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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
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 Type:
study report

Materials and methods

Test guidelineopen allclose all
according to guideline
other: 16CFR1500.3
equivalent or similar to guideline
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
Test type:
standard acute method
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
Phosphorodithioic acid, mixed O,O-bis(iso-Bu and pentyl) esters, zinc salts
EC Number:
EC Name:
Phosphorodithioic acid, mixed O,O-bis(iso-Bu and pentyl) esters, zinc salts
Cas Number:
Molecular formula:
{[(iso-C4H9O)0.64(C5H11O)0.36]PS2}2Zn - neutral, {[(iso-C4H9O)0.64(C5H11O)0.36]PS2}6Zn4O - basic
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

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
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.

2.0, 3.5, 5.0 and 8.75 g/kg

No. of animals per sex per dose:
Control animals:
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.


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
Dose descriptor:
Effect level:
3 600 mg/kg bw
95% CL:
>= 2.7 - <= 4.8
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
Migrated information
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.