Registration Dossier
Registration Dossier
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EC number: 221-435-4 | CAS number: 3091-25-6
Carcinogenicity
Administrative data
Description of key information
No carcinogenic effects were seen.
Under the conditions of this test, no relevant differences were found between treated and control animals for mortality distribution, clinical observations and examinations, body and organ weights, food and water consumption, as well as in hematology, except an increased number of white blood cells in female groups treated with 50 and 150 ppm of the test material.
A significantly increased frequency of primary tumours of the thymus, especially thymic lymphomas, was noted in females treated with 150 ppm. Further, an increased incidence of generalised malignant lymphomas in males of the two upper dose levels and in females of the top dosage group was observed. In animals treated at low dose levels (5.0 and 15 ppm) no increase was observed neither in the incidence of primary thymic tumours nor generalised malignant lymphomas.
The increased incidence of generalised malignant lymphomas in males of the two upper dose levels and in females of the top dosage group was considered by the authors to be within the limits of the historical incidence in control animals of the strain selected.
Frequency and type of other neoplasm occurring in this study were not influenced by the treatment. Also the other microscopical lesions and changes found in some control and test animals and described as congenital, degenerative or inflammatory in nature are attributed to naturally occurring diseases which are common in aged rats of this breeding colony.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 15 mg/kg bw/day
Justification for classification or non-classification
No carcinogenic effects were seen and so the substance will not be classified for this endpoint.
Additional information
In the key study for carcinogenicity there was no mention of what guideline was followed, however the methodology was well documented. The study was conducted in line with GLP. A reliability rating of 2 according to the criteria of Klimisch, 1997 was assigned as exposure concentrations were measured on the basis of total Sn and converted to and reported as the test substance. All measured Sn was attributed to the parent compound.
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