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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979/07/20-1979/10/12
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
Report date:
1979

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: 16CFR1500.3
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
only male rats used.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
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:
Sample was received at the laboratory on 1979/06/28 and described as amber liquid.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
50 male Wistar rats, at least 8 weeks old when received and between 220 and 300 g, were supplied by Ace Animals and equilibrated for at least one week in the laboratory. Apparently healthy rats were selected for the test. The animals were identified by cage tags noting test material, start date, animal number and sex. Each animal was identified by an indelible body mark. Animals were housed 5/cage in suspended wire mesh cages and were provided fresh Purina rat chow and water ad libitum except for 16-20 h prior to dosing when food was removed. The animal room was maintained at 20-21°C and was kept clean in accordance with AAALAC standards.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test material was given orally by gavage. One group of 10 male rats was dosed at 5.0 g/kg initially. Based on the results of the initial dose, four additional groups of 10 male rats were dosed at various levels in order to determine the LD 50 of the test material. The dose was based on the sample weight as calculated from specific gravity. The vehicle, if any, was chosen because of its lack of known toxicity, lack of physiological effect and because it is relatively unreactive with other chemical substances.
Doses:
1220, 1950, 3120, 3730, 5000 mg/kg
No. of animals per sex per dose:
10 animals per dose - male
Control animals:
no
Details on study design:
Rats were observed 3-4 h after dosing and once daily for 14 days. Mortality, toxicity and pharmacological effects were recorded. Body weights were recorded pretest and in survivors at 14 days. At 14 days, all survivors were sacrificed. All animals were examined for gross pathology.
Statistics:
LD 50 was calculated according to the method of Litchfield, J.T. Jr. and F. Wilcoxon, 1949.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
3 600 mg/kg bw
95% CL:
> 3 100 - < 4 200
Mortality:
Deaths occurred at the three highest dose levels;. 3120, 3730 and 5000 mg/kg. 10/10 animals died at the 5.0 g/kg dose.
Clinical signs:
other: Significant predeath signs included lethargy, piloerection, diarrhea, ptosis, ataxia, flaccid muscle tone, chromorhinorrhea, chromodacryorrhea, emaciation, dyspnea and urinary incontinence. Most surviving animals were normal by the end of the observation
Gross pathology:
Necropsy observations revealed gastrointestinal abnormalities.
Other findings:
No other findings to report

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
Migrated information
Conclusions:
Under the conditions of this study, the test substance had an LD50=3600 mg/kg when administered orally to male Wistar rats.
Executive summary:

In an acute oral toxicity study, male Wistar rats were exposed to the test substance at doses of 1220, 1950, 3120, 3730, and 5000 mg/kg. The oral LD50 is 3600 mg/kg. Sublethal effects of lethargy, piloerection, diarrhea, ptosis, chromodacryorrhea, and dyspnea were observed in all groups. Necropsy observations included gastrointestinal abnormalities. Based on the results of this study, this 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.