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Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

A subchronic oral toxicity study was performed with an analogue substance differing in the length of the two alkylchains (C12 versus C18). Details on this valid study (Pharmakon, 1993) are described in the section for repeated dose toxicity. No histopathology findings were observed in organs related to reproductive toxicity up to the highest tested dose of 1000 mg/kg bw.


Short description of key information:
No histopathology effects on reproductive toxicity organs were observed in a valid subchronic oral toxicity study with didodecyl 3,3’-thiodipropionate in rats.

Effects on developmental toxicity

Description of key information
The analogue substance didodecyl-3,3’-thiodipropionate was tested for teratogenicity in rats, hamsters, rabbits and mice. The studies performed are adequate in design and reporting to conclude on absence of a hazard. Tested were concentrations up to 1600 mg/kg bw (except in the study with rabbits, here up to 1000 mg/kg bw were tested). No indication of teratogenicity was recorded in any of these studies. In the study with rabbits, high mortality occured in all tested groups so that this study is considered inadequate for hazard assessment.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 600 mg/kg bw/day
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

The test item didodecyl 3,3’-thiodipropionate is an analogue substance that differs in having two C12 alkyl chains instead of two C18 alkyl chains. The shorter alkyl chain is expected to result in slightly more favourable solubility and absorption after uptake. Considering the 1.3 fold difference in molecular weight, application of the C12 analogue results in a higher number of molecules so that overall, any hazard identified for didodecyl 3,3’-thiodipropionate is considered relevant for dioctadecyl 3,3’-thiodipropionate. Didodecyl 3,3’-thiodipropionate was tested for teratogenicity in rats, hamsters, rabbits and mice on behalf of the U.S. Food and Drug Administration between 1972 and 1973 (Food and Drug Research Laboratories). Reports were available for review of the studies performed in rabbits, hamsters and rats. The study design of these studies follows OECD guideline (414, 2001) with deviations: no necropsy of dams, no statistics and no historical control data, uterine weight not recorded. The studies pre-date GLP requirements: No purity or physical/chemical properties reported, no numerical values reported for temperature and humidity, acclimatization period not reported, concentrations and stability were not verified, and no statistics were performed. It is noted in the reports that the studies were part of a project with more than 40 substances and that statistics would be performed once all studies had been completed.

The administration of up to 1600 mg/kg (body weight) of the test material to pregnant rats and mice for 10 consecutive days had no clearly discernible effect on nidation or on maternal or fetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.

The administration of up to 1600 mg/kg (body weight) to pregnant hamsters for 5 consecutive days had no clearly discernible effect on nidation or on maternal or fetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.


Justification for selection of Effect on developmental toxicity: via oral route:
study report acceptable for assessment

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for reproductive toxicity under Directive 67/548/EEC.

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for reproductive toxicity under Regulation (EC) No. 1272/2008.

Additional information