Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A literature search and evaluation programme on animal and human acute toxicity data of zinc selenite has been conducted.All data sources were assessed by expert toxicologists for quality and reliability, as well as relevance for regulatory risk assessment under REACH. The documentation of the literature search is attached to the technical dossier.

In-vivo skin sensitisation testing has been performed since no reliable literature data are available for zinc selenite.

The test data (GLP, OECD guideline conform) is reliable without restrictions.

Migrated from Short description of key information:
Zinc selenite has been tested in-vivo for skin sensitising properties in a Local Lymph Node Assay (LLNA). The test showed a negative response, thus zinc selenite does not require classification as a sensitiser.

Respiratory sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
No data is available on respiratory sensitisation of zinc selenite and no testing required.

Justification for classification or non-classification

Skin sensitisation:

The study report Leuschner (2010), Local lymph node assay (LLNA) in mice is considered as the key studies on skin sensitisation and will be used for classification. The overall sensitisation results are as follows:

Treatment with Zinc selenite at concentrations of 0.25%, 0.5%, 1.0% and 2.5% did not reveal statistical significantly increased values for lymph node cell count. The stimulation indices of the lymph node cell count did not exceed the threshold level of 1.4. Hence, the test item is classified as not sensitising. The threshold level for the ear weight of 1.1 was not exceeded and the lymph node weights were not increased in a dose-related way, i.e. no irritating properties were noted. In conclusion, under the present test conditions, Zinc selenite did not reveal any sensitising properties in the local lymph node assay. Thus, the classification criteria acc. Directive 67/548/EEC and regulation (EC) No. 1272/2008 as skin sensitizer are not met. No classification is required.

 

Respiratory sensitisation:

Substances shall be classified as respiratory sensitizers (Category 1) in accordance with the following criteria:

(a) if there is evidence in humans that the substance can lead to specific respiratory hypersensitivity and /or

(b) if there are positive results from an appropriate animal test.

According to the CLP Regulation Annex I, Section 3.4.2.1 substances fulfilling the criteria for respiratory sensitisation will be classified as such in Category 1. As no such information is available for zinc selenite, no classification is proposed on respiratory sensitisation. Furthermore,

based on an industry experience, during long-year industrial practice no cases of hypersensitivity were observed till now by workers exposed exclusively to zinc selenite.