Phosphorothioic acid, O,O-bis(2-methylpropyl) ester, sodium salt (1:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 10, 1991 - April 23, 1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Limited details on test material and environmental conditions. The observation period was limited to 7 days.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Limited details on test material and environmental conditions. The observation period was limited to 7 days.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium O,O-diisobutyl phosphorothioate

EC Number:

610-992-2

Cas Number:

53378-52-2

Molecular formula:

C8 H18 O3 P S . Na

IUPAC Name:

Sodium O,O-diisobutyl phosphorothioate

Test material form:

other: grease-like solid

Specific details on test material used for the study:

- Name of test material (as cited in study report): CT 473-91
- Name: Sodium diisobutyl monothiophoshate
- CAS: 53378-52-2
- Molecular formula: C8H18O3PS.Na
- Molecular weight: 248.26
- Substance type: Amber liquid
- Physical state: Liquid
- Lot/batch No.: SPS-17220
- Storage condition of test material: Store at room temperature in the dark

Test animals

Species:

rat

Strain:

not specified

Sex:

male

Details on test animals or test system and environmental conditions:

- Source: Ace Animals
- Age at study initiation: Not specified
- Weight at study initiation: 214 - 250 g
- Fasting period before study: 16 - 20 hours prior to dosing
- Housing: Individually in suspended cages
- Diet: Free access to Purina Rat Chow (diet #5012)
- Water: Free access to tap water.
- Acclimation period: At least 3 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature controlled
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

GAVAGE METHOD: syringe and dosing needle

Frequency: single

MAXIMUM DOSE VOLUME APPLIED: 1.1 cc. The dose was based on the sample weight as calculated from the specific gravity. The test substance was administered on g/kg basis.

DOSAGE PREPARATION: The test substance was used as recieved.

Doses:

5000 mg/kg body weight

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Animals were deprived of food 16 - 20 hours prior to dosing. Water was available ad libitum.

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing:
Mortality/Viability/Clinical signs: 1, 4 and 24 hours post dose and once daily thereafter for 7 days for mortality.
Body weights: Body weights were recorded pretest and at termination.
- Necropsy of survivors performed: not performed.
- Other examinations performed: none.

Statistics:

No statistical analysis was performed.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: Physical signs of lethargy, ataxia, chromodacryorrhea, chromorhinorrhea, dyspnea, wetness of the anagenital area and soiling of the body area were noted during the observation period.

Gross pathology:

No data.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute oral toxicity study with CT-473-91 in male rats, performed equivalent or similar to OECD 401 test guideline, an LD50 >5000 mg/kg bw was determined.

Executive summary:

CT-473-91, a 50% solution in water, was administered by oral gavage in five male rats equivalent or similar to OECD 401 guideline and according to GLP principles. No mortality occurred. Physical signs of lethargy, ataxia, chromodacryorrhea, chromorhinorrhea, dyspnea, wetness of the anagenital area and soiling of the body area were noted during the observation period. All animals gained weight during the study.

The oral LD₅₀ value of CT-473 -91, a 50% solution in water, in male rats was established as exceeding 5000 mg/kg body weight and no classification for oral toxicity is needed according to EC regulation 1272/2008.