Registration Dossier

Administrative data

Description of key information

  • In an in-vitro skin irritation study according to OECD 439 (Human Skin Model Test), sodium selenate was found to be irritating to the human skin.
  • In an in-vitro skin irritation study according to OECD 431 (Human Skin Model Test), sodium selenate was found to be non-corrosive to the human skin.
  • In an in-vitro Bovine corneal opacity and permeability test for identifying ocular corrosives and severe irritants accodring to OECD 437, sodium selenate was found to be non-corrosive and/or no eye irritant.

All studies are GLP-compliant and of high quality (Klimisch 1).

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

Two in vitro studies were conducted with Sodium selenate using the human skin model EpiDermTM.

One study was conducted according to OECD guideline 439 to evaluate skin irritating effects. After the treatment with 25 mg of the solid test item Sodium selenate for 60 minutes, the relative absorbance values were reduced to 4.5 %. This value is well below the threshold for irritation potential (50 %). Therefore, Sodium selenate is considered as irritant in the Human Skin Model Test.

In the second study conducted according to OECD guideline 431 tissues of the human skin model EpiDerm™ were treated with 25 mg of the solid test item Sodium selenate for three minutes and one hour, respectively. After three minutes treatment with the test item, the relative absorbance values were reduced to 88.8 %. This value is well above the threshold for corrosion potential (50 %). After one hour treatment, relative absorbance values were reduced to 79.2 %. This value, too, is well above the threshold for corrosion potential (15 %).

Therefore, Sodium selenate is considered as not corrosive in the Human Skin Model Test.

 

Eye irritation:

An in vitro study was conducted according to OECD guideline 437 and EU method B.47, Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants.

Bovine corneas were used. The test item was incubated on the cornea for 4 hours at 32 ± 1 °C. The test item Sodium selenate showed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 0.133. Under the experimental conditions reported, the test item Sodium selenate possesses no eye irritation potential (according to ICCVAM).

According to OECD Guideline no. 437 (2013), a substance that induces an IVIS ≤3 does not require classification for eye irritation or serious eye damage (UN GHS No Category).

Respiratory irritation:

Potential test item-related macroscopic findings were in the lungs were reported in the acute inhalation study with sodium selenate.

Justification for classification or non-classification

Skin irritation:

According to the CLP Regulation (EU GHS Regulation (EC) No 1272/2008) classification and labelling is required for skin irritation (Cat. 2 H312) of sodium selenate, 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 above the threshold for irritancy of ≤ 50%. 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). Sodium selenate is reported to be non-corrosive in an OECD 431 guideline study.

Eye irritation:

The test item Sodium selenate showed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 0.133. Under the experimental conditions reported, the test item Sodium selenate possesses no eye irritation potential (according to ICCVAM). According to OECD Guideline no. 437 (2013), a substance that induces an IVIS ≤3 does not require classification for eye irritation or serious eye damage (UN GHS No Category)

Based on the complete absence of irritating effects observed in the study and corresponding the ICCVAM classification, sodium selenate is considered to be non irritating to the eye and no classification is needed.

Respiratory irritation:

Potential test item-related macroscopic findings were in the lungs were reported in the acute inhalation study with sodium selenate.