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Description of key information

Read-across data from sodium chlorate to assess the acute toxicity of potassium chlorate is justified, because the toxicity is expected to be related to the chlorate ion and not to the sodium or potassium ion.


 


Animal studies with potassium chlorate show a low acute toxicity after inhalation (LC50(4h) > 5.1 mg/L) and dermal (LD50(24h) > 2000 mg/kg bw) exposure.


Animal studies with sodium chlorate show a low acute toxicity after inhalation (LC50(4.5h) > 5.59 mg/l), dermal (LD50(24h)  > 2000 mg/kg bw) and oral (LD50 = 4950-6250 mg/kg bw) exposure.


An evaluation by the French poison control center of sensitivity of humans to sodium chlorate compared to rats led to the following conclusion: If one considers that 50% methemoglobinemia starts to induce signs that may lead to death in the absence of treatment, the dose would be about 20 g / kg for the whole population and 4.5 g / kg for the most sensitive part is the same range as rats.


 


Despite the low acute toxicity in animals, potassium chlorate has an harmonised classification (index No. 017-004-00-3, ATP0) as Acute Tox. 4 *, H302 and Acute Tox. 4 *, H332 (* minimum classification for the category) based on human experience indicating that classification of sodium chlorate is justified.


 

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting 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
Conclusions:
1> The classification for acute toxicity: according to the test in rats the LD50 is greater than 2000 mg / kg and the product is not classified. The interpretation of these human data in terms of death is very difficult indeed reflect certain death at doses much lower than others that have led to few symptoms and occurred in some cases with very low methaemoglobinaemia (other associated toxic ?). If one considers that 50% methemoglobinemia starts to induce signs that may lead to death in the absence of treatment, the dose would be about 20 g / kg for the whole population and 4.5 g / kg for the most sensitive part is the same range as rats.

2> Limit values:
a. Acceptable daily intake (ADI) is proposed for 0045 mg / kg / day or 4200 times less than the dose inducing 3% Methemoglobinemia in the general population. The occurrence of methemoglobinemia in these circumstances, even in cases of repeated dose seems unlikely.
b. The acceptable dose for the operator proposed is 0.35 mg / kg / day or 420 times less than the dose inducing 3% Methemoglobinemia in the general population. The occurrence of methemoglobinemia in these circumstances, repeated dose seems unlikely.
Endpoint:
acute toxicity: oral
Type of information:
other: review
Adequacy of study:
supporting study
Study period:
1999-2008
Reliability:
other: review
Rationale for reliability incl. deficiencies:
other: Review of poison control center data in France in relation to poisoning incidents with sodium chlorate and toxicity in humans

Summary (translated):


The coordination committee for toxicovigilance (CCTV) has been seized by the French security agency Food Safety, to identify and analyze French cases of human exposure to specialties phytopharmaceutical products based on sodium chlorate. In particular, the analysis should study the threshold for methemoglobinemia in humans and the irritant during respiratory, ocular or dermal exposure.
To answer these questions, a retrospective study was conducted over a period ranging from 1999 to 2009 to identify human cases of exposure to chlorate preparations reported to poison control and toxicovigilance centers.
The survey identified 346 exposure cases over the period 1999 - December 2008. The analysis of the methaemoglobinant was based on the 179 cases of oral exposure. Over the period studied, 29 people who had ingested sodium chlorate had pathological methemoglobinemia (MetHb ≥ 3%). The smallest doses at the origin of a MetHb pathological per os in humans were in the range of one to two tens of grams of chlorate sodium.
These doses were also the smallest lethal doses, knowing that of these 29 cases of intoxication, all volunteers, nearly one in two (45%) had resulted in the death of the patient.
Irritation analysis of sodium chlorate preparations by mucocutaneous contact 68 cases identified during the period 1999 - December 2009. All cases with local irritation resulted from acute and accidental exposures. In more than 8 out of 10 cases, cases of local irritation with a plant protection product containing chlorate had occurred in the home, as part of a gardening activity or because of domestic accidents. Occupational exposures in agriculture were minor. Of the 68 cases in the sample, 2 cases of respiratory irritation and 1 case of irritation by eyepieces were considered severe (high severity score of 3, on a scale of 0 to 3). In their the vast majority of cases of severe local irritation attributable to sodium chlorate (burning cutaneous, keratitis, dyspnea and acute pulmonary edema, etc.) occurred during combustion and / or the explosion of preparations based on sodium chlorate. Other cases of accidental exposure, including professional, without explosion and / or combustion corresponded to irritative signs local and mild to skin burning sensation or ENT, skin or eye erythema, conjunctivitis.
A case of sequel is described: scar on the face of a 13-year-old boy burned during the explosion a homemade fireworks. These cicatricial sequelae are suspected in all cases with combustion and / or explosion of sodium chlorate, especially severe cases. In conclusion, the poisoning observed is to be considered in view of the relative accessibility of professional weedkillers and the general public based on sodium chlorate between 1999 and 2009. The cases Serious death with ingestion is common (45% of cases with methemoglobinemia pathology and a known ISD) but they only occur in suicide attempts with a dose assumed to be ingested from several grams of sodium chlorate. Severe cases of irritation mucocutaneous lesions appear to occur only during diversion of use of the preparations. herbicides (manufacture of bombs or explosive and colored rockets) or projection accidental ignition of a phytopharmaceutical product causing combustion and / or the explosion of sodium chlorate. Other cases of accidental exposure, including occupational exposure without explosion and / or combustion are at the origin of local and benign irritative signs.

Conclusions:
1> The classification for acute toxicity: according to the test in rats the LD50 is greater than 2000 mg / kg and the product is not classified. The interpretation of these human data in terms of death is very difficult indeed reflect certain death at doses much lower than others that have led to few symptoms and occurred in some cases with very low methaemoglobinaemia (other associated toxic ?). If one considers that 50% methemoglobinemia starts to induce signs that may lead to death in the absence of treatment, the dose would be about 20 g / kg for the whole population and 4.5 g / kg for the most sensitive part is the same range as rats.

2> Limit values:
a. Acceptable daily intake (ADI) is proposed for 0045 mg / kg / day or 4200 times less than the dose inducing 3% Methemoglobinemia in the general population. The occurrence of methemoglobinemia in these circumstances, even in cases of repeated dose seems unlikely.
b. The acceptable dose for the operator proposed is 0.35 mg / kg / day or 420 times less than the dose inducing 3% Methemoglobinemia in the general population. The occurrence of methemoglobinemia in these circumstances, repeated dose seems unlikely.
Endpoint:
acute toxicity: oral
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 source
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
Dose group 5000 mg/kg bw
- one female died
- Time of death: one day after dosing
Dose group 2000 mg/kg bw
- no animal died
Clinical signs:
- Dose group 5000 mg/kg bw
Shortly after dosing several animals appeared lethargic (2 females and 2 males) and had a hunched posture (2 females and 2 males). By 24 hours these conditions were no longer evident and survivors appeared active and healthy for the remainder of the test period. The female animal that died showed lethargy and ano-genital staining.
- Dose group 2000 mg/kg bw
one male animal, lethargic and hunched posture. By 24 hours these conditions were no longer evident and survivors appeared active and healthy for the remainder of the test period.
Body weight:
- Dose group 5000 mg/kg bw
all survivors gained weight between days 0 and 7 and again between days 7 and 14, although the weight gain in most cases was marginal.
- Dose group 200 mg/kg bw
all survivors gained weight between days 0 and 7 and again between days 7 and 14 at a rate generally expected for the strain and age of animals used.
Gross pathology:
- Dose group 5000 mg/kg bw
The female that died showed green discoloration of the intestines, a light green fluid in the stomach, pink liquid in the abdominal cavity and dark red lung discoloration. Other animals showed no significant abnormalities at necropsy, moderate redness in the lungs of all animals.
- Dose group 2000 mg/kg bw
Negligible, slight to moderate redness in the lungs of all animals.
Interpretation of results:
GHS criteria not met
Conclusions:
LD50 > 5000 mg/kg bw
Executive summary:

The study was performed in accordance with EPA Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation: Human and Domestic Animals, November 1984, Acute Exposure, oral Toxicity Limit Test (equivalent to OECD Guideline 401 - Acute Oral Toxicity -). Furthermore, the study was designed and performed according to Good Laboratory Practice Standards.

The test material, Sodium Chlorate Crystal, was evaluated for its acute oral toxicity potential in 30 Sprague Dawley rats. Ten animals were used in a rangefinding study (dose levels: 5, 2.5, 1.25, 0.6 and 0.3 g/kg bw). Thereafter Sodium Chlorate was administered as gavage doses in a first (5.0 g/kg and second (2.0 g/kg) limit test. No mortality occurred in animals dosed at 2.0 g/kg and 1 animal died at dose level 5.0 g/kg. Clinical signs of toxicity at 5.0 g/kg included hunched posture and reduced feces, which were no longer evident on Day 3. At 2.0 g/kg only hunched posture was observed at 2 -4 hours post dosing in one male. There was no meaningful effect on body weight gain in animals surviving to termination. Necropsy findings at 5.0 g/kg showed green discoloration of the intestines, a light green fluid in the stomach, pink liquid in the abdominal cavity and dark red lung discoloration. At 2.0 g/kg only slight to moderate redness in the lungs of all animals was observed.

Conclusions: The acute oral LD50 of Sodium Chlorate Crystal was determined to be greater than 5000 mg/kg bw.

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 October 1990 - 11 January 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed under GLP and according to internationally accpeted guidelines.
Qualifier:
according to guideline
Guideline:
EPA OPP 81-1 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hilltop Lab Animals, Scottdale, PA
- Age at study initiation: Young adults
- Weight at study initiation: weighing 222 - 293 grams
- Fasting period before study: Approximately 18 hours prior to selction and test initiation
- Housing: individually in suspended stainless steel caging with mesh floors
- Diet (e.g. ad libitum): Pelleted Purina Rat Chow #5012, ad lib
- Water (e.g. ad libitum): Tap water supplied by automatic water system, ad lib
- Acclimation period: 28 or 30 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): no info
- Air changes (per hr): no info
- Photoperiod (hrs dark / hrs light): no info


IN-LIFE DATES: Rangefinding: From: November 29, 1990 To: December 7, 1990;
Test: From: December 19, 1990 To: January 11, 1991
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50% w/w solution in distilled water
- Amount of vehicle (if gavage): no info
- Justification for choice of vehicle: no info
- Lot/batch no. (if required): no info
- Purity: no info


MAXIMUM DOSE VOLUME APPLIED: approximately 7 ml/kg
Doses:
- range finding study: 300, 600, 1250, 2500 and 5000 mg/kg bw; (one male and one female per dose)
- full acute oral limit test 1: 5000 mg/kg bw
- full acute oral limit test 2: 2000 mg/kg bw
No. of animals per sex per dose:
full acute oral limit test: 5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: rats were observed at 1, 2 and 4 hours post-dosing and at least once daily thereafter for signs of gross toxicity and mortality. Bodyweights were recorded initially, on day 7, at termination (day 14) or after death.
- Necropsy of survivors performed: yes, gross necropsies were performed on the animals that died during the study and at termination of the study
- Other examinations performed: clinical and behavioural signs, body weight, histopathology
Statistics:
No.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
Dose group 5000 mg/kg bw
- one female died
- Time of death: one day after dosing
Dose group 2000 mg/kg bw
- no animal died
Clinical signs:
- Dose group 5000 mg/kg bw
Shortly after dosing several animals appeared lethargic (2 females and 2 males) and had a hunched posture (2 females and 2 males). By 24 hours these conditions were no longer evident and survivors appeared active and healthy for the remainder of the test period. The female animal that died showed lethargy and ano-genital staining.
- Dose group 2000 mg/kg bw
one male animal, lethargic and hunched posture. By 24 hours these conditions were no longer evident and survivors appeared active and healthy for the remainder of the test period.
Body weight:
- Dose group 5000 mg/kg bw
all survivors gained weight between days 0 and 7 and again between days 7 and 14, although the weight gain in most cases was marginal.
- Dose group 200 mg/kg bw
all survivors gained weight between days 0 and 7 and again between days 7 and 14 at a rate generally expected for the strain and age of animals used.
Gross pathology:
- Dose group 5000 mg/kg bw
The female that died showed green discoloration of the intestines, a light green fluid in the stomach, pink liquid in the abdominal cavity and dark red lung discoloration. Other animals showed no significant abnormalities at necropsy, moderate redness in the lungs of all animals.
- Dose group 2000 mg/kg bw
Negligible, slight to moderate redness in the lungs of all animals.
Interpretation of results:
GHS criteria not met
Conclusions:
LD50 > 5000 mg/kg bw
Executive summary:

The study was performed in accordance with EPA Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation: Human and Domestic Animals, November 1984, Acute Exposure, oral Toxicity Limit Test (equivalent to OECD Guideline 401 - Acute Oral Toxicity -). Furthermore, the study was designed and performed according to Good Laboratory Practice Standards.

The test material, Sodium Chlorate Crystal, was evaluated for its acute oral toxicity potential in 30 Sprague Dawley rats. Ten animals were used in a rangefinding study (dose levels: 5, 2.5, 1.25, 0.6 and 0.3 g/kg bw). Thereafter Sodium Chlorate was administered as gavage doses in a first (5.0 g/kg and second (2.0 g/kg) limit test. No mortality occurred in animals dosed at 2.0 g/kg and 1 animal died at dose level 5.0 g/kg. Clinical signs of toxicity at 5.0 g/kg included hunched posture and reduced feces, which were no longer evident on Day 3. At 2.0 g/kg only hunched posture was observed at 2 -4 hours post dosing in one male. There was no meaningful effect on body weight gain in animals surviving to termination. Necropsy findings at 5.0 g/kg showed green discoloration of the intestines, a light green fluid in the stomach, pink liquid in the abdominal cavity and dark red lung discoloration. At 2.0 g/kg only slight to moderate redness in the lungs of all animals was observed.

Conclusions: The acute oral LD50 of Sodium Chlorate Crystal was determined to be greater than 5000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: inhalation
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
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.59 mg/L air
Exp. duration:
4.5 h
Mortality:
- Limit test 1: no mortality
- Limit test 2: no mortality
Clinical signs:
other:
Body weight:
- Limit test 1: All animals gained weight over the 14-day observation period.
- Limit test 2: All animals gained weight overall.
Gross pathology:
- Limit test 1: Red discoloration of the lungs in most animals (4 males and 2 females). Small cysts (1 female) or uneven texture (1 female and 1 male) was evident on the surface of the lungs.
- Limit test 2: Red discoloration of the lungs in all animals. The jejunum of 2 females from was red in colour.
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The acute (4.5 h) inhalation LC50 of aerosolized Sodium Chlorate Crystal was determined to be greater than 5.59 mg/L in males and females. Because higher concentrations than 5.59 mg/L had not been tested and effects at those concentrations are unknown the test material was classified in Category 5 according to OECD-GHS.
Executive summary:

Sodium Chlorate was evaluated for its acute inhalation toxicity potential in albino rats. The study was performed in accordance with EPA Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation: Human and Domestic Animals, November 1984, Acute Exposure, acute Inhalation Toxicity. Similar to OECD Guideline 403 (Acute Inhalation Toxicity). The study was designed and performed according to Good Laboratory Practice Standards.


The target gravimetric chamber concentration (5 mg/mL, which is also required by OECD 403) and particle size distribution (25% 1 micron) could not be reached simultaneously. Therefore two limit tests were performed in which one of both parameters was optimal. Five males and five females were assigned to each study and they were exposed for 4 ½ hours to an aerosol (test atmosphere generated from a 33.3% w/w solution in distilled water) at a level of 1.42 mg/L (limit test 1) and 5.59 mg/L (limit test 2). There was no mortality during both studies. Clinical signs of toxicity included facial staining, reduced movement, test material-stained fur and closed eyes and in limit test 2 also irregular respiration and hunched posture, which were no longer evident on Day 1 (limit test 1) or Day 2 (limit test 2). Observations were up to 14 days and all animals gained weight overall. The gross necropsy showed red discoloration of the lungs in most animals.


The acute (4.5 h) inhalation LC50 of aerosolized Sodium Chlorate Crystal was determined to be greater than 5.59 mg/L in males and females. Because higher concentrations than 5.59 mg/L had not been tested and effects at higher concentrations are unknown the test material was classified in Category 5 according to OECD-GHS.

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 1991 - February 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: study performed according to guideline and under GLP.
Qualifier:
according to guideline
Guideline:
EPA OPP 81-3 (Acute inhalation toxicity)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
Two limit tests are performed:
The target gravimetric chamber concentration (5 mg/mL which is also required by OECD 403) and particle size distribution (25% < 1 micron) could not be reached simultaneously. Therefore two experiments were performed in which one of both parameters was optimal.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hilltop Lab Animals, Scottdale, PA
- Age at study initiation: Young adult
- Weight at study initiation: weighing 216 - 249 g
- Fasting period before study: no info
- Housing: individually in suspended stainless steel caging with mesh floors
- Diet (e.g. ad libitum): Pelleted Purina Rat Chow, ad lib
- Water (e.g. ad libitum): Tap water supplied by automatic water system, ad lib
- Acclimation period: 7 or 12 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Limit test 1: 22 - 23; Limit test 2: 21 - 24
- Humidity (%): no info
- Air changes (per hr): no info
- Photoperiod (hrs dark / hrs light): no info


IN-LIFE DATES: From: January 30, 1991 To: February 25, 1991
Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
other:
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Rectangular perspex gravimetric chamber with a volume of 100 liters operated under slight negative pressure.
- Exposure chamber volume: 100 L
- Method of holding animals in test chamber: individually in stainless steel mesh cages within the inhalation chamber.
- Source and rate of air: breathing grade air from a compressed gas cylinder and additional "diluent" air from a filtered conditioned ambient source. Air flows were 26.1 – 28.2 lpm (limit test 1) and 34.6 – 38.8 lpm (limit test 2).
- Method of conditioning air: breathing grade air from a compressed gas cylinder and additional "diluent" air from a filtered conditioned ambient source.
- System of generating particulates/aerosols: 1/4 inch JCO atomizer (Spraying Systems Inc.) #2050 fluid cap and #73160 air cap. The test material was metered to the atomization nozzle through size 14 tygon tubing using a Master Flex Pump (Model 7520-35). In an attempt to affect the particle size distribution during Limit Test #1 and most of its associated trials, a circular tin disk (diameter 9.5 cm) was placed inside the exposure chamber 53 to 106 mm in front of the nebulizer during aerosol generation. Since this process tended to drastically lower attainable chamber concentration, it was not used for Limit Test #2.
- Method of particle size determination: An eight-stage Andersen cascade impactor was used to assess the particle size distribution of the test atmosphere. The filter paper collection stages were weighed before and at least 10 minutes after each sampling to determine the mass collected at each stage on a dry weight basis. The MMAD and GSD were determined graphically using two-cycle logarithmic probit axes.
- Treatment of exhaust air: no info
- Temperature, humidity, pressure in air chamber:
Chamber temperature range (°C): 22-23 (limit test 1) and 19-20 (limit test 2)
Rel. Humidity (% RH): 32.1-39.0 (limit test 1) and 27.2-32.5 (limit test 2)
Chamber under slight negative pressure.
T90 (min): 6-8
T99 (min): 13-17


TEST ATMOSPHERE
- Brief description of analytical method used: Gravimetric samples were withdrawn on 5 or 6 occasions from the breathing zone of the animals. Samples were collected using membrane filters in filter holders attached by 1/4 inch tygon tubing to a sampling pump. Filter papers were weighed before and at least 10 minutes after each sampling to determine the mass collected on a dry weight basis. On several occasions filters were re-weighed after 30 minutes to verify that complete drying had occurred. The collections were carried out for 1 minute at air flows of 4 lpm.
- Samples taken from breathing zone: yes


VEHICLE
- Composition of vehicle (if applicable): distilled water
- Concentration of test material in vehicle (if applicable): test material was aerosolized as a 33.3% w/w solution in distilled water
- Justification of choice of vehicle: no info


TEST ATMOSPHERE (if not tabulated)
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.):
Limit test 1: sample 1, MMAD = 2.1 µm and GSD = 1.9; sample 2, MMAD = 2.2 and GSD = 2.0
Limit test 2: sample 1, MMAD = 3.0 µm and GSD = 1.7; sample 2, MMAD = 3.0 and GSD = 1.8
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4.5 h
Concentrations:
limit test 1: 1.42 ± 0.38 mg/l (nominal concentration = 637.5 mg/L, 33.3% w/w solution)
limit test 2: 5.59 ± 1.64 mg/l (nominal concentration = 229.9 mg/L, 33.3% w/w solution)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed before exposure commencement, every 15 minutes during the first exposure hour, and every 30 minutes thereafter through exposure termination. On removal from the chamber the animals were individually examined. Bodyweights were recorded prior to exposure and on days 1, 2, 4, 7, 10 and 14.
- Necropsy of survivors performed: yes, All survivors to termination were euthanized by diethyl ether inhalation and subjected to necropsy examination. The lungs of all animals were removed and placed in buffered formalin.
- Other examinations performed: clinical signs, body weight, histopathology
Statistics:
Not required.
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.59 mg/L air
Exp. duration:
4.5 h
Mortality:
- Limit test 1: no mortality
- Limit test 2: no mortality
Clinical signs:
other:
Body weight:
- Limit test 1: All animals gained weight over the 14-day observation period.
- Limit test 2: All animals gained weight overall.
Gross pathology:
- Limit test 1: Red discoloration of the lungs in most animals (4 males and 2 females). Small cysts (1 female) or uneven texture (1 female and 1 male) was evident on the surface of the lungs.
- Limit test 2: Red discoloration of the lungs in all animals. The jejunum of 2 females from was red in colour.
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The acute (4.5 h) inhalation LC50 of aerosolized Sodium Chlorate Crystal was determined to be greater than 5.59 mg/L in males and females. Because higher concentrations than 5.59 mg/L had not been tested and effects at those concentrations are unknown the test material was classified in Category 5 according to OECD-GHS.
Executive summary:

Sodium Chlorate was evaluated for its acute inhalation toxicity potential in albino rats. The study was performed in accordance with EPA Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation: Human and Domestic Animals, November 1984, Acute Exposure, acute Inhalation Toxicity. Similar to OECD Guideline 403 (Acute Inhalation Toxicity). The study was designed and performed according to Good Laboratory Practice Standards.


The target gravimetric chamber concentration (5 mg/mL, which is also required by OECD 403) and particle size distribution (25% 1 micron) could not be reached simultaneously. Therefore two limit tests were performed in which one of both parameters was optimal. Five males and five females were assigned to each study and they were exposed for 4 ½ hours to an aerosol (test atmosphere generated from a 33.3% w/w solution in distilled water) at a level of 1.42 mg/L (limit test 1) and 5.59 mg/L (limit test 2). There was no mortality during both studies. Clinical signs of toxicity included facial staining, reduced movement, test material-stained fur and closed eyes and in limit test 2 also irregular respiration and hunched posture, which were no longer evident on Day 1 (limit test 1) or Day 2 (limit test 2). Observations were up to 14 days and all animals gained weight overall. The gross necropsy showed red discoloration of the lungs in most animals.


The acute (4.5 h) inhalation LC50 of aerosolized Sodium Chlorate Crystal was determined to be greater than 5.59 mg/L in males and females. Because higher concentrations than 5.59 mg/L had not been tested and effects at higher concentrations are unknown the test material was classified in Category 5 according to OECD-GHS.

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 October 2009 16 October 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: performed accoding to OECD test guidelines and GLP compliant
Qualifier:
according to guideline
Guideline:
OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Species Rat: Crl:WI(Han) (outbred, SPF-Quality)
The rat is recognised by international guidelines as the recommended test system (e.g. OECD, EC).
Source: Charles River Deutschland, Sulzfeld, Germany.
Number of animals 3 males and 3 females (females were nulliparous and non-pregnant).
Age and body weight Young adult animals were selected (approximately 11 weeks old).
Animals used within the study were of approximately the same age and body weight variation did not exceed +/- 20% of the sex mean.
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.

6.6. 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 ± 3.0C (actual range: 19.9 – 21.4C), a relative humidity of 30-70% (actual range: 31 - 77%) and 12 hours artificial fluorescent light and 12 hours darkness per day.
Cleaning procedures in the room might have caused the temporary fluctuations above the optimal maximum level of 70% for relative humidity. Based on laboratory historical data, these fluctuations were considered not to have affected the study integrity.

During exposure the temperature and relative humidity were 19.8 to 21.1C (mean 20.8 ± 0.4 C) and 21 to 50% (mean 29 ± 9%) respectively.

Accommodation
Animals were housed in groups of 3 animals per sex per cage in labelled Macrolon cages (type IV; height 18 cm) containing sterilised sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom).
After exposure, animals were placed in a cage with a stainless steel grid and the bedding and cage enrichment were withheld . At the end of the Day of exposure animals were housed as described above.

Acclimatisation period was at least 5 days before start of treatment under laboratory conditions. Animals were housed with maximally 5 animals per cage per sex as described above.

Diet
Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany) except during exposure to the test substance.

Water
Free access to tap water except during exposure to the test substance.

Results of analysis for each batch of diet (nutrients and contaminants), sawdust, paper 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.

Route of administration:
inhalation: dust
Type of inhalation exposure:
nose only
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
Animals were exposed to the test substance via the inhalatory route. For this purpose the animals were placed in restraining tubes, connected to the exposure chamber.
The design of the exposure chamber was based on the flow past nose-only inhalation chamber (Am. Ind. Hyg Assoc. J. 44(12): 923-928, 1983). The chamber consisted of 3 animal sections with 8 animal ports each. The number of animal sections and number of open animal ports were adapted to the air flow in such a way that at each animal port the theoretical air flow was on average 1.4 L/min, which ensures an adequate oxygen supply to the test animals. The inlet of the test atmosphere was located at the top section and the outlet was located at the bottom section. The direction of the flow of the test atmosphere guaranteed a freshly generated atmosphere for each individual animal.
The placement of the individual animals in the inhalation chamber is shown in figure 2. All components of the exposure chamber, which could come in contact with the test material, were made of stainless steel, glass, rubber or plastic. To avoid exposure of the personnel and contamination of the laboratory the exposure chamber was placed in a fume hood, which was maintained at a slightly negative pressure.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
4 h
Concentrations:
5.1 mg/L
No. of animals per sex per dose:
3 males / 3 females
Control animals:
no
Details on study design:
Potassium chlorate was administered as an aerosol by inhalation for a single but interrupted exposure lasting 4 hours and 8 minutes in total to one group of three male and three female Wistar rats. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15).
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.1 mg/L air
Exp. duration:
4 h
Mortality:
No mortality occurred.
Clinical signs:
other:
Body weight:
Overall body weight gain was within the range expected for rats of this strain and age used in this type of study.

Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.
Interpretation of results:
GHS criteria not met
Conclusions:
The inhalatory LC50, 4h value of potassium chlorate in Wistar rats was established
to exceed 5.1 mg/L.
Executive summary:

The assessment of the acute inhalation toxicity of the test item, potassium chlorate, in the rat (acute toxic class method) was carried out based on the guideline described in Organisation for Economic Co-operation and Development (OECD), OECD Guidelines for Testing of Chemicals, Section 4, Health Effects. No.436, "Acute Inhalation Toxicity-Acute Toxic Class Method", September 2009.


 


Potassium chloratewas administered as an aerosol by inhalation for a single but interrupted exposure lasting 4 hours and 8 minutes in total to one group of three male and three female Wistar rats. Animals were subjected to daily observations and weekly determination of body weight.Macroscopic examination was performed after terminal sacrifice (day 15).


 


The mean time-weighed actual concentration was 5.1 ± 0.3 mg/L. The nominal concentration was 144 mg/L. The generation efficiency (ratio of actual and nominal concentration) was 3.5%.


 


The Mass Median Aerodynamic Diameter (MMAD) and geometric standard deviation (gsd) were determined twice during exposure. The MMAD was 4.0 mm and 4.4 mm respectively and the gsd was 1.9 and 1.8 respectively. Agglomeration of aerosol particles at this high concentration might have resulted in these higher MMAD values, causing the second measurement to fall outside the recommended range of 1 – 4µm. Since the MMAD values were at or close to the upper limit of 4µm and since the gsd was appropriate (i.e. between 1.5 and 3), it can be assumed that deposition of particles in the lower respiratory tract had occurred. 


 


No mortality occurred andno clinical signs were noted during the study.


Overall body weight gain was within the range expected for rats of this strain and age used in this type of study.


No abnormalities were found at macroscopic post mortem examination of the animals.


 


The inhalatory LC50, 4h value of potassium chlorate in Wistar rats was established to exceed 5.1 mg/L.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
5

Acute toxicity: via dermal route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: dermal
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
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality.
Clinical signs:
All the animals appeared healthy and active during the study period. Slight to moderate skin irritation was observed at the dose site for several days after dosing.
Body weight:
All animals gained weight over the 14-day observation period.
Gross pathology:
Gross necropsy findings were unremarkable. All tissues and organs appeared normal.
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The Single Dose Acute Dermal LD50 of Sodium Chlorate Crystal, moistened with distilled water and applied to the skin for 24 hours, is greater than 2000 mg/kg bw. Because higher concentrations than 2000 mg/kg had not been tested and effects at those higher concentrations are unknown the test material was classified in Category 5 according to OECD-GHS.
Executive summary:

Sodium Chlorate was evaluated for its acute dermal toxicity potential in albino rabbits. The study was performed in accordance with EPA Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation: Human and Domestic Animals, November 1984, Acute Exposure, Dermal Toxicity. Similar to OECD Guideline 402 (Acute Dermal Toxicity). The study was designed and performed according to Good Laboratory Practice Standards.


For 24 hours 2000 mg/kg bw test substance (moistened with approximately 0.3 ml of distilled water per gram of test substance) is applied to the skin of ten albino rabbits. A single 24 -hour, occluded application of the test material to the intact skin produced a slight to moderate skin irritation. No mortality occurred. There were no signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour. All animals gained weight over the 14-day observation period. The gross necropsy showed that all tissues and organs appeared normal.


The Single Dose Acute Dermal LD50 of Sodium Chlorate Crystal, moistened with distilled water and applied to the skin for 24 hours, is greater than 2000 mg/kg bw. Because higher concentrations than 2000 mg/kg had not been tested and effects at those higher concentrations are unknown the test material was classified in Category 5 according to OECD-GHS.

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26 June 1991 - 07 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 81-2 (Acute Dermal Toxicity)
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
Principles other than OECD Guideline:
- 24-h occlusive application
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
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: males 2.6-2.8 kg; females 2.5-2.8 kg
- 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
- Humidity (%): no info
- Air changes (per hr): no info
- Photoperiod (hrs dark / hrs light): no info


IN-LIFE DATES: From: June 26, 1991 To: July 10, 1991
Type of coverage:
occlusive
Vehicle:
other: none, test substance applied moistened with water (0.3 ml per 1000mg)
Details on dermal exposure:
TEST SITE
- Area of exposure: 10.2x5.08cm2 (4x2") (dorsal and ventral surfaces from scapular to pelvic area)
- % coverage: no info (10% clipped)
- Type of wrap if used: an adhesive-backed gauze patch containing test substance was placed on each rabbit. The patches and entire trunk of each rabbit were then wrapped with tape to aid in maintaining test patch position and to minimize evaporation. Neck collars were then placed on each rabbit.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): after 24-h the patches and collars were removed and the exposed surface was gently wiped clean of any residual test substance.
- Time after start of exposure: 24-h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw (completely moistened with distilled water)
- Concentration (if solution): not applicable (sample moistened with approximately 0.3 ml of distilled water per gram of test substance).
- Constant volume or concentration used: yes
- For solids, paste formed: yes


VEHICLE
- Amount(s) applied (volume or weight with unit): 0.3 ml per gram of test substance
- Concentration (if solution): not applicable
Duration of exposure:
24-h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
10 (5 males and 5 females)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were observed at 1, 2, and 4 h after dosing and once daily for the next 14 days. Body weight was measured at day 0, 7 and 14.
- Necropsy of survivors performed: yes, necropsy was performed on all survivors.
- Other examinations performed: clinical signs, body weight, histopathology.
Statistics:
No statistics.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality.
Clinical signs:
All the animals appeared healthy and active during the study period. Slight to moderate skin irritation was observed at the dose site for several days after dosing.
Body weight:
All animals gained weight over the 14-day observation period.
Gross pathology:
Gross necropsy findings were unremarkable. All tissues and organs appeared normal.
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The Single Dose Acute Dermal LD50 of Sodium Chlorate Crystal, moistened with distilled water and applied to the skin for 24 hours, is greater than 2000 mg/kg bw. Because higher concentrations than 2000 mg/kg had not been tested and effects at those higher concentrations are unknown the test material was classified in Category 5 according to OECD-GHS.
Executive summary:

Sodium Chlorate was evaluated for its acute dermal toxicity potential in albino rabbits. The study was performed in accordance with EPA Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation: Human and Domestic Animals, November 1984, Acute Exposure, Dermal Toxicity. Similar to OECD Guideline 402 (Acute Dermal Toxicity). The study was designed and performed according to Good Laboratory Practice Standards.


For 24 hours 2000 mg/kg bw test substance (moistened with approximately 0.3 ml of distilled water per gram of test substance) is applied to the skin of ten albino rabbits. A single 24 -hour, occluded application of the test material to the intact skin produced a slight to moderate skin irritation. No mortality occurred. There were no signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour. All animals gained weight over the 14-day observation period. The gross necropsy showed that all tissues and organs appeared normal.


The Single Dose Acute Dermal LD50 of Sodium Chlorate Crystal, moistened with distilled water and applied to the skin for 24 hours, is greater than 2000 mg/kg bw. Because higher concentrations than 2000 mg/kg had not been tested and effects at those higher concentrations are unknown the test material was classified in Category 5 according to OECD-GHS.

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
29 December 2009 12 January 2010
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 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Species Rat, Wistar strain, Crl:WI (Han) (outbred, SPF-Quality).
Recognized by international guidelines as the recommended test system (e.g. OECD, EC).
Source: Charles River Deutschland, Sulzfeld, Germany.
Number of animals 5 males and 5 females (females were nulliparous and non-pregnant).
Age and body weight Young adult animals (approx. 10 weeks old) were selected. Body weight variation did not exceed +/- 20% of the sex mean.
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 skin to be treated, which was intact and 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: 19.4 – 21.9ºC), a relative humidity of 40-70% (actual range: 27 - 75%) and 12 hours artificial fluorescent light and 12 hours darkness per day.
Cleaning procedures in the room might have caused the temporary fluctuations above the optimal maximum level of 70% for relative humidity. Based on laboratory historical data, these fluctuations were considered not to have affected the study integrity.

Accommodation
Individually housed in labeled Macrolon cages (MIII type, height 18 cm.) containing sterilized sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, United Kingdom).
Acclimatization period was at least 5 days before start of treatment under laboratory conditions. During the acclimatization period the animals were group housed in Macrolon cages (MIV type).

Diet
Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).

Water
Free access to tap water.

Results of analysis for diet (nutrients and contaminants), sawdust, paper 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.
Type of coverage:
occlusive
Vehicle:
CMC (carboxymethyl cellulose)
Details on dermal exposure:
Method Dermal application.

Clipping One day before exposure (Day -1) an area of approximately 5x7 cm on the back of the animal was clipped.

Application The test substance formulation was applied in an area of approx. 10% of the total body surface, i.e. approx. 25 cm² for males and 18 cm² for females. The formulation was held in contact with the skin with a dressing, consisting of a surgical gauze patch (Surgy 1D)*, successively covered with aluminum foil and Coban elastic bandage*. A piece of Micropore tape* was additionally used for fixation of the bandages in females only.
*. Manufacturers: Laboratoires Stella s.a., Liege, Belgium (surgical gauze) and 3M, St. Paul, Minnesota, U.S.A. (Coban & Micropore).
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males / 5 females
Control animals:
not required
Details on study design:
POTASSIUM CHLORATE was administered to five Wistar rats of each sex by a single dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15).
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occurred.



Clinical signs:
Flat posture, hunched posture, chromodacryorrhoea and/or ptosis were noted among the animals on Day 1. Scales and/or scabs were seen in the treated skin-area of two females from Day 6 onwards.
Body weight:
The changes noted in body weight gain in males and females were within the range expected for rats used in this type of study and were therefore considered not indicative of toxicity.





Gross pathology:

No abnormalities were found at macroscopic post mortem examination of the animals.
Interpretation of results:
GHS criteria not met
Conclusions:
The dermal LD50 value of POTASSIUM CHLORATE in Wistar rats was established to exceed 2000 mg/kg body weight.
Executive summary:

The assessment of the acute dermal toxicity of the test item, Potassium Chlorate, in the rat was carried out based on the guidelines described in:


OECD No.402 (1987) "Acute Dermal Toxicity"


Commission Regulation (EC) No 440/2008, B3: "Acute Toxicity (Dermal)"


EPA, OPPTS 870.1200 (1998), "Acute Dermal Toxicity"


JMAFF Guidelines (2000), including the most recent revisions.


 


Potassium Chlorate was administered to five Wistar rats of each sex by a single dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15).


 


  


No mortality occurred.


Flat posture, hunched posture, chromodacryorrhoea and/or ptosis were noted among the animals on Day 1. Scales and/or scabs were seen in the treated skin-area of two females from Day 6 onwards.


The changes noted in body weight gain in males and females were within the range expected for rats used in this type of study and were therefore considered not indicative of toxicity.


No abnormalities were found at macroscopic post mortem examination of the animals.


 


 


The dermal LD50 value of Potassium Chlorate in Wistar rats was established to exceed 2000 mg/kg body weight

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information




As much as possible key data for sodium chlorate will be used for cross reading and complementing information available for potassium chlorate. Read across is possible for the chronic toxicity of these two substances, because the toxicity of the test substance is expected to be related to the chlorate ion and not by the sodium or potassium ion.

 

Acute toxicity data is compared here to prove that the toxicity is related to the chlorate ion and not the sodium or potassium ion. 

Animal studies with potassium chlorate show a low acute toxicity after inhalation (LC50(4h) > 5.1 mg/l), dermal (LD50(24h) > 2000 mg/kg bw) exposure. The same results were seen in animal studies with sodium chlorate show a low acute toxicity after inhalation (LC50(4.5h) > 5.59 mg/l), dermal (LD50(24h) > 2000 mg/kg bw) and oral (LD50 = 4950-6250 mg/kg bw) exposure.

 

Numerous human case studies are reported for sodium chlorate (not included). Due to vomiting occurring, sometimes rapidly after ingestion, the absorbed quantity is often uncertain. Therefore, variability occurs in the doses causing lethality. Since the 1960s, survival to higher dose levels of chlorate, up to 200 grams (± 3.33 g/kg bw), has increased due to the possibility of dialysis treatment in case of renal failure.

 

Acute toxicity of chlorate is mediated by methaemoglobin. There are marked species differences in susceptibility to form methaemoglobin. Humans are more affected than rodent species. Infants, particularly neonates, are more prone to methaemoglobinemia than older children and adults and are consequently likely to be more susceptible to the toxicity of chlorate. Related to the rapid urinary excretion, the highest levels of chlorates are reached in the kidneys. Nephrotoxicity also seems mediated by methaemoglobin catalysis. Animal studies show a relatively low acute toxicity with oral LD50 around 5 grams/kg or higher. In humans, doses of 5 to 10 grams (± 83-166 mg/kg bw1) can be fatal in adults, and doses of 2 grams (± 0.2 g/kg bw1) in children. But also multiple cases are described surviving intakes ranging from 40 g (± 666 mg/kg bw[1]) to even 150-200 grams (± 2.50-3.33 g/kg bw1). Which is likely related to the possibility of dialysis treatment in case of renal failure after 1960s.

There are no fatalities reported in recent years. The primary concern for acute chlorate exposure is oxidative damage to red blood cells. 

 

An evaluation by the French poison control center of sensitivity of humans to sodium chlorate compared to rats led to the following conclusion: If one considers that 50% methemoglobinemia starts to induce signs that may lead to death in the absence of treatment, the dose would be about 20 g / kg for the whole population and 4.5 g / kg for the most sensitive part is the same range as rats (AFSSA 2011).


[1]Estimated intakes per kg bw were calculated with adefault body weight assumption of 60 kg for adults, 10 kg for children and 5 kg for infants (WHO 2004).
There are no concerns related to dermal exposures, besides of hazards of ignition of dried potassium chlorate on clothing.



Justification for classification or non-classification

Despite the low acute oral toxicity in animals, potassium chlorate is considered as harmful to humans due to available data on human lethal effects.


 


Harmonized classification:


Potassium chlorate has an harmonised classification (index No. 017-004-00-3, ATP0) as Acute Tox. 4 *, H302 and Acute Tox. 4*, H332 (* minimum classification for the category).


However, an intention for a revised CLH has been submitted to Sweden on 24/06/2019 with Acute Tox. 3 , H301: https://echa.europa.eu/fr/registry-of-clh-intentions-until-outcome/-/dislist/details/0b0236e1835aa465


 


Self classification:


Acute toxicity (Oral):


Based on available read-across data from one study of sodium chlorate in rat, the LD50 was reported to be > 5000 mg/kg bw. This does not met the criteria of classification in Acute Tox. 4 for oral administration. However, information from human poisoning incident reports demonstrate lethal effects of potassium- and sodium chlorate at concentration ranges that warrant classification.


Therefore, potassium chlorate has an harmonised classification (index No. 017-004-00-3, ATP0) as Acute Tox. 4 *, H302 (* minimum classification for the category) based on human experience indicating that classification of potassium chlorate is justified.


Acute toxicity (Dermal):


Results from acute dermal study show that potassium chlorate does not require classification.


Under the test conditions, the dermal LD50 of the test item is considered to exceed 2000 mg/kg body weight, in both male and female rats. Therefore, the test item is not classified according to the Regulation (EC) N° 1272-2008 and according to the GHS. No signal word or hazard statement is required.


Acute toxicity (Inhalation):


Under the conditions of the acute inhalation toxicity study performed with a dust aerosol of potassium chlorate, the acute inhalation LC50 (rat, 4 hrs) was considered to be > 5.1 mg/L. Thus, the criteria (1< category 4 ≤ 5) for classification in acute inhalation toxicity category 4 is not met. 


However, potassium chlorate has an harmonised classification (index No. 017-004-00-3, ATP0) as Acute Tox. 4 *, H332 (* minimum classification for the category) for the inhalation route of exposure.