Potassium iodate

Endpoint summary

Description of key information

Skin Irritation:

Acute Dermal Irritation/corrosion Study of test chemical in Rabbits, was performed as per OECD guideline No. 404. A volume of 0.5 ml of test item (as such) was applied to the skin for 4 hours and rabbits were observed for erythema and oedema at 1, 24, 48 and 72 hours and on day 7 post patch removal, evaluated and graded as per draize method. The individual mean score at 24, 48 and 72 hours for Animal Nos. 1, 2 and 3 were 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00, for erythema and oedema formation, respectively Hence, it was concluded that the test chemical was Non-Irritating to the skin of male New Zealand White rabbits under the experimental conditions tested. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

 

Eye irritation

The ocular irritation potential of target chemical was assessedin various in vivo experimental studies which were conducted for test chemical and its structurally similar read across chemical.Based on the available key data and supporting studies,it can be concluded thatchemical is able to cause eye irritation and considered as slightly irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Category 2”.

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:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Data is from experimental study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

The objective of the study was to assess the irritant and/or corrosive effects of test chemical after dermal application on the intact skin of rabbits.

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:Procured from RABBI ROOF, Hyderabad.
- Age at study initiation:4 to 5 Months (Approximately).
- Weight (Prior to Treatment):Minimum: 1.674 kg and Maximum: 2.708 kg
- Health Status : Healthy young adults rabbits were used for the study.
- Housing:The animals were housed individually in stainless steel 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 minimum twice a week.
- Diet (e.g. ad libitum):All animals were provided conventional laboratory rabbit diet (Nutrivet Life Sciences, Pune) ad libitum.
- Water (e.g. ad libitum):Aqua guard filtered tap water was provided ad libitum.
- Acclimation period:Rabbits were acclimatised to the test conditions for a period of 5 days (Animal No.-1) and 10 days (Animal No.-2 and 3) prior to the application of the test item.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):Minimum: 19.30 °C and Maximum: 22.50 °C
- Humidity (%):Minimum: 43.80 % and Maximum: 68.40 %
- Air changes (per hr):More than 12 changes per hour
- Photoperiod (hrs dark / hrs light):12:12

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

other: distilled water

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 gm
- Concentration (if solution):N/A

VEHICLE
- Amount(s) applied (volume or weight with unit):0.5 ml of distilled water
- Concentration (if solution):N/A
- Lot/batch no. (if required):N/A
- Purity:N/A

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 male rabbits

Details on study design:

TEST SITE
- Area of exposure:The dorsal lumbar region at contralateral sites.
- % coverage:Approximately 6 X 6 cm.
- Type of wrap if used:A porous gauze dressing and non-irritating tape (Micropore 3”).

REMOVAL OF TEST SUBSTANCE
- Washing (if done):The residual test item was removed by using cotton soaked in distilled water.
- Time after start of exposure:4 hour

SCORING SYSTEM:Draize Method

Irritation parameter:

erythema score

Basis:

animal: #1 ,#2 and #3

Time point:

other: At 24, 48 and 72 hours

Score:

0

Max. score:

3

Reversibility:

no data

Remarks on result:

other: not irritating

Irritation parameter:

edema score

Basis:

animal: #1 ,#2 and #3

Time point:

other: At 24, 48 and 72 hours

Score:

0

Max. score:

3

Reversibility:

no data

Remarks on result:

other: not irritating

Irritant / corrosive response data:

The following were observed in treated rabbits.
The patch was removed after 4 hours and rabbits were observed for erythema and oedema at 1, 24, 48 and 72 hours after patch removal, evaluated and graded as per draize method.

In Animals No.1, 2 and 3 after post patch removal, revealed no erythema and oedema at 24 and 48 and 72 hour during the observation period.

The individual mean score at 24, 48 and 72 hours for Animal Nos. 1, 2 and 3 were 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00, for erythema and oedema formation, respectively.

Other effects:

Clinical Observation
No systemic toxicity was observed at treated rabbits during the experimental period.

Mortality
No mortality was observed during the observation period.

Table 1

Skin Reaction

 

In Treated area Dose:0.5 gm of test item                                                                    Sex:Male

 

Animal No.	Test	Treated  area*	Erythema score				Oedema score
			1h	24h	48h	72h	1h	24h	48h	72h
1	Initial	Right	0	0	0	0	0	0	0	0
2	Confirmatory	Left	0	0	0	0	0	0	0	0
3		Left	0	0	0	0	0	0	0	0

 

 

  

In Control area                    Dose:0.5 ml of distilled water                              Sex:Male

 

Animal No.	Test	Treated area*	Erythema score				Oedema score
			1h	24h	48h	72h	1h	24h	48h	72h
1	Initial	Left	0	0	0	0	0	0	0	0
2	Confirmatory	Right	0	0	0	0	0	0	0	0
3		Right	0	0	0	0	0	0	0	0

Key: h = Hour.

Erythema                                                                                                         Oedema

0 =No erythema                                                                                              0 =No oedema

Table 1 Continued…

Mean Individual Animal Score at 24, 48 and 72 hours

 

Animal Number                   Observations	1	2	3
Erythema	0.00	0.00	0.00
Oedema	0.00	0.00	0.00

 

 

 

Table 2

Individual Animal BodyWeight

Sex:Male

Animal No.	Body Weight (kg)
	Prior to Dosing	At termination
1	1.930	1.982
2	1.674	1.686
3	2.708	2.870

 

Table 3

Individual AnimalClinicalSigns

Sex:Male

Animal No.	Days (Post dosing Observation)
	0	1	2	3
1	1	1	1	1
2	1	1	1	1
3	1	1	1	1

Key: ./. = Not Applicable. 1 = Normal.

 

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No erythema and oedema (skin irritation) were found at the end of 72 hour observation period after patch removal.
Hence, it was concluded that “Potassium iodate (CAS No. 7758-05-6)” was Non-Irritating to the skin of Male New Zealand White rabbits under the experimental conditions tested and being classified as “Category-Unclassified” as per CLP Classification.

Executive summary:

Acute Dermal Irritation/corrosion Study of“Potassium iodate (CAS No.7758-05-6)”in Rabbits, sponsored bySustainability Support Services (Europe) AB was conducted at sa-FORD (Sanctuary for Research and Development), Maharashtra, India. This study was performed as per OECD guideline No. 404.

Three healthy young adult male rabbits were used for conducting acute dermal irritation study.Body weights were re­corded on day 0 (prior to application) and at termination.

Rabbits with good intact skin were selected for the study. The hairs of all the rabbits were clipped at contralateral sites, approximately 24 hours prior to treatment.A dose of0.5 gm of test item moistened with 0.5 ml of distilled water wasappliedto the skin,over an area of approximately 6 x 6 cm clippedof haironone side of rabbits.The other untreated side was kept as control area and0.5 ml of distilled water was applied at this site. At the end of 4 hours, the gauze patch was removed and test item application site was wiped with water without altering the integrity of the epidermis. 

Initially, the test item was applied to the clipped area of skin of one rabbit. The test site was covered with gauze patch.After 4 hours of exposure in Animal No. 1, there was no erythema and oedema observed at 1, 24, 48 and 72 hours observation.Hence the confirmatory test was conducted on additional two rabbits (No. 2 and 3) to confirm the non irritant nature of the test item.

In Animals No. 2 and 3 after post patch removal, revealed no erythema and oedema at 1, 24, 48 and 72 hours observation.

The patch was removed after 4 hours and rabbits were observed for erythema and oedema at 1, 24, 48 and 72 hours after patch removal, evaluated and graded as per draize method.

The individual mean score at 24, 48 and 72 hours for Animal Nos. 1, 2 and 3 were 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00, for erythema and oedema formation, respectively.  

Hence, it was concluded that “Potassium iodate (CAS No.7758-05-6)” was Non-Irritating to the skin of Male New Zealand White rabbits under the experimental conditions tested and Classified as “Category- Unclassified” as per CLP Classification.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

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 peer reviewed journal.

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

The clinical manifestations, toxic dosage of iodate, and ocular changes in five patients who had taken a test chemical overdose were analyzed. Electroretinography, visual evoked potential (VEP), and fundus fluorescein angiography (FA) were performed to study retinal function and changes.

GLP compliance:

not specified

Species:

human

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation:22-65 yrs.

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

KIO3 solution at a concentration between 187 and 470 mg/kg body weight was ingested.

Duration of treatment / exposure:

2 - 12 hours

Observation period (in vivo):

3 months

Number of animals or in vitro replicates:

Two men and three women

Irritation parameter:

other: Retinal pigment epithelial (RPE) window defects

Basis:

mean

Time point:

other: 2-12 hours

Score:

20

Max. score:

80

Reversibility:

not specified

Remarks on result:

other: Two men and three women (age 22-65 years) ingested KIO3 solution at a concentration between 187 and 470 mg/kg body weight. Visual acuity ranged from light perception with projection to counting fingers and decreased from 2 to 12 hours after ingestion.

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

The test chemical can produce retinal toxicity that damages RPE and photoreceptor cells. The recovery of retinal function depends on the amount of chemical absorption, the regeneration of RPE, and the recovery function of photoreceptor cells. On the basis of observed effects, the test chemical can be considered as irritating to the human eyes.

Executive summary:

The clinical manifestations, toxic dosage of iodate, and ocular changes in five patients who had taken a overdose of test chemical were analyzed. Electroretinography, visual evoked potential (VEP), and fundus fluorescein angiography (FA) were performed to study retinal function and changes.

Two men and three women (age 22-65 years) ingested test chemical solution at a concentration between 187 and 470 mg/kg body weight. Visual acuity ranged from light perception with projection to counting fingers and decreased from 2 to 12 hours after ingestion. Fundus FA showed bilateral extensive areas of retinal pigment epithelial (RPE) window defects, and electroretinography and VEP showed marked impairment of retinal function. Visual acuity improved from counting fingers to 20/80 in 3 months.

The test chemical can produce retinal toxicity that damages RPE and photoreceptor cells. The recovery of retinal function depends on the amount of chemical absorption, the regeneration of RPE, and the recovery function of photoreceptor cells.

On the basis of observed effects, the test chemical can be considered as irritating to the human eyes.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

Acute Dermal Irritation/corrosion Study of test chemical was performed as per OECD guideline No. 404 using three healthy young adult male.

The hairs of all the rabbits were clipped at contralateral sites, approximately 24 hours prior to treatment. A dose of 0.5 g of test item (moistened with 0.5 ml distilled water) was applied to the skin, over an area of approximately 6 x 6 cm clipped of hair on one side of rabbits. The other untreated side was kept as control area and0.5 ml of distilled water was applied at this site. At the end of 4 hours, the gauze patch was removed and test item application site was wiped with water without altering the integrity of the epidermis. Initially, the test item was applied to the clipped area of skin of one rabbit. The test site was covered with gauze patch. After 4 hours of exposure in animal no. 1, no erythema and no oedema observed at 1, 24 and 48 hour of observation hence a confirmatory test was conducted on additional two rabbits (No. 2 and 3) to confirm the non-irritant nature of the test item.

In Animals No. 2 and 3 after post patch removal, revealed no erythema and oedema at 1, 24, 48 and 72 hours observation.

The patch was removed after 4 hours and rabbits were observed for erythema and oedema at 1, 24, 48 and 72 hours after patch removal, evaluated and graded as per draize method.

The individual mean score at 24, 48 and 72 hours for Animal Nos. 1, 2 and 3 were 0.00, 0.00, 0.00 and 0.00, 0.00, 0.00, for erythema and oedema formation, respectively.  

Hence, the test chemical can be considered as Non-Irritating to the skin of Male New Zealand White rabbits under the experimental conditions tested and Classified as “Not Classified” as per CLP Classification.

 

Eye irritation

In different studies, the test chemical has been investigated for potential for ocular irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits for target chemical and its structurally similar read across substance that have been summarized as below;

 

The clinical manifestations, toxic dosage of iodate, and ocular changes in five patients who had taken an overdose of test chemical were analyzed. Electroretinography, visual evoked potential (VEP), and fundus fluorescein angiography (FA) were performed to study retinal function and changes. Two men and three women (age 22-65 years) ingested test chemical solution at a concentration between 187 and 470 mg/kg body weight. Visual acuity ranged from light perception with projection to counting fingers and decreased from 2 to 12 hours after ingestion. Fundus FA showed bilateral extensive areas of retinal pigment epithelial (RPE) window defects, and electroretinography and VEP showed marked impairment of retinal function. Visual acuity improved from counting fingers to 20/80 in 3 months. The test chemical can produce retinal toxicity that damages RPE and photoreceptor cells. The recovery of retinal function depends on the amount of chemical absorption, the regeneration of RPE, and the recovery function of photoreceptor cells. On the basis of observed effects, the test chemical can be considered as irritating to the human eyes.

 

A Standard Draize test was conducted to determine the irritation potential of the similar read across 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 further 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.

 

Thus based on the available data for the target as well as supporting studies, it can be concluded that test chemical is able to cause severe eye irritation and considered as irritating. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Category 2”.

Justification for classification or non-classification

The skin and eye irritation potential of test chemical were observed in various studies. The results obtained from these studies indicates that the chemical is unlikely to cause skin irritation but can cause severe eye damage. Hence the test chemical can be classified under the category “Not Classified” for skin and “Category 2” for eye as per CLP.