Phosphorodithioic acid, mixed O,O-bis(iso-Bu and pentyl) esters, zinc salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1979/11/20-1979/12/19

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This non-GLP study was not conducted under OECD 401, however the reported data is similar enough not to warrant restriction.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: 16CFR1500.3

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Phosphorodithioic acid, mixed O,O-bis(iso-Bu and pentyl) esters, zinc salts

EC Number:

270-608-0

EC Name:

Phosphorodithioic acid, mixed O,O-bis(iso-Bu and pentyl) esters, zinc salts

Cas Number:

68457-79-4

Molecular formula:

{[(iso-C4H9O)0.64(C5H11O)0.36]PS2}2Zn - neutral, {[(iso-C4H9O)0.64(C5H11O)0.36]PS2}6Zn4O - basic

IUPAC Name:

Phosphorodithioic acid, mixed O,O-bis(iso-Bu and pentyl) esters, zinc salts

Details on test material:

Test material is described as amber liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

Animals supplied by Ace Animals were approximately 8 weeks old and weighed between 200-262 g when received. Animals were equilibrated to the laboratory for 1 week. Apparently healthy rats were selected for the test and identified by cage tags and indelible body marks. Animals were housed 5/cage in suspended wire mesh cages. Fresh Purina rat chow and water were freely available except 16-20 h prior to dosing when food was removed. The animal room was maintained at 20-21 °C and kept clean in accordance with AAALAC standards.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

One group of 10 male rats was dosed 5 g/kg initially (data not available in the report). Based on those results, 3 additional groups of 10 male rats were dosed at various levels in order to determine the LD 50. The dose administered was based on the sample weight as calculated by the specific gravity.

Doses:

2.0, 3.5, 5.0 and 8.75 g/kg

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

A single dose of the undiluted test material was administered intragastrically to ten fasted (over night) male rats at each treatment level. The animals were observed for signs of toxicity or behavioral changess daily. Individual weights were recorded on the day of dosing and at termination. All animals were euthanized at the conclusion of the observation period. Gross autopsies were performed on all animals after 14 days.

Statistics:

LD 50 was calculated according to the method of Litchfield, J. T. Jr. and F. Wilcoxon (1949)

Results and discussion

Preliminary study:

Conducted at 10 g/kg, however details from this study are not available in this report.

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

3 600 mg/kg bw

95% CL:

>= 2.7 - <= 4.8

Mortality:

Deaths occured at the 3.5, 5.0 and 8.75 g/kg dose levels. Most deaths occurred within the first two days.

Clinical signs:

other: Lethargy, diarrhea, piloerection, chromodacryorrhea, chromorhinorrhea and ptosis. These findings were no longer evident in the two lowest groups by the middle of week two. Tremors and spasms were noted at the 5.0 g/kg dose level.

Gross pathology:

Lung congestion, gastrointestinal findings and staining around the mouth, nose and anus were common necropsy findings for the animals that died. All surviving animals were normal at necropsy.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Remarks:

Migrated information

Conclusions:

The test article, when administered as received to male Wistar rats, had an acute oral LD 50 of 3.6 g/kg.

Executive summary:

In an acute oral toxicity study, male Wistar rats were exposed to test substance at doses of 2.0, 3.5, 5.0 and 8.75 g/kg. The oral LD50 is 3.6 g/kg. Sublethal effects of lethargy, diarrhea, piloerection, chromodacryorrhea, chromorhinorrhea and ptosis were observed. Necropsy observations included lung and gastrointestinal abnormalities. Based on the results of this study, the test substance would be classified as Category 5 in accordance with the classification system of GHS. This toxicity study is classified as acceptable and satisfies the guideline requirement for acute oral toxicity in rats.