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Physical & Chemical properties

Stability in organic solvents and identity of relevant degradation products

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Administrative data

Endpoint:
stability in organic solvents and identity of relevant degradation products
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2012-03-21 - 2012-05-23
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP guideline study, however no analysis was carried out to determine the homogeneity, concentration or stability of the test item formulations. The test item was formulated within two hours of being administered; it is assumed that the formulation was stable for this duration. This exception is considered not to affect the purpose or integrity of the study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: The study was performed according to the Study Plan and was designed to provide information for further repeated dose toxicity studies.
Principles of method if other than guideline:
The test item was administered by gavage to three groups, each of three male and three female Wistar Han™:RccHan™:WIST strain rats, for fourteen consecutive days, at dose levels of 50, 250 and 1000 mg/kg bw/day. A control group of three males and three females was dosed with vehicle alone (Arachis oil BP).
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Liquid
Details on test material:
- Name of test material (as cited in study report): 1,3,4-Thiadiazolidine-2,5-dithione, reaction products with hydrogen peroxide and tert-nonanethiol
- Physical state: Liquid
- Expiration date of the lot/batch: 2013-09-05
- Storage condition of test material: Room temperature in the dark
- Other:
Description: Amber coloured liquid
Label: Performance Additive (1,3,4-Thiadiazolidine-2,5-dithione, reaction products with hydrogen peroxide and tert-nonanethiol)

For the purpose of this study, the test item was prepared at the appropriate concentrations as a solution in Arachis oil BP.
The test item was formulated within two hours of it being administered. It is assumed that the formulation was stable for this duration.

Results and discussion

Test substance stable:
yes
Transformation products:
not measured

Applicant's summary and conclusion

Conclusions:
Observation during an experimental result from a repeated dose study (14-days, oral route, rats). The test substance was found to be stable in Arachis oil BP.
Executive summary:

The oral administration of 1,3,4-Thiadiazolidine-2,5-dithione, reaction products with hydrogen peroxide and tert-nonanethiol to rats by gavage, at dose levels of 50, 250 and 1000 mg/kg bw/day, did not result in any toxicologically significant effects in treated animals (Harlan, 2012). The 'No Observed Effect Level' (NOEL) was therefore considered to be 1000 mg/kg bw/day. The test substance was found to be stable in Arachis oil BP, which was used as vehicle.