Phosphorodithioic acid, mixed O,O-bis(1,3-dimethylbutyl and iso-Pr) esters, zinc salts

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981/08/27

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This non-GLP study is similar to current guideline, but deviates significantly enough to warrant restriction.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

Minimal detail provided. No histopathology conducted to determine cause of gross pathology findings.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Phosphorodithioic acid, mixed O,O-bis(1,3-dimethylbutyl and iso-Pr) esters, zinc salts

EC Number:

283-392-8

EC Name:

Phosphorodithioic acid, mixed O,O-bis(1,3-dimethylbutyl and iso-Pr) esters, zinc salts

Cas Number:

84605-29-8

Molecular formula:

Not applicable

IUPAC Name:

Phosphorodithioic acid, mixed O,O-bis(1,3-dimethylbutyl and iso-Pr) esters, zinc salts

Details on test material:

The test article was stored in the original container at room temperature.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Animals weighing approximately 135 g were supplied by King Animal Labs. Upon arrival, the animals were quarantined to the laboratory for 1 week. Apparently healthy rats were selected for the study. Animals were housed 3/sex/cage and then individually after the exposure period in suspended stainless steel cages. Animal rooms were maintained at 22 °C, 40% humidity, and 12 h light cycles. Purina Rodent Chow 5001 and water were available ad libitum except during the exposure period.

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

A generating system was used to generate concentrated vapor of the test article. An air-vapor mixture was produced by bubbling dry air at 5 L/min through 1 L of test article heated to 66 °C. This vapor mixture passed into the exposure chamber with no dilution air added.

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

4 h

Concentrations:

2.3 mg/L nominal concentration

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Rats were exposed for 4 h to vapours generated from a single batch of the test article. The projected exposure concentration was not to exceed 15 mg/l. The concentration of the test article in the atmosphere was determined by dividing the quantity for the test article consumed by the volume of air passed through the chamber during the exposure period (nominal concentration). All rats were observed for 14 days following exposure.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 2.3 mg/L air (nominal)

Exp. duration:

4 h

Mortality:

No animals died following exposure to the test article.

Clinical signs:

other: Diarrhea was noted in one rat following exposure. All remaining rats appeared normal.

Body weight:

All test rats were weighed immediately prior to exposure. Body weights were not recorded following the observation period for comparison.

Gross pathology:

Gross necropsy findings for nine rats were within normal limits. The remaining rat had red foci throughout the liver.

Other findings:

Tan livers and kidneys were observed at necropsy, however, these were not deemed to be treatment related.

Applicant's summary and conclusion

Interpretation of results:

other: Not classifiable

Remarks:

Criteria used for interpretation of results: OECD GHS

Conclusions:

Under the conditions of this study, the test material did not produce significant toxicity at the nominal concentration of 2.3 mg/l in male or female Sprague Dawley rats.

Executive summary:

In an acute inhalation toxicity study, male and female Wistar rats were exposed to test substance at a nominal concentration of 2.3 mg/l under continuous air flow conditions for 4 h. The LC50 is >2.3 mg/l. Diarrhea was noted in one animal, all other animals appeared normal. Based on the results of this study, the test substance would be unclassifiable in accordance with the classification system of GHS. The LC50 only eliminates Category 1 or 2 classification. This toxicity study is classified as acceptable and satisfies the guideline requirement for acute inhalation toxicity in rats.