticed. No evidence of a dose-related pathological condition at any time in treated rats of either sex regarding hematological and clinical-chemical parameters could be seen. An increased urinary lactate dehydrogenase and epithelial cell excretion and exacerbation of hyaline droplet accumulation in the cytoplasm of renal cortical cells in male rats in all treated groups was noticed; further a tubular single cell necrosis, dilated tubules with granular cast formation in male rats after 4 and 13 weeks at 150 to 600 mg/kg was observed. There was no indication of a nephrotoxic action in females. The effects on the kidney in males correspond to the light hydrocarbon nephrotoxicity. The NOAEL was found to be <75 mg/kg bw/day.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- < 75 mg/kg bw/day (nominal)
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
One male in both the 300 and the 600 mg/kg dose group died.
Mortality was not increased by treatment, because the pathological-anatomical findings suggest that inadvertent insertion of the stomac tube into the lung may be the cause of death.
Applicant's summary and conclusion
- Executive summary:
A study (GLP) focusing on the effects on the lidney during the oral administration by gavage of the test substance in F344 rats was carried out during 13 weeks. Following doses were tested: 75, 150, 300 or 600 mg/kg bw d. No substance related effects on mortality, clinical signs, food consumption or growth in male or female rats were observed. A dose-dependent increased water consumption in all treated males from 20% (75 mg/kg) to 40% (600 mg/kg) was seen and slightlyelevated water intake (23%) in females at 600 mg/kg were noticed. No evidence of a dose-related pathological condition at any time in treated rats of either sex regarding hematological and clinical-chemical parameters could be seen. An increased urinary lactate dehydrogenase and epithelial cell excretion and exacerbation of hyaline droplet accumulation in the cytoplasm of renal cortical cells in male rats in all treated groups was noticed; further a tubular single cell necrosis, dilated tubules with granular cast formation in male rats after 4 and 13 weeks at 150 to 600 mg/kg was observed. There was no indication of a nephrotoxic action in females. The effects on the kidney in males correspond to the light hydrocarbon nephrotoxicity. The NOAEL was found to be <75 mg/kg bw/day.
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.
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