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EC number: 204-429-6 | CAS number: 120-83-2
- 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
Carcinogenicity
Administrative data
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4 MARCH 1981 to 30 JUNE 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted according to internationally recognised guidelines and under good laboratory practice. The following deviations from the guideline were noted: Only two dose concentrations were used. Satellite interim sacrifice groups were not included.However given the clear outcome with respect to oncogenicity those deviations from the guideline do not impact on the validity of the conclusion.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 451 (Carcinogenicity Studies)
- Deviations:
- yes
- Remarks:
- Only two dose concentrations were used. Satellite interim sacrifice groups were not included.
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,4-dichlorophenol
- EC Number:
- 204-429-6
- EC Name:
- 2,4-dichlorophenol
- Cas Number:
- 120-83-2
- Molecular formula:
- C6H4Cl2O
- IUPAC Name:
- 2,4-dichlorophenol
- Details on test material:
- - Name of test material (as cited in study report): 2,4 Dichlorophenol
- Physical state: colourless crystalline solid
- Analytical purity: Lot number OCR-640-57, >99%; and OCR-808-125, 99.5%
- Lot/batch No.:Lot numbers OCR-640-57 and and OCR-808-125
- Expiration date of the lot/batch: None specified
- Stability under test conditions: Not stated
- Storage condition of test material: Not stated
- Other: Diets incorporating the test item were stored at 4°C for a maximum of 2 weeks
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: Charles River Breeding Laboratories, Kingston, NY, USA
- Age at study initiation: 7 weeks
- Weight at study initiation: 121 g males, 105 g females
- Fasting period before study: None
- Housing: Polycarbonate cages (Lab Products, Inc.,Rochelle Park, NJ), 5 animals per cage
- Diet: NIH 07 Rat and Mouse Ration (Zeigler Bros., Inc., Gardners, PA); available ad libitum
- Water: Automatic watering system (Edstrom Industries,, Waterford, WI); available ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 12-28
- Humidity (%): 29-73
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 h light / 12 h dark
IN-LIFE DATES: From: 28 February 1981 To: 3 March 1983
Administration / exposure
- Route of administration:
- oral: feed
- Details on exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency):no longer than 2 weeks
- Mixing appropriate amounts with (Type of food): NIH 07 Rat and Mouse Ration
- Storage temperature of food: 4°C - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Formulated diets were analysed at approximately 8-week intervals and were within 10% of the target concentrations approximately 82% (42/51) of the time throughout the 2-year studies. Referee analyses were periodically performed by the study and analytical chemistry laboratories; results between the laboratories varied from 1% to 6%.
Studies to determine the homogeneity of a formulated diet mixture indicated a less than 4% deviation from the target concentration for samples taken from three locations in the blender after 10 minutes of mixing; homogeneity was not improved after 15 minutes of mixing. The recovery of 2,4-dichlorophenol from formulated diets by methanol extraction, although essentially complete immediately after preparation, decreased with time to about 58% after 7 days. The addition of 1% hydrochloric acid to the methanol extracting solvent resulted in only a marginal improvement in the amount recovered. Consequently, for the study of compound stability in feed, acid digestion of the feed mixtures was carried out before extraction with ether:hexane ( l : l ) , and a recovery of 88% from feed samples stored for 2 weeks at 25°C was obtained. 2,4-DichlorophenoI at a concentration of 4,000 ppm in feed was stable for 5 weeks at -20° C. Recovery of 2,4-dichlorophenol from the feed mixture stored under these conditions was 95% relative to the zero-time recovery. For different samples of this feed mixture stored for 2 weeks at 5° C, recovery of 2,4-dichIorophenol was 93%. - Duration of treatment / exposure:
- Animals were fed ad libitum diets containing the test material for 103 weeks
- Frequency of treatment:
- Daily ad libitum in the diet
- Post exposure period:
- There were no recovery groups. All animals were sacrificed post terminal dosing.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0 ppm
Basis:
nominal in diet
Males and females
- Remarks:
- Doses / Concentrations:
2500 ppm
Basis:
nominal in diet
Females only. Equivalent to 120 mg/kg/day
- Remarks:
- Doses / Concentrations:
5000 ppm
Basis:
nominal in diet
Males and females. Equivalent to 210 mg/kg/day in males and 250 mg/kg/day for females
- Remarks:
- Doses / Concentrations:
10000ppm
Basis:
nominal in diet
Males only. Equivalent to 440 mg/kg/day. Dose level not selected for females based on bone marrow atrophy observed in a 13 week study.
- No. of animals per sex per dose:
- 50
- Control animals:
- yes, plain diet
- Details on study design:
- - Dose selection rationale: based on effects seen in preceding 90 day study
- Rationale for selecting satellite groups: There were no satellite groups
- Post-exposure recovery period in satellite groups: There were no recovery groups - Positive control:
- None
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Observations made twice per day
DETAILED CLINICAL OBSERVATIONS: Yes
- made once per day
BODY WEIGHT: Yes
- Body weights were recorded once per week for the first 13 weeks and once per month thereafter.
FOOD CONSUMPTION: Yes.
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg day: Yes
COMPOUND INTAKE (if feeding study): Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: males 0, 210 and 440 mg/kg bw/day, females 0, 120 and 250 mg/kg/day.
FOOD EFFICIENCY:
No data was presented on food efficiency but estimates were made from bodyweight data and food consumption.
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: No
CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, all organs and tissues were examined
HISTOPATHOLOGY: Yes
The following tissues were examined histologically for control and high dose groups: adrenal glands, blood smear, brain, colon, oesophagus, eyes, gross lesions, heart, kidneys, liver, lungs and mainstem bronchi, mammary gland, mandibular or mesenteric lymph nodes, pancreas, parathyroid glands, pituitary gland, prostate/testes or ovaries/uterus, regional lymph nodes, salivary glands, skin, small intestine, spleen, sternum or femur or vertebrae including marrow, stomach, thymus, thyroid gland, tissue masses, trachea, and urinary bladder. Tissues examined from low dose groups included liver, nose, pituitary gland, and thyroid gland for male rats; adrenal glands, lymph nodes, pancreas, and spleen for female rats.
Peripheral nerves were not examined. - Statistics:
- Three statistical methods are used to analyse tumor incidence data: life table tests, logistic regression and Fisher exact/Cochran-Armitage trend analyses. Tests of significance include pair-wise comparisons of high dose and low dose groups with controls and tests for overall dose-response trends. For studies in which administration of the study compound has little effect on survival, the results of the three alternative analyses will generally be similar. When differing results are obtained by the three methods, the final interpretation of the data will depend on the extent to which the tumor under consideration is regarded as being the cause of death. Continuity-corrected tests are used in the analysis of tumor incidence, and reported P values are one-sided.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Body weight gain was depressed in both sexes, resulting in bodyweight reductions of ca. 10% compared to controls in top dose in males (10000 ppm) and females (5000 ppm).
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- The average daily feed consumption by rats in the low dose and high dose groups was 95% of that by the controls for males and 94-97% for females.
- Food efficiency:
- not examined
- Description (incidence and severity):
- Calculations performed on data in the report indicate no consistent discernible effect of treatment on food efficiency in males or females.
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- No remarkable findings
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- In males – dose-related increase in the incidence of multifocal degeneration of the respiratory epithelium compared with controls, and a significant decrease in incidence of mononuclear cell leukemia in low and high dosed animals (34%) compared with contr
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- No treatment related increase in any tumor incidence was noted.
- Details on results:
- SURVIVAL
Survival was unaffected by treatment. Survival of animals was greater than 50% at termination giving validity to the negative carcinogenicity result.
BODY WEIGHT AND WEIGHT GAIN
Mean body weights of high dose male rats were generally 5%-11% lower than those of controls from week 3 to the end of the study. Mean body weights of high dose female rats were 6%-12% lower than those of controls from week 31 to the end of the study.
FOOD CONSUMPTION AND COMPOUND INTAKE
Food consumption was reduced in both sexes in treated groups. The average daily feed consumption by rats in the low dose and high dose groups was 95% of that by the controls for males and 97% and 94% for females.
FOOD EFFICIENCY
Not calculated. However decreased body weights and bodyweight gains are likely to be due to reduced food consumption, compounded by diets consisting of 0.25 to 1% test material.
HISTOPATHOLOGY: NON-NEOPLASTIC
Nose: The incidences of multifocal degeneration of the respiratory epithelium were increased in dosed male rats (control, 25/45; low dose, 38/48; high dose, 42/46). This lesion was characterized by the formation of small cysts and increased numbers of goblet cells within the epithelium and was located in the arch of the dorsal nasal meatus. - Relevance of carcinogenic effects / potential:
- No treatment related oncogenicity was seen in the study.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- > 10 000 ppm (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: No test material related oncogenicity was observed
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Dose descriptor:
- NOAEL
- Effect level:
- > 5 000 ppm
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No test material oncogenicity was observed.
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this 2-year feeding study, there was no evidence of carcinogenic activity for male F344/N rats fed diets containing 5,000 or 10,000 ppm 2,4-dichlorophenol or for female F344/N rats fed diets containing 2,500 or 5,000 ppm 2,4-dichlorophenol.
- Executive summary:
In a carcinogenicity study (NTP TR 353 ), 2,4-dichlorophenol was administered to 50 F344 rats/sex/dose in the diet at dose levels of 0, 5000, and 10,000 ppm (0, 210 and 440 mg/kg bw/day) in males and 0, 2,500, and 5,000 ppm (0, 120 and 250 mg/kg bw/day) in females for 2 years.
There were no compound-related effects on mortality, and there were no clinical signs of toxicity observed. Body weights in top dose males and females were depressed by ca. 10% compared to the controls. Food consumption,was reduced by 5% in males at both dose levels and by 3% and 6% at the low and high dose levels respectively in females. The NOAEL for carcinogenicity is 440 mg/kg bw/day in males and 250 mg/kg bw/day in females, which were the highest dose levels tested, based on the absence of any treatment related tumorigenicity/oncogencity.
At the doses tested, there were no treatment related increase in tumor incidences of any type when compared to controls. Dosing was considered adequate based on the reduction in bodyweight gain and analysis of diets.
This carcinogenicity study in the rat is acceptable and satisfies the major points of the guideline requirements for a chronic/carcinogenicity study; OECD 451 in the rat with the exception that no interim sacrifice satellite groups were included, and only two dose levels were investigated. However given the clear outcome with respect to oncogenicity those deviations from the guideline do not impact on the validity of the conclusion.
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