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EC number: 202-462-0 | CAS number: 95-88-5
- 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
Description of key information
The Carcinogenic NOEL value for the test substance 4-Chlororesorcinol is found to be 17 mg/Kg in mice. Thus 4-Chlororesorcinol is found to be
non carcinogenc in nature.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Link to relevant study records
- Endpoint:
- carcinogenicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer reviewed journal.
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- The carcinogenic potential following skin painting in mice was evaluated for oxidative dye (4-Chlororesorcinol) for 20 months.
- GLP compliance:
- not specified
- Species:
- mouse
- Strain:
- Swiss Webster
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Roscoe B. Jackson Memorial Laboratory (Bar Harbor, Me.)
- Age at study initiation: 6-8 wk old,
- Fasting period before study: No data available
- Housing: Individually housed, Mice were housed in plastic cages with granular cellulose bedding (Bed-O'-Cobs, Anderson Mills, Mony, Ohio). They were moved twice weekly to clean cages and bedding
- Diet (e.g. ad libitum): Commercial Wayne Lab-Blox pellets were available ad libitum.
- Water (e.g. ad libitum): Tap water was available ad libitum
- Acclimation period:14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Controlled
- Humidity (%):Controlled - Route of administration:
- dermal
- Type of inhalation exposure (if applicable):
- other: not applicable
- Vehicle:
- other: 6% Hydrogen peroxide
- Details on exposure:
- TEST SITE
- Area of exposure: All animals were treated at a single site in the interscapular region
- Time intervals for shavings or clipplings: 24 h before dosing
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.05-ml
- Concentration (if solution): 0.025 ml
VEHICLE
- Concentration (if solution): 6% - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 21 months
- Frequency of treatment:
- Once weekly
- Remarks:
- Doses / Concentrations:
0.05 ml/Kg (equivalent to 17 mg/kg)
Basis:
no data - No. of animals per sex per dose:
- 50/sex/dose
- Control animals:
- yes, concurrent vehicle
- Positive control:
- No data
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Daily
DERMAL IRRITATION (if dermal study): Yes - Time schedule for examinations: Daily
BODY WEIGHT: Yes
- Time schedule for examinations: monthly - Sacrifice and pathology:
- GROSS PATHOLOGY: After 7 and 9 mo of treatment, 10 males and 10 females, randomly selected from each test and control group, were weighed and killed by ether inhalation and a gross necropsy was performed. For each animal the liver and kidney weights were recorded and the organ-to-body weight ratios calculated.
HISTOPATHOLOGY:
Yes , The following were preserved in 10% phosphate-buffered formalin and stained with hematoxylin and eosin for microscopic pathological evaluation: skin, neck (thyroid level), lung, gastrointestinal tract, spleen, pancreas, liver, skeletal muscle, pituitary, kidney, urinary bladder, ureters, bone marrow, lymph nodes, adrenals, gonads, brain, eyes, tumors, and other pathological lesions. - Statistics:
- Fischer’s exact test, chi square values significant at p: 0.05
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- 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:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- 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:
- not specified
- Details on results:
- Organ Weights: A considerable variation in the ratios, even among the controls was observed and none of the differences represent significant departures from control values.
Gross pathology: Gross examinations were performed on all mice found dead or sacrificed in moribund condition or at termination of the study.
No unusual tumor types developed in either treatment or control groups. A few skin tumors were diagnosed in both treatment and control groups; however, they occurred at low incidence and were not treatment-related. The predominant tumor types in the male and female mice of the Eppley colony are liver hemangioma, lung adenoma, and malignant lymphoma; the high spontaneous incidence of malignant lymphomas is characteristic of the Eppley Swiss colony
Histopathology: non-neoplastic: All mice were necropsied and examined thoroughly for neoplastic growth except one male mouse. Pathology of the skin was of special interest since the dyes were applied to a shaved area of skin in the interscapular region. A few skin tumors were diagnosed in both treatment and control groups; - Dose descriptor:
- NOEL
- Effect level:
- 17 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Lesions observed
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Conclusions:
- The Carcinogenic NOEL value for the test substance 4-Chlororesorcinol is found to be 17 mg/Kg in mice.
- Executive summary:
The chronic toxicological and carcinogenic potential following skin painting in mice was evaluated for 4-Chlororesorcinol.
Groups of 50 male and female Swiss mice were treated one time weekly for at least 20 month with one dose level of each dye.
The oxidative dyes were mixed 1:1 with 6% hydrogen peroxide before treatment. Control groups were shaved only and received no applications.
Body weights and survival rates did not differ between appropriate male and female treatment and control groups.
Absolute and relative liver and kidney weights were equivalent for treatment and control groups. After 7 and 9 month of treatment, 10 males and 10 females randomly selected from each group were necropsied and tissues taken for histopathological evaluation. Animals found dead or sacrificed in moribund condition or at termination of the study were necropsied and evaluated histopathologically.
Comparison of incidence of tumors and of non tumor pathology among the various treatment and control groups revealed no biologically significant differences. Toxicological and carcinogenic effects were not induced by the hair dye formulations.
Therefore NOEL was found to be 17 mg/Kg for 4-Chlororesorcinol formulations tested by skin painting procedures in this chronic study on male and female Swiss mice. Hence it is concluded that substance 4-Chlororesorcinol is likely to be non carcinogenic in nature.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 17 mg/kg bw/day
- Study duration:
- chronic
- Species:
- mouse
- Quality of whole database:
- The data is of K2 level and is obtained from publication.
Justification for classification or non-classification
The avaialable study indicates that the substance 4-Chlororesorcinol is likely to be non carcinogenic in nature.
Additional information
The chronic toxicological and carcinogenic potential following skin painting in mice was evaluated for 4-Chlororesorcinol.
Groups of 50 male and female Swiss mice were treated one time weekly for at least 20 month with one dose level of each dye.The oxidative dyes were mixed 1:1 with 6% hydrogen peroxide before treatment. Control groups were shaved only and received no applications.
Body weights and survival rates did not differ between appropriate male and female treatment and control groups. Absolute and relative liver and kidney weights were equivalent for treatment and control groups. After 7 and 9 month of treatment, 10 males and 10 females randomly selected from each group were necropsied and tissues taken for histopathological evaluation. Animals found dead or sacrificed in moribund condition or at termination of the study were necropsied and evaluated histopathologically.
Comparison of incidence of tumors and of non tumor pathology among the various treatment and control groups revealed no biologically significant differences. Toxicological and carcinogenic effects were not induced by the hair dye formulations.
Therefore NOEL was found to be 17mg/Kg for 4-Chlororesorcinol formulations tested by skin painting procedures in this chronic study on male and female Swiss mice. Hence it is concluded that substance 4-Chlororesorcinol is likely to be non carcinogenic in nature.
Justification for selection of carcinogenicity via dermal route endpoint:
The Carcinogenic NOEL value for the test substance 4-Chlororesorcinol is found to be 0.05 mL/Kg in mice.
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