Potassium iodate

Endpoint summary

Description of key information

Acute oral toxicity: 

The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is between 300-2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified for acute oral toxicity class IV.

 

Acute Inhalation Toxicity:

 

The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 6.82E-19 Pa. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver. 

 

Acute Dermal toxicity:

 

The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from secondary source

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

Acute oral toxicity of test chemical in mouse

GLP compliance:

not specified

Test type:

other: not specified

Limit test:

no

Species:

mouse

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

not specified

Route of administration:

oral: unspecified

Vehicle:

not specified

Details on oral exposure:

not specified

Doses:

531 mg/kg bw

No. of animals per sex per dose:

not specified

Control animals:

not specified

Details on study design:

not specified

Statistics:

not specified

Preliminary study:

not specified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

513 mg/kg bw

Based on:

test mat.

Remarks on result:

other:

Remarks:

50% mortality observed

Mortality:

50% mortality observed

Clinical signs:

other: not specified

Gross pathology:

not specified

Other findings:

not specified

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The acute oral LD50 value was considered to be 513 ± 211 mg/kg bw when mice were treated with test chemical via oral route.

Executive summary:

Acute oral toxicity study of test chemical was conducted on mice at the dose concentration of 513 ± 211 mg/kg bw. The test chemical was administered via oral route. All animals were maintained under close observation for recording toxic signs and time of death for 14 days.Therefore, LD50 value was considered to be 513 ± 211 mg/kg bw, when mice were treated with test chemical via oral route.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

513 mg/kg bw

Quality of whole database:

Data is Klimisch 4 and from authoritive database

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Quality of whole database:

Waiver

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

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:

Data is from study report

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

The objective of the study was to assess the dermal toxicity of test chemical after single dose application by dermal route in rats.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:In-House Bred at Sa-Ford, Animal Facility
- Age at study initiation:N/A
- Health Status:Healthy young adult animals were used for the study. Females were nulliparous and non pregnant.
- Weight (Prior to Treatment):Male: Minimum: 227 g and Maximum: 251 g , Female: Minimum: 200 g and Maximum: 224 g
- Fasting period before study:N/A
- Housing:The animals were housed individually in polycarbonate cages.
- Bedding : All cages were provided with corn cobs.
- 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 (e.g. ad libitum):All animals were provided conventional laboratory rodent diet (Nutrivet Life Sciences, Pune) ad libitum.
- Water (e.g. ad libitum):Aqua guard filtered tap water was provided ad libitum via drinking bottles.
- Acclimation period:All animals were acclimatized to the test conditions for 6 days prior to administration of the test item.
- Randomization : Animals were selected manually. No computer generated randomization program was used.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):Minimum: 20.00 °C and Maximum: 23.60 °C
- Humidity (%):Minimum: 37.40% and Maximum: 61.80%
- Air changes (per hr):More than 12 changes per hour
- Photoperiod (hrs dark / hrs light):12:12

Type of coverage:

semiocclusive

Vehicle:

other: distilled water

Details on dermal exposure:

TEST SITE
- Area of exposure:The test item was applied uniformly over clipped dorsal area of rat skin.
- % coverage:Approximately 10% body surface area of rat.
- Type of wrap if used:The porous gauze dressing and non-irritating tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done):The residual test item was removed by using distilled water.
- Time after start of exposure:24-hour.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):A limit dose of 2000 mg/ kg body weight of test item was applied.
- Constant volume or concentration used: yes
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit):0.2 ml distilled water
- Concentration (if solution):N/A
- Lot/batch no. (if required):N/A
- Purity:N/A

Duration of exposure:

24 hrs

Doses:

2000 mg/kg body weight.

No. of animals per sex per dose:

10 (Five per sex)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:Daily
- Necropsy of survivors performed: yes
At the end of 14 day observation period, all the surviving rats were euthanised by overdose of CO2 and subjected to gross pathology examination, for external and internal observations.
- Other examinations performed:
- Clinical signs : After test item administration, individual animals were frequently observed at 1, 2, 3 and 4 hours post dosing on day 0 (day of dosing). Subsequently, all animals were observed once a day during the 14 day observation period.

- Body weight: All rats were weighed on days 0 (prior to dosing), 7 and 14.

other:
- Local Signs/Skin Reactions
All animals were observed once daily during days 1-14 (in common with clinical signs).

- Mortality
Animals were observed twice daily for any mortality during the experimental period.

Statistics:

No statistical analysis was performed since the study was terminated with limit test.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Non toxic to animals

Mortality:

No mortality was observed at limit dose of 2000 mg/kg body weight of test item during the 14 day observation period.

Clinical signs:

other: No clinical signs were observed in any of the treated rats at the dose of 2000 mg/kg body weight during the 14 day observation period.

Gross pathology:

The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality.

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	238	229	227	-3.78	-4.62
2		245	231	261	-5.71	6.53
3		251	244	263	-2.79	4.78
4		244	228	231	-6.56	-5.33
5		227	227	248	0.00	9.25
6	Female	208	209	223	0.48	7.21
7		224	221	234	-1.34	4.46
8		211	197	242	-6.64	14.69
9		219	216	218	-1.37	-0.46
10		200	180	199	-10.00	-0.50

Keys:* = Based on day 0 body weight taken prior to dose application.

 

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

Keys: 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

 

Interpretation of results:

other: Not classified

Conclusions:

Under the conditions of this; acute dermal toxicity study of test chemical in rats is as given below:
The acute dermal median lethal dose of test chemical was >2000 mg/kg body weight.Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not exhibit acute dermal toxicity i.e it is acutely non toxic to animals.

Executive summary:

Acute Dermal Toxicity Study of test chemical in Wistar Rats was performed as per OECD No.402.

Five male and five female healthy young adult rats were randomly selected and used for conducting acute dermal toxicity study. Rats free from injury and irritation of skin were selected for the study. Twenty four hours prior to dermal application of test item, approximately 10% of body surface area of each rat was clipped. A limit dose of 2000 mg/ kg body weight of test item moistened with 0.2 ml distilled water was applied by single dermal application and observed for 14 days after treatment.

On test day 0, anamount of pulverized test item moistened with 0.2 ml distilled water was applied directly on the intact skin of clipped area of rats; the porous gauze dressing was put on to the intact skin of clipped area.This porous gauze dressing was covered with a non-irritating tape.The dressing was wrapped around the abdomen and anchored with non-irritating adhesive tape.After the 24-hour application period, the dressings were removed and the skin was gently wiped with distilled water.The skin reactions were assessed.

The animals were observed daily for mortality and clinical signs, during the acclimatization period. All animals were observed for clinical signs at approximately 1, 2, 3 and 4 hours after treatment on day 0 and once daily during test days 1‑14. Mortality was recorded after application on test day 0 and twice daily during days 1-14 (at least once on the day of sacrifice). Local signs / Skin reactions were observed daily from test days 1-14 (in common with clinical signs). Body weights were re­corded on day 0 (prior to application) and on day 7 and 14. All animals were necropsied and examined macroscopically.

No mortality and clinical sign was observed in any animal treated at the dose of 2000mg/kg, during the 14 day observation period.

At 2000 mg/kg, decline in mean body weight of male and female on day 7, whereas gain in mean body weight was observed on day 14 as compared to day 0.

The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality.

Under the conditions of this; acute dermal toxicity study of test chemical in rats is as given below:

The acute dermal median lethal dose of test chemical was >2000 mg/kg body weight.Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not exhibit acute dermal toxicity i.e it is acutely non toxic to animals.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Data is Klimisch 1 and from study report

Additional information

Acute oral toxicity:

In different studies, the given test chemical has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats for test chemical. The studies are summarized as below –

 

1 Acute oral toxicity study of test chemical was conducted on mice at the dose concentration of 513 ± 211 mg/kg bw. The test chemical was administered via oral route. All animals were maintained under close observation for recording toxic signs and time of death for 14 days.Therefore, LD50 value was considered to be 513 ± 211 mg/kg bw, when mice were treated with test chemical via oral route.

 

2. The study was designed to investigate the action of test chemical on female Swiss mice and to measure its toxicity when given orally. Fasted and non fasted mice both served as a control. The lethal dose (LD50) of test chemical was considered to be 531 to 1177 mg/kg of body weight.. Clinical signs like Behavioral - convulsions or effect on seizure threshold; excitement, gastrointestinal - hyper motility, diarrhea were observed. Administered in sufficient quantities, the test chemical cause intoxication and death.

Histopathologic study disclosed degeneration of many parietal cells of the stomach, at 1 to 24 hours after the administration of 6 per cent test chemical (501 mgm./kgm.). The changes ranged from slight pyknosis to frank necrosis and exfoliation and were least pronounced at the base of the glands. Some necrotic cells could not be identified. Hemosiderin deposits in the kidneys were noted in 14-day survivors, particularly in the non-fasted animals that had received more than 1000 mgm./kgm test chemical. Hemolytic effects are evidenced by hemoglobinuria and, histologically,by hemoglobin casts and hemosiderin deposits in the kidneys. Control mice fasted overnight showed marked fatty changes in the liver, kidney, and, occasionally, in the heart.

Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical exhibit acute toxicity via the oral route in category IV. 

 

3. The study was designed to investigate the action of test chemical on guinea pig and to measure its toxicity when given orally.The median lethal dose (LD50) of test chemical was considered to be <400 mg/kg of body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical exhibit acute toxicity via the oral route in category IV.

4. Acute oral toxicity study of test chemical was conducted on rats at the dose concentration of 1200 mg/kg bw. The test chemical was administered via oral unspecified route. All animals were maintained under close observation for recording toxic signs and time of death for 14 days. Therefore, LD50 value was considered to be 1200 mg/kg bw, when rats were treated with test chemical via oral route.

5. The study was designed to investigate the action of test chemical on female Swiss mice and to measure its toxicity when given orally. Fasted and non fasted mice both served as a control. The lethal dose (LD50) of test chemical was considered to be 505 mg/kg of body weight. Effects observed on mortality, clinical signs, hematology and histopathology. Clinical signs like Behavioral convulsions or effect on seizure threshold; excitement, Gastrointestinal hypermotility, diarrhea were observed. Histopathologic study disclosed degeneration of many parietal cells of the stomach, at 1 to 24 hours after the administration of 6 per cent test chemical (501 mgm./kgm.). The changes ranged from slight pyknosis to frank necrosis and exfoliation and were least pronounced at the base of the glands. Some necrotic cells could not be identified. Hemosiderin deposits in the kidneys were noted in 14-day survivors, particularly in the non-fasted animals that had received more than 1000 mgm./kgm test chemical. Hemolytic effects are evidenced by hemoglobinuria and, histologically,by hemoglobin casts and hemosiderin deposits in the kidneys. Control mice fasted overnight showed marked fatty changes in the liver, kidney, and, occasionally, in the heart. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical exhibit acute toxicity via the oral route in category IV.

Thus, based on the above summarized studies on test chemical, it can be concluded that LD50 value is between 300-2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified for acute oral toxicity class IV.

 

Acute Inhalation Toxicity:

 

The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 6.82E-19 Pa. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver. 

 

Acute Dermal Toxicity:

 

In the following study report, the given test chemical has been investigated for acute dermal toxicity to a greater or lesser extent. Often are the studies based on in-vivo experiments in rodents, i.e. most commonly in rats for test chemical. The studies are summarized as below –

 

1. Acute Dermal Toxicity Study of test chemical in Wistar Rats was performed as per OECD No.402. Five male and five female healthy young adult rats were randomly selected and used for conducting acute dermal toxicity study. Rats free from injury and irritation of skin were selected for the study. Twenty four hours prior to dermal application of test item, approximately 10% of body surface area of each rat was clipped. A limit dose of 2000 mg/ kg body weight of test item moistened with 0.2 ml distilled water was applied by single dermal application and observed for 14 days after treatment. On test day 0, anamount of pulverized test item moistened with 0.2 ml distilled water was applied directly on the intact skin of clipped area of rats; the porous gauze dressing was put on to the intact skin of clipped area.This porous gauze dressing was covered with a non-irritating tape.The dressing was wrapped around the abdomen and anchored with non-irritating adhesive tape.After the 24-hour application period, the dressings were removed and the skin was gently wiped with distilled water.The skin reactions were assessed.

 

The animals were observed daily for mortality and clinical signs, during the acclimatization period. All animals were observed for clinical signs at approximately 1, 2, 3 and 4 hours after treatment on day 0 and once daily during test days 1‑14. Mortality was recorded after application on test day 0 and twice daily during days 1-14 (at least once on the day of sacrifice). Local signs / Skin reactions were observed daily from test days 1-14 (in common with clinical signs). Body weights were re­corded on day 0 (prior to application) and on day 7 and 14. All animals were necropsied and examined macroscopically. No mortality and clinical sign was observed in any animal treated at the dose of 2000mg/kg, during the 14 day observation period. At 2000 mg/kg, decline in mean body weight of male and female on day 7, whereas gain in mean body weight was observed on day 14 as compared to day 0. The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality. Under the conditions of this; acute dermal toxicity study of test chemical in rats is as given below:

The acute dermal median lethal dose of test chemical was >2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not exhibit acute dermal toxicity i.e it is acutely non toxic to animals.

Justification for classification or non-classification

Based on the above studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity and LD50 value is between 300-2000 mg/kg bw for acute oral toxicity. Thus, comparing this value and range with the criteria of CLP regulation, the given test chemical can be classified in "Category 4" for acute oral and cannot be classified for acute dermal toxicity. For acute inhalation toxicity wavier was added so, not possible to classify.