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EC number: 203-585-2 | CAS number: 108-46-3
- 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
No evidence of carcinogenic activity was observed when rats and mice were given resorcinol by gavage on 5 days/week for 2 years
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline Study
- Principles of method if other than guideline:
- Method: other: NTP board EPA/FDA guidelines
- GLP compliance:
- yes
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- 104 weeks
- Frequency of treatment:
- Daily: 5 days a week
- Post exposure period:
- No data
- Remarks:
- Doses / Concentrations:
0, 112, 225 mg/kg bw
Basis: - No. of animals per sex per dose:
- 10 mice of each sex per dose group
- Control animals:
- yes
- Details on study design:
Groups of 60 mice of each sex were administered 0, 112, or 225 mg/kg resorcinol in deionized water by gavage.
Ten mice of each sex per dose group were designated for interim evaluations (organ weights, hematology, clinical chemistry, and histopathology) after 15 months (66 weeks) of chemical administration.- Observations and examinations performed and frequency:
- Clinical Examinations
All animals were observed twice daily. Clinical signs of toxicity were recorded every 4 weeks. Individual body weights were obtained weekly for the first13 weeks and every 4 weeks thereafter until the last 3 months of the studies, when body weights were recorded every 2 weeks. After 15 months on study, 10 male and 10 female mice from each dose group were sacrificed for evaluation of organ weights, hematology, and clinical chemistry.
Parameters measured were:
Hematology: hematocrit, hemoglobin, erythrocytes, mean cell volume, mean cell hemoglobin, mean cell hemoglobin concentration, leukocytes, segmented neutrophils, lymphocytes, monocytes, eosinophils, and nucleated erythrocytes.
Clinical chemistry: urea nitrogen, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, and sorbitol dehydrogenase. - Sacrifice and pathology:
- A necropsy was performed on all animals. During necropsy, all organs and tissues were examined for grossly visible lesions. Complete histologic examination was conducted all mice from the 15-month studies, and all control and high-dose mice from the 2-year studies. Only tissues containing gross lesions observed at necropsy were examined from the low-dose mouse groups from the 15-month and 2-year studies. In addition to tissue masses and gross lesions, the following organs and/or tissues were included in complete histopathologic examinations: adrenal glands, aorta, bone (femur including marrow), brain, epididymis, esophagus, eye (if grossly abnormal), gallbladder (mice), heart, kidneys, large intestine (cecum, colon, rectum), liver, lungs, mammary gland, mesenteric lymph node, nasal cavity, ovaries, pancreas, parathyroids, pituitary, prostate, salivary gland, skin, small intestine (duodenum, jejunum, ileum), spleen, stomach, testes, thymus, thyroids, trachea, urinary bladder, and uterus.
Pathology evaluations were completed by the study laboratory pathologist and the pathology data were entered into the Toxicology Data ManagementSystem (TDMS). The slides, paraffin blocks, and residual wet tissues were sent to the NTP Archives for inventory, slide/block match, and wet tissue audit for accuracy of labeling and animal identification and for thoroughness of tissue trimming. The slides, individual animal data records, and pathology tables were evaluated by an independent quality assessment laboratory. The individual animal records and tables were compared for accuracy, slides and tissue counts were verified, and histotechnique was evaluated. A quality assessment pathologist reviewed selected tissues from the 15-month and 2-year studies for accuracy and consistency of lesion diagnosis. All diagnosed neoplasms in all animals, and forestomachs from all female mice were reviewed. In addition, all tissues were examined from six mice of each sex randomly selected from each control and high-dose group in the 15-month studies, and from five mice of each sex randomly selected from each control and high-dose group in the 2-year studies.
The quality assessment report and slides were submitted to a PWG chairperson, who reviewed tissues for which there was a disagreement in diagnosisbetween the laboratory and quality assessment pathologists. Representative examples of nonneoplastic lesions and neoplasms and examples of disagreements in diagnosis between the laboratory and quality assessment pathologists were reviewed by the PWG. Each PWG included the quality assessment pathologist as well as other pathologists experienced in rodent toxicologic pathology, who examined these tissues without knowledge of dose group or previously rendered diagnoses. When the consensus diagnosis of a PWG differed from that of the laboratory pathologist, the final diagnosis was changed to reflect the opinion of the PWG. Details of these review procedures have been described, in part, by Maronpot and Boorman (1982) and Boorman et al. (1985). For subsequent analysis of pathology data, the diagnosed lesions for each tissue type are evaluated separately or combined according to the guidelines of McConnell et aL (1986). - Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Result (Carcinogenicity): Negative
- Dose descriptor:
- NOAEL
- Remarks on result:
- other: no NOAEL identified
- Conclusions:
- No carcinogenic or neoplastic effects when mice were given resorcinol by gavage on 5 days/week for 2 years.
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline Study
- Qualifier:
- according to guideline
- Principles of method if other than guideline:
- Method: T39-05:NTP Board EPA/FDA guidelines
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- The rats were 6-7 weeks at start of study.
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- 104 weeks
- Frequency of treatment:
- Daily: 5 days a week
- Post exposure period:
- No data
- Remarks:
- Doses / Concentrations:
0, 112, 225 mg/kg bw (males); 0, 50, 100 150 mg/kg (females)
Basis: - Control animals:
- yes
- Details on study design:
- Groups of 60 male rats were administered 0, 112 or 225 mg/kg resorcinol in deionized water by gavage. The rats were 6-7 weeks at start of study. Groups of 60 females rats were initially administered the same doses as the male rats , but by week 22 of the study, 16 of the high dose females had died. Consequently, the female rat study was restarted using doses of 0, 50, 100 or 150 mg/kg. Doses were given at a volume of 5ml/kg, 5 days a week for 103 weeks.
- Observations and examinations performed and frequency:
- Clinical Examinations
All animals were observed twice daily. Clinical signs of toxicity were recorded every 4 weeks. Individual body weights were obtained weekly for the first13 weeks and every 4 weeks thereafter until the last 3 months of the studies, when body weights were recorded every 2 weeks. After 15 months on study, 10 male and 10 female rats from each dose group were sacrificed for evaluation of organ weights, hematology, and clinical chemistry.
Parameters measured were:
Hematology: hematocrit, hemoglobin, erythrocytes, mean cell volume, mean cell hemoglobin, mean cell hemoglobin concentration, leukocytes, segmented neutrophils, lymphocytes, monocytes, eosinophils, and nucleated erythrocytes.
Clinical chemistry: urea nitrogen, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, and sorbitol dehydrogenase. - Sacrifice and pathology:
- A necropsy was performed on all animals. During necropsy, all organs and tissues were examined for grossly visible lesions. Organ weights recordedfor all brain, right kidney and liver of all animals sacrificed at 15 months except male rats receiving 225 mg/kg.
Complete histologic examination was conducted on all control and high-dose male rats from the 15-month study and all rats from the 2-year study. Gross lesions only were examined from low-dose male rats and all female rats from the 15-month studies. In addition to tissue masses and gross lesions, the following organs and/or tissues were included in complete histopathologic examinations: adrenal glands, aorta, bone (femur including marrow), brain, clitoral gland (rats), epididymis, esophagus, eye (if grossly abnormal), heart, kidneys, large intestine (cecum, colon, rectum), liver, lungs, mammary gland, mesenteric lymph node, nasal cavity, ovaries, pancreas, parathyroids, pituitary, preputial gland (rats), prostate, salivary gland, skin, small intestine (duodenum, jejunum, ileum), spleen, stomach, testes, thymus, thyroids, trachea, urinary bladder, and uterus.
Pathology evaluations were completed by the study laboratory pathologist and the pathology data were entered into the Toxicology Data ManagementSystem (TDMS). The slides, paraffin blocks, and residual wet tissues were sent to the NTP Archives for inventory, slide/block match, and wet tissue audit for accuracy of labeling and animal identification and for thoroughness of tissue trimming. The slides, individual animal data records, and pathology tables were evaluated by an independent quality assessment laboratory. The individual animal records and tables were compared for accuracy, slides and tissue counts were verified, and histotechnique was evaluated. A quality assessment pathologist reviewed selected tissues from the
15-month and 2-year studies for accuracy and consistency of lesion diagnosis. All diagnosed neoplasms in all animals, brains from all male rats werereviewed. In addition, all tissues were examined from six rats of each sex randomly selected from each control and high-dose group in the 15-month studies, and from five rats of each sex randomly selected from each control and high-dose group in the 2-year studies.
The quality assessment report and slides were submitted to a PWG chairperson, who reviewed tissues for which there was a disagreement in diagnosisbetween the laboratory and quality assessment pathologists. Representative examples of non-neoplastic lesions and neoplasms and examples of disagreements in diagnosis between the laboratory and quality assessment pathologists were reviewed by the PWG. Each PWG included the quality assessment pathologist as well as other pathologists experienced in rodent toxicologic pathology, who examined these tissues without knowledge ofdose group or previously rendered diagnoses. When the consensus diagnosis of a PWG differed from that of the laboratory pathologist, the final diagnosis was changed to reflect the opinion of the PWG. Details of these review procedures have been described, in part, by Maronpot and Boorman (1982) and Boorman et al (1985). For subsequent analysis of pathology data, the diagnosed lesions for each tissue type are evaluated separately or combined according to the guidelines of McConnell et al (1986). - Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- See below in regards to early mortality in high dose males
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- See below in regards to early mortality in high dose males
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Result (carcinogenicity): Negative
Non-Neoplastic effects are reported under the section on repeat dose. - Relevance of carcinogenic effects / potential:
- Negative
- Dose descriptor:
- NOAEL
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified.
- Conclusions:
- No carcinogenic or neoplastic effects when rats were given resorcinol by gavage on 5 days/week for 2 years.
Referenceopen allclose all
Tumor type and incidence were in the same range as those of the control.
15-Month Interim Evaluations
Ten mice of each sex in each dose group were predesignated for interim evaluation at 15 months. There were no significant differences in absolute and relative organ weights. No treatment-related changes in hematology or clinical chemistry parameters were seen. No treatment-related neoplasms or nonneoplastic lesions were found during histopathologic examination.
Survival
The terminal survival of males and females receiving resorcinol was similar to that of the controls. By week 45 of the study, no male mice in the control and low-dose groups had died, but eight high-dose male mice had died.
Sentinel Animals
Positive titers for mouse hepatitis virus were found in sentinel animals examined at 6, 12, 18, and 24 months. However, there was no clinical or histopathologic evidence of disease.
Pathology and Statistical Analysis of Results
Administration of resorcinol by gavage to male and female B6C3F, mice for 2 years did not result in any statistically or biologically significant increased incidence in neoplastic or nonneoplastic lesions in any site.
Subcutaneous tissue: The incidence of subcutaneous sarcoma or fibroma (combined) in males occurred with a significant negative trend and the incidence was significantly lower in the high-dose group (8/50, 6/50, 1/50
Tumor type and incidence were in the same range as those of the control.
15-Month Interim Evaluations
Ten rats of each sex in each dose, group were predesignated or interim evaluations at 15 months. Due to early mortality in the high-dose males, animals from this group were not sacrificed at 15 months. Instead, 10 high-dose males that died or were sacrificed in a moribund condition near month 15 were included in the interim evaluation. No treatment-related differences in hematology or clinical chemistry parameters were seen. No treatment-related neoplasms or nonneoplastic lesions were found during histopathologic examination.
Survival
The survival of high-dose males and females wassignificantly lower than that of the control. The remaining dose groups had survival rates similar to those of the controls.
Sentinel Animals
Positive serological titers for Sendai virus and rat corona virus/ sialodacryoadenitis were found in sentinel animals at 6, 12, 18, and 24 months. However, there was no clinical or histopathologic evidence of disease.
Pathology and Statistical Analysis of Results
Summaries of the incidences of neoplasms and nonneoplastic lesions, individual animal tumor diagnoses, and statistical analyses of primary tumors that occurred with an incidence of at least 5% in at least one animal group mentioned in
this section are presented in Appendixes A and B of the report for male and female rats.
Administration of resorcinol by gavage to male and female F344/N rats for 2 years did not result in any statistically or biologically significant increases in the incidences of neoplasms or nonneoplastic lesions at any site. Incidences of a variety of neoplasms in high-dose males and nonneoplastic lesions in high-dose males and females were decreased as compared with controls due to the lower survival in the dosed groups.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
No evidence of carcinogenic activity was observed when rats and mice were given resorcinol by gavage on 5 days/week for 2 years.
Additional information
In a 104 week repeated dose study in 60 male Fischer 344 rats were administered 0, 112, 225 mg/kg bw and 60 female Fischer 344 rats were administered 0, 50, 100 and 150 mg/kg bw resorcinol in water by gavage (NTP, 1992). Microscopic examination of a comprehensive range of tissues and organs found no increases in the incidence of tumours. Incidences of a variety of neoplasms in high-dose males and nonneoplastic lesions in high-dose males and females were decreased as compared with controls due to the lower survival in the dosed groups.
In a 104 week repeated dose study, 60 male and 60 female B6C3F1 mice were administered 0, 112, 225 mg/kg bw resorcinol in water by gavage (NTP, 1992). Microscopic examination of a comprehensive range of tissues and organs found no increases in the incidence of tumours.
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