Sodium iodide

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:

2014

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

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:

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.

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.