Zinc O,O,O',O'-tetrakis(1,3-dimethylbutyl) bis(phosphorodithioate)

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978/12/14-1978/12/16

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study pre-dates GLP and deviates from current guidelines.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: 49 CFR 173.343(a)(2)

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

yes

Remarks:

1 h exposure and only male rats used

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(2-ethylhexyl and iso-Pr) esters, zinc salts

EC Number:

272-723-1

EC Name:

Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Pr) esters, zinc salts

Cas Number:

68909-93-3

Molecular formula:

Too complex

IUPAC Name:

Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Pr) esters, zinc salts

Details on test material:

Test material from lot no. EC-47904 is described as pale amber viscous liquid with pH 5.34

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

Young adult, apparently in good health, male rats were supplied by Ace Animals, Inc. and equilibrated in the laboratory for about one week. The rats were housed 5/cage in wire mesh cages in a temperature controlled room kept clean in accordance with AAALAC standards. Animals had free access to water and fresh Purina Rat Chow except during dosing.

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

Rats were placed in individual cages, in a 435 litre stainless steel chamber with continuous air flow. The material was introduced by a spray system designed to disperse the liquid into respirable particles. The amount delivered was calculated to result in an average concentration of 2 mg/l over the one hour exposure period.

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

1 h

Concentrations:

Nominal concentration = 2 mg/L

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

The animals were observed frequently during dosing, 3-4 h post dosing and daily for 2 days. Mortality and signs of pharmacological and toxicological effects were recorded. Body weights were recorded pre-test and terminally. At 2 days the survivors were sacrificed. Necropsies were performed in all rats and abnormal findings were noted.

Statistics:

No data.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LC50

Effect level:

> 2 mg/L air (nominal)

Exp. duration:

1 h

Mortality:

0/10

Clinical signs:

other: All animals were sniffing and grooming throughout exposure period. Eyes appeared irritated, bodies were oily with hair stuck together and head and face were swollen. Lethargy, ptosis and chromodacryorrhea were noted in all animals. Isolated instances o

Body weight:

All animals maintained or increased body weight.

Gross pathology:

One animal had dark areas in the lung.

Other findings:

None noted.

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 is not a class B poison as defined by 49 CFR 173.343(a)(2) in male Wistar rats.

Executive summary:

In an acute inhalation toxicity study, male Wistar rats were exposed to the test substance at a nominal concentration of 2 mg/l under continuous air flow conditions for one hour. The LC50 is >2 mg/l. Sublethal effects of lethargy, ptosis and chromodacryorrhea were noted in all animals. Based on the results of this study, the test substance would be unclassifiable in accordance with the classification system of GHS. When converted to a 4 h exposure, the LC50 is calculated greater than 0.5 mg/l and 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.