Registration Dossier

Administrative data

Description of key information

No irritation/corrosion to skin or eye was observed in the conducted studies with Tellurium. Furthermore no irritation was reported in an acute inhalation study with tellurium powder. 

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

Skin irritation:

In a study conducted according to OECD guideline 439 in-vitro skin irritation of Tellurium was tested using the EPISKIN model.

Following exposure with Tellurium, the mean relative viability of epidermis was 103 %. All validity criteria were within acceptable limits and therefore the study can be considered as valid.

In conclusion results indicate that Tellurium can be considered to be non-irritating.

Eye irritation:

An in vitro eye irritation study of the test item Tellurium was performed in isolated chicken’s eyes (OECD guideline 438). The irritation effects of the test item were evaluated according to the OECD No.: 438 (07th September 2009).

In this in vitro eye irritation study in the Isolated Chicken Eyes model with Tellurium, the results suggest that the test item is not a severe eye irritant, all scores were zero. Tellurium remained adhered to the cornea surface after the post-treatment rinse.


Justification for selection of skin irritation / corrosion endpoint:
In an in vitro skin irritation study according to OECD 439 (Human Skin Model Test) Tellurium was found to be not irritating to the human skin.

Justification for selection of eye irritation endpoint:
In an in vitro "Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants" according to OECD 438, Tellurium was proven to be non-corrosive and/or not severe irritanting.

Justification for classification or non-classification

Skin irritation:

According to the CLP Regulation (EU GHS Regulation (EC) No 1272/2008) no classification and labelling is required for skin irritation of tellurium, based on reliable data from an in-vitro study according to OECD 439 (Human Skin Model Test). The mean relative viability of epidermis is well below the threshold for irritancy of ≤ 50%, for Tellurium, the mean relative viability of epidermis was 103 %.

The method is approved by international regulatory agencies as a replacement for the identification of irritants / corrosives in the in vivo Rabbit skin assay (OECD 404).

Eye irritation:

In an in vitro study conducted according to OECD Guideline no. 438, (2009), the observed scores for Tellurium in the study were all zero for maximum corneal swelling (up to 75 and 240 min), corneal opacity and fluorescein retention.

This corresponds to ICE class I for all parameters.

The absence of severe eye irritation is proven in the study and no classification and labelling for severe eye irritation according to CLP Regulation (EU GHS Regulation (EC) No 1272/2008) is required.

The ICE test method was re-evaluation by international regulatory agencies and the OECD guideline 438 was adopted (26 July 2013), mainly with respect to applicability domain for classification.

Now the use of the ICE test method is also recommended to identify chemicals that do not require classification for eye irritation or serious eye damage as defined by the UN GHS (No Category, NC).

The ICE test method is therefore suitable to be used as an initial step within a Bottom-Up testing strategy approach and negative results can be used for classification purposes.

In conclusion no classification and labelling for eye irritation according to CLP Regulation (EU GHS Regulation (EC) No 1272/2008) is required.