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EC number: 243-947-7 | CAS number: 20661-21-6
- 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
Assessment of the acute oral toxicity of indium in Asakura et al 2008:
A limit study with Crj:CD (SD) IGS rats (SPF) was carried out according to OECD guideline no 401 to assess the oral LD50. No deaths and no abnormalities in clinical signs, body weights, and necropsy findings were observed for any of the animals. An LD50 value >2000mg/kg bw was reported.
No acute inhalation toxicity data were identified, or are required at this tonnage (1-10 tpa).
No acute dermal toxicity data were identified, or are required at this tonnage (1-10 tpa).
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- not applicable
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Please refer to read-across justification report in section 13
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Crj: CD(SD) IGS rats (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Japan, Inc
- Age at study initiation: 5 wk
- Weight at study initiation: 125-145 g (male) and 116-130g (female)
- Fasting period before study: 18h
- Diet (ad libitum): pellet diet (MF, Oriental Yeast co, Ltd)
- Water (ad libitum): tap water irradiated by UV rays after passing through a 5µm filter
- Acclimation period: 6days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.2 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): 12 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: the dosing volume was set at 10mg/kg and the dose volume for individual animals was calculated based on the body weight measured just before dosing
DOSAGE PREPARATION (if unusual): done on the administration day - Doses:
- 2000mg/kg
- No. of animals per sex per dose:
- 12
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: body weights of all animals were measured before dosing and on days 4, 8, and 15 (day of administration was designated as day 1)
- Necropsy of survivors performed: no
- Other examinations performed:
clinical signs: observed 5 times (shortly before dosing, and 0.5, 1, 3 and 5h after dosing) on the those day and thereafter once a day for 14 days
body weight: measured before dosing and on days 4, 8, and 15 - Statistics:
- Barlett's test: to test the homogeneity of the variances of the data
one way analysis of variance: used when to variances of the treatment group and the control group were homogenous; to analyze statistical significances in the numerical data (body weight, food consumption, hematology, blood chemistry, and organ weights)
Kruskal-Wallis test: used when to variances of the treatment group and the control group were heterogenous; to analyze statistical significances in the numerical data (body weight, food consumption, hematology, blood chemistry, and organ weights)
Dunnett's test or Dunnett-type ranksum test: to examine statistical significances in the data between groups
chi square test: to examine statistical significances in graded categorical data (urinalysis) - Preliminary study:
- a preliminary study was done in which no death were observed
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality observed
- Clinical signs:
- other: No abnormalities in clinical signs observed
- Gross pathology:
- Necroscopy:
no abnormalities observed - Other findings:
- spontaneous changes: in one male of the 2000 mg/kg group pelvic dilatation of the kidneys was observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Tests done according to standard protocol. Good quality and considered useful for setting the reference value for acute oral toxicity (LD50>2000mg/kg)
- Executive summary:
A limit study with Crj:CD (SD) IGS rats (SPF) was carried out according to OECD guideline no 401 to assess the oral LD50. No deaths and no abnormalities in clinical signs, body weights, and necropsy findings were observed for any of the animals. An LD50 value >2000mg/kg bw was reported.
Reference
none
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the results of the available acute oral rat study with indium metal and upon read across, indium trihydroxide does not require classification for acute oral toxicity according to EU CLP criteria (EC 1272/2008).
No clear evidence of specific target organ toxicity was noted. As such, classification for STOT-SE is not considered appropriate.
There are no available data on which to evaluate acute dermal toxicity and also not required at this tonnage band. However, acute dermal toxicity can be considered to be low in view of the poor absorption by this route and the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route. Therefore, indium trihydroxide does not require classfication for acute dermal toxicity according to EU CLP criteria (EC 1272/2008)
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