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EC number: 231-831-9 | CAS number: 7758-05-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
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
- 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. - 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.
Reference
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.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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.
Reference
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.
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