Sodium iodide

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 >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.

 

Acute Inhalation Toxicity:

 

The acute Inhalation toxicity dose (LC50) was considered based on different studies conducted on rats for the test chemical. The LC50 value is >5000 mg/m³, for acute inhalation toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute inhalation toxicity.

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:

key study

Reliability:

2 (reliable with restrictions)

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:

To perform Acute oral toxicity test of test chemical on rats.

GLP compliance:

not specified

Test type:

other: Not specified

Limit test:

no

Species:

rat

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:

4340 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:

4 340 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Details of toxic effects not reported other than lethal dose value

Mortality:

Lethal dose, 50 percent kill

Clinical signs:

other: Not specified

Gross pathology:

Not specified

Other findings:

Not specified

Interpretation of results:

other: Not classified

Conclusions:

The LD50 value was considered to be 4340 mg/kg bw, when rats were treated with the given test chemical orally.

Executive summary:

Acute oral toxicity study of test chemical was conducted on rats at the dose concentration of 4340 mg/kg bw. All animals were maintained under close observation for recording toxic signs and time of death . Therefore, LD50 value was considered to be 4340 mg/kg bw, when rats were treated with test chemical via oral route.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

4 340 mg/kg bw

Quality of whole database:

Data is Klimisch 2 and from experemental report

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from experemental study report

Qualifier:

according to guideline

Guideline:

other: As mentioned below

Principles of method if other than guideline:

Acute inhalation toxicity 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:

inhalation

Type of inhalation exposure:

not specified

Vehicle:

not specified

Details on inhalation exposure:

not specified

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

2 h

Remarks on duration:

not specified

Concentrations:

not specified

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:

LCLo

Effect level:

50 000 mg/m³ air

Based on:

test mat.

Exp. duration:

2 h

Mortality:

not specified

Clinical signs:

other: not specified

Body weight:

not specified

Gross pathology:

not specified

Other findings:

not specified

Interpretation of results:

other: Not classified

Conclusions:

Inhalation toxicity (LCLo value) of test chemical was examined for 2 hrs. in mouse at a dose concentration of 50000 mg/m3.Hence the LC50 value is >50000 mg/m3.This value suggests that the test chemical is non toxic to mouse by the inhalation route.

Executive summary:

Acute inhalation toxicity study (LCLo) of test chemical was conducted on mouse at the dose concentration of 50000mg/m³ for 2 hours. All animals were maintained under close observation for recording toxic signs and time of death. Therefore, LC50 value was considered to be >50000mg/m³, when mice were treated with test chemical. This value suggests that the test chemical is non toxic to mouse by the inhalation route.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating conc.

Value:

50 000 mg/m³ air

Quality of whole database:

Data is Klimisch 4 and from experemental report.

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

read-across from supporting substance (structural analogue or surrogate)

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

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

Acute oral toxicity of test material in rat.

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

1) 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


2)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: 1) unchanged (no vehicle) 2) Distilled water

Details on dermal exposure:

1)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.


2)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:

1) 24 hrs
2) 24 hrs

Doses:

1) 2000 mg/kg bw
2) 2000 mg/kg bw

No. of animals per sex per dose:

1) 10 (5/sex)
2) 10 (5/sex)

Control animals:

not specified

Details on study design:

1)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.



2) - 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:

1) Not specified
2) Not specified

Preliminary study:

Not specified

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

1) No mortality was observed at limit dose of 2000 mg/kg body weight of test item during the 14 day observation period
2) 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: 1)At 2000 mg/kg, all the animals were observed normal throughout the experimental period 2)At 2000 mg/kg, all the animals were observed normal throughout the experimental period

Gross pathology:

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

Other findings:

1)Not specified
2)Not specified

Interpretation of results:

other: Not classified

Conclusions:

1)The acute dermal median lethal dose of test chemical was > 2000 mg/kg body weight.
2)The acute dermal median lethal dose of test chemical was > 2000 mg/kg body weight.

Executive summary:

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) The study now reported was designed and conducted to determine the acute dermal toxicity profile of test chemical in Wistar Rats.

The test item 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.

 

2) Acute Dermal Toxicity Study of test chemical inWistar 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 chemical, 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 chemical 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 (atleast 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, based on the above summarised studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Data is Klimisch 2 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 rats at the dose concentration of 4340 mg/kg bw. All animals were maintained under close observation for recording toxic signs and time of death . Therefore, LD50 value was considered to be 4340 mg/kg bw, when rats were treated with test chemical via oral route.

 

2. Acute oral toxicity study of test chemical was performed as per OECD No. 432 on 6 female wistar rats. The test chemical was dissolved in water and given in dose concentration >2000 mg/kg bw by oral route. The time intervals between dosing were determined by the onset, duration and severity of toxic signs.

Mortality was observed in the animals no. 2 and 5 on day 0 and on day 1 respectively post dosing. Mean body weight of all ten animals was observed with gain on day 7 and 14.

 Clinical signs observed in animal no. 1 and 3 were observed with 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 with lethargy at 2 to 4 hours, Salivation at 3 and 4 hours and was found dead at 4 hours on day 0. Animal no. 4 was observed with lethargy at 2, 3 and 4 hours, Salivation at 4 hours and normal from day 1 till termination. Animal no. 5 was observed with lethargy at 2, 3, 4 hours and on day 1, Salivation at 4 hours and found dead on day 1. Animal no. 6 was observed with lethargy at 3 and 4 hours and was normal from day 1 to till termination.

During external gross pathological examination, all test animals were found dead and terminally sacrificed animals were observed with no abnormalities except animal no. 2 in which red area around nose were observed. During Internal gross pathological examination, terminally sacrificed animal did not show abnormality.

 Hence, the LD50 value was considered to be >2000 mg/kg bw, when 6 female wistar rats were treated with test chemical orally.

 

3. Acute oral toxicity study of test chemical was conducted on rats at the dose concentration of 3500 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. Therefore, LD50 value was considered to be 3500 mg/kg bw, when rats were treated with test chemical via oral route.

 

4) Acute oral toxicity study of test chemical was conducted on mouse at the dose concentration of 1000 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. Therefore, LD50 value was considered to be 1000 mg/kg bw, when rats were treated with test chemical via oral route.

 

From the above experimental studies, maximum number of studies concluded that the LD50 value is >2000 mg/kg bw, with detailed and reliable data. Also, the test animal “rats” are most preferred in animal toxicity studies. Thus, comparing this value with the criteria of CLP regulation, test chemical cannot be classified for acute oral toxicity.

 

Acute Inhalation Toxicity:

In different studies, the given test chemical has been investigated for acute inhalation 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 inhalation toxicity study (LCLo) of test chemical was conducted on mouse at the dose concentration of 50000mg/m3 for 2 hours. All animals were maintained under close observation for recording toxic signs and time of death. Therefore, LC50 value was considered to be >50000mg/m3, when mice were treated with test chemical. This value suggests that the test chemical is non toxic to mouse by the inhalation route.

 

2) Acute inhalation toxicity study of test chemical was conducted on rats at the dose concentration of 42000mg/m3 for 1 hour. All animals were maintained under close observation for recording toxic signs and time of death. Therefore, LC50 value was considered to be 42000mg/m3, when rats were treated with test chemical.

Thus, based on the above summarized studies on test chemical, it can be concluded that LC50 value is >5000 mg/m³. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute inhalation toxicity.

 

Acute Dermal Toxicity:

 

In different studies, 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. 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 > 2000 mg/kg body weight.

 

2. 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 chemical, 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, an amount of pulverized test chemical 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 theday 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, based on the above summarized studies on test chemical, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.

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 oral and acute dermal toxicity and the LC50 value is >5000mg/m³for acute inhalation toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral, acute dermal toxicity and acute inhalation toxicity.