Registration Dossier
Registration Dossier
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EC number: 231-887-4 | CAS number: 7775-09-9
Toxicological information
Repeated dose toxicity: other routes
Administrative data
- Endpoint:
- short-term repeated dose toxicity: other route
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Limited reporting of study design and results. Purity and composition of test substance not explicit stated. Only one dose level used, without controls.
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicity of sodium chlorate to the dog
- Author:
- Heywood R, Sortwell RJ, Kelly PJ, Street AE
- Year:
- 1 972
- Bibliographic source:
- Vet Rec.90(15):416-418
Materials and methods
- Principles of method if other than guideline:
- Method: other
- GLP compliance:
- no
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- - Name of test material (as cited in study report): Test substance: other TS: commercial preparation marketed as a weed killer.
- Physical state: Powdered Sodium chlorate marketed as weed killer.
Constituent 1
Test animals
- Species:
- dog
- Strain:
- Beagle
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Pedigree Beagle Dog
- Age at study initiation: no info
- Weight at study initiation: females 9.2 - 11.75 kg; males 10.95 - 15.0 kg
Administration / exposure
- Route of administration:
- other: stomach-tube
- Vehicle:
- water
- Details on exposure:
- Total volume applied: 50 ml/day
Doses: 3 gram (50 ml, 60 g/L) - Duration of treatment / exposure:
- 5 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
200-326 mg/kg/day (50 ml of 6 % w/v solution)
- No. of animals per sex per dose:
- 4 male, 4 female
- Control animals:
- other: no data specified
- Details on study design:
- Post-exposure period: for 4 of 8 animals: 7 days
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule:
- Cage side observations included: mortality
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: frequency not indicated
BODY WEIGHT: Yes
- Time schedule for examinations: frequency not indicated
FOOD CONSUMPTION: not indicated
FOOD EFFICIENCY: not indicated
WATER CONSUMPTION: not indicated
OPHTHALMOSCOPIC EXAMINATION: no data
HAEMATOLOGY: Yes
- Time schedule for collection of blood: pre-dose, after 5 days, after recovery period
- Parameters examined: haemogram (PCV, RBC, TReticulocytes, WBC) blood urea, Hb and Met-Hb
CLINICAL CHEMISTRY: Yes
URINALYSIS: Yes
- Parameters examined: protein, total reducing substances, glucose, ketones, bile pigments and salts
NEUROBEHAVIOURAL EXAMINATION: no data - Sacrifice and pathology:
- - Macroscopic: yes
- Microscopic: yes - Other examinations:
- no
- Statistics:
- no
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- effects observed, treatment-related
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- CLINICAL SIGNS AND MORTALITY
- Mortality and time to death: 1/8, after 4 days dosing, (one female (308 mg/kgbw/d) after 4 days).
- Clinical signs: Two animals that received dosages > 300 mg/kg/day produced marked clinical symptoms (loss apetite, loss body weight, vomiting and blood streaked faeces, and blood in urine). Other 6 animals showed no clinical symptoms besides slight body weight loss in three animals.
BODY WEIGHT AND WEIGHT GAIN
- Body weight gain: not listed
FOOD CONSUMPTION / WATER CONSUMPTION
- Food/water consumption: not listed
OPHTHALMOSCOPIC EXAMINATION
- Ophthalmoscopic examination: no
HAEMATOLOGY
- Haematology: Red blood cell values reduced (PCV, Hb, RBC); reticulocytes increased
CLINICAL CHEMISTRY
- Clinical chemistry: Increase plasma urea level which returned to normal during recovery period. Only the animal that died showed elevated Met-Hb.
URINALYSIS
- Urinalysis: All free from protein, total reducing substances, glucose, ketones, bile pigments and salts.
NEUROBEHAVIOUR
-
ORGAN WEIGHTS
- Organ weights: no information
GROSS PATHOLOGY
- Gross pathology: Bluish coloured kidneys in both animals that received > 300 mg/kg, and clotted blood in bladder in the animal that died. No significant findings in other animals.
HISTOPATHOLOGY: NON-NEOPLASTIC
- Histopathology: haematopoeitic activity in spleen (3/8) and dark pigment in liver Kupffer cells (3/8). Haematogenous casts in kidney tubules in animal that died.
HISTOPATHOLOGY: NEOPLASTIC (if applicable)
-
HISTORICAL CONTROL DATA (if applicable)
-
IN GENERAL:
Two animals that received dosages > 300 mg/kg/day produced marked clinical symptoms and haematological and biochemical changes; One of them died after 4 days dosing. Other animals showed no clinical signs, and revealed no significant macroscopic post-mortem findings. Pathological findings were limited to changes indicative of haemolysis (pigmented Kupffer cells liver) and extra medullar haematopoeisis in spleen in some dogs. Red blood cell values were reduced, and reticulocyte counts increased. Plasma urea levels were increased, and returned to normal during recovery period. Only the animal that died showed elevated Met-Hb.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- < 200
- Sex:
- male/female
- Dose descriptor:
- LOAEL
- Effect level:
- 200 other: mg/kg
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
ACTUAL DOSE RECEIVED BY DOSE LEVEL BY SEX: males: 200 – 274 mg/kgbw/d; females 255-326 mg/kgbw/d.
Applicant's summary and conclusion
- Conclusions:
- Doses of 200 mg Sodium chlorate/kg/day in dogs seem to be a well tolerated dose level.
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