Zinc bis[O-(2-ethylhexyl)] bis[O-(isobutyl)] bis(dithiophosphate)

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:

1981

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

Test material information

Constituent 1

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

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 levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

3 400 mg/kg bw

95% CL:

2.2 - 5 200

Effect levels 2

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

Conclusions:

The acute oral LD50 for male rats was 3400 mg/kg and 2900 mg/kg for female rats.

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.