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EC number: 231-679-3 | CAS number: 7681-82-5
- 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:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Data is from study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- To perform Acute dermal toxicity test of test chemical on rats.
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Potassium iodide
- EC Number:
- 231-659-4
- EC Name:
- Potassium iodide
- Cas Number:
- 7681-11-0
- Molecular formula:
- IK
- IUPAC Name:
- potassium iodide
- Test material form:
- other: solid
- Details on test material:
- Appearance: White Solid
Batch number: Lot. 03/32AI
Content: 99.50 %
Storage conditions :
Room temperature (20 - 30 °C)
Handling and DisposalSafety precautions:Aprons, masks, caps, gloves and goggles were used to ensure the health and safety of the Personnel.Disposal No test item remained and the same was documented in the raw data.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Species:Rat (Rattus norvegicus)
Strain:Wistar
Sex:Male and Female
Number of Animals:10 (Five per sex)
Supplier/Source:In-House Bred
Health Status :Healthy young adult animals were used for the study. Females were nulliparous and non pregnant
Body weight of animals : Male: Minimum: 273 g and Maximum: 280 g
(Prior to Treatment) Female: Minimum: 236 g and Maximum: 250 g
Acclimatisation : All animals were acclimatized to the test conditions for 8 days prior to test item application.
Identification : During Acclimatization, animals were marked temporary by permanent marker, on their tails. After acclimatization, the animals were marked by toe pad micro tattooing and cage cards. Individual cage cards were labelled with study no., study type, test system, group, dose, sex, animal number experimental start and completion date.
Randomization: Animals were selected manually. No computer generated randomization program was used.
Husbandry Conditions
Diet : All animals were provided conventional laboratory rodent diet
Bedding : All cages were provided with corn cobs
Water : Aqua guard filtered tap water was provided ad libitum via drinking bottles.
Husbandry : The animals were housed individually in polycarbonate cages.
Room Sanitation : The experimental room floor and work tops were swept and mopped with disinfectant solution every day.
Cages and water bottle: All the cages and water bottles were changed at least twice every week.
Experimental Room Condition
Temperature : Minimum: 19.60 °C Maximum: 21.40 °C
Relative humidity : Minimum: 47.40% Maximum: 58.60%
Light-dark-rhythm : 12:12
Air Changes : More than 12 changes per hour
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Preparation of Application Site
Approximately 24 h prior to treatment, the fur of dorsal area of the trunk (greater than 10% body surface area) of rats was clipped by using clipper
Test Item Application Procedure
The test item was applied uniformly over clipped dorsal area of rat skin. Individual rat was applied with an amount of test item moistened with 0.2 ml distilled water. Test item was held in contact with the skin with a porous gauze dressing (Approx. 10% of body surface area of rat) and non-irritating tape throughout a 24-hour exposure period. It was ensured that the animals cannot ingest the test item. At the end of the exposure period, residual test item was removed by using distilled water. The animals were dosed between 12:45 to 12:58 p.m.
Limit Test
Five male and five female wistar rats were treated with test item by a single dermal application at the dose level of 2000 mg/kg body weight.
Since no test item related mortality was observed, the study was terminated with limit test only. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 per sex (male and female)-2000 mg/kg bw
- Control animals:
- not specified
- Details on study design:
- Preparation of Application Site
Approximately 24 h prior to treatment, the fur of dorsal area of the trunk (approximately 10% body surface area) of rats was clipped by using clipper.
Test Item Application Procedure
The test item was applied uniformly over clipped dorsal area of rat skin. Individual rat was applied with an amount of test item, calculated based on the density (1.0898) and latest body weight. Test item was held in contact with the skin with a porous gauze dressing (Approx. 10% of body surface area of rat) and non-irritating tape throughout a 24-hour exposure period. It was ensured that the animals cannot ingest the test item. At the end of the exposure period, residual test item was removed by using distilled water. The animals were dosed between 11:19 to 11:32 a.m.
Limit Test
Five male and five female wistar rats were treated with test item by a single dermal application at the dose level of 2000 mg/kg body weight.
Since no test item related mortality was observed, the study was terminated with limit test only. - Statistics:
- Not specified
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed at limit dose of 2000 mg/kg body weight of test item during the 14 day observation period (refer table 3).
- Clinical signs:
- other: At 2000 mg/kg, all the animals were observed normal throughout the experimental period (refer table 2).
- Gross pathology:
- The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality (refer table 5).
- Other findings:
- Not specified
Any other information on results incl. tables
Table 1: Individual Animal Body Weight (g) andBody Weight Changes(%
Dose:2000 mg/ kg bodyweight
Animal No. |
Sex |
Body Weight (gram) |
Body Weight Change (%) |
|||
Day 0 |
Day 7 |
Day 14 |
Day 0-7 |
Day 0-14 |
||
1 |
Male |
277 |
282 |
289 |
1.81 |
4.33 |
2 |
274 |
295 |
315 |
7.66 |
14.96 |
|
3 |
280 |
296 |
319 |
5.71 |
13.93 |
|
4 |
273 |
286 |
312 |
4.76 |
14.29 |
|
5 |
277 |
292 |
309 |
5.42 |
11.55 |
|
6 |
Female |
236 |
238 |
241 |
0.85 |
2.12 |
7 |
241 |
245 |
248 |
1.66 |
2.90 |
|
8 |
236 |
238 |
241 |
0.85 |
2.12 |
|
9 |
237 |
241 |
242 |
1.69 |
2.11 |
|
10 |
250 |
256 |
258 |
2.40 |
3.20 |
Table 2: Individual Animal Clinical Signs and Symptoms
Dose:2000 mg/kg body weight
Animal No. |
Sex |
Hour(s) - Day 0 |
Day |
|||||||||
1 |
2 |
3 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
||
1 |
Male |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
3 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
4 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
5 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
6 |
Female |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
7 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
8 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
9 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
10 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Animal No. |
Sex |
Day |
||||||
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
1 |
Male |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
3 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
4 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
5 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
6 |
Female |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
7 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
8 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
9 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|
10 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Key: 1 = Normal
Table 3: Individual Animal Mortality Record
Dose:2000 mg/kg body weight
Animal No. |
Sex |
Days of Observation (0 to 14) |
|
Morning Observations |
Evening Observations |
||
1 |
Male |
No mortality and morbidity |
No mortality and morbidity |
2 |
No mortality and morbidity |
No mortality and morbidity |
|
3 |
No mortality and morbidity |
No mortality and morbidity |
|
4 |
No mortality and morbidity |
No mortality and morbidity |
|
5 |
No mortality and morbidity |
No mortality and morbidity |
|
6 |
Female |
No mortality and morbidity |
No mortality and morbidity |
7 |
No mortality and morbidity |
No mortality and morbidity |
|
8 |
No mortality and morbidity |
No mortality and morbidity |
|
9 |
No mortality and morbidity |
No mortality and morbidity |
|
10 |
No mortality and morbidity |
No mortality and morbidity |
Table 4:Summaryof Animal Body Weight (g) and Body Weight Changes (%)
Dose:2000 mg/kg body weight
Sex |
Body Weight (gram) |
Body Weight Changes (%) |
||||
Day 0 |
Day 7 |
Day 14 |
Day 0-7 |
Day 0-14 |
||
Male |
Mean |
276.20 |
290.20 |
308.80 |
5.07 |
11.81 |
SD |
2.77 |
6.02 |
11.67 |
2.12 |
4.37 |
|
n |
5 |
5 |
5 |
5 |
5 |
|
Female |
Mean |
240.00 |
243.60 |
246.00 |
1.49 |
2.49 |
SD |
5.96 |
7.50 |
7.31 |
0.66 |
0.52 |
|
n |
5 |
5 |
5 |
5 |
5 |
Keys:SD= Standard deviation, n = Number of animals
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- The acute dermal median lethal dose of test chemical was > 2000 mg/kg body weight.
- Executive summary:
The study reported was designed and conducted to determine the acute dermal toxicity profile of test chemical in Wistar Rats.
The test chemical was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days.
Mean body weight of male and female animals was observed with gain on day 7 and 14 as compared to day 0.
Gross pathological examination did not reveal any abnormalities attributable to the treatment.
It was concluded that the acute dermal median lethal dose (LD50) of test chemical, when administered to male and female wistar rats was found to be greater than 2000 mg/kg body weight.
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