Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979/12/12-1980/01/29
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 are similar enough not to warrant restriction.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

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:
no
GLP compliance:
no
Remarks:
Quality Assurance signed and inspection dated 1980/02/11
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Zinc O,O,O',O'-tetrakis(1,3-dimethylbutyl) bis(phosphorodithioate)
EC Number:
218-679-9
EC Name:
Zinc O,O,O',O'-tetrakis(1,3-dimethylbutyl) bis(phosphorodithioate)
Cas Number:
2215-35-2
Molecular formula:
Too complex
IUPAC Name:
zinc O,O,O',O'-tetrakis(1,3-dimethylbutyl) bis(phosphorodithioate)
Details on test material:
Sample was received at the laboratory on 1979/10/04 and described as a brown liquid with specific gravity of 1.1.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
45 male and 5 female 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:
not specified
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:
0.6, 1.22, 1.73, 2.47 and 5.0 g/kg


No. of animals per sex per dose:
10 males per dose except at 5.0 g/kg where 5 males and 5 females were dosed.
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

Preliminary study:
A preliminary study was conducted in male rats at 10 g/kg, however no details about the results are provided in the report.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 230 mg/kg bw
95% CL:
>= 1.66 - <= 2.99
Mortality:
No mortalities occurred following administration of 0.6 g/kg. 1/10 animals died at the dose level of 1.22 g/kg, 3/10 at 1.73 g/kg, and 10/10 at 2.47 g/kg and 5.0 g/kg.
Clinical signs:
Generally, lethargy, diarrhea, piloerection and ptosis occurred 3-4 h post dose and occasionally later, at all doses. At 5.0 g/kg, diarrhoea was the only toxic sign at 3-4 h post dose.

Body weight:
Body weight changes in the survivors were within normal limits.



Gross pathology:
Necropsy observations included lung and gastrointestinal abnormalities.

Other findings:
No other findings reported.

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 material is toxic as defined in 16 CFR 1500.3 in male and female Wistar rats.
Executive summary:

In an acute oral toxicity study, male and female Wistar rats were exposed to the test substance at doses of 0.6, 1.22, 1.73, 2.47 and 5.0 g/kg. The oral LD50 is 2.23 g/kg. Sublethal effects of lethargy, diarrhea, piloerection and ptosis were observed in all groups. Necropsy observations included lung and 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.

Categories Display