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EC number: 204-420-7 | CAS number: 120-72-9
- 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
Endpoint summary
Administrative data
Description of key information
This (Kaiser 1953) is just a one dose level examinations (100 mg/kg bw) ( 1 group / 25 animal/ sex) , and it had adverse effect. To determine a NOEL we would need different dose levels. Extrapolation of NOEL or LOEL is not possible from this test, therefore using for REACH has low value, it is just ranked as Klimisch 3 or 4.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: oral, other
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1953
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- WHO report
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Kaiser, K. (1953) Investigations on the carcinogenic activity of indole in rats. Zeitschrift Krebsforschung, 59, 488–495.
- GLP compliance:
- no
- Species:
- rat
- Strain:
- other: Strain W
- Details on species / strain selection:
- Groups of five male and twenty female strain W rats were maintained on a diet providing indole at a dose of 0 or 100 mg/kg bw per day for 460 days, followed by a 30-day period of no treatment to examine the possible reversibility of any
treatment-related effects. - Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Groups of five male and twenty female strain W rats were maintained on a diet providing indole at a dose of 0 or 100 mg/kg bw per day for 460 days, followed by a 30-day period of no treatment to examine the possible reversibility of any
treatment-related effects. - Route of administration:
- oral: feed
- Duration of treatment / exposure:
- Groups of five male and twenty female strain W rats were maintained on a diet providing indole at a dose of 0 or 100 mg/kg bw per day for 460 days, followed by a 30-day period of no treatment to examine the possible reversibility of any
treatment-related effects. Following the reversibility period, treatment with a diet providing indole at a dose of 200 mg/kg bw per day was continued for 100 additional days. - Dose / conc.:
- 100 mg/kg bw (total dose)
- Dose / conc.:
- 0 mg/kg bw (total dose)
- Dose / conc.:
- 200 mg/kg bw (total dose)
- No. of animals per sex per dose:
- Groups of five male and twenty female strain W rats were maintained on a diet
- Control animals:
- yes
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Animals were monitored every 2 weeks for food consumption, body weight,
survival and haematological effects. At necropsy, liver, kidney, and spleen were examined microscopically. Rats maintained on a diet supplemented with indole showed a 20% reduction in body-weight gain compared with controls. The
haematological profile obtained for the first 460 days revealed slightly reduced concentrations of haemoglobin and erythrocyte counts compared with thoseof the controls (i.e. haemoglobin, 15.2 versus 13.8 g Hb/100 ml blood; and erythrocyte count, 8 versus 6.4 million cells/ml blood, respectively), which were reversible upon cessation of treatment. By day 460, the leukocyte counts reached twice their
original values, which the authors stated were still within the normal range of values for rats. No leukaemia or other tumours attributable to administration of indole were observed in the animals. The average life expectancy of the rats was not altered by the inclusion of indole in the diet. Except for indications of moderate reversible anaemia, no other adverse effects were reported (Kaiser, 1953). - Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Animals were monitored every 2 weeks for food consumption, body weight,
survival and haematological effects. At necropsy, liver, kidney, and spleen were examined microscopically. Rats maintained on a diet supplemented with indole showed a 20% reduction in body-weight gain compared with controls. - Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Animals were monitored every 2 weeks for food consumption, body weight,
survival and haematological effects. At necropsy, liver, kidney, and spleen were examined microscopically. Rats maintained on a diet supplemented with indole showed a 20% reduction in body-weight gain compared with controls. The
haematological profile obtained for the first 460 days revealed slightly reduced concentrations of haemoglobin and erythrocyte counts compared with thoseof the controls (i.e. haemoglobin, 15.2 versus 13.8 g Hb/100 ml blood; and erythrocyte count, 8 versus 6.4 million cells/ml blood, respectively), which were reversible upon cessation of treatment. By day 460, the leukocyte counts reached twice their
original values, which the authors stated were still within the normal range of values for rats. No leukaemia or other tumours attributable to administration of indole were observed in the animals. The average life expectancy of the rats was not altered by the inclusion of indole in the diet. Except for indications of moderate reversible anaemia, no other adverse effects were reported (Kaiser, 1953). - Key result
- Dose descriptor:
- NOEL
- Effect level:
- < 100 mg/kg bw (total dose)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- haematology
- mortality
- Remarks on result:
- not determinable due to adverse toxic effects at highest dose / concentration tested
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 100 mg/kg bw (total dose)
- System:
- haematopoietic
- Organ:
- kidney
- liver
- spleen
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
- Conclusions:
- 590 days NOEL is l < 100 mg/kg bw/day determined by WHO report. .
- Executive summary:
Groups of five male and twenty female strain W rats were maintained on a diet providing indole at a dose of 0 or 100 mg/kg bw per day for 460 days, followed by a 30-day period of no treatment to examine the possible reversibility of any
treatment-related effects. Following the reversibility period, treatment with a diet providing indole at a dose of 200 mg/kg bw per day was continued for 100 additional days. A concurrent control group was maintained, but was not described.
Animals were monitored every 2 weeks for food consumption, body weight,
survival and haematological effects. At necropsy, liver, kidney, and spleen were examined microscopically. Rats maintained on a diet supplemented with indole showed a 20% reduction in body-weight gain compared with controls. The
haematological profile obtained for the first 460 days revealed slightly reduced concentrations of haemoglobin and erythrocyte counts compared with thoseof the controls (i.e. haemoglobin, 15.2 versus 13.8 g Hb/100 ml blood; and erythrocyte count, 8 versus 6.4 million cells/ml blood, respectively), which were reversible upon cessation of treatment. By day 460, the leukocyte counts reached twice their
original values, which the authors stated were still within the normal range of values for rats. No leukaemia or other tumours attributable to administration of indole were observed in the animals. The average life expectancy of the rats was not altered by the inclusion of indole in the diet. Except for indications of moderate reversible anaemia, no other adverse effects were reported (Kaiser, 1953).
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 100 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- This (Kaiser 1953) is just a one dose level examinations (100 mg/kg bw) ( 1 group / 25 animal/ sex) , and it had adverse effect. To determine a NOEL we would need different dose levels. Extrapolation of NOEL or LOEL is not possible from this test, therefore using for REACH has low value, it is just ranked as Klimisch 3 or 4.
- System:
- haematopoietic
Additional information
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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