Potassium iodide

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:

2014

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

Test material information

Constituent 1

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

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.