Registration Dossier
Registration Dossier
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EC number: 204-875-1 | CAS number: 128-03-0
Carcinogenicity
Administrative data
Description of key information
KDDC is not expected to be carcinogenic based on read across form ziram data.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 171 mg/kg bw/day
Justification for classification or non-classification
Additional information
Carcinogenicity studies with KDDC have not been performed. It is proposed to read across the respective available data on the similar active substance, ziram, to KDDC.
The similarity of KDDC (represented by SDDC) and ziram with regard to their toxicological properties can be established by comparison of the outcome of the subchronic oral study in rats with SDDC and the subchronic oral study with dogs and the chronic oral study with rats with ziram.
A 2-year rat study and an 80-week mouse study, both using dietary administration, have been conducted with ziram. In the rat, benign haemangiomata were seen in the mesenteric lymph nodes of five male terminal kill rats receiving 540 ppm ziram. Haemangiomata are benign multilocular tumours occasionally seen in low numbers of rats of this strain and age range, mesenteric lymph nodes and the spleen being the most common sites for their detection.
This incidence was statistically significant in comparison to the control group and was not observed in other tissues of these animals and or seen in any rats receiving lower doses of ziram. Therefore it can be considered that the presence of these haemangiomata at a dosage level of 540 ppm in male animals was a consequence of the administration of ziram.
In contrast the incidence of the various neoplasms observed in the mouse study showed no significant deviation from the expected tumour profile of laboratory-maintained mice of this strain.
On the basis of the increased incidence of haemangiomata, a tumorigenic effect of high doses of ziram in the rat cannot be excluded. Since the overall conclusion with regard to mutagenicity is negative, also in the case of KDDC, the possible tumorigenic mechanism remains unclear.
However, the occurrence of a benign tumour in only one sex of only one species is of low toxicological significance and does not justify classification of KDDC as a carcinogen.
Classification for carcinogenicity: None
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