Registration Dossier

Toxicological information

Immunotoxicity

Currently viewing:

Administrative data

Description of key information

Key Study: De Witt et al (2007): Immune function of adult and offspring rats was not impaired following repeat exposure to dimethyltin dichloride.

Key value for chemical safety assessment

Effect on immunotoxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
3.4 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
The key study available for is a well reported literature paper investigating the effects of the substance on the immune system during the development and adulthood of rats. Although the other available studies submitted for this endpoint were reported in limited detail, the results and conclusions of these studies supported the lack of immunotoxic effects observed in the key study. The quality of the database was therefore considered to be high.

Effect on immunotoxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Effect on immunotoxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In the key study adult male and female rats were given drinking water containing 0, 20 or 40 mg DMTC/L (0, 1.7, or 3.4 mg DMTC/kg body weight [bw]) for 28 days. Pregnant females were given the same DMTC drinking water concentrations for a total of 37 days, from gestational day (GD) six through weaning of pups (0, 2.4, or 4.6 mg DMTC/kg bw during gestational exposure; 0, 3.6, or 6.9 mg DMTC/kg bw during postnatal exposure). On postnatal day (PND) two, litters were sexed, weighed, and culled to four males and four females per dam. Delayed-type hypersensitivity (DTH), antibody synthesis, and natural killer (NK) cell activity were evaluated in adults (N= 8/sex/group) and in immunologically mature offspring (N= 6/sex/group). Although water consumption was decreased in all of the DMTC dose groups, the immune functions evaluated were not affected.


Justification for selection of effect on immunotoxicity via oral route endpoint:
Only one reliable study was available to evaluate this endpoint. The key study was selected as it was considered the most reliable , based on the level of quality in the reporting of the data and the study design.

Justification for classification or non-classification

In accordance with the criteria outlined in Regulation (EC) No. 1272/2008 (CLP) and Directive 67/548/EEC (DSD), the substance does not meet the criteria for classification for immunotoxicity, based on the data available.