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EC number: 231-442-4 | CAS number: 7553-56-2
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2005-11-30 to 2006-01-17
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- August 1998
- Deviations:
- yes
- Remarks:
- 4-h systemic observations for the 500 mg/kg dose level were inadvertently not recorded. This did not affect the outcome of the study since the animals appeared normal at the 2-h and day 1 of the observation periods.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Iodine
- EC Number:
- 231-442-4
- EC Name:
- Iodine
- Cas Number:
- 7553-56-2
- Molecular formula:
- I2
- IUPAC Name:
- iodine
- Details on test material:
- - Name of test material (as cited in study report): Iodine
- Substance type: Iodine ACS/USP/BP grade
- Physical state: Solid, grey balls
- Analytical purity: over 99%
- Impurities (identity and concentrations): Inorganic salts, none relevant
- Composition of test material, percentage of components: over 99%
- Isomers composition: Not applicable
- Purity test date: Not available
- Lot/batch No.: #22682
- Expiration date of the lot/batch: Not applicable
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature and humidity
- Other:
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, MA
- Age at study initiation: approximately 3 months old
- Weight at study initiation: 2.3-3.3 kg males and 2.7-3.3 kg for females
- Fasting period before study: None
- Housing: 1 animal per cage (suspended wire cages)
- Diet (e.g. ad libitum): Fresh purina Rabbit Chow daily
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Temperature was controlled, but no data presented
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12 h light/dark cycle
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: 10% of the body weight
- Type of wrap if used: surgical gauze patch and plastic with non-irritating tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): gently washing with distilled water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): dose level 2000 mg/kg: 5.4-6.6 (g); 1000 mg/kg: 2.3-2.5 (g); 500 mg/kg: 1.35-1.60 (g)
- For solids, paste formed: yes
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.25-1.0 mL - Duration of exposure:
- 24-h
- Doses:
- 2000, 1000, 500 mg/kg bw
- No. of animals per sex per dose:
- At 2000 mg/kg bw five males and five females, at 1000 mg/kg bw five males, and at 500 mg/kg bw five males
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Toxicity: 1,2 and 4 hours postdose and once daily for 14 days. Mortality: twice daily for 14 days. Body weights: pretest, weekly and at study/termination.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology, other: dermal irritation - Statistics:
- LD50, 95% confidence limits according to Litchfield, J.T., Jr. & Wilcoxon, F. F., JPET 96:99, 1949.
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 425 mg/kg bw
- 95% CL:
- > 996 - < 2 038
- Mortality:
- 2000 mg/kg bw: one of five males and three of five females survived
1000 mg/kg bw: four of five males survived
500 mg/kg bw: all five males survived - Clinical signs:
- other: 2000 mg/kg bw Predeath: few feces, emaciation, soiling of the anogenital area, lethargy and nose/mouth area stained brown. In the survivors: instances of few faeces and soiling of the anogenital area. 1000 mg/kg bw Predeath: diarrhoea and soiling of the
- Gross pathology:
- 2000 mg/kg bw:
Dead animals: abnormalities of the treated skin, lungs, kidneys, liver, stomach, intestines, peritoneal cavity and spleen. Soiling of the anogenital cavity, emacination, brown staining of the nose/mouth area and excess fluid in the abdominal cavity.
Survivors: abnormalities of the spleen, kidneys, intestines, treated skin, thymus, pancreas and testicle, as well as soiling of the anogenital area.
1000 mg/kg bw:
dead animals: abnormalities of the treated skin, lungs, liver, kidneys, intestines, spleen and stomach, as well as brown staining of the nose/mouth area and soiling of the anogenital area.
Survivors: abnormalities of the treated skin, spleen, kidneys, thymus and pancreas.
500 mg/kg bw
Abnormalities of the treated skin, pancreas, thymus and spleen.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Under testing conditions, the dermal LD50 of iodine in male rabbits is 1425 mg/kg bw. It appeared that females are not markedly more sensitive to the substance and the LD50 in females is greater than 2000 mg/kg bw.
- Executive summary:
To determine the potential for toxicity of iodine when applied dermally, the substance was tested following set forth in US EPA Health Effects Testing Guidelines, OPPTS 870.1200, final guideline, August 1998.
Five healthy male and healthy female New Zealand White rabbits were dosed dermally with iodine at 2000 mg/kg bw. Since compound related mortality occurred at this level, five additional males were dosed at 1000 mg/kg bw and five males were dosed at 500 mg/kg bw. The test article was kept in contact with the skin for 24 h. Animals were observed for toxicity and mortality at 1, 2 and 4 hours postdose and daily for 14 days. Body weights and gross pathology were examined in all animals.
The dermal LD50 and 95% confidence limits of iodine in male rabbits is 1425 (996 -2038) mg/kg bw. It appeared that females are not markedly more sensitive to the substance and the LD50 in females is greater than 2000 mg/kg bw.
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