Sodium iodide

Endpoint summary

Description of key information

Skin Irritation:

A Standard Draize test was performed to determine the irritation potential of the test chemical in rabbits. About 500 mg of the undiluted test chemical was applied to the rabbit skin and observed for signs of irritation till 24 hours. The test chemical developed skin reactions during the observation period. Hence the test chemical was moderately irritating to rabbit skin after 24 hours of exposure. Thuscomparing the above annotations with the criteria of CLP regulation, Test chemical can be classified under the category “Category 2 (irritant)”.

 

Eye Irritation:

A Standard Draize test was conducted to determine the irritation potential of the test chemical. Rabbit eyes were exposed to 100mg of the undiluted test chemical for 24 hours and observed for effects. Exposure to 100mg of the undiluted test chemical for 24 hours showed moderate signs of irritation. Hence, the chemical was considered to be irritating to eyes. Thuscomparing the above annotations with the criteria of CLP regulation, Test chemical can be classified under the category “Category 2 (irritant)”.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

data is from RTECS

Qualifier:

according to guideline

Guideline:

other: Standard Draize test

Principles of method if other than guideline:

Standard Draize test was performed to determine the irritation potential of the test chemical

GLP compliance:

not specified

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

no data available

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

24hours

Observation period:

24hours

Number of animals:

no data available

Details on study design:

no data available

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Reversibility:

not specified

Remarks on result:

probability of moderate irritation

Irritant / corrosive response data:

Moderately irritating to rabbit skin

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

In a standard Draize test, the test chemical was moderately irritating to rabbit skin after 24 hours of exposure.

Executive summary:

A Standard Draize test was performed to determine the irritation potential of the test chemical in rabbits.

500 mg of the undiluted test chemical was applied to the rabbit skin and observed for signs of irritation till 24 hours.

The test chemical was moderately irritating to rabbit skin after 24 hours of exposure.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

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 RTECS

Qualifier:

according to guideline

Guideline:

other: Standard Draize test

Principles of method if other than guideline:

Standard Draize test was conducted to determine the irritation potential of the test chemical

GLP compliance:

not specified

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

no data available

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

undiluted

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

24 hours

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

no data available

Details on study design:

no data available

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Reversibility:

not specified

Remarks on result:

probability of moderate irritation

Irritant / corrosive response data:

Signs of irritation observed

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

In a Standard Draize test, exposure to 100mg of the undiluted test chemical for 24 hours showed moderate signs of irritation.
Hence, the chemical was considered to be irritating to eyes.

Executive summary:

Standard Draize test was conducted to determine the irritation potential of the test chemical.

Rabbit eyes were exposed to 100mg of the undiluted test chemical for 24 hours and observed for effects.

Exposure to 100mg of the undiluted test chemical for 24 hours showed moderate signs of irritation.

Hence, the chemical was considered to be irritating to eyes.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin Irritation:

Various studieshas been investigated for the test chemical to observe the potential for dermal irritation to a greater or lesser extent. The studies are based on in vivo experiments conducted for target chemicaland its structurally and functionally similar read across substanceswhich have beensummarized as below;

 

 

A Standard Draize test was performed to determine the irritation potential of the test chemical in rabbits.

About 500 mg of the undiluted test chemical was applied to the rabbit skin and observed for signs of irritation till 24 hours. The test chemical developed skin reactions during the observation period. Hence the test chemical was moderately irritating to rabbit skin after 24 hours of exposure.

 

The above result was supported by the primary skin irritation study conducted for read across chemical on male albino rabbits of the SPF- Russian strain in order to evaluate the dermal irritation potential caued by the chemical. About 500mg oftest chemical was applied onto the intact and abraded skin of each rabbit (6 rabbits/ group) at concentration of0.1%, 0.5%, 1.2% and 2.5%for the exposure period of 24 hours. The untreated sites were served as control.All the sites were rinsed after 24 hours and scores again at 24 and 48 hours. Since the chemical cause skin lesions, the test chemicalwas considered to be irritating to the skin of SPF- Russian rabbits.

 

The above result was supported by the skin irritation study conducted for another read across chemical on New Zealand white rabbits. During this study, the undiluted test chemical was applied on back of each rabbits under occlusive condition. The backs of 6 rabbits were clipped free of hair in an area of about 15 X 12 square cm. The backs of the animals were divided into quadrants. The animals were abraded in a 2 square mm cross-hatch pattern on the tattoo side by drawing a lancet across the skin, being careful not to penetrate the dermis. Two-one square inch areas on each rabbit were tested. Two unabraided additional 1 squre inch sites on each rabbit were also tested. 0.5 gram of crystalline test chemical were placed in a double layered 1 square inch gauze pad and affixed to the four test sites on each animal with adhesive tape. The gauze was moistened with about 1 mL of distilled deionized water and a polyethylene wrapper was placed over the bandages and wound around the trunk. The wrapper was secured with masking tape. The animals were placed in a restraining box and replaced in their individual cages. Water was available to the animals during the test. Since the test chemical caused moderate skin irritating effects, the test chemical was considered to be moderately irritating to the skin of New Zealand white rabbits.

 

 

All these studies lead to a conclusion that Test chemical is able to cause skin irritation and can be considered as irritating to skin. Hence, comparing the above annotations with the criteria of CLP regulation, Test chemical can be classified under the category “Category 2 (irritant)”.

 

 

Eye Irritation:

Various studieshas been investigated for the test chemical to observe the potential for ocular irritation to a greater or lesser extent. The studies are based on in vivo experiments conducted for target chemicaland its structurally and functionally similar read across substanceswhich have beensummarized as below;

 

A Standard Draize test was conducted to determine the irritation potential of the test chemical. Rabbit eyes were exposed to 100mg of the undiluted test chemical for 24 hours and observed for effects. Exposure to 100mg of the undiluted test chemical for 24 hours showed moderate signs of irritation. Hence, the chemical was considered to be irritating to eyes.

 

An Acute Eye Irritation/Corrosion Study of similar read across chemical was performed as per OECD guideline no. 405 in Rabbits. Rabbits free from injury of eye were selected for the study. In the initial test, 100 mg (0.1 g) of test item was instilled into the conjunctival sac of the right eye of animal no.1 whereas the left eye of the rabbit served as the control. Some swelling above normal (includes nictitating membranes) in all three animals. At 24 hours observation the rabbits were examined for corneal epithelium cell damage using sodium fluorescein strips and noticed 20%, 30% and 20% damage in animal no. 1, 2 and 3 respectively. The individual mean score for animal nos. 1, 2 and 3at 24, 48, 72 hours for corneal opacity, iris, conjunctiva and chemosis were found 0.00, 0.00, 0.00, 0.00, 0.00, 0.00, 1.67, 1.67, 1.00 and 0.33, 1.00, 0.67, respectively. Under the experimental conditions tested, all the three animals were fully reversible within an observation period of 7 days. Hence under the experimental test conditions, the test chemical was observed to be “Mildly irritating to eyes” of New Zealand White Female rabbit eyes.

 

The above results were supported by an eye irritation study performed on read across chemical according to US EPA Pesticide Assessment Guidelines, 1982. 0.1 g undiluted test chemical was instilled in to the eyes of 6 New Zealand White rabbits and observed for effects. The treated eyes were assessed1, 24, 48 and 72 hours after treatment and on Day 8.A well– defined appearance to the conjunctival blood vessels, iridial congestion, a moderate or slight discharge and slight chemosis were observed in all rabbits one hour after treatment. No corneal lesions were observed. The observed changes resolved within 3 days after treatment and all eyes were normal by 8 days. The test chemical was considered to be slightly irritating to rabbit eyes.

 

The overall results were further supported by the ocular irritation potential study conducted on another read across chemical in rabbits. About 50 mg of the powdered substance was administered in to the eyes of Vienna White rabbits and observed for signs of irritation. The reactions were observed after 10min, 1 and 24hrs, 72 hours of exposure till day 8. After 10min, 1 and 24hrs, clear signs of inflammation with redness, swelling and cloudy corneal opacity were observed. All effects were still observable 72 hours after exposure, but were not visible by the end of the eight day observation period. The chemical was considered to be irritating to the eyes of Vienna White rabbits.

 

All these studies lead to a conclusion that the test chemical is able to cause eye irritation and can be considered as irritating to eyes. Hence, comparing the above annotations with the criteria of CLP regulation, Test chemical can be classified under the category “Category 2 (irritant)”.

Justification for classification or non-classification

The skin and eye irritation potential of test chemical was observed in various studies. The results obtained from these studies indicate that the chemical is likely to cause skin and eye irritation. Hence the test chemical can be classified under the category “Category 2 (irritant)” for skin and eye as per CLP.