Registration Dossier

Administrative data

Description of key information

Zinc selenite is not considered to be a skin-, eye- or respiratory irritant.
- skin irritation: in-vitro testing resulted in no irritiating potential of zinc selenite
- eye irritation: in-vivo testing resulted in no irritating potential of zinc selenite to eyes
- respiratory irritation: no reliable studies directly relating to respiratory irritation are available for zinc selenite; based on the absence of skin and eye irritation, the absence of strong pH effects and the absence of any human data indicating concern, zinc selenite is not considered to be irritating to the respiratory tract

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

General

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-vitro skin irritation and in-vivo eye irritation testing has been performed since no reliable literature data are available on irritating properties of zinc selenite.

Skin irritation:

The test method based on the EPISKIN™ assay allows the prediction of both irritant and non-irritant substances and can thus be considered as a standalone method to be used as replacement for the animal test. The test method, OECD Guideline for the Testing of Chemicals, Draft Proposal for a New Guideline, In Vitro Skin Irritation: Reconstructed Human Epidermis (RhE) Test Method, 9 September 2009, 3rd WNT circulation, Vers. 7, has been finalised as OECD guideline No. 439 on 22 July 2010. Guideline No. 439 may be used to determine the skin irritancy of chemicals as a stand-alone replacement test for in vivo skin irritation testing.

Eye irritation:

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

Respiratory irritation:

In the acute toxicity inhalation study (Leuschner_2010) the gross pathological changes were recorded for each animal with particular attention to any changes in the respiratory tract. However, no abnormalities were detected at necropsy. No further reliable studies on respiratory irritation are available for zinc selenite. Zinc selenite is also not irritating to skin and eyes and does not show a strong pH-effect upon dissolution in aqueous media. There are also no human data available indicating any concern for respiratory irritation of zinc selenite. Thus, there are no indications that the substance is a respiratory irritant.

Justification for classification or non-classification

Both tests showed a negative responses, thus zinc selenite does not require classification either as skin or as eye irritant.

Skin irritation:

Heppenheimer (2010): After treatment with the test item Zinc selenite the relative absorbance values were decreased to 78.6%. This value is above the threshold for irritancy of ≤ 50%. Therefore, the test item is not considered to possess an irritant potential.

Hence no classification as "skin irritant" is required for zinc selenite according to regulation (EC) No. 1272/2008 and subsequent regulations.

Eye irritation:

Leuschner (2010): Conjunctival redness (grade 1) was observed in all animals 1 hour after instillation. Chemosis(grade 1) was observed in animal no. two 1 hour after instillation. In addition, secretion was observed in all animals 1 hour after instillation. The corneae and the irises were not affected by instillation of the test item. The fluorescein test performed 24 hours after instillation did not reveal any changes. There were no systemic intolerance reactions. Zinc selenite was non-irritating to eyes. The classification criteria according to regulation (EC) No. 1272/2008 and subsequent regulations as "irritating to eyes" are not met for Zinc selenite. Hence no classification for causing eye damage or eye irritation is required.

Respiratory irritation:

In the acute toxicity inhalation study (Leuschner_2010) the gross pathological changes were recorded for each animal with particular attention to any changes in the respiratory tract. However, no abnormalities were detected at necropsy. No further data are available for respiratory irritation of zinc selenite. Zinc selenite is also not irritating to skin and eyes and does not show a strong pH-effect upon dissolution in aqueous media. There are also no human data available indicating any concern for respiratory irritation of zinc selenite. Thus, there are no indications that the substance is a respiratory irritant. Classification as a respiratory irritant is not required.