Registration Dossier
Registration Dossier
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EC number: 223-289-7 | CAS number: 3811-04-9
Endpoint summary
Administrative data
Description of key information
Read-across data from sodium chlorate to assess the toxicity of potassium chlorate for the skin and eye irritation/corrosion is justified, because the toxicity is expected to be related to the chlorate ion and not to the sodium or potassium ion. As much as possible key data for sodium chlorate will be used for cross reading and complementing information available for potassium chlorate.
STUDIES WITH POTASSIUM CHLORATE
Skin irritation/corrosion
- In vitro skin irritation (eq. to OECD 439, K, Rel.1): Not irritant to skin
- In vitro skin corrosion (OECD 431, K, Rel.1): Non-corrosive to skin
Eye irritation
- In vivo eye irritation (OECD 405, K, Rel.1): Not irritant to the eyes
- In vitro eye irritation (eq. to BCOP, OECD 437, K, Rel.1): Mild irritant (old data evaluation)
Respiratory irritation
No signs of respiratory irritation were noted in an acute inhalation study.
STUDIES WITH SODIUM CHLORATE
Skin irritation/corrosion
- In vivo skin irritation (eq. to OECD 404, K, Rel.1): Not irritant to skin
Eye irritation
- In vivo eye irritation (eq. to OECD 405, K, Rel.1): Not irritant to the eyes
Respiratory irritation
No signs of respiratory irritation were noted in an acute inhalation study.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- See the RAAF document.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- The incidence and severity of irritation generally decreased by 24 hours. By 72 hours all sites (intact and abraded) were free of irritation. No irritation was noted at any of the control sites during the study.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the present study, it was concluded that undiluted Sodium Chlorate Crystal moistened with 0.2 ml distilled water induced a reversible very slight skin irritation. Therefore, the substance is not classifiable according to OECD-GHS.
- Executive summary:
A primary dermal irritation study was conducted on six albino rabbits using test substance Sodium Chlorate Crystal. The study was performed according to EPA Pesticide Assessment Guidelines, subdivision F, Hazard Evaluation: Human and Domestic Animals, November 1984, Acute Exposure, Skin Irritation. The method is equivalent to OECD Guideline 404 (acute Dermal Irritation/Corrosion). The study is designed and performed according to Good Laboratory Practice Standards.
Each animal had 2 test sites (clipped and abraded) and 2 untreated control sites (clipped and abraded). On each test site 0.5 g test material moistened with 0.2 ml of distilled water was applied. A single 4 -hour, occluded application of the test material to the intact skin produced immediately after patch removal none to very slight erythema and oedema. By 48 hours these test sites were free of irritation again and the observations were only up to 72 hours. Necrosis and ulceration were not reported.
Based on the results of the present study, it was concluded that undiluted Sodium Chlorate Crystal moistened with 0.2 ml distilled water induced a reversible very slight skin irritation. Therefore, the substance is not classifiable according to OECD-GHS.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 1991 - July 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to standard US EPA protocol and under GLP.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 4h occlusive application, 2 applications on 1 animal (intact and abraded skin), skin reactions were recorded up to 72 h after patch removal (no observations up to 14 days), 6 rabbits
- Principles of method if other than guideline:
- Principles other than OECD Guideline:
- 4-h occlusive application
- 2 applications on 1 animal (intact and abraded skin)
- skin reactions were recorded up to 72 h after patch removal (no observations up to 14 days)
- 6 rabbits - GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Davidson's Mill Farm, S. Brunswick, NJ
- Age at study initiation: no info
- Weight at study initiation: no info
- Housing: individually in suspended stainless steel caging with mesh floors
- Diet (e.g. ad libitum): Purina Rabbit Chow, ad lib
- Water (e.g. ad libitum): tap water, ad lib
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 22
- Humidity (%): no info
- Air changes (per hr): no info
- Photoperiod (hrs dark / hrs light): no info
IN-LIFE DATES: From: June 26, 1991 To: June 29, 1991 - Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped + abraded
- Vehicle:
- other: none, applied as received undiluted, moistened with 0.2 mL water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g undiluted test substance moistened with 0.2 ml of distilled water
- Concentration (if solution): not applicable
VEHICLE
- Amount(s) applied (volume or weight with unit): not apllicable
- Concentration (if solution): not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable - Duration of treatment / exposure:
- 4 hours
- Observation period:
- After patch removal: 1, 24, 48 and 72 hours
- Number of animals:
- 6 (3 males and 3 females): each with 2 test sites (intact and abraded) and 2 untreated control sites (intact and abraded)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm2 (2 test application sites -abraded and intact- and 2 untreated control sites)
- % coverage: clipped skin is 10% of the body surface
- Type of wrap if used: adhesive backed-gauze patches secured in place with tape wrapping
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test sites were gently wiped clean of any residual test substance
- Time after start of exposure: after 4 hours patches were removed
SCORING SYSTEM: Draize scoring system (Primary Dermal Irriation Scores) (see below) - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0.11
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- The incidence and severity of irritation generally decreased by 24 hours. By 72 hours all sites (intact and abraded) were free of irritation. No irritation was noted at any of the control sites during the study.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the present study, it was concluded that undiluted Sodium Chlorate Crystal moistened with 0.2 ml distilled water induced a reversible very slight skin irritation. Therefore, the substance is not classifiable according to OECD-GHS.
- Executive summary:
A primary dermal irritation study was conducted on six albino rabbits using test substance Sodium Chlorate Crystal. The study was performed according to EPA Pesticide Assessment Guidelines, subdivision F, Hazard Evaluation: Human and Domestic Animals, November 1984, Acute Exposure, Skin Irritation. The method is equivalent to OECD Guideline 404 (acute Dermal Irritation/Corrosion). The study is designed and performed according to Good Laboratory Practice Standards.
Each animal had 2 test sites (clipped and abraded) and 2 untreated control sites (clipped and abraded). On each test site 0.5 g test material moistened with 0.2 ml of distilled water was applied. A single 4 -hour, occluded application of the test material to the intact skin produced immediately after patch removal none to very slight erythema and oedema. By 48 hours these test sites were free of irritation again and the observations were only up to 72 hours. Necrosis and ulceration were not reported.
Based on the results of the present study, it was concluded that undiluted Sodium Chlorate Crystal moistened with 0.2 ml distilled water induced a reversible very slight skin irritation. Therefore, the substance is not classifiable according to OECD-GHS.
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28-jul-2009 to 31-jul-2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: Foreskin
- Justification for test system used:
- Following the REACH top-down strategy described in the ECHA R.7a guidance, the Epiderm Skin Model method was used to assess skin corrosion.
- Vehicle:
- not specified
- Details on test system:
- - EpiDerm Skin Model (EPI-200,no.: 12222 kit 2)
The model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiDerm tissues (surface 0.6 cm²) were cultured on polycarbonate membranes of 10 mm cell culture inserts. - Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 25 mg, moistened with 25 µl water
NEGATIVE CONTROL
- Amount(s) applied (volume or weight with unit): Test substance was moistened with 25 μl of Milli-Q water
POSITIVE CONTROL
- Amount(s) applied (volume or weight with unit): 50 µl KOH
- Concentration (if solution): 8 N - Duration of treatment / exposure:
- - 3 minutes and 1 hour exposure times
- Details on study design:
- TEST SITE
- Area of exposure: human skin model
- % coverage: 0.6 cm2
REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline
- Time after start of exposure: 3 minutes and 1 hour
SCORING SYSTEM:
- Percentage viability - Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minutes
- Value:
- 110
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour
- Value:
- 99
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, the test substance is not classified for skin corrosion according to Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
- Executive summary:
An in vitro skin corrosion study was performed according to the OECD Guideline 431 and in compliance with GLP, using the EpiDerm reconstructed human epidermis model.
The positive control had a mean relative tissue viability of 12% after 3 minutes exposure. The absolute mean OD540 (optical density at 540 nm) of the negative control tissues was within the laboratory historical control data range. The maximum inter-tissue variability in viability between two tissues treated identically was less than 15% and the maximum difference in percentage between the mean viability of two tissues and one of the two tissues was less than 8%, indicating that the test system functioned properly.
Skin corrosion is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 3-minute and 1-hour treatments with Potassium chlorate compared to the negative control tissues was 110% and 99%, respectively. Because the mean relative tissue viability for Potassium chlorate was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment Potassium chlorate is considered to be not corrosive.
Finally, it is concluded that this test is valid and that Potassium chlorate is not corrosive in the in vitro skin corrosion test under the experimental conditions described in the report.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08-sep-2009 to 19-oct-2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.
- Qualifier:
- according to guideline
- Guideline:
- other: EU method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Draft Proposal for a New Guideline: In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: foreskin
- Vehicle:
- not specified
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
EPISKIN Standard Model TM (EPISKIN-SMTM, 0.38 cm2, Lot no.: 09-EKIN-035).
This model is a three-dimensional human epidermis model, which consists of adult human-derived epidermal keratinocytes which have been seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. The keratinocytes were cultured for 13-days, which results in a highly differentiated and stratified epidermis model comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum.
TEST SITE
- Area of exposure: human epidermis model
- % coverage: 0.38 cm2
REMOVAL OF TEST SUBSTANCE
- Washing (if done): phosphate buffered saline
- Time after start of exposure: 15 minutes
POST INCUBATION PERIOD
- 42 hours
SCORING SYSTEM:
- After a 42 hour incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment. Cell viability was calculated for each tissue as a percentage of the mean of the negative control tissues. - Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 mg, moistened with 10 µl of water
NEGATIVE CONTROL
- Amount(s) applied (volume or weight with unit): 10 µl Phosphate buffered saline
POSITIVE CONTROL
- Amount(s) applied (volume or weight with unit): 10 µl
- Concentration (if solution): 5% (aq) Sodium dodecyl sulphate - Duration of treatment / exposure:
- Exposure: 15 minutes
Post incubation period: 42 hours - Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 15 minutes
- Value:
- 118
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The mean percent viability of the treated tissues is 118%, versus 17% in the positive control (5% Sodium Dodecyl Sulfate). Under the test conditions, test substance is not classified as irritating to skin according to the criteria of the Annex I of the Regulation EC No. 1272/2008 (CLP) and according to the GHS.
- Executive summary:
An in vitro skin irritation test using the Reconstructed human Epidermis (Episkin Standard model) was performed according to the OECD Guideline 439 and in compliance with GLP to predict the acute skin irritation potential of the test substance.
Skin irritation is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 15 minutes treatment with Potassium chlorate compared to the negative control tissues was 118%. Since the mean relative tissue viability for Potassium chlorate was above 50% after 15 minutes treatment Potassium chlorate is considered to be non-irritant.
The positive control had a mean cell viability after 15 minutes exposure of 17%. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was less than 18%, indicating that the test system functioned properly.
Finally, it is concluded that this test is valid and that Potassium chlorate is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report.
Referenceopen allclose all
Summary of dermal lesions on clipped (intact) skin (following 4-h application).
Remark: Erythema and oedema skin effects on abraded skin were slightly more severe compared with those on unabraded skin.
no. |
Effect |
Hour |
Days after application |
Mean score erythema 24/48/72 h * |
Mean score oedema 24/48/72 h * |
|||||
1 |
1 |
2 |
3 |
7 |
14 |
|||||
8903 |
Erythema/ eschar Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
- - |
- - |
0 |
0 |
|
8904 |
Erythema/ eschar Oedema |
1 0 |
0 0 |
0 0 |
0 0 |
- - |
- - |
0 |
0 |
|
8905 |
Erythema/ eschar Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
- - |
- - |
0 |
0 |
|
8906 |
Erythema/ eschar Oedema |
1 1 |
1 0 |
0 0 |
0 0 |
- - |
- - |
0.33 |
0 |
|
8907 |
Erythema/ eschar Oedema |
0 0 |
1 0 |
0 0 |
0 0 |
- - |
- - |
0.33 |
0 |
|
8908 |
Erythema/ eschar Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
- - |
- - |
0 |
0 |
|
Mean Group |
0.11 |
0 |
||||||||
* Mean score based on 24, 48 and 72 h after application
Summary of dermal lesions on clipped (intact) skin (following 4-h application).
Remark: Erythema and oedema skin effects on abraded skin were slightly more severe compared with those on unabraded skin.
no. |
Effect |
Hour |
Days after application |
Mean score erythema 24/48/72 h * |
Mean score oedema 24/48/72 h * |
|||||
1 |
1 |
2 |
3 |
7 |
14 |
|||||
8903 |
Erythema/ eschar Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
- - |
- - |
0 |
0 |
|
8904 |
Erythema/ eschar Oedema |
1 0 |
0 0 |
0 0 |
0 0 |
- - |
- - |
0 |
0 |
|
8905 |
Erythema/ eschar Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
- - |
- - |
0 |
0 |
|
8906 |
Erythema/ eschar Oedema |
1 1 |
1 0 |
0 0 |
0 0 |
- - |
- - |
0.33 |
0 |
|
8907 |
Erythema/ eschar Oedema |
0 0 |
1 0 |
0 0 |
0 0 |
- - |
- - |
0.33 |
0 |
|
8908 |
Erythema/ eschar Oedema |
0 0 |
0 0 |
0 0 |
0 0 |
- - |
- - |
0 |
0 |
|
Mean Group |
0.11 |
0 |
||||||||
* Mean score based on 24, 48 and 72 h after application
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
- Study period:
- December 1990 - January 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to standard US EPA protocol and under GLP.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- limited reported study (not all details available), no initial and confirmatory test, six rabbits, observations until day 14: reversibility is seen (21 days not necessary)
- Principles of method if other than guideline:
- Principles other than OECD Guideline:
- limited reported study (not all details available)
- no initial and confirmatory test
- six rabbits
- observations until day 14: reversibility is seen (21 days not necessary) - GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Davidson's Mill Farm, S. Brunswick, NJ
- Age at study initiation: no info
- Weight at study initiation: no info
- Housing: individually in suspended stainless steel caging with mesh floors
- Diet (e.g. ad libitum): Purina Rabbit Chow, ad lib
- Water (e.g. ad libitum): no info
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23
- Humidity (%): no info
- Air changes (per hr): no info
- Photoperiod (hrs dark / hrs light): no info
IN-LIFE DATES: From: December 3, 1990 To: December 17, 1990 - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g of sieved test material (425 micron sieve)
- Concentration (if solution): 0.1 g
VEHICLE
- Amount(s) applied (volume or weight with unit): not applicable
- Concentration (if solution): not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable - Duration of treatment / exposure:
- single application of 0,1 g test material into the left of right eye (other eye served as a control).
- Observation period (in vivo):
- At 1, 24, 48 and 72 hours and 4, 7, 10 and 14 days.
- Number of animals or in vitro replicates:
- 6 (3 males and 3 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing if done): not rinsed
- Time after start of exposure: not applicable
SCORING SYSTEM: Evaluated by the method of Draize (see table below) and further classified by the system of Kay and Calandra, Maximum Mean Total Score.
TOOL USED TO ASSESS SCORE: fluorescein to examine eyes before the test and incidentally to examine after the test - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: After treatment no opacity is seen
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 1.56
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0.72
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritant / corrosive response data:
- No ulceration of corrosive effetcts were mentioned.
- Cornea: One hour post-instillation corneal opacity was noted in one treated eye. This was the only evidence seen for opacity.
- Iris: After 1, 24 and 48 hour(s) post-instillation iritis was observed in 2, 3 and 1 eye, respectively.
- Conjuntivae (Redness): Until 48 hours post-instillation conjunctival irritation was observed in all treated eyes.
- Conjuntivae (Chemosis): Up to 24 hr after dosing chemosis with partial eversion of the lids was observed in 3 animals in to other animals slight swelling was reported. All symptoms dissapeared 48 hours after exposure. - Other effects:
- Localized injection of blood vessels was seen on days 4-7 in one rabbit. This was probably due to physical abrasion, possibly as a result of clawing.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the present study, it was concluded that the test compound induced a reversible slight eye irritation. Therefore, the substance is not classifiable according to OECD-GHS.
- Executive summary:
A study was conducted to assess the irritancy potential of Sodium Chlorate Crystal to the eye of six New Zealand Albino rabbits. The study was performed according to EPA Pesticide Assessment Guidelines, subdivision F, Hazard Evaluation: Human and Domestic Animals, November 1984, Acute Exposure, Eye Irritation. The irritation score used is according to the recommendations by Draize (1959) and OECD Guideline 405 (Acute Eye Irritation/Corrosion). The study was designed and performed according to Good Laboratory Practice Standards.
A single application of 0.1 g of Sodium Chlorate Crystal to the left or the right eye of the rabbit produced moderate to severe redness of the conjunctivae. And all the treated conjunctivae showed moderate chemosis. Slight iritis was seen and no cornea-reaction occurred. Iris and conjunctivae effects are reversible within 7 days.
Based on the results of the present study, it was concluded that the test compound induced a reversible slight eye irritation. Therefore, the substance is not classifiable according to OECD-GHS.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- See the RAAF document.
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: After treatment no opacity is seen
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0.22
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 1.56
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0.72
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritant / corrosive response data:
- No ulceration of corrosive effetcts were mentioned.
- Cornea: One hour post-instillation corneal opacity was noted in one treated eye. This was the only evidence seen for opacity.
- Iris: After 1, 24 and 48 hour(s) post-instillation iritis was observed in 2, 3 and 1 eye, respectively.
- Conjuntivae (Redness): Until 48 hours post-instillation conjunctival irritation was observed in all treated eyes.
- Conjuntivae (Chemosis): Up to 24 hr after dosing chemosis with partial eversion of the lids was observed in 3 animals in to other animals slight swelling was reported. All symptoms dissapeared 48 hours after exposure. - Other effects:
- Localized injection of blood vessels was seen on days 4-7 in one rabbit. This was probably due to physical abrasion, possibly as a result of clawing.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the present study, it was concluded that the test compound induced a reversible slight eye irritation. Therefore, the substance is not classifiable according to OECD-GHS.
- Executive summary:
A study was conducted to assess the irritancy potential of Sodium Chlorate Crystal to the eye of six New Zealand Albino rabbits. The study was performed according to EPA Pesticide Assessment Guidelines, subdivision F, Hazard Evaluation: Human and Domestic Animals, November 1984, Acute Exposure, Eye Irritation. The irritation score used is according to the recommendations by Draize (1959) and OECD Guideline 405 (Acute Eye Irritation/Corrosion). The study was designed and performed according to Good Laboratory Practice Standards.
A single application of 0.1 g of Sodium Chlorate Crystal to the left or the right eye of the rabbit produced moderate to severe redness of the conjunctivae. And all the treated conjunctivae showed moderate chemosis. Slight iritis was seen and no cornea-reaction occurred. Iris and conjunctivae effects are reversible within 7 days.
Based on the results of the present study, it was concluded that the test compound induced a reversible slight eye irritation. Therefore, the substance is not classifiable according to OECD-GHS.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21-jul-2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles
- Qualifier:
- according to guideline
- Guideline:
- other: Draft proposal for a new guideline: "Bovine Corneal Opacity and Permeability (BCOP) Test Method for Identifying Ocular Corrosives and Severe Irritants"
- Deviations:
- no
- Principles of method if other than guideline:
- - The Ocular Toxicity Working Group (OTWG) of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the National Interagency Centre for the Evaluation of Alternative Toxicological Methods (NICEATM), Background Review Document (BRD): current status of in vitro test methods for identifying ocular corrosives and severe irritants: The Bovine Corneal Opacity and Permeability (BCOP) Test Method, March 2006.
- GLP compliance:
- yes (incl. QA statement)
- Vehicle:
- physiological saline
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µl per cornea
- Concentration (if solution): 20% (w/v)
VEHICLE
- Amount(s) applied (volume or weight with unit): 750 µl of in physiological saline per cornea
- Lot/batch no. (if required): 8242A241
POSITIVE CONTROL
Amount(s) applied (volume or weight with unit): 750 µl per cornea
Concentration (if solution): 20% (w/v) Imidazole
- Lot/batch no. (if required): S4946223 - Duration of treatment / exposure:
- 240 minutes
- Details on study design:
- TEST SITE
- Isolated bovine cornea
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 240 minutes
SCORING SYSTEM:
- After exposure the cornea is thoroughly rinsed to remove the test substance followed by immediate opacity measurement and permeability evaluation of the cornea.
- The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro score:
In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).
TOOL USED TO ASSESS SCORE:
- opacitymeter and fluorescein
DATA EVALUATION:
In vitro score range In vitro classification
0 - 3 Non irritant
3.1 - 25 Mild irritant
25.1 - 55 Moderate irritant
55.1 - 80 Severe irritant
> 80 Very severe irritant - Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 240 minutes
- Value:
- 14.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- The corneas were slightly turbid after the 240 minutes of treatment with Potassium chlorate.
- Interpretation of results:
- other: Mild irritant
- Remarks:
- Criteria used for interpretation of results: expert judgment
- Conclusions:
- According to the current study and under the experimental conditions reported, the test item is considered as a mild irritant to the eye in the Bovine Corneal Opacity and Permeability test.
- Executive summary:
In an in vitro eye irritation study performed according to the OECD Guideline 437 and in compliance with GLP, 750 µL per cornea of diluted test item in physiological saline solution was applied to isolated bovine corneas for 240 minutes. Negative control (saline solution) and positive control (Imidazole) were used.
The mean in vitro irritancy score obtained with the negative control was less than 3.1 indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (20% w/v Imidazole) was 138.5 and within the historical positive control data range. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.
Potassium chlorate induced mild ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 14.7 after 240 minutes of treatment.
Finally, it is concluded that this test is valid and that Potassium chlorate is a mild irritant in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in the report.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 December 2009 28 December 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: performed according to EU and OECD test guidelines and GLP compliant
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Species Albino rabbit, New Zealand White, (SPF-Quality).
Recognized by international guidelines as the recommended test system (e.g. EC, OECD)
Source: Harlan, Belton, Leics, England
Number of animals 3 Males.
Age and body weight Animals used within the study were at least 6 weeks old and body weights were at least 1.0 kg.
Identification Earmark.
Health inspection A health inspection was performed prior to commencement of treatment, to ensure that the animals were in a good state of health. Special attention was paid to the eyes, which were free from any abnormality.
6.3. Animal husbandry
Conditions
Animals were housed in a controlled environment, in which optimal conditions were considered to be approximately 15 air changes per hour, a temperature of 21.0 ± 3.0ºC (actual range: 19.5 – 20.4ºC), a relative humidity of 40-70% (actual range: 36 - 65%) and 12 hours artificial fluorescent light and 12 hours darkness per day.
Accommodation
Animals were individually housed in labeled cages with perforated floors (Ebeco, Germany, dimensions 67 x 62 x 55 cm) and shelters (Ebeco, Germany, dimensions 40 x 32 x 23 cm).
Acclimatization period was at least 5 days before start of treatment under laboratory conditions.
Diet
Pelleted diet for rabbits (Global Diet 2030 from Harlan Teklad®, Mucedola, Milanese, Italy) approximately 100 grams per day. Hay (TecniLab-BMI BV, Someren, The Netherlands) was provided at least three times a week.
Water
Free access to tap water.
Results of analysis for diet (nutrients and contaminants), hay and water were assessed and did not reveal any findings that were considered to have affected the study integrity. All certificates and results of analysis are retained in the NOTOX archives. - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 ml of the neat test substance
- Duration of treatment / exposure:
- One instillation in rabbit eye
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Single samples of approximately 100 mg of POTASSIUM CHLORATE (a volume of approximately 0.1 mL) were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours and/or 7 days after instillation.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.46
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- Instillation of approximately 100 mg of POTASSIUM CHLORATE (a volume of approximately 0.1 mL) into one eye of each of three rabbits resulted in effects on the iris and conjunctivae.
Iridial irritation grade 1 was observed in two animals and resolved within 24 hours.
The irritation of the conjunctivae consisted of redness, chemosis and discharge and completely resolved within 72 hours in one animal and within 7 days in the other two animals.
No corneal opacity was observed, and treatment of the eyes with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage. - Other effects:
- none
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the test item is not classified as an eye irritant according to the Regulation (EC) No. 1272/2008 (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
- Executive summary:
An eye irritation study was carried out based on the guidelines described below:
OECD No.405 (2002) "Acute Eye Irritation / Corrosion"
EC, No 440/2008, B5: "Acute Toxicity: Eye Irritation/Corrosion"
EPA, OPPTS 870.2400 (1998): "Acute Eye Irritation"
JMAFF guidelines (2000); including the most recent partial revisions.
In compliance with GLP, 0.1 mL of undiluted test item (Single samples of approximately 100 mg of Potassium Chlorate) was instilled into one eye of 3 males New Zealand White strain rabbits. The eyes were examined and the changes were observed at 1, 24, 48, 72 h and 7 days after instillation of test item and graded according to the Draize method.
Iridial irritation grade 1 was observed in two animals and resolved within 24 hours. The irritation of the conjunctivae consisted of redness, chemosis and discharge and completely resolved within 72 hours in one animal and within 7 days in the other two animals. Remnants of the test substance were present in the eye of one animal on Day 1.
Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0.0 / 0.0 / 0.0 for cornea score; 0.0 / 0.0 / 0.0 for iris score; 1.0 / 1.7 / 1.7 for conjunctivae score and 0.0 / 0.3 / 0.3 for chemosis score.
Instillation of Potassium Chlorate resulted in slight to moderate transient effects on the rabbit eye, resolving within 7 days after instillation.
Under the test conditions, the test item is not classified as an eye irritant according to the Regulation (EC) No. 1272/2008 (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). No signal word is required.
Referenceopen allclose all
Summary of ocular lesions
Anim. No. |
Effect |
Hours |
Days after application |
Mean score cornea Days 1/2/3 |
Mean score iritis Days 1/2/3 |
Mean score redness Days 1/2/3 |
Mean score chemosis Days 1/2/3 |
||||
1 |
1 |
2 |
3 |
7 |
14 |
||||||
7914 |
Cornea Iris Redness Chemosis |
0 0 2 0 |
0 0 2 1 |
0 0 1 0 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
0 |
0 |
1 |
0.33 |
7915 |
Cornea Iris Redness Chemosis |
0 0 2 1 |
0 1 2 1 |
0 1 2 1 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
0 |
0.67 |
1.33 |
0.67 |
7916 |
Cornea Iris Redness Chemosis |
0 0 2 1 |
0 0 2 1 |
0 0 1 1 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
0 |
0 |
1 |
0.67 |
7917 |
Cornea Iris Redness Chemosis |
0 0 3 2 |
0 1 3 2 |
0 0 2 1 |
0 0 1 0 |
0 0 0 0 |
0 0 0 0 |
0 |
0.33 |
3 |
1 |
7918 |
Cornea Iris Redness Chemosis |
0 1 2 2 |
0 1 2 2 |
0 0 2 1 |
0 0 1 0 |
0 0 0 0 |
0 0 0 0 |
0 |
0.33 |
1.67 |
1 |
7919 |
Cornea Iris Redness Chemosis |
1 1 2 2 |
0 0 2 2 |
0 0 1 0 |
0 0 1 0 |
0 0 0 0 |
0 0 0 0 |
0 |
0 |
1.33 |
0.67 |
Mean all anim. |
0 |
0.22 |
1.56 |
0.72 |
|||||||
* Nothing can be said about the area involved, because the author always scored 4 even if no effects are seen.
Summary of ocular lesions
Anim. No. |
Effect |
Hours |
Days after application |
Mean score cornea Days 1/2/3 |
Mean score iritis Days 1/2/3 |
Mean score redness Days 1/2/3 |
Mean score chemosis Days 1/2/3 |
||||
1 |
1 |
2 |
3 |
7 |
14 |
||||||
7914 |
Cornea Iris Redness Chemosis |
0 0 2 0 |
0 0 2 1 |
0 0 1 0 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
0 |
0 |
1 |
0.33 |
7915 |
Cornea Iris Redness Chemosis |
0 0 2 1 |
0 1 2 1 |
0 1 2 1 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
0 |
0.67 |
1.33 |
0.67 |
7916 |
Cornea Iris Redness Chemosis |
0 0 2 1 |
0 0 2 1 |
0 0 1 1 |
0 0 0 0 |
0 0 0 0 |
0 0 0 0 |
0 |
0 |
1 |
0.67 |
7917 |
Cornea Iris Redness Chemosis |
0 0 3 2 |
0 1 3 2 |
0 0 2 1 |
0 0 1 0 |
0 0 0 0 |
0 0 0 0 |
0 |
0.33 |
3 |
1 |
7918 |
Cornea Iris Redness Chemosis |
0 1 2 2 |
0 1 2 2 |
0 0 2 1 |
0 0 1 0 |
0 0 0 0 |
0 0 0 0 |
0 |
0.33 |
1.67 |
1 |
7919 |
Cornea Iris Redness Chemosis |
1 1 2 2 |
0 0 2 2 |
0 0 1 0 |
0 0 1 0 |
0 0 0 0 |
0 0 0 0 |
0 |
0 |
1.33 |
0.67 |
Mean all anim. |
0 |
0.22 |
1.56 |
0.72 |
|||||||
* Nothing can be said about the area involved, because the author always scored 4 even if no effects are seen.
Table1: Individual eye irritation scores.
|
|
Cornea |
|
Iris |
|
Conjunctivae |
|
Comments |
|||||||
Animal |
Time after dosing |
|
Opacity (0-4) |
Area (0-4) |
Fluor area (%)2 |
|
(0-2) |
|
Redness (0-3) |
Chemosis (0-4) |
Discharge (0-3) |
|
|||
|
|
|
|
||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
2811 |
1 hour |
|
0 |
0 |
- |
|
0 |
|
2 |
1 |
1 |
|
- |
||
|
24 hours |
|
0 |
0 |
0 |
|
0 |
|
2 |
0 |
0 |
|
- |
||
|
48 hours |
|
0 |
0 |
- |
|
0 |
|
1 |
0 |
0 |
|
- |
||
|
72 hours |
|
0 |
0 |
- |
|
0 |
|
0 |
0 |
0 |
|
- |
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
284 |
1 hour |
|
0 |
0 |
- |
|
1 |
|
2 |
2 |
1 |
|
- |
||
|
24 hours |
|
0 |
0 |
0 |
|
0 |
|
2 |
1 |
1 |
|
- |
||
|
48 hours |
|
0 |
0 |
- |
|
0 |
|
2 |
0 |
0 |
|
- |
||
|
72 hours |
|
0 |
0 |
- |
|
0 |
|
1 |
0 |
0 |
|
- |
||
|
7 days |
|
0 |
0 |
- |
|
0 |
|
0 |
0 |
0 |
|
- |
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||
285 |
1 hour |
|
0 |
0 |
- |
|
1 |
|
2 |
2 |
1 |
|
b |
||
|
24 hours |
|
0 |
0 |
0 |
|
0 |
|
2 |
1 |
0 |
|
- |
||
|
48 hours |
|
0 |
0 |
- |
|
0 |
|
2 |
0 |
0 |
|
- |
||
|
72 hours |
|
0 |
0 |
- |
|
0 |
|
1 |
0 |
0 |
|
- |
||
|
7 days |
|
0 |
0 |
- |
|
0 |
|
0 |
0 |
0 |
|
- |
||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||
1Sentinel,2 Green staining after fluorescein treatment (percentage of total corneal area)
Comments:
b Remnants of the test substance in the eye.
Table2: Mean value eye irritation scores.
Animal |
|
Mean 24, 48 and 72 hours |
||||||
|
Corneal |
|
Iris |
|
Conjunctivae |
|||
|
opacity |
|
Redness |
|
Chemosis |
|||
281 |
|
0.0 |
|
0.0 |
|
1.0 |
|
0.0 |
284 |
|
0.0 |
|
0.0 |
|
1.7 |
|
0.3 |
285 |
|
0.0 |
|
0.0 |
|
1.7 |
|
0.3 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
STUDIES WITH POTASSIUM CHLORATE
Skin irritation/corrosion
- In vitro skin irritation (eq. to OECD 439, K, Rel.1)
An in vitro skin irritation test using the Reconstructed human Epidermis (Episkin Standard model) was performed according to the OECD Guideline 439 and in compliance with GLP to predict the acute skin irritation potential of the test substance.
Skin irritation is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 15 minutes treatment with Potassium chlorate compared to the negative control tissues was 118%. Since the mean relative tissue viability for Potassium chlorate was above 50% after 15 minutes treatment Potassium chlorate is considered to be non-irritant.
The positive control had a mean cell viability after 15 minutes exposure of 17%. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was less than 18%, indicating that the test system functioned properly.
Finally, it is concluded that this test is valid and that Potassium chlorate is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report.
- In vitro skin corrosion (OECD 431, K, Rel.1)
An in vitro skin corrosion study was performed according to the OECD Guideline 431 and in compliance with GLP, using the EpiDerm reconstructed human epidermis model.
The positive control had a mean relative tissue viability of 12% after 3 minutes exposure. The absolute mean OD540 (optical density at 540 nm) of the negative control tissues was within the laboratory historical control data range. The maximum inter-tissue variability in viability between two tissues treated identically was less than 15% and the maximum difference in percentage between the mean viability of two tissues and one of the two tissues was less than 8%, indicating that the test system functioned properly.
Skin corrosion is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 3-minute and 1-hour treatments with Potassium chlorate compared to the negative control tissues was 110% and 99%, respectively. Because the mean relative tissue viability for Potassium chlorate was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment Potassium chlorate is considered to be not corrosive.
Finally, it is concluded that this test is valid and that Potassium chlorate is not corrosive in the in vitro skin corrosion test under the experimental conditions described in the report.
Eye irritation
- In vivo eye irritation (OECD 405, K, Rel.1)
An eye irritation study was carried out based on the guidelines described below:
OECD No.405 (2002) "Acute Eye Irritation / Corrosion"
EC, No 440/2008, B5: "Acute Toxicity: Eye Irritation/Corrosion"
EPA, OPPTS 870.2400 (1998): "Acute Eye Irritation"
JMAFF guidelines (2000); including the most recent partial revisions.
In compliance with GLP, 0.1 mL of undiluted test item (Single samples of approximately 100 mg of Potassium Chlorate) was instilled into one eye of 3 males New Zealand White strain rabbits. The eyes were examined and the changes were observed at 1, 24, 48, 72 h and 7 days after instillation of test item and graded according to the Draize method.
Iridial irritation grade 1 was observed in two animals and resolved within 24 hours. The irritation of the conjunctivae consisted of redness, chemosis and discharge and completely resolved within 72 hours in one animal and within 7 days in the other two animals. Remnants of the test substance were present in the eye of one animal on Day 1.
Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0.0 / 0.0 / 0.0 for cornea score; 0.0 / 0.0 / 0.0 for iris score; 1.0 / 1.7 / 1.7 for conjunctivae score and 0.0 / 0.3 / 0.3 for chemosis score.
Instillation of Potassium Chlorate resulted in slight to moderate transient effects on the rabbit eye, resolving within 7 days after instillation.
Under the test conditions, the test item is not classified as an eye irritant according to the Regulation (EC) No. 1272/2008 (CLP) and the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). No signal word is required.
- In vitro eye irritation (eq. to BCOP, OECD 437, K, Rel.1)
In an in vitro eye irritation study performed according to the OECD Guideline 437 and in compliance with GLP, 750 µL per cornea of diluted test item in physiological saline solution was applied to isolated bovine corneas for 240 minutes. Negative control (saline solution) and positive control (Imidazole) were used.
The mean in vitro irritancy score obtained with the negative control was less than 3.1 indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (20% w/v Imidazole) was 138.5 and within the historical positive control data range. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.
Potassium chlorate induced mild ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 14.7 after 240 minutes of treatment.
Finally, it is concluded that this test is valid and that Potassium chlorate is a mild irritant in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in the report.
STUDIES WITH SODIUM CHLORATE
Skin irritation/corrosion
- In vivo skin irritation (eq. to OECD 404, K, Rel.1)
A primary dermal irritation study was conducted on six albino rabbits using test substance Sodium Chlorate Crystal. The study was performed according to EPA Pesticide Assessment Guidelines, subdivision F, Hazard Evaluation: Human and Domestic Animals, November 1984, Acute Exposure, Skin Irritation. The method is equivalent to OECD Guideline 404 (acute Dermal Irritation/Corrosion). The study is designed and performed according to Good Laboratory Practice Standards.
Each animal had 2 test sites (clipped and abraded) and 2 untreated control sites (clipped and abraded). On each test site 0.5 g test material moistened with 0.2 ml of distilled water was applied. A single 4 -hour, occluded application of the test material to the intact skin produced immediately after patch removal none to very slight erythema and oedema. By 48 hours these test sites were free of irritation again and the observations were only up to 72 hours. Necrosis and ulceration were not reported.
Based on the results of the present study, it was concluded that undiluted Sodium Chlorate Crystal moistened with 0.2 ml distilled water induced a reversible very slight skin irritation. Therefore, the substance is not classifiable according to OECD-GHS.
Eye irritation
- In vivo eye irritation (eq. to OECD 405, K, Rel.1)
A study was conducted to assess the irritancy potential of Sodium Chlorate Crystal to the eye of six New Zealand Albino rabbits. The study was performed according to EPA Pesticide Assessment Guidelines, subdivision F, Hazard Evaluation: Human and Domestic Animals, November 1984, Acute Exposure, Eye Irritation. The irritation score used is according to the recommendations by Draize (1959) and OECD Guideline 405 (Acute Eye Irritation/Corrosion). The study was designed and performed according to Good Laboratory Practice Standards.A single application of 0.1 g of Sodium Chlorate Crystal to the left or the right eye of the rabbit produced moderate to severe redness of the conjunctivae. And all the treated conjunctivae showed moderate chemosis. Slight iritis was seen and no cornea-reaction occurred. Iris and conjunctivae effects are reversible within 7 days. Based on the results of the present study, it was concluded that the test compound induced a reversible slight eye irritation. Therefore, the substance is not classifiable according to OECD-GHS.
Justification for classification or non-classification
Respiratory irritation:
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