Ammonium iodide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

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:

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:

Acute Oral toxicity test was performed to study the effects of test chemical on rats.

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

yes

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

Details on test material:

- Name of test material (IUPAC name): Potassium Iodide
- Common name: Potassium monoiodide
- Molecular formula: KI
- Molecular weight: 165.998 g/mol
- Smiles notation: [K+].[I-]
- InChl: 1S/HI.K/h1H;/q;+1/p-1
- Substance type: inorganic
-Appearance: White Solid
-Purity :99.50 %
-Batch number: LOT. 03/32

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

-Source: In-house animals,bred at Animal House, sa-FORD.
- Age at study initiation:9-11 weeks at the time of dosing.
- Weight at study initiation:Minimum: 144 g
Maximum: 167 g (Individual body weights were within ± 6% prior to treatment after overnight fasting)
-Health Status : Healthy young adult animals were used for the study. Females were nulliparous and non pregnant.
- Fasting period before study:16-18 hours
-Bedding:All cages were provided with corn cobs (Sparconn Life Sciences Bangalore) SPAR – 26 /2014 and SPAR – 27 /2014.
-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.
-Diet:All animals were provided conventional laboratory rodent diet (Nutrivet Life Sciences, Pune) ad libitum. Batch No.: 400010.
-Water: Aqua guard filtered tap water was provided ad libitum via drinking bottles.
-Acclimatisation:Animal nos. 1-3 were acclimatized for 7 days and 4-6 for 9 days, prior to administration of the test item.


Experimental Condition:
-Temperature(°C):Minimum: 19.60 °C Maximum: 21.40 °C
-Relative humidity(%):Minimum: 47.40% Maximum: 58.60%
-Air Changes(per hr):More than 12 changes per hour
- Photoperiod (hrs dark / hrs light):12:12

IN-LIFE DATES: From:October 15, 2014
To:November, 2014

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Distilled water

Details on oral exposure:

VEHICLE
- Amount of vehicle :10 ml
- Justification for choice of vehicle:distilled water was selected as a vehicle because test item was soluble in distilled water.
- Purity:N/A

MAXIMUM DOSE VOLUME APPLIED:10 ml/kg body weight.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

total : 6 females

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 h
ours 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 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.
Pathology:
At the end of 14 day observation period, all the survived rats were euthanised by overdose of CO2. All the animals were observed for external and internal gross pathology.

Statistics:

no data available

Results and discussion

Preliminary study:

no data available

Effect levels

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

2 500 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no 50% mortality was observed

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.

Other findings:

no data available

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 Anima

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

Table 5: Gross Necropsy Observation

 

Sex:Female                                                                                                                                        

Animal No.	Group/ Dose (mg/kg)	Mode of Death	Gross Observation
			External	Internal
1	G1/ 2000	Terminal sacrifice	No abnormality detected	No abnormality detected
2		Found dead	Red area around nose	Lungs: Red discolouration, all lobes(3+)
3		Terminal sacrifice	No abnormality detected	No abnormality detected
4		Terminal sacrifice	No abnormality detected	No abnormality detected
5		Found dead	No abnormality detected	Lungs: Red discolouration, all lobes(2+) Stomach: congestion (1+) Brain: congestion (3+)  Intestine : congestion (+)
6		Terminal sacrifice	No abnormality detected	No abnormality detected

Keys:+= Minimal, 1+= mild, 2+= Moderate, 3+= Severe

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Conclusions:

The acute oral median lethal dose (LD50) (Cut-off value) of test chemical was considered to be 2500 mg/kg body weight, when Wistar female rats were treated with test chemical orally by gavage as per OECD No. 423.

Executive summary:

Acute Oral Toxicity Study of test chemical performed on Six female Wistar Rats as per OECD No. 423. 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.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 anotherthree 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. Mean Body 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. Hence, The acute oral median lethal dose (LD50) (Cut-off value) of test chemical was considered to be 2500 mg/kg body weight, when Wistar female rats were treated with test chemical orally by gavage as per OECD No. 423.