Didodecyl 3,3'-thiodipropionate

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Additional information

A subchronic oral toxicity study was performed with the test substance (Pharmakon, 380/573, 1993), which is 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:
Since there were no histopathology effects on reproductive organs observed in a subchronic study (Pharmakon 380/573, 1993) and developmental toxicity studies did not indicate disturbances of fertility and reproductive performance, the test does not need to be conducted in accordance with Annex IX (8.7.3) of the REACH legislation.

Effects on developmental toxicity

Description of key information

The test substance was tested for teratogenicity in rats, mice, hamsters, rabbits (FDA, 1972 and 1973). 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.

Toxicity to reproduction: other studies

Additional information

The test substance was tested for teratogenicity in rats, hamsters, rabbits and mice on the behalf of the U.S. Food and Drug Administration between 1972 and 1973. The study design of these studies follows OECD guideline 414. 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 bw/day of the test material to pregnant rats and mice for 10 consecutive days had no clearly discernible effect on nidation or on maternal or foetal 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 bw/day 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 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. On the basis of the available data, 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. On the basis of the available data, the substance is not considered to be classified for reproductive toxicity under Regulation (EC) No. 1272/2008.