Registration Dossier
Registration Dossier
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EC number: 205-232-8 | CAS number: 136-23-2
Carcinogenicity
Administrative data
Description of key information
Based on the absence of any histopathological changes in the available 17-weeks oral study with rats and the findings of the available, albeit poorly reported carcinogenicity study with mice, zinc bis(dibutyldithiocarbamate) (ZDBC) is considered to be non-carcinogenic.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the evidence from the available oral carcinogenicity study with mice and the 17 -week oral study with rats, zinc bis(dibutyldithiocarbamate) (ZDBC) does not need to be classified for carcinogenicity in accordance with EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Additional information
One carcinogenicity study with mice, although poorly reported, was available for assessment (Innes et al., 1969). Maximal tolerated dose (which corresponded to 1000 mg/kg bw/day) was administered orally to 18 male and 18 female mice of 2 different strains starting at the age of 7 days by oral gavage for the first 3 weeks and then in diet (corresponding to concentration in diet of 2600 ppm) for the rest of the study period of 18 months. After this the animals were necropsied and histological evaluation of major organs and all grossly visible lesions was performed. The paper reported an overview of the results on selected pesticides and industrial compounds, amounting in total to 120 substances. Only data on 11 compounds which induced significant increase in tumor incidences were reported. No data on tumor incidences are reported for zinc bis(dibutyldithiocarbamate), as it gave no significant indication of tumorigenicity according to authors.
In addition, the available 17-weeks study with rats administered zinc bis(dibutyldithiocarbamate) (ZDBC) in diet at levels up to 2500 ppm gave no indication of histopathological changes, including hyperplasia or (pre)-neoplastic lesions. Based on the overall evidence from these two studies, zinc bis(dibutyldithiocarbamate) is considered to be not carcinogenic.
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