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EC number: 237-393-5 | CAS number: 13770-61-1
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- see section 13 in IUCLID for read-across justification report
Data source
Reference
- Reference Type:
- publication
- Title:
- Embryotoxic and teratogenic effects of indium chloride in rats and rabbits.
- Author:
- Ungváry G, Szakmáry E, Tátrai E, Hudák A, Náray M and Morvai V.
- Year:
- 2 000
- Bibliographic source:
- J Toxicol Environ Health A, 59(1):27-42
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Indium trichloride
- EC Number:
- 233-043-0
- EC Name:
- Indium trichloride
- Cas Number:
- 10025-82-8
- Molecular formula:
- Cl3In
- IUPAC Name:
- indium trichloride
- Details on test material:
- - Name of test material (as cited in study report): indium chloride
- Molecular formula (if other than submission substance): InCl3, CAS: 10025-82-8), Aldrich Chemical, Inc)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: LATI, Gödöllö
- Weight at study initiation: 210-240g
- Housing: climatized animal house, plastic cages, on steam-sterilized, hardwood shavings
- Diet (ad libitum): standard rat pellets (LATI, Gödöllö)
- Water (ad libitum): tap water
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 40-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): hours 06-08, dim light; 08-18, daylight; 18-20, dim light; 20-06, darkness
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- none
- Details on mating procedure:
- Rats were mated as follows: Males were placed among the females overnight. Vaginal smears were taken daily and stained with 1% methylene
blue solution. The day when sperm were found in the vaginal smear of the females in estrus was regarded as the first day of gestation. - Duration of treatment / exposure:
- -rats treated with 0, 50, 100, 200 and 400 mg/kg bw on GD 6-15
-rats treated with 0, 400 mg/kg bw on one of GD 8, 9, 10, 11, 12, 13, 14 or 15 - Frequency of treatment:
- daily
- Duration of test:
- 21 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 50 mg/kg bw/day
- Dose / conc.:
- 100 mg/kg bw/day
- Dose / conc.:
- 200 mg/kg bw/day
- Dose / conc.:
- 400 mg/kg bw/day
- No. of animals per sex per dose:
- No. of pregnant animals/group:
control: 33
Gestation days6-15 :
50 mg/kg: 20
100 mg/kg: 20
200 mg/kg: 20
400 mg/kg: 21 - Control animals:
- yes, concurrent no treatment
- Details on study design:
- none
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes
FOOD CONSUMPTION: Yes
WATER CONSUMPTION : Yes
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day #21
- Organs examined: brain, hypophysis, thymus, lungs, heart, liver, spleen, kidneys, adrenals, and ovaries , stomach, and uterus - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes:
- Soft tissue examinations: Yes:
- Skeletal examinations: Yes
- Head examinations: No - Statistics:
- Parametric data (maternal organ weights, clinical and biochemical parameters, food and fluid consumption, fetal and placental weights) of groups were compared using analysis of variance and Dunnett’s test, while nonparametric variables (maternal weight gain, frequencies of pre- and postimplantational lossess, frequencies of body weight, skeletal and internal organ retardations, minor and major anomalies) of groups were compared using a Kruskal–Wallis test. The level of significance was chosen at 5%.
- Indices:
- none
- Historical control data:
- none
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Mortality:
- no mortality observed
- Description (incidence):
- no death occurred
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- dose-related inhibition of weight gain
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- significant decrease with increasing doses of InCl3; the greatest reduction in the group treated with 400 mg/kg
- Food efficiency:
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- following parameters did not change markedly: red and white cell counts, hematocrit, MCV, MCH, and MCHC values, hemoglobin, serum total protein, albumin concentrations
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- bilirubin concentration, and AST and ALT acitiviets in serum significantly decreased
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- at the highest dosage (400mg/kg), the relative weights of liver, pancreas, and brain increased
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- hemorrhagic foci at the cortico-medullar border in the interstitium of the kidneys of dams treated with 400 mg/kg indium chloride
- Histopathological findings: neoplastic:
- no effects observed
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- effects observed, treatment-related
- Dead fetuses:
- effects observed, treatment-related
- Details on maternal toxic effects:
- Details on maternal toxic effects:
- Mortality and time to death: no death occurred
- Body weight gain: dose-related inhibition of weight gain
- Food consumption: significant decrease with increasing doses of InCl3; the greatest reduction in the group treated with 400 mg/kg
- organ weights: at the highest dosage (400mg/kg), the relative weights of liver, pancreas, and brain increased
- clinical parameters: bilirubin concentration, and AST and ALT acitiviets in serum significantly decreased
Effect levels (maternal animals)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 100 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- food consumption and compound intake
Results (fetuses)
- Fetal body weight changes:
- effects observed, treatment-related
- Reduction in number of live offspring:
- effects observed, treatment-related
- External malformations:
- effects observed, treatment-related
- Skeletal malformations:
- effects observed, treatment-related
- Visceral malformations:
- effects observed, treatment-related
- Details on embryotoxic / teratogenic effects:
- Details on embryotoxic / teratogenic effects:
-postimplantation loss, frequency of fetuses with retarded body weight, skeletal and visceral retardation: significantly increase with dose of InCl3
-gross external malformations, visceral anomalies, congenital major skeletal anomalies: significantly increase with dose of InCl3
Effect levels (fetuses)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: % of malformed fetuses
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 100 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: % of malformed fetuses
Fetal abnormalities
- Abnormalities:
- effects observed, treatment-related
- Localisation:
- external: tail
- skeletal: forelimb
- skeletal: sternum
- skeletal: rib
- skeletal: vertebra
- skeletal: hindlimb
- visceral/soft tissue: urinary
- visceral/soft tissue: male reproductive system
Overall developmental toxicity
- Developmental effects observed:
- yes
- Lowest effective dose / conc.:
- 100 mg/kg bw/day
- Treatment related:
- yes
- Relation to maternal toxicity:
- developmental effects as a secondary non-specific consequence of maternal toxicity effects
- Dose response relationship:
- yes
- Relevant for humans:
- no
Any other information on results incl. tables
Indium concentration in the maternal blood was increased dose-dependently 24 h after oral administration. Indium appeared also in the fetal blood in concentrations lower than that found in maternal blood. For the lowest and highest doses, indium concentrations in the fetal blood were 33% and 11% of those in maternal blood, respectively.
Applicant's summary and conclusion
- Conclusions:
- InCl3 was teratogenic and embryotoxic but only at maternally toxic doses
- Executive summary:
Daily indium chloride doses of control ( 0) , 50, 100, 200, or 400 mg/ kg were administered orally to Sprague-Dawley rats by gavage, on d 6–15 of gestation, and daily metal doses of control ( 0) , 50, 100, or 200 mg/ kg were administered to New Zealand rabbits on d 6–20 of gestation. Further groups of pregnant rats were treated with control ( 0) or 400 mg/ kg indium chloride orally on one of d 8, 9, 10, 11, 12, 13, 14, or 15 of gestation. The dams and fetuses were examined on d 21 ( rats) and 30 ( rabbits) of gestation, using standard teratological methods. Indium concentrations in maternal and fetal blood of rats increased dose-dependently. Percentage bioavailability of indium in the dams increased with increasing dose. Indium concentration in fetal blood was lower than that of the dams being 33 and 11% of that of the dams at the lowest and highest doses, respectively.
The repeat oral administration of indium chloride to pregnant SD rats from GD 6 through 15 (positive for sperm presence = GD 1) induced rudimentary tail, anury, syndactyly, clubfoot, exencephaly, undescended testis, dilatation of the renal pelvis and ureter, and skeletal anomalies of the rib, vertebrae, and sternebrae in GD 21 fetuses at 100 mg/kg/day. The repeat oral administration of indium chloride to pregnant New Zealand rabbits from GD 6 through 20 (positive for sperm presence = GD 1) induced renal agenesia and ectopic kidney in GD 30 fetuses at 100 mg/kg/day or more. The maternal and fetal toxicity NOAEL for rats and rabbits was 50 mg/kg bw. The LOAEL (maternal and fetal toxicity) in rats was 100 mg/kg and in rabbits (maternal and fetal) was 200 mg/kg (except for the possibility of renal effects in the foetuses at the 100mg/kg level). Increasing dose above the NOAEL, increased post-implantation loss, reduced fetal body weight and increased skeletal and visceral retardation. Fetal retardation in rats was independent of exposure time (not tested in rabbits) occurring after oral administration of 400 mg/kg InCl3 on days 10, 11, 12, 14 or 15 of gestation. A single oral dose of 400 mg/kg InCl3 resulted in a maternal blood indium concentration of 1038 ug/l. Unlike continuous administration of InCl3 on GD 6-15, there were no major anomalies of the fetal urogenital system in rats following single day administrations. In rabbits there was a low overall malformation rate of 3.5 and 6.3% at 100 and 200mg/kg bw but this was considered positive when compared to the usual spontaneous malformation rate in rabbits of 0.7 – 4.2% and the malformations were renal which has a usual malformation rate of <1%. Decreased weight gain was seen in both rat and rabbit dams but decreased weight gain alone was not associated with teratogenic or embryolethal effects which were seen only when bilirubin concentration and AST and ALT activities were significantly decreased in dams (rats – no information on rabbits). The main target organ in the rat and rabbit dams was the kidney.
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