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EC number: 201-029-3 | CAS number: 77-47-4
- 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: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 25 October 1983 to 27 January 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)
- Deviations:
- yes
- Remarks:
- No FOB and ophthalmological examination were performed.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Hexachlorocyclopentadiene
- EC Number:
- 201-029-3
- EC Name:
- Hexachlorocyclopentadiene
- Cas Number:
- 77-47-4
- Molecular formula:
- C5Cl6
- IUPAC Name:
- hexachlorocyclopentadiene
- Reference substance name:
- Hexachlorobuta-1,3-diene
- EC Number:
- 201-765-5
- EC Name:
- Hexachlorobuta-1,3-diene
- Cas Number:
- 87-68-3
- Molecular formula:
- C4Cl6
- IUPAC Name:
- 1,1,2,3,4,4-hexachlorobuta-1,3-diene
- Test material form:
- liquid
Constituent 1
impurity 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Frederick Cancer Research Facility
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 6 weeks
- Weight at study initiation: Females: 101 to 108g / Males: 118 to 127g
- Housing: individually in stainless steel cages (Hazleton Systems)
- Diet (e.g. ad libitum): NIH-07 pelleted rodent diet ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 2 weeks
DETAILS OF FOOD AND WATER QUALITY:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C-21°C
- Humidity (%): 35%-65%
- Air changes (per hr): 20 changes/h
- Photoperiod (hrs dark / hrs light): 12h/12h
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Stainless steel whole-body inhalation chamber (Hazleton Systems)
- Source and rate of air: fresh air
- System of generating particulates/aerosols: Vaporizer. Gardner Type CN condensation nuclei detector used to ensure the generation of vapour and not of aerosol.
TEST ATMOSPHERE
- Brief description of analytical method used: On-line gas chromatograph with electron capture detector.
- Samples taken from breathing zone: yes - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- A gas chromatograph with an electron capture detector was used. The system was a 3% OV-225 coating on a 100/120 mesh Gas Chrom Q column and an argon/methane (9O:lO) carrier gas at a flow rate of 30 mL/minute. Column was maintained isothermally at 125°C.
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 6 hours per day, 5 days per week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 ppm (nominal)
- Remarks:
- Equivalent to 0 mg/m3.
- Dose / conc.:
- 0.04 ppm (nominal)
- Remarks:
- Equivalent to 0.45 mg/m3.
- Dose / conc.:
- 0.15 ppm (nominal)
- Remarks:
- Equivalent to 1.67 mg/m3.
- Dose / conc.:
- 0.4 ppm (nominal)
- Remarks:
- Equivalent to 4.46 mg/m3.
- Dose / conc.:
- 1 ppm (nominal)
- Remarks:
- Equivalent to 11.14 mg/m3.
- Dose / conc.:
- 2 ppm (nominal)
- Remarks:
- Equivalent to 22.28 mg/m3.
- No. of animals per sex per dose:
- 10 animals/sex/dose.
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Dose selection rationale: Not specified
- Positive control:
- No
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Weekly
BODY WEIGHT: Yes
- Time schedule for examinations: At beginning, weekly, and at termination
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
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Days 4, 16, 46 and 93
- Anaesthetic used for blood collection: Not specified
- Animals fasted: Not specified
- How many animals: All animals
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: Days 4, 16, 46 and 93
- Anaesthetic used for blood collection: Not specified
- Animals fasted: Not specified
- How many animals: All animals
URINALYSIS: Yes
- Time schedule for collection of urine: Days 3, 15, 45, 92
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Not specified
NEUROBEHAVIOURAL EXAMINATION: No
IMMUNOLOGY: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- Statistical analyses for possible dose-related effects on survival used Cox’s (1972) method for testing two groups for equality and Tarone’s (1975) life table test to identify dose-related trends.
The probability of survival was estimated by the product-limit procedure of Kaplan and Meier (1958).
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Listlessness was observed in rats exposed to 0.4, 1 and 2 ppm. Respiratory distress was observed in rats exposed to 1 and 2 ppm.
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- All rats exposed to 1 or 2 ppm of test substance died in the first 4 weeks of exposure. All rats exposed to lower concentrations survived.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Final mean body weight and mean body weight gain of male rats exposed to 0.4 ppm were significantly lower than those of the control animals.
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Statistically significant differences in haematology parameters were observed but were not attributed to the test substance as they were not persistent nor dose-related.
- Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Statistically significant differences in clinical biochemistry parameters were observed but were not attributed to the test substance as they were not persistent nor dose-related.
- Urinalysis findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Statistically significant differences in urinalysis parameters were observed but were not attributed to the test substance as they were not persistent nor dose-related.
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Lung weights of male rats exposed to 0.4 ppm of test substance were significantly greater than those of the controls. Other differences in organ weights were likely related to the lower body weights observed in exposed rats.
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- In rats exposed to 1 and 2 ppm of test substance, an extensive coagulation necrosis of the respiratory epithellium of the nose, larynx, trachea, bronchi, and bronchioles was observed.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- In rats exposed to 1 and 2 ppm of test substance, acute and subacute inflammation was observed in the respiratory tract consisting of vascular congestion, edema, accumulation of fibrin, and infiltrates of neutrophils and mononuclear cells. In some animals fibrinosuppurative exudate and suppurative alveolar inflammation were observed.
In rats exposed to 0.4 ppm, focal or multifocal suppurative inflammation of the nose or lung was observed (especially in male rats). Focal squamous metaplasia was observed in some male rats exposed to 0.4 ppm and some male and female rats exposed to 1 and 2 ppm. - Histopathological findings: neoplastic:
- no effects observed
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEC
- Remarks:
- systemic
- Effect level:
- 1.67 mg/m³ air (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical signs
- mortality
- Dose descriptor:
- NOAEC
- Remarks:
- local
- Effect level:
- 1.67 mg/m³ air (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- gross pathology
- histopathology: non-neoplastic
- organ weights and organ / body weight ratios
Target system / organ toxicity
open allclose all
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 4.46 mg/m³ air (nominal)
- System:
- respiratory system: upper respiratory tract
- Organ:
- larynx
- nasal cavity
- trachea
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 4.46 mg/m³ air (nominal)
- System:
- respiratory system: lower respiratory tract
- Organ:
- bronchi
- bronchioles
- lungs
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- A subchronic toxicity study by inhalation was performed on rats using Hexachlorocyclopentadiene that allowed to determine NOAEC of 0.15 ppm (equivalent to 1.67 mg/m3) for both local and systemic effects based on mortality, body weight, and effects on upper and lower respiratory tract.
- Executive summary:
The repeated dose toxicity of Hexachlorocyclopentadiene by inhalation was evaluated using a method similar to the OECD Test Guideline 413 (GLP) with deviations.
Rats were exposed at concentrations of 0, 0.04, 0.15, 0.4, 1 and 2 ppm of Hexachlorocyclopentadiene in air(equivalent to 0, 0.45, 1.67, 4.46, 11.14 and 22.28 mg/m3) for 6 hours per day, 5 days per week, for 13 weeks. Mortality, clinical signs, body weight, and haematology, clinical biochemistry, and urinalysis parameters were recorded. At the end of the study, surviving animals were subjected to gross necropsy and histopathology. All rats exposed to 1 or 2 ppm of test substance died in the first 4 weeks of exposure. All rats exposed to lower concentrations survived. Listlessness was observed in rats exposed to 0.4, 1 and 2 ppm. Respiratory distress was observed in rats exposed to 1 and 2 ppm. Final mean body weight and mean body weight gain of male rats exposed to 0.4 ppm were significantly lower than those of the control animals. Lung weights of male rats exposed to 0.4 ppm of test substance were significantly greater than those of the controls. Other differences in organ weights were likely related to the lower body weights observed in exposed rats. In rats exposed to 1 and 2 ppm of test substance, an extensive coagulation necrosis of the respiratory epithellium of the nose, larynx, trachea, bronchi, and bronchioles was observed. In rats exposed to 1 and 2 ppm of test substance, acute and subacute inflammation was observed consisting of vascular congestion, edema, accumulation of fibrin, and infiltrates of neutrophils and mononuclear cells. In some animals fibrinosuppurative exudate and suppurative alveolar inflammation were observed. In rats exposed to 0.4 ppm, focal or multifocal suppurative inflammation of the nose or lung was observed (especially in male rats). Focal squamous metaplasia was observed in some male rats exposed to 0.4 ppm and some male and female rats exposed to 1 and 2 ppm. Statistically significant differences in haematology, clinical biochemestry, and urinalysis parameters were observed but were not attributed to the test substance as they were not persistent nor dose-related.
This subchronic toxicity study by inhalation allowed to determine a NOAEC of 0.15 ppm (equivalent to 1.67 mg/m3) for both local and systemic effects based on mortality, body weight, and upper and lower respiratory tract.
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