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EC number: 220-701-7 | CAS number: 2871-01-4
- 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
Carcinogenicity
Administrative data
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- From 11 March 1978 To 27 November 1981
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Remarks:
- This study was performed in rats which were treated 5 days per week instead of 7 days per week required in the guideline. Chosen doses were low and not apprpriate to induce low threshold effect as mentionned in the guideline.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- F344/N rats, groups of 50 males and 50 females (7-8 weeks old), were exposed to HC Red n° 3 by oral gavage 5 days per week for 105 weeks. The rats received 0 (control), 250 (low dose), and 500 mg/kg bw (high dose). The animals were observed twice daily.At the termination of the study, gross necropsy and hispathological analysis were performed.
- GLP compliance:
- no
- Remarks:
- NTP practices
Test material
- Reference substance name:
- 2-(4-amino-2-nitroanilino)ethanol
- EC Number:
- 220-701-7
- EC Name:
- 2-(4-amino-2-nitroanilino)ethanol
- Cas Number:
- 2871-01-4
- Molecular formula:
- C8H11N3O3
- IUPAC Name:
- 2-(4-amino-2-nitroanilino)ethanol
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 5890377 (used date : 27.11.79) ; C080480 (used date : 24.10.80)
- Expiration date of the lot/batch: not specified
- Purity test date:not specifed
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: stored at 22°C
- Stability under test conditions: Stable in corn oil
- Solubility and stability of the test substance in the solvent/vehicle: Stable in vehicle for 7 days at room temperature
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The dose preparation method consisted of suspending the HC Red NO.3 in corn oil on a weight/volume basis with a magnetic stirrer. The dose mixtures were prepared weekly and stored at 22°C until used for dosing.
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Remarks:
- F344/N
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratory
- Females (if applicable) nulliparous and non-pregnant:Not specified
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 286g (males) ; 189 g(females)
- Fasting period before study: not specified
- Housing: 5 rats were housed in polycarbonate cages
- Diet (e.g. ad libitum): NIH07 Open Formula ad libitum
- Water (e.g. ad libitum): ad libitum, provided by automatic watering system
- Acclimation period: 20 days
DETAILS OF FOOD AND WATER QUALITY: Not reported
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23°C
- Humidity (%): 30-70% except 12/79 : 40-60%
- Air changes (per hr): 15 room air changes per hour
- Photoperiod (hrs dark / hrs light): 12h fluorescent light/12 h dark
IN-LIFE DATES: From: approximately 7 November 1979 To: 11 December 1981
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The dose preparation method consisted of suspending the HC Red NO.3 in corn oil on a weight/volume basis with a magnetic stirrer. The dose mixtures were prepared weekly and stored at 22°C until used for dosing.
VEHICLE
- Justification for use and choice of vehicle (if other than water): not specified
- Concentration in vehicle: not specified
- Amount of vehicle (if gavage): 5mL /kg - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Doses mixture of HC Red in corn oil were analyzed periodically by spectrophotometric quantitation. It was estimated that doses were formulated within specifications 86% of the time during the 2 years study
- Duration of treatment / exposure:
- 105 weeks
- Frequency of treatment:
- Once a day, five days per week
- Post exposure period:
- 24 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 250 mg/kg bw/day (nominal)
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 50 animales per sex per dose were used
- Control animals:
- yes
- yes, concurrent vehicle
- Details on study design:
- - Toxicokinetic data not specified
- Dose selection rationale: Selected doses were based on a previous 13 weeks repeated toxicity study in which rats were dosed with up 1000 mg/kg/day.
- Rationale for animal assignment (if not random): assignaed to cages according to one table of random numbers and then to groups according to another table of random numbers
- Rationale for selecting satellite groups: not performed
Examinations
- Observations and examinations performed and frequency:
- All animals were observed twice daily, and clinical signs were recorded once per week. Body weights by cage were recorded once per week for the first 12 weeks of the studies and once month thereafter. Mean bodyweights were calculated for each group. Moribund animals were killed, as were animals that survived to the end of the studies.
- Sacrifice and pathology:
- A necropsy was performed on all animals, including those found dead unless they were excessively autolyzed or cannibalized. Thus, the number of animals from which particular organs or tissues were examined microscopically varies and is not necessarily equal to the number of animals that were placed on study in each group. Examinations for grossly visible lesions were performed on major tissues or organs. Tissues were preserved in 10% neutral buffered formalin, embedded in paraffin, sectioned, and stained with hematoxylin and eosin. Tissues examined microscopically were : gross lesions, skin, mandibular, lymph node, mammary gland, salivary gland, thigh muscle, sciatic nerve, femur including marrow, thymus, costochondral junction, larynx, lungs and bronchi, trachea, heart, thyroid gland, parathyroids, esophagus, stomach, duodenum, jejunum, eyes, tissue masses with regional lymph node, ileum, colon, cecum, rectum, liver, mesenteric lymph node, inguinal lymph node, pancreas, spleen, kidneys, adrenal glands, urinary bladder, testis/epididymus/seminal vesicles/prostate or ovaries/uterus/fallopian tube/vagina, nasal cavity, brain, preputial gland, pituitary gland, spinal cord, external and middle ear.
- Statistics:
- Survival analysis of survival was estimated by the product limit procedure of Kaplan and Meier (1958). Statistical analyses for a possible dose-related effect on survival for a possible dose-related effect on survival used the method of Cox (1972) for testing two groups for equality and Tarone's (1975) life table test for dose related trend. All reported P value for the survival analysis were two sided. The incidence of neoplastic or nonneoplastic lesions was given as the ratio of number of animals in which that site was examined. Tumor incidence was evaluated by three methods. The two that adjust for interconcurrent mortality emplyed the classical method for combining contingency tables developed by Mantel and Haznszel (1959). Test of significance included pairwise comparisons of high dose and low dose groups with vehicle controls and tests for overall dose-response trends. For studies in which compound administration has little effect on survival , the results of the three alternatives analysis will generally be similar. When differing results were obtained by the three methods, the final interpretation if the data will depend on the extent to which the tumor under consideration is regarded as being the cause of death. All reported P value for tumor analysis were one-sided
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No compound related clinical signs were observed
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- No significant differences in survival were observed between any groups of either sex.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Throughout most of the study, there was little or no difference in the mean body weights of dosed rats either sex as compared with those vehicle controls.
- 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:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- effects observed, treatment-related
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Pigmentation of various tissues was a common observation. The pigment was not identified but was presumed to be a derivative of HC Red n° 3. Very minimal nephropathy was found in dosed female rats, but its relationship to HC Red n° 3 was considered equivocal.
- Histopathological findings: neoplastic:
- no effects observed
- Description (incidence and severity):
- There was an increase in the incidence of mammary gland fibroadenomas or cystadenomas in low dose female rats. The incidence of this lesion in high dose female rats was not increased (vehicle control, 14/50, 28%; low dose, 25/50, 50%; high dose, 11/50, 22%). Largely because of the lack of a dose response, the increased incidence in the low dose females was not considered to be due to HC Red n° 3. No increased incidences of neoplasms were seen in male rats.
Transitional cell papillomas of the urinary bladder were detected in one high dose male rat, two low dose female rats, and one high dose female rat; none was observed in the vehicle controls. These uncommon neoplasms were found in animals that survived to the termination of the study and were not accompanied by other proliferative lesions. - Other effects:
- not examined
- Relevance of carcinogenic effects / potential:
- There was no evidence of carcinogenicity for male and female F344/N rats given 250 or 500 mg/kg/day.
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 500
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- gross pathology
- histopathology: neoplastic
- histopathology: non-neoplastic
- mortality
Applicant's summary and conclusion
- Conclusions:
- It was concluded that under the conditions of this 2-year gavage study of HC Red n° 3, there was no evidence of carcinogenicity for male or female F344/N rats given 250 or 500 mg/kg bw/day. Both sexes of the rats may have been able to tolerate higher doses of HC Red n° 3. The rats were treated only 5 days per weekd instead of 7 days per week required in the OECD 451 method. Therefore, the sensitivity of this study for detecting carcinogenesis may have been limited.
- Executive summary:
The purpose of this no GLP compliant study was to evaluate to potential carcinogenicity of the test item HC Red No. 3 when administered orally to F344/N rats during a Two-years carcinogenicity study.
F344/N rats, groups of 50 males and 50 females (7-8 weeks old), were exposed to HC Red n° 3 by oral gavage 5 days per week for 105 weeks. The rats received 0 (control), 250 (low dose), and 500 mg/kg bw (high dose). The animals were observed twice daily.At the termination of the study, gross necropsy and hispathological analysis were performed. The animals were observed twice daily.
No significant differences in survival were observed between any groups of either sex. Neither did the treatment affect body weight or body weight gains. No compound-related clinical signs were observed. Pigmentation of various tissues was a common observation. The pigment was not identified but was presumed to be a derivative of HC Red n° 3. Very minimal nephropathy was found in dosed female rats, but its relationship to HC Red n° 3 was considered equivocal.
There was an increase in the incidence of mammary gland fibroadenomas or cystadenomas in low dose female rats. The incidence of this lesion in high dose female rats was not increased (vehicle control, 14/50, 28%; low dose, 25/50, 50%; high dose, 11/50, 22%). Largely because of the lack of a dose response, the increased incidence in the low dose females was not considered to be due to HC Red n° 3. No increased incidences of
neoplasms were seen in male rats. Transitional cell papillomas of the urinary bladder were detected in one high dose male rat, two low dose female rats, and one high dose female rat; none was observed in the vehicle
controls. These uncommon neoplasms were found in animals that survived to the termination of the study and were not accompanied by other proliferative lesions.
It was concluded that under the conditions of this 2-year gavage study of HC Red n° 3, there was no evidence of carcinogenicity for male or female F344/N rats given 250 or 500 mg/kg bw/day. Both sexes of the rats may have been able to tolerate higher doses of HC Red n° 3. The rats were treated only 5 days per weekd instead of 7 days per week required in the OECD 451 method. Therefore, the sensitivity of this study for detecting carcinogenesis may have been limited.
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