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EC number: 231-659-4 | CAS number: 7681-11-0
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Experimental test result performed using standard test guidelines
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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Principles of method if other than guideline:
- The aim of this study was to assess the toxicity potential of test chemical after single oral administration in rats and an observation period of 14 days.
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
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:
- Identification: Potassium Iodide
Appearance: White Solid
Batch number: LOT. 03/32
CAS No.: 7681-11-0AI
Content: 99.50 %
Room temperature: (20 - 30 °C)
IUPAC name: Sodium iodide
Smiles: [Na+].[IH-]
InChI:1S/HI.Na/h1H;/q;+1/p-1
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
Species:Rattus norvegicus (Rat)
Strain-Wistar Number
Sex:Six Females
Supplier / Source: In-house animals
Health Status:Healthy young adult animals were used for the study. Females were nulliparous and non pregnant.
Body weight of animals:Minimum: 144 g Maximum: 167 g (Individual body weights were within ± 6% prior to treatment after overnight fasting)
Age:9-11 weeks at the time of dosing.
Acclimatisation:Animal nos. 1-3 were acclimatized for 7 days and 4-6 for 9 days, prior to administration of the test item.
Identification:The animals were marked temporarily on tail, permanently on 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.
Husbandry Conditions
Diet:All animals were provided conventional laboratory rodent diet (Nutrivet Life Sciences, Pune) ad libitum.
Batch No.: 400010.
Bedding:All cages were provided with corn cobs (Sparconn Life Sciences Bangalore) SPAR – 26 /2014 and SPAR – 27 /2014.
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.
ENVIRONMENTAL CONDITIONS
Experimental Room ConditionTemperature: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
- Route of administration:
- oral: unspecified
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2000 mg/kg
- Amount of vehicle (if gavage):10 ml/kg body weight
- Justification for choice of vehicle: Distilled water was seleted as a vehicle based on solubility testing. - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- G1 - 2000 mg/kg bw-3 Female Rats
G2 - 2000 mg/kg bw-3 Female Rats - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical Observation -After test item administration, individual animals were frequently observed at 30 minutes, 1, 2, 3 and 4 hours post dosing on day 0 (day of dosing). Subsequently, all surviving animals were observed once a day during the 14 day observation period.
Mortality - All surviving animals were observed twice daily (morning and evening) for morbidity and mortality, throughout the acclimatization and study period.
Body weight - All rats were weighed on days 0 (prior to dosing), 7 and 14. Animals were weighed immediately after found dead. - Statistics:
- Not specified
Results and discussion
- Preliminary study:
- Not specified
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 2 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Non toxic
- Mortality:
- Mortality was observed in the animals no. 2 and 5 on day 0 and on day 1 respectively post dosing
- Clinical signs:
- other: At 2000 mg/kg, animal no. 1 and 3 was observed normal at 30 minutes and 1 hour, lethargy at 2, 3 and 4 hours, Salivation was observed at 3 and 4 hours and normal from day 1 thereafter till termination. Animal no. 2 was observed normal at 30 minutes and
- Gross pathology:
- During external gross pathological examination, all found dead and terminally sacrificed animals were observed with no abnormalities except animal no. 2 in which red area around nose were seen. During Internal gross pathological examination, terminaly sacrificed animal did not show abnormality . In found dead animals following observation was observed, lungs: Red discolouration of all lobes was observed in animal no. 2 and 5; Stomach: congestion was observed in animal no. 5; Brain: congestion was observed in animal no. 5; Intestine: congestion congestion was observed in animal no. 5. .
Any other information on results incl. tables
Table 1: Individual Animal Body Weight (g) andBody Weight Changes(%)
Sex:Female
Animal No. |
Group/ Dose (mg/kg) |
Body Weight (gram) |
Body Weight Change (%) |
||||
Day 0 |
Day 7 |
Day 14 |
Found Dead |
Day 0-7 |
Day 0-14 |
||
1 |
G1/ 2000 |
163 |
186 |
207 |
- |
14.11 |
26.99 |
2 |
167 |
- |
- |
161 |
- |
- |
|
3 |
157 |
179 |
199 |
- |
14.01 |
26.75 |
|
4 |
144 |
165 |
178 |
- |
14.58 |
23.61 |
|
5 |
147 |
- |
- |
143 |
- |
- |
|
6 |
152 |
172 |
190 |
- |
13.16 |
25.00 |
Key:- = Not applicable
Table 2: Summary of Animal Body Weight (g) and Body Weight Changes (%)
Sex:Female
Group/ Dose (mg/kg) |
Rats Body Weight (g) |
Body Weight Changes (%) |
||||
Day 0 |
Day 7 |
Day 14 |
0-7 |
0-14 |
||
G1/ 2000 |
Mean |
155.00 |
175.50 |
193.50 |
13.97 |
25.59 |
SD |
9.01 |
9.04 |
12.45 |
0.59 |
1.59 |
|
n |
6 |
4 |
4 |
4 |
4 |
Keys:SD = Standard Deviation, n = Number of Animals
Table 3: Individual Animal Clinical Signs and Symptoms
Sex:Female
Animal No. |
Group/ Dose (mg/kg) |
Hours (Day 0) |
||||
1/2 |
1 |
2 |
3 |
4 |
||
1 |
G1/ 2000 |
1 |
1 |
99+ |
99+ 145+ |
99+ 145+ |
2 |
1 |
1 |
99+ |
99+ 145+ |
99++ 145+,2 |
|
3 |
1 |
1 |
99+ |
99+ 145+ |
99+ 145+ |
|
4 |
1 |
1 |
99+ |
99+ |
99+ 145+ |
|
5 |
1 |
1 |
99+ |
99+ |
99+ 145+ |
|
6 |
1 |
1 |
1 |
99+ |
99+ |
Animal No. |
Group/ Dose (mg/kg) |
Days post dosing |
|||||||||||||||||||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||||||||||||||||||
1 |
G1/ 2000 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
||||||||||||||||
2 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|||||||||||||||||
3 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|||||||||||||||||
4 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|||||||||||||||||
5 |
99++, 2 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|||||||||||||||||
6 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Keys: - = Not applicable, 1 = Normal, 2 = Found dead, 99 = Lethargy, 145 = Salivation,+= Mild, ++ = Moderate.
Table 4: Individual Animal Mortality Record
Sex:Female
Animal No. |
Group/ Dose (mg/kg) |
Day of Observation (Day 0 to 14) |
|
Morning Observations |
Evening Observations |
||
1 |
G1/ 2000 |
No mortality and morbidity |
No mortality and morbidity |
2 |
No mortality and morbidity till day 0 |
Found dead on day 0 post dosing |
|
3 |
No mortality and morbidity |
No mortality and morbidity |
|
4 |
No mortality and morbidity |
No mortality and morbidity |
|
5 |
No mortality and morbidity till day 1 |
No mortality and morbidity till day 0 Found dead on day 1 post dosing |
|
6 |
No mortality and morbidity |
No mortality and morbidity |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- The acute oral LD50 (Cut-off)value of test chemical was considered to be 2500 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that the given test chemical is considered to be Not classified as per the CLP regulation.
- Executive summary:
Acute oral toxicity study of the given test chemical was conducted as per OECD No. 423 in rats.Six female Wistar rats were selected for acute oral toxicity study. The animals were fasted for minimum 16-18 hours prior to dosing and for 4 hours post dosing, food was withheld but drinking water providedad libitum. The time intervals between dosing were determined by the onset, duration and severity of toxic signs.Three rats of first group were dosed with starting dose of 2000 mg/kg body weight and one mortality was observed on day 0 post dosing so another three animals of the same group were dosed with 2000 mg/kg body weight and again one mortality was observed on day 1 post dosing. Hence, further dosing was stopped.Body weights of surviving animals were recorded on day 0 (prior to dosing) 7 and 14. The animal was weighed immediately after found dead. MeanBody weight of all surviving animals treated with 2000 mg/kg body weight was observed with gain on day 7 and 14, as compared to day 0.At 2000 mg/kg, animal no. 1 and 3 was observed normal at 30 minutes and 1 hour, lethargy at 2, 3 and 4 hours,Salivationwas observed at 3 and 4 hours and normal from day 1 thereafter till termination. Animal no. 2 was observed normal at 30 minutes and 1 hour, lethargy at 2 to 4 hours,Salivationat 3 and 4 hours and was found dead at 4 hours on day 0. Animal no. 4 was observed normal at 30 minutes and 1 hour, lethargy at 2, 3 and 4 hours,Salivationat 4 hours and normal from day 1 till termination. Animal no. 5 was observed normal at 30 minutes and 1 hour , lethargy at 2, 3, 4 hours and on day 1,Salivationat 4 hours and found dead on day 1. Animal no. 6 was observed normal at 30 minutes to 2 hour, lethargy at 3 and 4 hours and was normal from day 1 to till termination.During external gross pathological examination, all found dead and terminally sacrificed animals were observed with no abnormalities except animal no. 2 in which red area around nose were seen.During Internal gross pathological examination, terminaly sacrificed animal did not show abnormality . In found dead animals following observation was observed, lungs: Red discolouration of all lobes was observed in animal no. 2 and 5; Stomach: congestion was observed in animal no. 5; Brain: congestion was observed in animal no. 5; Intestine: congestion was observed in animal no. 5.Under the conditions of this;the acute oral LD50(Cut-off value) of test chemical was 2500 mg/kgbody weight.Thus considering the CLP criteria for classification it is concluded that the test substance is non toxic via oral route.
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