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Toxicological information

Acute Toxicity: oral

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Administrative data

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.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-1 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Sodium Chlorate Crystal
- Physical state: white flake solid
- Analytical purity: 101.1% Sodium chlorate
- Impurities (identity and concentrations): Chromium concentration = 2.1 ppm as Cr6
- Composition of test material, percentage of components: 101.1% Sodium Chlorate Crystal (Ercocide C)
- Purity test date: October 3, 1990 - October 11, 1990
- Lot/batch No.: #DL-1
- Expiration date of the lot/batch: 9-1-91
- Stability under test conditions: Stable at ambient temerature
- Storage condition of test material: Cool and dry storage
- Other: pH 5.5

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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

Administration / exposure

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.

Results and discussion

Effect levels
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.

Applicant's summary and conclusion

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.