Registration Dossier
Registration Dossier
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EC number: 272-238-5 | CAS number: 68784-31-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Phosphorodithioic acid, mixed O,O-bis(sec-Bu and 1,3-dimethylbutyl) esters, zinc salts
- EC Number:
- 272-238-5
- EC Name:
- Phosphorodithioic acid, mixed O,O-bis(sec-Bu and 1,3-dimethylbutyl) esters, zinc salts
- Cas Number:
- 68784-31-6
- Molecular formula:
- C(16-24) H(36-42) O4 P2 S4 Zn
- IUPAC Name:
- Phosphorodithioic acid, mixed O,O-bis(sec-Bu and 1,3-dimethylbutyl) esters, zinc salts
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation: 62-68 days (male); 81-87 days (female)
- Weight at study initiation: 251-317 g (male); 214-249 g (female)
- Fasting period before study: overnight
- Housing: Housed individually in wire bottom cages
- Diet (e.g. ad libitum): ad libitum except overnight prior to dosing
- Water (e.g. ad libitum): ad libitum except overnight prior to dosing
- Acclimation period: 16-22 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50-77
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):
IN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 0, 5000 mg/kg
0, 1800, 2700, 4000, 6000 mg/kg - No. of animals per sex per dose:
- 5 male and 5 female
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 7 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology including: nasal passages, trachea, bronchi, heart, lungs, liver, kidneys, adrenal glnds, spleen, gonads, gastrointestinal tract, bladder, body fat and skin.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 3 400 mg/kg bw
- 95% CL:
- 2.2 - 5 200
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 900 mg/kg bw
- 95% CL:
- 1 900 - 4 700
- Mortality:
- Male:
0 mg/kg: 0/5
5000 mg/kg: 4/5 rats died 1-3 days after exposure
0 mg/kg: 0/5
1800 mg/kg: 0/5
2700 mg/kg: 0/5
4000 mg/kg: 3/5 rats died 2-6 days after exposure
6000 mg/kg: 5/5 rats died 1-3 days after exposure - Clinical signs:
- other: Clinical signs of toxicity included diarrhea, depression, reduced food consumption, weakness, salivation, blood in the urine and death.
- Gross pathology:
- No gross pathological changes observed attributed to the test material.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- Migrated information
- Executive summary:
ACUTE ORAL TOXICITY: SINGLE DOSES RANGING FROM 1.8 G/KG TO 6.0 G/KG OF THE UNDILUTED TEST MATERIAL WERE ADMINISTERED INTRAGASTRICALLY TO FIVE FASTED RATS OF EACH SEX. MORTALITY OCCURRED IN MALES DOSED WITH 4.0 G/KG AND GREATER AND IN FEMALES DOSED WITH 2.7 G/KG AND GREATER. SIGNS OF TOXICITY OBSERVED DURING THE STUDY WERE DIARRHEA, DEPRESSION, REDUCED FOOD CONSUMPTION, WEAKNESS, SALIVATION, BLOOD IN URINE, AND DEATH. THE BODY WEIGHTS OF THE TREATED MALES AT THE 2.7 G/KG DOSE LEVEL WERE SIGNIFICANTLY LESS THAN CONTROLS AT SEVEN DAYS. AT AUTOPSY, NO GROSS PATHOLOGICAL CHANGES WERE OBSERVED THAT COULD BE ATTRIBUTED TO THE TEST MATERIAL. THE LD50 (95% CONFIDENCE LIMITS) FOR MALE RATS WAS 3.4 (2.2-5.2) G/KG AND 2.9(1.9-4.7) G/KG FOR FEMALES.
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